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IMPROVING PREDICTABILITY AND TRANSPARENCY 

IN DEA AND FDA REGULATION 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRTEENTH CONGRESS 

SECOND SESSION 

APRIL 7, 2014 

Serial No. 113–137 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

RALPH M. HALL, Texas 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

BEN RAY LUJAN, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

SUBCOMMITTEE ON HEALTH

JOSEPH R. PITTS, Pennsylvania 

Chairman 

MICHAEL C. BURGESS, Texas 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

RENEE L. ELLMERS, North Carolina 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

JOHN D. DINGELL, Michigan 

ELIOT L. ENGEL, New York 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

GENE GREEN, Texas 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

HENRY A. WAXMAN, California (ex officio) 

(II) 

(III) 

C O N T E N T S 

Page 

Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 1 

Prepared statement .......................................................................................... 44 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 45 

Hon. John D. Dingell, a Representative in Congress from the State of Michigan, opening statement ....................................................................................... 47 

Hon. Fred Upton, a Representative in Congress from the State of Michigan, 

opening statement ................................................................................................ 47 

Prepared statement .......................................................................................... 48 

Hon. Marsha Blackburn, a Representative in Congress from the State of 

Tennessee, opening statement ............................................................................ 48 

Prepared statement .......................................................................................... 66 

Hon. Ed Whitfield, a Representative in Congress from the Commonwealth 

of Kentucky, opening statement ......................................................................... 67 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, opening statement .................................................................................... 67 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, opening statement ............................................................................. 68 

WITNESSES

Janet Woodcock, Director, Center for Drug Evaluation and Research, Food 

and Drug Administration, Department of Health and Human Services ......... 69 

Prepared statement .......................................................................................... 72 

Answers to submitted questions ...................................................................... 184 

Joseph T. Rannazzisi, Deputy Assistant Administrator, Office of Diversion 

Control, Drug Enforcement Administration, Department of Justice ............... 80 

Prepared statement .......................................................................................... 82 

Answers to submitted questions ...................................................................... 194 

Nathan B. Fountain, Chair, Professional Advisory Board, Epilepsy Foundation of America ..................................................................................................... 122 

Prepared statement .......................................................................................... 126 

John M. Gray, President and Chief Executive Officer, Healthcare Distribution 

Management Association ..................................................................................... 134 

Prepared statement .......................................................................................... 136 

D. Linden Barber, Partner and Director, DEA Compliance and Litigation 

Practice, Quarles & Brady, LLP ......................................................................... 141 

Prepared statement .......................................................................................... 143 

Answers to submitted questions ...................................................................... 212 

Wendy K.D. Selig, President and Chief Executive Officer, Melanoma Research 

Alliance ................................................................................................................. 155 

Prepared statement .......................................................................................... 157 

Scott Faber, Senior Vice President for Government Affairs, Environmental 

Working Group ..................................................................................................... 163 

Prepared statement .......................................................................................... 165 

SUBMITTED MATERIAL

H.R. 4069, the Ensuring Patient Access and Effective Drug Enforcement 

Act of 2013, submitted by Mr. Pitts ................................................................... 2 

H.R. 4250, the Sunscreen Innovation Act, submitted by Mr. Pitts ..................... 15 

H.R. 4299, the Improving Regulatory Transparency for New Medical Therapies Act, submitted by Mr. Pitts ......................................................................... 41 

Page

IV 

Letter of April 7, 2014, from Gina F. Adams, Corporate Vice President, 

Government Affairs, FedEx Corporation, to Mr. Upton, et al., submitted 

by Mrs. Blackburn ................................................................................................ 50 

Statement of April 7, 2014, by the National Association of Chain Drug Stores, 

submitted by Mrs. Blackburn ............................................................................. 51 

Letter of April 7, 2014, from Alliance to Prevent the Abuse of Medicines 

to Hon. Tom Marino and Mrs. Blackburn, submitted by Mrs. Blackburn ...... 64 

Letter of April 4, 2014, from Brett M. Coldiron, President, American Academy 

of Dermatology Association to Mr. Pitts and Mr. Pallone, submitted by 

Mr. Whitfield ........................................................................................................ 108 

Letter of April 7, 2014, from Bill Piper, Director, Office of National Affairs, 

Drug Policy Alliance, to Mr. Pitts and Mr. Pallone, submitted by Mr. 

Pallone .................................................................................................................. 120 

Statement of April 7, 2014, by the Global Healthy Living Foundation, submitted by Mr. Pitts .............................................................................................. 182 

(1) 

IMPROVING PREDICTABILITY AND TRANSPARENCY IN DEA AND FDA REGULATION 

MONDAY, APRIL 7, 2014 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON HEALTH, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 3:00 p.m., in room 

2123, Rayburn House Office Building, Hon. Joseph R. Pitts (chairman of the subcommittee) presiding. 

Members present: Representatives Pitts, Burgess, Whitfield, 

Shimkus, Murphy, Blackburn, Lance, Griffith, Bilirakis, Ellmers, 

Upton (ex officio), Pallone, Dingell, Green, Barrow, and Waxman 

(ex officio). 

Staff present: Clay Alspach, Chief Counsel, Health; Gary Andres, 

Staff Director; Noelle Clemente, Press Secretary; Paul Edattel, Professional Staff Member, Health; Sydne Harwick, Legislative Clerk; 

Robert Horne, Professional Staff Member, Health; Carly 

McWilliams, Professional Staff Member, Health; Heidi Stirrup, Policy Coordinator, Health; John Stone, Counsel, Health; Ziky 

Ababiya, Democratic Staff Assistant; Eric Flamm, Democratic FDA 

Detailee; Elizabeth Letter, Democratic Press Secretary; Karen 

Lightfoot, Democratic Communications Director and Senior Policy 

Advisor; and Karen Nelson, Democratic Deputy Staff Director, 

Health. 

Mr. PITTS. The subcommittee will come to order. 

The Chair will recognize himself for an opening statement. 

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF PENNSYLVANIA 

Today’s legislative hearing focuses on three bills designed to improve the predictability and transparency in Drug Enforcement Administration and Food and Drug Administration regulation. 

H.R. 4069, the Ensuring Patient Access and Effective Drug Enforcement Act, introduced by Representatives Marino and 

Blackburn, will facilitate greater collaboration between industry 

stakeholders and regulators in an effort to combat our Nation’s prescription drug abuse epidemic. 

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Mr. PITTS. H.R. 4250, the Sunscreen Innovation Act, introduced 

by Representatives Whitfield and Dingell, seeks to expedite the 

FDA’s approval process for active ingredients in sunscreens that 

have long been approved for use in places like Europe, Canada, and 

other countries to ensure that U.S. consumers have access to the 

safest, most effective sunscreens available. 

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Mr. PITTS. And H.R. 4299, the Improving Regulatory Transparency for New Medical Therapies Act, which Ranking Member 

Pallone and I introduced. 

Mr. Pallone and I introduced H.R. 4299, which seeks to improve 

the transparency and consistency of DEA’s scheduling of new FDAapproved drugs under the Controlled Substances Act, CSA, and its 

registration process for manufacturing controlled substances for 

use in clinical trials. Ultimately, this will allow new and innovative 

treatments to get to patients who desperately need them faster. It 

now takes on average well over a billion dollars and 14 years from 

the time a drug is discovered to the time of approval. 

[The information follows:] 

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42 

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Mr. PITTS. This committee has taken steps to provide more 

transparency and consistency in the drug approval process through 

the Prescription Drug User Fee Program and a commitment to review goals imbedded in the PDUFA agreements. However, drugs 

that contain substances that have not been previously marketed in 

the United States and that have abuse potential must also be 

scheduled under the CSA by the DEA before they can begin marketing their product. But under the CSA, there is no deadline for 

the DEA to make a scheduling decision, and the delays in DEA decisions have increased nearly fivefold since the year 2000. This lack 

of predictability in the timing of DEA’s scheduling decisions leads 

to unnecessary uncertainty in the drug development process and 

needless delays in patients’ access to new therapies. 

H.R. 4299 simply requires the DEA to issue an interim final rule 

45 days after it receives FDA’s scheduling recommendation for a 

new drug, allowing patients access to new therapies 45 days after 

FDA approval. DEA would retain its authority to subsequently 

transfer the drug between schedules under the Section 201 of the 

CSA. 

This bill also establishes a timeline for DEA to grant approval 

of manufacturers’ applications to register controlled substances not 

yet approved by FDA to be used in clinical trials, allowing companies to properly plan clinical trial schedules for prospective new 

therapies. This provision will get products to the market faster because innovators will be able to get clinical trials under way in a 

timely and predictable way, which is critical to drug developers and 

patients alike. 

H.R. 4299 requires that if the DEA has not made a final decision 

on whether to approve a registration application for products in the 

investigational new drug, IND, phase within 180 days of submission of the application, then the DEA shall provide notice to the applicant on the outstanding issues that must be resolved in order to 

reach a final decision and an estimated date on which a final decision on the registration application will be made. 

Such a solution does not force the DEA to make a particular decision but will provide transparency to the process so companies can 

better plan when regulatory decisions will be made. 

I would like to thank all of our witnesses for being here today. 

I look forward to having a constructive discussion on these legislative proposals. These bills touch on very important issues for this 

committee, and they offer and excellent starting point for finding 

solutions. 

[The prepared statement of Mr. Pitts follows:] 

PREPARED STATEMENT OF HON. JOSEPH R. PITTS

Today’s legislative hearing focuses on three bills designed to improve the predictability and transparency in Drug Enforcement Administration (DEA) and Food and 

Drug Administration (FDA) regulation: 

• H.R. 4069, the Ensuring Patient Access and Effective Drug Enforcement Act, introduced by Reps. Marino and Blackburn, will facilitate greater collaboration between industry stakeholders and regulators in an effort to combat our Nation’s prescription drug abuse epidemic; 

• H.R. 4250, the Sunscreen Innovation Act, introduced by Reps. Whitfield and 

Dingell, seeks to expedite the FDA’s approval process for active ingredients in sunscreens that have long been approved for use in places like Europe, Canada, and 

45 

other countries to ensure that U.S. consumers have access to the safest, most effective sunscreens available; and • H.R. 4299, the Improving Regulatory Transparency for New Medical Therapies 

Act, which Ranking Member Pallone and I introduced. 

Mr. Pallone and I introduced H.R. 4299 seeks to improve the transparency and 

consistency of DEA’s scheduling of new FDA-approved drugs under the Controlled 

Substances Act (CSA), and its registration process for manufacturing controlled substances for use in clinical trials. Ultimately, this will allow new and innovative 

treatments to get to patients who desperately need them faster. 

It now takes, on average, well over a billion dollars and 14 years from the time 

a drug is discovered to the time of approval. This committee has taken steps to provide more transparency and consistency in the drug approval process through the 

Prescription Drug User Fee program and a commitment to review goals embedded 

in the PDUFA agreements. 

However, drugs that contain substances that have not been previously marketed 

in the United States and that have abuse potential must also be scheduled under 

the CSA by the DEA before they can begin marketing their product. 

But, under the CSA, there is no deadline for the DEA to make a scheduling decision, and the delays in DEA decisions have increased nearly five-fold since 2000. 

This lack of predictability in the timing of DEA scheduling decisions leads to unnecessary uncertainty in the drug development process and needless delays in patients’ access to new therapies. 

H.R. 4299 simply requires DEA to issue an Interim Final Rule 45 days after it 

receives FDA’s scheduling recommendation for a new drug, allowing patients access 

to new therapies 45 days after FDA approval. 

The DEA would retain its authority to subsequently transfer the drug between 

schedules under the Section 201 of the CSA. 

This bill also establishes a timeline for DEA to grant approval of manufacturers’ 

applications to register controlled substances, not yet approved by FDA, to be used 

in clinical trials, allowing companies to properly plan clinical trial schedules for prospective new therapies. 

This provision will get products to the market faster because innovators will be 

able to get clinical trials underway in a timely and predictable way; which is critical 

to drug developers and patients alike. 

H.R. 4299 requires that if the DEA has not made a final decision on whether to 

approve a registration application for products in the investigational new drug 

(IND) phase within 180 days of submission of the application, then the DEA shall 

provide notice to the applicant on the outstanding issues that must be resolved in 

order to reach a final decision, and, an estimated date on which a final decision on 

the registration application will be made. 

Such a solution does not force the DEA to make a particular decision but will provide transparency to the process so companies can better plan when regulatory decisions will be made. 

I would like to thank all of our witnesses for being here today, and I look forward 

to having a constructive discussion on these legislative proposals. These bills touch 

on very important issues for this committee and they offer an excellent starting 

point for finding solutions. 

Thank you. 

Mr. PITTS. I yield back the balance of my time and, at this point, 

recognize the ranking member, Mr. Pallone, 5 minutes for an opening statement. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. Thank you, Chairman Pitts. 

Today’s important hearing will examine a number of bills that 

aim to provide predictability and transparency for medicines and 

other products. 

This committee has an important balancing act it must play. As 

prescription drug abuse threatens the safety and health of too 

many people in this country, we must find ways to combat this 

growing public health epidemic. At the same time as we examine 

46 

different policies to address this issue, we must also ensure patient 

access to necessary medications. We all agree that the Food and 

Drug Administration, the FDA, and the Drug Enforcement Agency, 

the DEA, have critical missions. 

FDA ensures that innovative medicines and other products are 

safe and effective, while the DEA safeguards our communities from 

illegal and diverted drugs. Once the FDA approves a drug, the 

DEA’s role is to utilize the scheduling process under the Controlled 

Substances Act, which helps them to keep the medicine in the 

hands of those who need them and away from criminals and abusers who aim to break the law or, in some unfortunate cases, abuse 

these drugs. 

While both agencies typically work independently, it is important 

that their authorities and actions work in a complimentary way. 

There is no question that DEA has an important role in combatting 

drug abuse, but there must be some recognition by DEA of the legitimate therapies that improve the public health. 

One of the bills under consideration today is one that I am proud 

to sponsor with Chairman Pitts. H.R. 4299, the Improving Regulatory Transparency For New Medical Therapies Act, aims to improve the DEA’s scheduling process for new FDA approved drugs 

under the Controlled Substances Act and the registration process 

for the use of controlled substances in clinical trials. In recent 

years, this committee has worked successfully to improve review of 

new medications. Without weakening FDA oversight, we have 

given manufacturers and patient groups a more predictable process 

allowing patients to get timely access to the latest innovation 

therapies available. 

But unfortunately, when a medicine has abuse potential, the 

DEA’s authorities under the Controlled Substances Act are hindering this progress. Specifically the draft bill would require DEA 

to make a final determination 45 days after receiving FDA’s scheduling recommendation for a new drug. Additionally, it would generate more transparency in the application process for clinical 

trials by requiring the DEA make a final determination within 180 

days or provide the applicant with details about what outstanding 

issues remain unresolved. I hope we can better understand today 

what is happening at the DEA and find ways to address it. 

In addition today, we will examine H.R. 4069, the Ensuring Patient Access and Effective Drug Enforcement Act, introduced by 

Representatives Blackburn and Marino. The bill aims to improve 

and better coordinate enforcement efforts within the drug supply 

chain regarding prescription drug diversion and abuse. It also aims 

to curtail unnecessary supply chain disruptions that may be affecting patient access to needed medications. 

And lastly, we will hear from our witnesses about H.R. 4250, the 

Sunscreen Innovation Act, introduced by Representatives Whitfield 

and Dingell. Skin cancer is the most common cancer in the U.S., 

and one in five Americans will develop skin cancer in their lifetime. 

Research has shown that sunscreen helps reduce the risk of skin 

cancer and is essential to protecting the public. However, to date, 

the FDA has not approved a new sunscreen ingredient in nearly 

two decades. This is a real issue that needs to be addressed, and 

I am hopeful we can all work together to establish a process that 

47 

promotes the timely review of sunscreen ingredients while ensuring 

consumer safety and product efficacy. 

So I want to thank all of our witnesses here today. 

Dr. Woodcock, I don’t know, is this the second time in 2 weeks? 

And I look forward to your comments. 

I would like to yield the remainder of my time to Mr. Dingell, 

who is the lead sponsor, Democratic sponsor, of H.R. 4205. 

OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. DINGELL. Mr. Chairman, I thank the gentleman, and I thank 

you and commend you for this hearing. 

I am particularly grateful to the gentleman from New Jersey for 

his courtesy to me. I ask unanimous consent that my remarks be 

extended in the record. 

And I would like to address H.R. 4250 and particularly with my 

concerns as they might exist with regard to Food and Drug. There 

is no reason why a piece of legislation like this is necessary after 

10 years, and why it is that the Congress of the United States has 

not received the counsel of Food and Drug, that they have had need 

of legislation of this kind to address a serious problem like skin 

cancer. This is a great shame indeed. It is the kind of thing that 

causes distress on the part of the public, puts the public at risk, 

and puts them at risk of a particularly deadly form of cancer, 

which is one of the most frequently achieved levels of cancer and 

kinds of cancer in our society. 

Food and Drug did not come up here to talk to us about it. We 

think that this is legislation, which was crafted somewhat with and 

somewhat without the assistance of the Food and Drug Administration, but it would have been so much better had Food and Drug 

come up here with the legislation earlier on. 

I want to thank you for holding this hearing, Mr. Chairman. 

And I want to particularly thank my good friend Mr. Whitfield 

for his leadership and responsibility in this matter. I hope that we 

are going to have supportive testimony from Food and Drug and 

that the Food and Drug Administration will not let this kind of 

thing happen again. 

Thank you, Mr. Chairman. 

Mr. PITTS. The Chair thanks the gentleman. 

I now recognize the chairman of the full committee, Mr. Upton, 

for an opening statement. 

OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. UPTON. Thank you, Mr. Chairman. 

Today the subcommittee will hear testimony on what I think will 

be three bipartisan bills that address important problems facing 

the Nation. First, Chairman Pitts and Ranking Member Pallone 

are collaborating on H.R. 4299, the Improving Regulatory Transparency for New Medical Therapies Act. Their bill would provide 

more certainty among the Drug Enforcement Administration’s review of scheduling decisions for new drug products. 

48 

Second, Vice Chair of the Committee Marsha Blackburn is working with Representative Marino on H.R. 4069, the Ensuring Patient Access and Effective Drug Enforcement Act. This bill establishes a collaborative and coordinated approach to the prescription 

drug abuse crisis that certainly is plaguing our local communities 

across the country. And finally, we are going to be discussing H.R. 

4250, which is cosponsored by Ed Whitfield and Mr. Dingell. Everyone does seem to agree that the current system for approving sunscreen ingredients is broken. It is long overdue that we find a solution to the current backlog of sunscreen ingredients pending at the 

FDA, and this bill does it. I want to commend my colleagues for 

working together to develop these legislative solutions. We have 

had a strong record of bipartisan success this Congress in our work 

to improve public health, and these bills further that effort. 

[The prepared statement of Mr. Upton follows:] 

PREPARED STATEMENT OF HON. FRED UPTON

Today the subcommittee will hear testimony on three bills that address important 

problems facing our country. 

First, Chairman Pitts and Ranking Member Pallone are collaborating on H.R. 

4299, the ‘‘Improving Regulatory Transparency for New Medical Therapies Act.’’ 

Their bill would provide more certainty around the Drug Enforcement Administration’s review of scheduling decisions for new drug products. 

Second, Marsha Blackburn, vice chair of the committee, is working with Representative Marino on H.R. 4069, the ‘‘Ensuring Patient Access and Effective Drug 

Enforcement Act.’’ The bill would help establish a collaborative and coordinated approach to the prescription drug abuse crisis that is plaguing our local communities 

across the country. 

Finally, today we will discuss H.R. 4250, which is co-sponsored by Ed Whitfield 

and John Dingell. Everyone seems to agree that the current system for approving 

sunscreen ingredients is broken. This bill would help provide a solution to the current backlog of sunscreen ingredients pending at the FDA. 

I want to commend my colleagues for working together to develop these legislative 

solutions. We look forward to working in a bipartisan manner to perfect them so 

we can move them swiftly through the legislative process. 

We have had a strong record of bipartisan success this Congress in our work to 

improve public health, and these bills further our efforts. 

Thank you for holding this hearing. 

Mr. UPTON. And I yield the balance of my time to Ms. Blackburn. 

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE 

Mrs. BLACKBURN. I thank the chairman for yielding, and Mr. 

Pitts for the hearing. 

And, yes, I have worked with Congressman Marino; 4069 is a 

piece of legislation that we have put some effort into to come up 

with the Ensuring Patient Access and Effective Drug Enforcement 

Act. And there is a necessity to clarify a couple of definitions and 

provide some certainty and some consistency. We will talk more 

about that. 

And Mr. Chairman, I would like to submit my full statement to 

the record. 

Mr. PITTS. Without objection. 

Mrs. BLACKBURN. And also three letters of support for our legislation, one from FedEx, another National Association of Chain 

49 

Drug stores, and then also the Alliance to Prevent Abuse of Medications. 

Mr. PITTS. Without objection, so ordered. 

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Mrs. BLACKBURN. And I appreciate that so much. 

Congressman Marino and I are working to clarify the two 

phrases, ‘‘consistent with public health and safety,’’ and how that 

corresponds to substantial relationship to preventing diversion and 

abuse of controlled substances, and further define ‘‘imminent danger’’ by providing clarification and harmonizing the CSA with other 

statutes using the imminent danger standard, such as the Federal 

Mines Safety and Health Act. And these definitions do matter. We 

all realize that. 

We are also interested in moving forward with the prescription 

drug abuse working group, which would give Government, public 

policy, and industry the ability to collaborate and provide recommendations to Congress on initiatives to reduce prescription 

drug diversion and abuse. 

This is an issue that has grown to epidemic proportions in our 

country, and we had about 27,000 unintentional drug overdose 

deaths which occurred in the U.S. during 2007 and a number that 

has increased fivefold since 1990. 

[The prepared statement of Mrs. Blackburn follows:] 

PREPARED STATEMENT OF HON. MARSHA BLACKBURN

Prescription drug abuse is an epidemic that is killing tens of thousands of Americans each year. 

According to the Centers for Disease Control and Prevention (CDC), approximately 27,000 unintentional drug overdose deaths occurred in the United States 

during 2007—a number that has increased five-fold since 1990. 

This is a problem that’s greatly in need of a solution. However, simply acknowledging the epidemic of prescription drug abuse isn’t enough. 

There needs to be a clear distinction between the legitimate pharmaceutical supply chain that directly serves patients and the criminals who are diverting and selling illegal drugs. Supply chain stakeholders need further guidance on how to collaborate more effectively with law enforcement. Stated simply, their obligation to 

prevent diversion is only achievable if the DEA and other regulators will work with 

them to get it done. 

I believe these stakeholders—physicians, pharmacies, and distributors who want 

to do the right thing—stand ready to work with law enforcement in combating prescription drug abuse. 

That’s why I worked with my colleague Congressman Tom Marino in crafting, 

H.R. 4069, the Ensuring Patient Access and Effective Drug Enforcement Act of 

2014. 

Our legislation clarifies two definitions within the Controlled Substances Act 

(CSA) which is essential to providing a clear path forward for enforcement agencies. 

We specify that the phrase ‘‘consistent with the public health and safety’’ corresponds to a ‘‘substantial relationship to .preventing diversion and abuse of controlled substances.’’ 

We also further define ‘‘imminent danger’’ by providing clarification and harmonizing the CSA with other statutes using the ‘‘imminent danger’’ standard such as 

the Federal Mine Safety and Health Act. 

Why do definitions matter? Because Congress—this subcommittee—has a responsibility to make sure the law is crystal clear for both DEA and legitimate businesses 

who want to understand what the rules are so they can do the right thing. Our job 

is to make sure they’re on the same page. 

We also expect industry to step up and do more to minimize the risk of diversion. 

To protect the integrity of the distribution system, we require criminal background 

checks and drug testing for employees of distributors who have access to controlled 

substances. I should note that we are continuing to work with the interested parties 

to make sure that provision is narrowly crafted to achieve the right policy objective. 

Lastly, we establish a Prescription Drug Abuse Working Group which will give 

Government, public policy and industry the ability to collaborate and provide recommendations to Congress on initiatives to reduce prescription drug diversion and 

abuse. 

67 

I’ve said many times since I took the lead on this issue over 2 years ago that on 

this one, the tragic prescription drug abuse epidemic in America, we are all in this 

together. And that’s where Congressman Marino and I are coming from with this 

bill. A bill which already has the support of three former United States Attorneys 

now in Congress, including Mr. Marino. 

I thank Chairman Pitts for holding this hearing this afternoon, and I look forward 

to working with my colleagues and our witnesses today on bringing an effective solution to this growing epidemic. I yield back. 

Mrs. BLACKBURN. At this time, I yield the balance of my time to 

Mr. Whitfield. 

OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF KENTUCKY 

Mr. WHITFIELD. Thank you very much. 

FDA has not expanded its approval list of sunscreen ingredients 

since 1999, even though many innovative products have been used 

safely for years abroad. In fact, there are eight pending applications, all of which have been used in other parts of the world. Some 

of them have been under the process of being scrutinized for 12 

years. 

That is why we have introduced the Sunscreen Innovation Act, 

Mr. Dingell and others, and we look forward to working with FDA 

because we need to pass legislation to make sure that this process 

is speeded up in some way, and I yield the balance of the time to 

the gentleman from Texas, Mr. Burgess. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. I thank the gentleman for yielding the time. 

Glad to have both the FDA and the DEA here today. Time is 

short. Let me confine my observations to the Drug Enforcement 

Administration. I am hearing that manufacturers and distributors 

are having a difficult time working with your agency. They say the 

relationship is not collaborative. It is one where intimidation and 

lack of communication is all too common. I am willing to work with 

anyone to close loopholes to target bad actors and even propose 

policies that might raise the ire of those in my party, but I will not 

sit by while patients cannot access lawfully prescribed medication. 

No doctor, no wholesaler, no pharmacist, should live in fear that 

in their attempt to alleviate human suffering, they are likely to be 

put out of business. 

I understand your mission, but I want to know that you have a 

strong voice for patients, for providers, and I want you to know the 

effect that you have. It is necessary to enter conversations on everything from the scheduling of certain drugs to prescribing drug 

abuse with an interactive perspective. 

No one should stand down in the face of bullying, aggressive and 

narrow-minded tactics. 

Thank you, Mr. Chairman. I will now yield back the balance of 

my time. 

Mr. PITTS. The Chair thanks the gentleman. 

I will now recognize the ranking member, Mr. Waxman, for 5 

minutes of opening statement. 

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OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Mr. WAXMAN. Thank you, Chairman Pitts, for holding this hearing today. 

Today’s hearing focuses on three bills, all addressing important 

issues. Mr. Marino and Mrs. Blackburn’s bill, H.R. 4069, makes 

changes to the Controlled Substances Act that will help drug distributors and others work with the DEA to keep controlled substance prescription drugs out of the hands of drug abusers. It also 

will help them avoid inappropriately limiting legitimate access to 

these same drugs by patients who need them. Achieving that balance is a difficult challenge. I will be interested to learn DEA’s 

views on the bill. 

Mr. Pitts and Mr. Pallone’s bill, H.R. 4299, would speed up DEA 

decisions on scheduling new FDA approved drugs containing controlled substances so they could get to patients more quickly. It 

also would speed up the DEA registration process, allowing the 

manufacture and distribution of controlled substances for use only 

in clinical trials. It is aiming to address a problem faced by those 

with epilepsy and other patients, the delay in getting a new FDA 

approved controlled substance medication to patients in need. I 

think their bill could make a significant contribution to solving this 

problem, and I applaud them for introducing it. 

DEA’s mission and focus is combatting drug abuse. I applaud its 

work in that area. At the same time, we need to find a way for new 

FDA-approved controlled substance medicines to get to patients 

who need them more quickly, and I hope DEA shares that goal and 

will work with the committee to achieve it. 

Mr. Whitfield and Mr. Dingell’s bill, H.R. 4250, aims to speed up 

FDA’s regulatory decisions on sunscreens that have been marketed 

in other countries for at least 5 years. Sunscreens are an important 

tool in lowering the risk of skin cancer. Skin cancer is the most 

common cancer in the United States, and its incidence continues to 

grow. Melanoma, the deadliest kind, kills over 9,000 Americans a 

year. One way to prevent skin cancer is to minimize exposure to 

UV rays. 

I have had a long interest in this issue. I have been working with 

Chairman Upton to protect teenagers from the dangers of sun 

lamps. Getting better sunscreens to market and increasing sunscreen use is another critical element in the fight against skin cancer. We need a regulatory system that enables safe and effective 

sunscreens to make it to the market in a reasonable amount of 

time. Under our current system, sunscreen applications have been 

languishing for 5 to 10 years. I don’t think anyone could call that 

a reasonable amount of time. 

Mr. Whitfield and Mr. Dingell, working with the PASS Coalition, 

have made a good faith effort to come up with a bill that would 

help FDA reach decisions in a timely fashion on such sunscreen applications. I strongly support those efforts. However, I do have concerns with a number of elements of the bill, most notably the bill 

effectively cedes FDA’s jurisdiction to an advisory committee. If the 

advisory committee recommends approval, the approval goes into 

effect, unless FDA rejects it within 45 days, and even then, the 

69 

burden is on FDA to justify its decision not to accept the recommendation. I think this would be a bad precedent. 

I applaud the bill’s sponsors and the PASS Coalition for working 

on this issue and developing a bill for us to consider. That alone 

is a step forward. I share the goal of having an FDA review process 

that enables safe and effective sunscreens to get to market as 

quickly as possible. I recognize that the current system does not 

achieve that goal. I hope FDA will commit to work with the committee and with the coalition and other stakeholders to reach that 

goal. 

I look forward to the hearing today and, while I may not be here 

all of the time, to reviewing the testimony from our witnesses. 

Thank you, Mr. Chairman. I would be happy to yield my time if 

anybody seeks it. If not, I yield it back. 

Mr. PITTS. The Chair thanks the gentleman. 

That concludes the opening statements. All members’ written 

opening statements will be submitted for the record. 

We have two panels before us today. On our first panel we have 

Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research of the U.S. Food and Drug Administration. 

Thank you again for coming to the subcommittee. 

And Mr. Joseph Rannazzisi, Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration. 

Your written testimony will be made part of the record. You will 

be each given 5 minutes to summarize. Thank you for coming 

today. 

And Dr. Woodcock, you are recognized for 5 minutes for your 

opening statement. 

STATEMENTS OF JANET WOODCOCK, DIRECTOR, CENTER FOR 

DRUG EVALUATION AND RESEARCH, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

SERVICES; AND JOSEPH T. RANNAZZISI, DEPUTY ASSISTANT 

ADMINISTRATOR, OFFICE OF DIVERSION CONTROL, DRUG 

ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE 

STATEMENT OF JANET WOODCOCK 

Ms. WOODCOCK. Thank you and good afternoon. 

I am Janet Woodcock, Director of the Center for Drug Evaluation 

and Research at FDA, and thank you for the opportunity to discuss 

important issues concerning sunscreen products. 

Now, as you know, manufacturers must have an approved new 

drug or abbreviated new drug application before they can market 

a drug in the United States, unless they have a drug that complies 

with an over-the-counter monograph. The monograph is a regulation that describes the conditions OTC drugs must meet. This allows these monograph products to be offered in many different configurations to the public without filing different applications. And 

this has been a very successful program. There are over 100,000 

products out there, OTC products out there, it is estimated, that 

are monograph products. And most sunscreens are marketed in the 

U.S. under the sunscreen monograph. 

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Now, the FDA must conclude that an ingredient is generally recognized as safe and effective for the condition of use if it is going 

to be put into a monograph. But the real world conditions of use 

and what is scientifically considered safe and effective can change 

over time. And by over time, I mean over decades of time. And in 

the 1970s, when examination of sunscreens began in the OTC drug 

review, they were used primarily on a seasonal basis to prevent 

sunburn. That is what sunscreens were thought to be for back in 

the day. And the Sunscreen Advisory Panel thought people would 

be exposed to these sunscreen active ingredients in modest 

amounts and for short intermittent time periods. And also the ingredients weren’t thought to get below the skin, so systemic exposure to these drugs was not a concern. This was before we had all 

the transdermal skin products that we have now—for hypertension 

and so forth—that are delivered through the skin. The advisory 

panel safety evaluation focused on ensuring that sunscreen products caused minimal skin irritation and sensitivity and then, on 

their efficacy, just that they prevented sunburn. 

Today people are urged to apply sunscreen in generous amounts 

and to reapply it frequently and to use it year round, resulting in 

exposure to the products that is massively greater than what was 

contemplated originally in the monograph. In addition, sunscreens 

are applied all over babies and children repeatedly as well to prevent them from the deleterious effects of the sun. 

There is increasing evidence, though, that some sunscreen ingredients are absorbed through the skin, and that leads to systemic 

exposures that are chronic, that have not previously been understood or anticipated. This shift in sunscreen use, together with advances in scientific understanding and our own safety evaluation 

methods have raised questions about what is needed to assure sunscreen safety. 

FDA has undertaken major actions on important sunscreen 

issues in the last several years. We have not been inactive. In 

2011, we published a regulation that updated efficacy testing and 

sunscreen labels. This put on what people are used to now the 

broad spectrum claim that we urge people to use to protect against 

various types of UV, and also it put information in the label about 

preventing skin cancer and about decreasing skin aging, so important information about the use of these sunscreens. 

We also issued a proposed rule with a maximum SPF value of 

50 plus for all sunscreen monograph products, and we put an advance notice of proposed rulemaking about additional information 

on the safety and effectiveness of various dosage forms, like sprays, 

that raise new concerns about flammability, for example, and inhalation. 

We have also been evaluating these Time and Extent Applications to add eight new ingredients to the sunscreen monograph. 

This process, established in 2002, provides a potential pathway for 

newer active ingredients. We recently sent sponsors letters on two 

of these applications, giving them feedback and noting that their 

record is insufficient to establish that they are safe for OTC sunscreen use. 

We will be holding a public meeting later this year to further 

clarify our thinking about safety testing for all OTC sunscreen 

71 

products. And given the expansion of sunscreen use and scientific 

advances since the OTC evaluation began, our evaluation must include potential endocrine or other effects from systemic absorption. 

Now this process has taken too long. I agree with that, and we 

really recognize the entire OTC monograph process is outdated, 

and about 2 weeks ago, we had a public hearing to discuss ways 

we might be able to modernize the process. 

In closing, the OTC monograph process that had historically been 

so successful is no longer really serving the needs of consumers, industry or the FDA. We have embarked on consideration of how to 

revise it to work in the current environment, and the problem with 

sunscreens is really a microcosm of the larger issues we have with 

the OTC monograph process. Thank you. 

[The prepared statement of Ms. Woodcock follows:] 

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Mr. PITTS. The Chair thanks the gentlelady. 

I now recognize Mr. Rannazzisi for 5 minutes for an opening 

statement. 

STATEMENT OF JOSEPH T. RANNAZZISI 

Mr. RANNAZZISI. Thank you, sir. 

Chairman Pitts, Ranking Member Pallone, distinguished members of the subcommittee, on behalf of Administrator Michele 

Leonhart and the men and women of the Drug Enforcement Agency, thank you for the opportunity to discuss today the drug scheduling process and the registration and verification suspension process. 

First, the DEA was not given the opportunity to comment when 

legislation that was pending before the subcommittee was drafted. 

The Department and the administration has not taken a position 

on the legislation. Therefore, I must emphasize that I am unable 

to discuss with you the specific details of the legislation. 

The Controlled Substances Act provides the DEA with the authority to administratively control substances with abuse potential. 

As fully explored in my written testimony, generally, the complexity and length of time to complete the scheduling process depends on many variables. There are two important points I will 

emphasize. 

With respect to newly approved medicines, the DEA initiates the 

scheduling process when it receives a recommendation from HHS. 

The DEA might receive the recommendation before or after the approval for marketing. One recent example I will share involves two 

similar medications that are indicated for epilepsy. The DEA completed the scheduling process in about the same time, 10 and 11 

months from the time we received the recommendation. However, 

in one instance, we received the recommendation 5 months before 

the drug was marketed—was approved for marketing. In the other 

instance, we received it 4 months after it was approved for marketing. The result was that one drug was controlled 6 months after 

market approval, and the other drug was controlled 14 months 

after market approval. The experience here is that the sooner DEA 

receives the recommendation to control, the closer to market approval a drug can be scheduled. 

The next point also concerns timing. Patent holders of recently 

approved medicines have paid fees to expedite their products 

through the market approval process, but that is not the process 

when it comes to scheduling. Like most Federal law enforcement 

agencies, DEA must prioritize resources to meet the threats and to 

accomplish the mission. Any perceived delays to control newly approved drugs in the past 3 years must be viewed as part of a bigger 

picture. 

In the 13 years from 1997 to 2010, the DEA controlled nine new 

pharmaceutical drugs and temporarily controlled four substances to 

avoid an imminent hazard to public safety, but in the last 3 years, 

DEA has controlled four new pharmaceutical drugs and 28 different synthetic drugs to avoid imminent hazard to public safety. 

To be sure, the additional responsibility to control 28 different synthetic drugs had an effect on the time to control new pharmaceuticals. 

81 

In 2010, designer drugs exploded in the retail market, resulting 

in serious injury and death across America. Faced with the responsibility to get these drugs off the retail shelves, the DEA had no 

choice but to control these substances as quickly as possible. The 

DEA acted to stop the imminent hazard these drugs caused, which 

in turn required significant resources. 

Another use of DEA’s administrative authorities to stop an imminent threat is the authority to immediately suspend a DEA registration. As a law enforcement agency with a regulatory function, 

the DEA has the authority to revoke a registration and also immediately suspend a registration that poses an imminent danger. In 

addition to revocation and immediate suspension, there are other 

nonpunitive actions available to DEA, including a letter of admonition or an informal hearing. 

From 2007 to 2013, the DEA issued approximately 5,500 letters 

of admonition and held approximately 118 informal hearings. This 

fiscal year to date, DEA issued less than 20 orders to show cause 

and immediate suspensions combined. When the DEA issues a 

show cause order, the registrant is afforded the opportunity to 

present his case at a formal hearing in front of a neutral fact finder 

before any action may be taken. An immediate suspension is authorized during the pendency of the show cause proceeding and is 

effective immediately. Immediate suspensions are by law reserved 

for those entities that are an imminent danger to public health and 

safety. 

The DEA’s administrative enforcement authorities are important 

tools in DEA’s arsenal to ensure compliance, deter and prevent diversion, and ensure that every registration is within the public interest. Without these administrative tools, civil and criminal sanctions would increase, and it would be tremendously more difficult 

to protect the public health and safety from the diversion of pharmaceutically controlled substances. 

In closing, I would like to comment on other testimony that the 

subcommittee will hear today. Some of the witnesses may assume 

to advocate on behalf of DEA, representing that they believe new 

legislation will help DEA. I encourage you to look beyond the selfinterested statements of witnesses who are here to lobby you to 

protect their paying clients, present and future, from administrative sanction. 

The DEA has a responsibility to maintain the closed system of 

distribution established by the Controlled Substances Act. As such, 

the DEA’s sole interest is protecting the public from harm. That is 

what the administrative and regulatory process is for. That is what 

we do best: Keeping industry in compliance and protecting the public health and safety. 

I appreciate the invitation to appear today and look forward to 

your questions. Thank you. 

[The prepared statement of Mr. Rannazzisi follows:] 

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Mr. PITTS. The Chair thanks the gentleman. 

We will now go to questioning. I will recognize myself for 5 minutes for that purpose. 

Dr. Woodcock, with respect to scheduling of controlled substances, would you elaborate on what types of data FDA uses in 

conducting its analysis for a new molecular entity prior to sending 

the agency’s recommendation to DEA, and what is the purpose of 

this evaluation? Do the scientists at FDA do everything they can 

to make this evaluation as comprehensive and accurate as possible? 

Ms. WOODCOCK. Certainly. Well, the FDA and our partner, we 

work with NIDA, are trying to predict, based on what data we 

have, how abusable, how attractive, a drug may be once it is out 

on the market for abuse and addiction. We use everything from the 

structural knowledge of the drug to animal studies, and there are 

animal studies that can look at whether the animals find the drug 

attractive, to actual human studies, likability studies, where we 

ask experienced humans what they think of the effects of the drug, 

and that is very illuminating. 

We put all that information together plus epidemiology on similar and related substances, and basically, we do what is called an 

eight factor analysis, and we put all those factors together into an 

analysis. 

Mr. PITTS. Thank you. 

Mr. Rannazzisi, what is the average time it takes DEA to schedule a new molecular entity after your agency receives FDA’s recommendation? 

Mr. RANNAZZISI. I don’t know what the average time is, but it is 

very product specific. It depends on when we receive the recommendation. See, in some products, we receive the recommendation way before approval, so we could go ahead and start our eight 

factor because, like my colleague, we have to do an eight factor as 

well, and three of the factors are based on DEA findings. 

Mr. PITTS. And why does it sometimes take over a year to make 

this determination? 

Mr. RANNAZZISI. Depending on when we receive the recommendation, generally there could be problems. When we get the recommendation, we have to send it back to FDA for a clarification. 

There might have been something that FDA missed that we want 

them to look at. Remember, when we take the final scheduling action, and we publish it, there may be a hearing and DEA, not FDA, 

but DEA has to justify the schedule that the product is being put 

in. We have to provide the evidence that the drug is properly 

scheduled. So if the scheduling action is questioned and a hearing 

is requested, DEA is the one that goes into court and justifies the 

scheduling. We bring FDA in to provide testimony, but in the end, 

it is our scheduling action based on 811. 

Mr. PITTS. In your opinion, are there instances where the agency 

has taken too long to schedule a new molecular entity after FDA 

approval? 

Mr. RANNAZZISI. No. In fact, there was a statement I think somebody made with a fivefold increase since 1999. I have no idea 

where that number came from because you have to look at when 

we received the actual recommendation. It is not when the drug is 

96 

scheduled. We have to go back because, like I said, sometimes we 

get the recommendation well after the approval has been done, 3 

to 4 months, so that is when we start. We cannot start the process 

until we receive the eight factor from HHS. 

Mr. PITTS. Section 201–B of the Control Substances Act, it states 

that DEA is bound by the medical and scientific recommendations 

of the FDA. Is that correct? 

Mr. RANNAZZISI. That is correct. 

Mr. PITTS. And FDA’s recommendations are made after a thorough analysis of the potential for abuse and misuse of the drug 

products, right? 

Mr. RANNAZZISI. That is correct. 

Mr. PITTS. Now, after a drug product is scheduled and available 

for marketing, it can be rescheduled. Would you explain how DEA 

participates in that process and how often has DEA initiated these 

rescheduling discussions? 

Mr. RANNAZZISI. Rescheduling action, most recently we have one 

pending with hydrocodone. We did a scheduling action on 

carisoprodol, which we had to go and justify in court. Carisoprodol 

is a muscle relaxant that was not scheduled. We requested a medical and scientific evaluation from HHS on two or three occasions. 

We finally got the justification necessary to reschedule it. It was 

challenged. We went into court. We justified based on evidence, 

and we prevailed. It just depends on the specific drug that we are 

dealing with at the time. Hydrocodone is pending. That is still a 

pending action. 

Mr. PITTS. The Chair thanks the gentleman. 

My time is expired. I recognize the Ranking Member, Mr. 

Pallone, for 5 minutes of questions. 

Mr. PALLONE. Dr. Woodcock, do you want to respond to what Mr. 

Rannazzisi said about, you know, when the clock stops, in other 

words— I mean, when the clock starts, that even after you have 

approved the drug, it may be like another 4 months or so before 

its scheduled? He was talking about that. 

Ms. WOODCOCK. Well, there are multiple clocks involved here. 

We are working off the user fee clock that has been agreed to by 

Congress and so forth, and sometimes there may be additional information that we need for the eight factor that may come in at different times, and so that might prolong that particular determination. At the moment, that doesn’t prevent us from approving the 

drug, so we go ahead and approve the drug, but we are still working on information that we may have received later in the cycle, 

which might mean a gap between the time the drug is approved, 

and that is information on safety and efficacy, and the drug, when 

we can make a recommendation for scheduling. 

Mr. PALLONE. I am going to go back to Mr. Rannazzisi. I just 

want to get a little information on some other aspects of this scheduling process. I know Mr. Pitts has addressed this in some way, so 

I apologize if some of these questions are repetitive, but your responses are significant as we try to move this bill. What is the percentage of times in which DEA scheduled a new drug into a class 

different from which FDA recommended? 

Mr. RANNAZZISI. I don’t know of a time where we have not scheduled the drug outside of the recommendation. 

97 

Mr. PALLONE. OK. So there has never been any instance? 

Mr. RANNAZZISI. Not that I can remember. 

Mr. PALLONE. OK. Can you tell us how long it takes on average 

for DEA to issue a final scheduling decision starting from the time 

DEA receives a scheduling recommendation from the FDA? 

Mr. RANNAZZISI. Again, I can’t tell you on average because different drugs require different time periods. It just depends on the 

information that came back from the HHS on the eight factor analysis. It depends on when we received that information. It depends 

on if there needs clarification on any one of the eight factors. It is 

variable. It depends, especially on new molecular entity, because a 

new molecular entity, we have to do our research, which we try 

and do as soon as possible. But, again, it involves when we receive 

the recommendation. 

Mr. DINGELL. Will you yield? 

Mr. PALLONE. Sure. 

Mr. DINGELL. Will you explain why you have to do your research 

and why you can’t use FDA’s research and why you can’t get a 

memorandum of understanding as to how you are going to cooperate? 

Mr. RANNAZZISI. Actually, we do have a memorandum of understanding pending. It is being reviewed by both agencies. 

Mr. DINGELL. I am not hearing you say that today. 

Mr. RANNAZZISI. Well, we have a memorandum of understanding 

pending, and we are working out the differences in the MOA, but 

I am pretty confident that we will have that in place very shortly. 

But in the meantime, again, our scientists are the ones who will 

be testifying in the hearing when it is challenged. 

Mr. PALLONE. I am going to run out of time, so I just want to 

turn now to the process for registering manufacturers and distributors of controlled substances. What is the statutory deadline for 

making a decision on an application to become registered as a manufacturer or distributor of a controlled substance, or is there no 

deadline? 

Mr. RANNAZZISI. I think it is within a reasonable time period. 

Mr. PALLONE. Within a what you said? 

Mr. RANNAZZISI. I think it is a reasonable time period. Once we 

receive all of the data, we do an investigation of the physical location. We grant the registration. As long as they have the proper, 

appropriate, State licensing. 

Mr. PALLONE. How long does it usually take on average from application of registration? 

Mr. RANNAZZISI. Again, it just depends on the entity we are registering. 

Mr. PALLONE. Does the DEA look at any application to manufacture or distribute a controlled substance for a clinical trial any differently than an application to manufacture or distribute for commercial use? Because I would imagine that the quantities would be 

considerably smaller for clinical trials? 

Mr. RANNAZZISI. On a clinical trial, a researcher for a clinical 

trial, they would send in their application with their research protocols. Once we receive the research protocols, we send the research 

protocols to FDA. FDA and NIDA review the research protocols. 

They make a determination that the protocols are consistent with 

98 

good research. At that point in time, they are approved. They come 

back to us, and we send diversion investigators on site to review, 

to ensure that they have the appropriate storage container to lock 

whatever investigational drug that may be a controlled substance 

they are using, and we give them the application once they understand what paperwork’s involved and security is in place. It is no 

different than anybody else really, except that the protocols must 

be approved by HHS. 

Mr. PALLONE. My time is expired, Mr. Chairman. 

Mr. PITTS. The Chair thanks the gentleman. 

I now recognize the vice chairman of the full committee, Mrs. 

Blackburn, for 5 minutes for questioning. 

Mrs. BLACKBURN. Thank you so very much, and I appreciate that 

both of you are here and have just a couple of questions. I want 

us to be able to move on so we can get to the second panel. 

Continuing along kind of with the line that Mr. Pallone was 

going, I think that when we look at the DEA and look at what is 

happening with prescription drugs, you know, you can look at—the 

laws are very clear when it comes to the illegal drug trade. You 

know that distribution of heroin or the methamphetamines, you 

know it is illegal. That type clarity is very helpful in enforcing the 

law, but when we are talking about the pharmaceutical products, 

what constitutes legal prescribing and dispensing is not quite as 

clear. 

So let me just ask you if you can list for us what you are doing, 

articulate what the efforts are that the DEA is engaged in to promulgate some clear standards for the prescribers, for the pharmacies, for the distributors. What is your step by step? You say you 

have got an MOA. You say that is pending, so give me your tick 

list. 

Mr. RANNAZZISI. Well, let’s talk about the prescribers first. I believe that the courts have settled what a prescriber must do. He 

must issue a prescription, a controlled substance prescription for a 

legitimate medical purpose in the usual course of professional practice. That was given to us by U.S. v. Moore 1975, and that hasn’t 

changed. It is very obvious. When we go out and talk to physicians 

groups, we tell them that is their standard. They know that is the 

standard. If you looked back when we were doing the Internet 

pharmacy debacle, when doctors weren’t seeing patients—they 

were just writing prescriptions without seeing the patient and having a pharmacy over the Internet fill them—that was not for legitimate medical purpose, not in the usual course of professional practice. There was no established doctor-patient relationship. 

Now let’s talk about the pharmacists. The pharmacists have a 

corresponding responsibility to ensure the prescription is valid. We 

go out and we teach the pharmacists, as does the National Associations of the Boards of Pharmacy and the particular pharmacy 

boards that the pharmacist sits in, that they have a corresponding 

responsibility to ensure that the prescription is valid, that it is 

issued for a legitimate medical purpose in the usual course of professional practice. Pharmacists understand that. There is transparency in the case law. There is transparency in how we do 

things. We have done prescription drug pharmacy diversion awareness conferences in, I think, 14 States. 

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Mrs. BLACKBURN. OK. Well, a lot of that we know. We were looking for a little bit of that new information, and I guess it is kind 

of a Monday attitude sort of day, so let me move on. 

Mr. RANNAZZISI. I would like to finish my answer. I guess not. 

Mrs. BLACKBURN. What are you doing to help well-intentioned 

registrants to determine who they can do business with? 

Mr. RANNAZZISI. I am sorry? We don’t dictate who the registrant 

does business with. 

Mrs. BLACKBURN. OK. I thought maybe you were doing a little 

bit to help—— 

Mr. RANNAZZISI. Well, we are, if I can proceed with the wholesalers and distributors, besides having one-on-one contact with the 

wholesalers and distributors in the distributor initiative, telling 

them what to look for and what red flags to look for, our yearly 

conference with the distributors as a whole to talk to them about 

what red flags, what we are seeing trend-wise and what they need 

to look for, besides the onsite investigations that we do, the cyclical 

investigations, to determination compliance and to assist them in 

complying, besides the fact that they call in and request assistance—— 

Mrs. BLACKBURN. Let me move on, then, if it is laborious. 

Mr. RANNAZZISI. It is not laborious. You asked me to tick off 

what I do: 16,651 people in 2010 died of opiate overdose, OK, opiate-associated overdose. This is not a game. We are not playing a 

game. 

Mrs. BLACKBURN. Nobody is saying it is a game, sir. We are just 

trying to craft some legislation. 

Mr. RANNAZZISI. Especially in Tennessee. There is 340—— 

Mrs. BLACKBURN. Your written statement indicates that the DEA 

has initiated less than 20 administrative cases in the last 6 

months. What is behind the significant decline in case initiation, 

and are you satisfied with the number of cases being initiated? 

Mr. RANNAZZISI. Well, we are initiating cases, for sure. Our case 

numbers have not gone down. 

Mrs. BLACKBURN. I think the case numbers have gone down. OK. 

If DEA has only initiated 20 administrative cases in the last 6 

months, what is DEA doing to help registrants identify the prescribers and pharmacies that they should refuse to do business 

with? 

Mr. RANNAZZISI. Ma’am, that is a due process issue. We can’t direct a wholesaler or distributor or a pharmacy not to sell to a particular person. They are afforded due process like every other person. So if I told them, ‘‘Don’t sell to this pharmacy, don’t sell to this 

doctor,’’ then they wouldn’t be afforded due process. 

Mrs. BLACKBURN. My time has expired. I yield back. 

Mr. PITTS. The Chair recognizes the ranking member of the full 

committee, Mr. Waxman, for 5 minutes of questions. 

Mr. WAXMAN. Thank you. 

Dr. Woodcock, I think we can all agree that the current process 

has not been working. Mr. Whitfield and Mr. Dingell have a bill 

that attempts to fix the problem. Of course, it is rather strange because we have got three different bills under discussion, and I am 

taking a leap from the last one. While I have concerns about elements of their bill, I share their frustration with the current FDA 

100 

process and their desire to fix it. Will you commit to work with the 

committee, with the PASS Coalition, and other stakeholders, to 

come up with a process under which new, safe and effective sunscreens can get to market quickly? 

Ms. WOODCOCK. Yes. 

Mr. WAXMAN. I would like to better understand the current process and how we can help improve it. The central element in H.R. 

4250 seems to be giving an FDA advisory committee the ability to 

make approval decisions, albeit providing FDA with some authority 

to reject that decision. I have serious concerns about such a model. 

Can you tell us if there are precedents at FDA for using an advisory committee in this way, what are FDA’s views of such an approval, and it does at least appear to have the virtue of speeding 

up the process? 

Ms. WOODCOCK. Well, I believe possibly in the device realm in 

the past, there were some areas where the panel recommendations 

were more binding. However, this is not true for pharmaceuticals. 

The process problems with the OTC monograph go well beyond 

sunscreens and related or pertain to the entire monograph process, 

which has to be done by regulations. The Time and Extent Applications is what we are talking about here for sunscreens, were put 

in place by us actually in the early 2000s to try to bring more products that seemed to be most appropriate for monographs into the 

monograph system. However, what happened is that got caught up 

into the prolonged and torturous history of the sunscreen monograph and all the other monographs that we have to get out under 

the OTC system. 

So, personally, the administration does not have a position on 

this bill, but I would say that, you know, it is making steps forward, and we need to change some things if we are going to make 

an efficient process that can respond both to safety problems and 

get more products into the monograph. 

Mr. WAXMAN. What do you think of the idea of an advisory committee making that decision instead of you? 

Ms. WOODCOCK. Well, I think that will be very difficult because 

it is a voluminous amount of data, and one of the problems that 

we have had in general is having time to go through all these data, 

find out what is missing, figure out what the gaps are, communicate with the sponsors. It is not a typical type of thing that an 

AC would do. 

Mr. WAXMAN. And do you think if there were such a process, the 

committee members, I don’t know how they would be chosen in 

particular, how would it affect conflict of interest issues? 

Ms. WOODCOCK. Well, like any other advisory committee, we 

have to do an extensive screening for conflict of interest, and a 

committee considering this wide range of issues would have to have 

a very broad representation, all of whom would have to be relatively free of conflict of interest. 

Mr. WAXMAN. The bill sets outs mandatory time frames for decisions both by the advisory committee and the FDA and even time 

frames for applicants to submit new information. I understand the 

sponsors’ interest in moving things along quickly. However, the 

time frame seems somewhat more ambitious or optimistic than is 

reasonable. 

101 

The advisory committee would have 180 days to make its recommendations after receiving an application. Considering that 

there are eight outstanding applications, that could be a lot of work 

to expect the committee to accomplish. It also gives FDA 45 days 

to agree or disagree with the committee recommendation. Again, 

that seems rather ambitious, even if the committee were to be 

making only one recommendation for consideration within that 

time frame. What are FDA’s views on those time frames? What 

times frames would FDA consider reasonable? 

Ms. WOODCOCK. Well, I understand the impetus behind the desire for short time frames, however, I feel it may be self-defeating. 

If it is not possible to identify all the problems and get to a considered opinion in that time frame, then it would be likely to turn 

something down rather than turn it loose on the public. 

Mr. WAXMAN. And what do you think about the shifting of the 

burden? It appears the advisory committee decision is presumed to 

be right, unless FDA can prove it is wrong. That seems like an inappropriate shifting of the burden of proof. Seems like a decision 

could be reversed simply because the FDA reviewer didn’t adequately write down the basis for the decision. What is the FDA’s 

view of the appeals process? 

Ms. WOODCOCK. Well, I think this does put a tremendous burden 

on the FDA. And probably inappropriate—as written currently, difficult or undoable burden on the advisory committees as well. So 

I am not sure this process would end up with the desired outcome, 

which is clarity, public standards, knowing what needs to be done, 

and the most efficient process for getting it done. 

Mr. WAXMAN. I thank you for your answers and especially your 

willingness to work with us. I think that is going to be very important. 

Mr. PITTS. Chair thanks the gentleman, now recognize the vice 

chairman of the subcommittee, Dr. Burgess, 5 minutes for questions. 

Mr. BURGESS. Thank you, Mr. Chairman. 

Dr. Woodcock, always good to have you back before the committee. 

And in fact, let me ask you a question, it is a little bit off topic 

today. Can you provide the committee with the status of the FDA’s 

guidance on biosimilar naming? 

Ms. WOODCOCK. It is still under consideration, it has not been be 

issued. 

Mr. BURGESS. But when is that guidance likely to become final? 

Ms. WOODCOCK. I do not know. However, I realize that it is urgent. We certainly hope that that program will get up and running 

this year. 

Mr. BURGESS. Sure. Is there anyone advising, outside of the— 

anybody in the administration outside of the FDA itself? Is there 

anyone in the administration who is playing a role in this, giving 

you suggestions or recommendations with respect to the guidance? 

Ms. WOODCOCK. Well, the administration has not come to a conclusion on this topic. 

Mr. BURGESS. Who in the administration? 

Ms. WOODCOCK. I would have to get back to you on that question. 

102 

Mr. BURGESS. I really would like for you to do that. And please 

expect some follow-up on that, because it looks to me as if the administration may be the impediment. You all are taking the fall for 

it. But it is far too long, and we actually need that. 

Mr. Rannazzisi, you mentioned the memorandum of agreement. 

And you and Dr. Woodcock, I think, both acknowledge there is a 

memorandum of agreement that is pending; is that correct? 

Mr. RANNAZZISI. Yes, sir. 

Mr. BURGESS. You know, I don’t know that I was aware of the 

memorandum of agreement. Is that something, can you make the 

text of the memorandum available to the subcommittee? 

Mr. RANNAZZISI. I don’t believe we can. Well, you would have to 

request that from the Department of Justice because it is actually 

between the Department of Justice and HHS. 

Mr. BURGESS. Mr. Chairman, I would, then, suggest that the 

subcommittee do request that from the Department of Justice. 

What is your time line? What is your expectation of when this 

will be accomplished? 

Mr. RANNAZZISI. There are several components to this MOA, and 

I think there are just some things regarding proprietary information that needs to be passed, and I think that is what they were 

working on. The time limit, we hope to have it soon because it will 

make the process more efficient in scheduling once we get it in 

place. 

Mr. BURGESS. Let me ask you the same question I asked Dr. 

Woodcock. Is there anyone in the administration that is affecting 

the timeline of this thing adversely? 

Mr. RANNAZZISI. I don’t believe so, no. It is—— 

Mr. BURGESS. But you won’t share it with us so we couldn’t possibly know that, could we? Since you won’t share it with us, I am 

going to let my imagination run wild. It seems as if we have got 

someone in the administration that is holding this up, and you 

won’t allow us to see the memorandum. 

I would suggest, Mr. Chairman, that that memorandum of agreement be made available to the committee, and allow us to participate before you just visit this upon everyone who is involved in this 

process. 

Mr. RANNAZZISI. Well, the problem is, sir, the memorandum of 

agreement is not finalized. If I gave you a memorandum of agreement right now, it is not a final agreement. 

Mr. BURGESS. Share the draft with us. 

Mr. RANNAZZISI. I am going to share something that is not finalized. Really? 

Mr. BURGESS. Sure. We could help you. We could inform you. We 

could direct you. Sometimes the legislative and the administrative 

branches have worked together historically; Mr. Waxman, Mr. Dingell may be able to give you such a time that that happened, but 

this administration has not worked well with the legislative 

branch. Here would be an excellent opportunity to start. 

Let me just ask you a question. Because it keeps coming up. We 

are going to hear from people on the supply side in the second 

panel. 

But, what are you doing to draw the line between prosecuting 

those who overprescribe and not differentiating between those indiVerDate Mar 15 2010 13:37 May 11, 2015 Jkt 037690 PO 00000 Frm 00106 Fmt 6633 Sfmt 6633 F:\113-137 DEA, FDA REGS 2ND SCAN REQ 5-7-15\113-137 DEA, FDA REGS PENDING
103 

viduals who are legitimately trying to help? And bearing in mind 

the people they are trying to help is a pretty vulnerable population? 

Mr. RANNAZZISI. Well, it depends. Again, every case is fact specific. The U.S. Attorney makes a judgment call on how we proceed 

on the cases based on the evidence that is presented to him or her. 

The fact is, is the cases that we bring forward are generally pretty egregious. There is no doctor-patient relationship attached, these 

pain clinics that are operating in Texas, in Tennessee, and pretty 

much throughout the country now, there is no medical care for 

rogue pain clinics. They are operating as a facade to distribute controlled substances. In Florida—— 

Mr. BURGESS. And yet they continue to operate. So, you know, 

look, we do have to get a balance here taking care of people—— 

Mr. RANNAZZISI. Absolutely. 

Mr. BURGESS [continuing]. Who really need the help that they 

are looking to receive. But sometimes it seems that all the DEA 

cares about is the number of enforcement actions and not real solutions to stop the abuse. 

Mr. RANNAZZISI. That is not correct. 

Mr. BURGESS. Provide to us data on how that—what you have 

done to stop the abuse without interfering with the legitimate practice, medicine, pharmacy, and distribution. 

Mr. RANNAZZISI. If you would go on our Web site and look at the 

cases that are posted on our Web site, both on the cases against 

practitioners and also cases, the administrative cases against registrants, you will see that—— 

Mr. BURGESS. Well, it would have been great had you been prepared to provide that for us. 

Mr. Chairman, let me ask that on this memorandum of agreement that we have been talking about, maybe at least the Department could provide us with the goals of what they are trying to 

achieve with this. Because, after all, we do have legislation pending 

before this committee that could be impacted as to what those 

goals are and how they would affect the practice of medicine pharmacy. 

I’ll yield back my time. 

Mr. RANNAZZISI. May I finish my answer? I was not—— 

Mr. PITTS. You may finish. 

Mr. RANNAZZISI. The administration has a four-pillar strategy, 

we follow the four-pillar strategy. Education, treatment, enforcement. The three basic tenets that we provide. Now, education, we 

provide education throughout the supply chain. We make sure that 

the supply chain, the registrants understand what their obligations 

are under the act. We provide them with red flags. We provide all 

of the case law, all of the administrative actions are posted on our 

Web site. We can direct them to particular circumstances and cases 

that they are inquiring about. We go out and look at them face to 

face and explain to them. The distributors we talk to before enforcement action is taken on them and give them an opportunity. 

See, the fact is, we are not just enforcement, we are a regulatory 

organization. We go out to their—on-site and look at their facilities 

and determine if there is any exploitation within their site that 

could be cause of diversion, and I don’t see where you think we are 

104 

just an enforcement agency, because we do so much more than enforcement. Talk to the pharmacists that have been to our classes. 

Mr. BURGESS. Mr. Chairman, I will reclaim my time. But the vice 

chair brought it up. 

The clarity and the consistency of these regulations at the level 

of the distribution are things that we hear about all the time. But 

let’s go on with the hearing, and I will yield back. 

Mr. PITTS. Chair thanks the gentlemen. 

Now recognize the ranking member emeritus of the full committee, Mr. Dingell, 5 minutes for questions. 

Mr. DINGELL. Thank you for your courtesy. 

I am reminded today of when I was a very small boy and used 

to go to my granddad’s farm out in Iowa. He had a bunch of chickens, and so to keep the chickens happy and keep them laying, 

when he would take the hens—rather, take the eggs out from 

under the hens, he would always put a porcelain doorknob in, and 

those damn chickens would sit on that porcelain doorknob until 

hell froze over. 

I am reminded very much, Dr. Woodcock, of those happy days in 

Iowa and the chickens that were sitting there very happily on the 

bloody doorknob. 

Now, we got 2 million Americans developed skin cancer each 

year. Sixty-one thousand developed melanoma last year, and 9,000 

people died. How many of these do you have laying around down 

there at Food and Drug where you have an application on these? 

Just if you haven’t got it, submit it for the record. 

And how long has each one of them been laying around there? 

And when will you have action taken on each of them? And how 

long is it going to take to reach action on each of them? And why 

have you not been able to reach action on any of them as of this 

particular time? 

Because I note, Doctor, that all of them have been approved and 

are being used in Europe and other places which have food and 

drug laws that are roughly equal to ours in terms of their safety. 

Ms. WOODCOCK. The sunscreens are marketed as cosmetics in 

Europe. 

Mr. DINGELL. Well, you are still sitting on them like a hen on 

a plastic doorknob, and I just find myself thoroughly dissatisfied. 

So if you will please submit that for the record, I believe it will be 

most helpful. 

[The information apears at the conclusion of the hearing.] 

Mr. DINGELL. Now, skin cancer is an epidemic in the United 

States. It is a pressing public health issue, is it not? 

Ms. WOODCOCK. Yes. 

Mr. DINGELL. All right. One of the best ways that we could ensure that the American people have access to the most effective 

sunscreen ingredients is to see to it that we allow those which 

are—been proven to be safe by long use in Europe; isn’t that so? 

So you are just sitting there looking at these things. Food and 

Drug is doing nothing about it. Very comfortable. You come up here 

and tell us how concerned we are that we are not doing anything. 

So now, Doctor, do you believe that the American people should 

have the access to the latest safe and effective sunscreens to prevent skin cancer and melanoma? 

105 

Ms. WOODCOCK. Yes, I do. 

Mr. DINGELL. Rest of Food and Drug agree with that? 

Ms. WOODCOCK. Yes. 

Mr. DINGELL. Now, Doctor, is it correct that there are eight applications for new sunscreen ingredients that have not received 

final determination under the time and extent application process 

at FDA? Yes or no? 

Ms. WOODCOCK. Yes. 

Mr. DINGELL. Do you believe that time and extent application 

process has ever worked as intended, yes or no? 

Ms. WOODCOCK. No. 

Mr. DINGELL. Yes? 

Ms. WOODCOCK. No, I don’t believe it has worked. 

Mr. DINGELL. But you still got eight sitting around and Food and 

Drug sitting on them like a hen on an egg, right? 

Now, do you believe that we need to reform this? 

Ms. WOODCOCK. Yes. 

Mr. DINGELL. And this is precisely why I have been joined by 

dear friend Mr. Whitfield to introduce the Sunscreen Innovation 

Act. The goal of this legislation is to ensure a predictable time 

frame for the review of new sunscreen ingredients while making 

sure FDA has the final say on all scientific and safety determinations. 

Now, Dr. Woodcock, I know there is a request for technical assistance on the Sunscreen Innovation Act that is still outstanding. 

Will you commit to working with me on this legislation with a goal 

of resolve the remaining differences by the end of this month? 

Ms. WOODCOCK. I will commit to working with you and with the 

Congress. 

Mr. DINGELL. Well, and I would like to have the requested information that I have sought: How many applications you got sitting 

around down there? How long have they been there? What is holding up each and every one of them? And the other questions that 

I asked relative to the delay on them, if you please. 

Ms. WOODCOCK. Certainly. There are eight applications for sunscreens to TEA. We have responded to two of those. We hope to respond to the remainder soon. 

Mr. DINGELL. But in Europe they are all approved; right? 

Ms. WOODCOCK. In Europe, they are marketed as sunscreens, I 

am not familiar, but I don’t believe there is an application process, 

such as we are discussing here. 

Mr. DINGELL. They are selling them, aren’t they? 

Ms. WOODCOCK. Correct. 

Mr. DINGELL. And people are using them, aren’t they? 

Ms. WOODCOCK. Absolutely. 

Mr. DINGELL. Do you have any evidence of them being unsafe or 

causing any danger or—there are two things that a pharmaceutical 

has got to be in this country, one, it has got to be safe, and the 

other, it has got to be effective. Do you have any evidence that any 

of these doesn’t meet those two tests? 

Ms. WOODCOCK. Well, that is part of the point of the TEA process, to have people submit to us what the evidence is about the 

safety in marketing. 

106 

Mr. DINGELL. You know the affectionate respect I have for you. 

But you also know that you are make a bad case today. You just 

can’t defend the fact that these things have been sitting around for 

8 to 12 years. 

I yield back the balance of my time. Thank you. 

Mr. PITTS. Chair thanks the gentleman. 

Now recognize the gentleman from Kentucky, Mr. Whitfield, 5 

minutes for questions. 

Mr. WHITFIELD. Thank you very much. 

Dr. Woodcock, you had indicated earlier that FDA had not taken 

a position on this legislation; is that correct? 

Ms. WOODCOCK. That is correct. 

Mr. WHITFIELD. And I think you said in your testimony and in 

response to Mr. Dingell’s questions and others, you do agree that 

the TEA process is not working very well as it relates to sunscreens; correct? 

Ms. WOODCOCK. Generally, I believe the monograph process is no 

longer functioning the way it was intended, and the TEA process 

is simply a route to get into the monograph process. 

Mr. WHITFIELD. Do you consider the TEA process working? 

Ms. WOODCOCK. I think if it were coupled with a more functional 

monograph process, it could work, yes. 

Mr. WHITFIELD. Well, how difficult is it to get a more functional 

monograph process? 

Ms. WOODCOCK. Well, as I said, we had a public meeting 2 weeks 

ago, and we had few really substantive suggestions there, except 

we should work harder. 

Mr. WHITFIELD. Yes. Well, we all agree on that. But that is why, 

you know, at least we have a product here, a piece of legislation. 

Because there is genuine concern and everyone agrees that there 

is genuine concern. 

Ms. WOODCOCK. I share the concern. 

Mr. WHITFIELD. And when you have these eight applications, 

earliest of which was submitted in 2002, and you have only responded to two of them in 12 years, you know, something is not 

working. 

Ms. WOODCOCK. That is a problem. 

Mr. WHITFIELD. So Mr. Waxman, now, he pointed out that he 

was concerned about this advisory committee, and yet you have indicated in your testimony that in nonprescription drugs or in medical devices, you do have an advisory committee that makes recommendation, and, of course, we are talking about over-the-counter 

here, we are not even talking about prescription drugs, this is over 

the counter; and the medical devices, I mean, the artificial knee 

joints are placed in bodies, and that is recommended by advisory 

committee. 

So are you genuinely opposed to the advisory committee part of 

this legislation and the process that we have set out in this bill? 

Ms. WOODCOCK. I am not sure that the process you have set out 

will be functional. I mean, the problem with the current process is 

not functioning correctly, and I am worried that— I think that 

there are some good steps here, and we can build on this. And perhaps get something that will really work for everyone. 

107 

But, you know, if you press people too hard on matters of safety 

where you are exposing much of the population of the United 

States to something, you know, you need to give them the appropriate time and tools. 

Mr. WHITFIELD. Well, I think you know, I hope that you—— 

Mr. DINGELL. Will the gentleman yield? 

Mr. WHITFIELD. I would be happy to yield. 

Mr. DINGELL. Is 12 years too much pressing? Is 8 years too much 

pressing? I don’t find it so. 

And I thank the gentleman for yielding. 

Mr. WHITFIELD. Well, I mean, I agree, I mean, I think we all 

agree this is ridiculous. Twelve years. 

Ms. WOODCOCK. We all agree. I am not defending the fact that 

it has taken that long. There are a variety of factors, but that is 

not appropriate and this process is not working. 

Mr. WHITFIELD. And these ingredients are being used elsewhere. 

But, the commitment that I am asking for from you and others at 

FDA is to work with us in a sincere way to improve this process 

for the health and welfare of the American people. Because we 

know that skin cancer is the most prevalent cancer out there. 

So you will make that commitment to me and we can work—— 

Ms. WOODCOCK. Yes, we would be delighted to work with you, although we would like to reform the whole process of the monographs. Because the sunscreens are just a microcosm, as I said, of 

a process of has encountered tremendous problems. 

Mr. WHITFIELD. Well we are focused on sunscreens because of 

the prevalence of skin cancer. 

And in concluding, I know my time hasn’t quite expired yet, but 

I would like to submit for the record, Mr. Chairman, a letter of 

support from the American Academy of Dermatology Association. 

Mr. PITTS. Without objection. 

[The information follows:] 

108 

109 

Mr. WHITFIELD. And with that, I would yield back the balance 

of my time. 

Mr. PITTS. Chair thanks the gentleman. 

And I now recognize the gentleman from Texas, Mr. Green, 5 

minutes for questions. 

Mr. GREEN. Thank you, Mr. Chairman. 

Thank you and both our Ranking Member Pallone for having this 

hearing, and our witnesses for taking the time. 

First, Dr. Woodcock, I learned just recently that the FDA advisory committee voted last week to recommend that the FDA approve two new antibiotics. These drugs were approved based on the 

GAIN Act that we passed, this committee passed last Congress, 

and I know they were in the development stage and before GAIN 

was enacted and their approval was welcome news. And of course 

we didn’t get everything we wanted to out of the Senate, so we 

have a real bipartisan bill called Adapt that we are working with 

FDA on now. But I appreciate that. 

Mr. Rannazzisi, the FDA is vital to meeting the growing challenges our country faces, including reducing prescription drug 

abuse, one of our fastest growing public health threats. I commend 

the FDA for meeting the public safety threats head-on and appreciate it. Because I have seen those same clinics in my area, and 

frankly, we have a pretty aggressive U.S. Attorney sometimes that 

gets involved in them. So I am glad of that. 

However, the FDA, as it tackles its mandate in a number of 

fronts, it is critical that patients who desperately need these medicines have access without undue delay, particularly those with limited potential for abuse or addiction. In 2011, I sent a letter to FDA 

after learning it takes an average of 5 to 6 months for the DEA— 

I sent a letter to DEA—5 or 6 months for DEA to schedule a medicine, notwithstanding the drug’s classification or potential for diversion. Since then, we have learned that the delays have not 

shortened and may actually have increased. 

I am concerned over the substantial and growing length of time 

between when the FDA approves a new molecular entity and provides a scheduling recommendation and when the DEA schedules 

the drug. According to testimony from Dr. Fountain of the Epilepsy 

Foundation and University of Virginia School of Medicine, the average time between FDA approval and the DEA’s final scheduling increased from an average of 49.3 days in the 1990s to an average 

now of 237.6 days. These delays can result in lack of patient’s access to potentially life-saving therapies. Also, a lack of transparency of the DEA scheduling process provides disincentives to 

companies developing these therapies. 

Mr. Rannazzisi, specifically what is the sequence of the internal 

actions at DEA from a receipt of recommendation by the FDA to 

the DEA’s Federal Register publication? 

Mr. RANNAZZISI. When we receive the recommendation, our pharmacists, our pharmacologists begin the process of drafting the eight 

factor. They look at all the information that has been presented by 

FDA, and then all the information that they have procured over 

the last however long when they know the drug is coming. That is 

a lot of scientific data. They look at all the abuse data, if there is 

any abuse data. 

110 

Remember, there is transparency in the system. It is called the 

Administrative Procedures Act. The APA is our guidance on how 

we get drugs into the scheduling process. 

We provide a period of public comment after we do the notice. 

We have to look at every one of those comments. At that point in 

time, the public may request a hearing from an administrative law 

judge. 

So the process is very transparent. It just takes time because it 

is a science. The scientific method takes time, and our scientists, 

just like the FDA scientists, have to ensure that we have the justification to prevail in court. 

Mr. GREEN. Well, but it is still is the average increase from the 

late 1990s to today was from 49 days to 237 days. 

Mr. RANNAZZISI. I don’t know where that is coming from. 

Mr. GREEN. OK, we will get it to you. We will get the numbers 

there. Because if that is the issue, then somewhere along the way, 

whether you are not giving some kind of courtesy to what the FDA 

scientists did and, I expect—you know, I want FDA to do it. But 

I also know that they expect—— 

What is your opinion of the shortest time that might plausibly 

achieve to accomplish this process from start to finish? Is there an 

average time that the DEA aims for? 

Mr. RANNAZZISI. I don’t believe there is. Because it depends on— 

if it is a new molecular entity, that is going to take longer than 

an established drug that is in a different, you know, a combination 

of formulations. A drug that we know, a drug that we have done 

very significant research on. 

Mr. GREEN. Well, I know Congress and the FDA is taking steps 

to improve the transparency and consistency of the regulatory process for new drugs, to provide patients access for these new therapies in a timely manner. The lack of predictability, though, and 

timing of the DEA scheduling decisions, at least on certainty and 

drug development, and the process and some delays. 

Delays in patient access to new therapies should be addressed in 

a manner that doesn’t threaten public health or weaken the DEA’s 

ability to ensure public safety. But somewhere along the way, we 

need to make the system work faster than we are seeing. 

And I know I am out of time, Mr. Chairman. Thank you. 

Mr. PITTS. Chair thanks the gentleman. 

Now recognize the gentlelady from North Carolina, Mrs. Ellmers, 

5 minutes for questions. 

Mrs. ELLMERS. Thank you, Mr. Chairman. 

Dr. Woodcock, and thank you to our panel for being here today. 

I do have questions about the sunscreen. I think that we have 

gone over that pretty well here in committee, and as a nurse prior 

to coming to Congress, obviously, this is an issue that we are all 

very concerned about, with skin cancer. And I guess what I would 

like to hear from you, is, please, can you just tell our committee 

that you are committed to improving upon this issue? I mean, obviously the time has been too long. 

Ms. WOODCOCK. It has been too long. As I said a number of 

months ago when I appeared before this committee, I think I am 

almost as frustrated as the manufacturers and some of you all 

111 

about this issue. So I do commit to improving it. We have already 

taken steps to speed up this process and move it along. 

Mrs. ELLMERS. OK. Moving along to some of the issues having 

to do with Ensuring Patient Access and Effective Drug Enforcement Act of 2013. 

There again, a very important issue. This is one that I think 

many of us, you know, we understand the drug abuse issue, we understand the deaths that have occurred as a result, and we need 

to be proactive on this issue. 

One of the solutions that has been put forward that holds promise is the development of abuse-resistant prescription drug products. Such formulations make it harder for individuals to break 

down prescription drugs for abuse purposes. Obviously, that would 

be the actual drug itself. 

And I would just like to thank you for the work that you have 

been doing, and I do want a clarification. My understanding is that 

there is some progress being made right now, that the agency is 

contracting with some of the academic and research institutions, 

utilizing research grant funding through the Generic Drug User 

Fee Act, to study this evaluation of abuse-deterrent formulations. 

Is this correct? 

Ms. WOODCOCK. I can’t comment on the funding. But the research is correct, yes. 

And we are trying to develop a framework so that as—we don’t 

want to approve abuse-deterrent formulations that then 

disincentivize people from developing better ones. We have approved one, and it has some abuse-deterrent properties. However, 

we need to get much better than that. So what we need to do is 

kind of establish both the—you know, the carrot and the stick incentives, and we are doing research in our own laboratories as well 

as elsewhere. 

Mrs. ELLMERS. Will the FDA in its guidance provide flexibility 

and encourage manufacturers to pursue alternative methods and 

approaches to develop meaningful abuse-deterrent technologies 

rather than a single development path such that the innovation 

and advancement in science are effective harness—I mean, are 

there incentives that are being put forward? 

Ms. WOODCOCK. Absolutely. That is part of the strategy, is to 

have multiple different abuse-deterrent mechanisms so that if one 

might be overcome—Mr. Rannazzisi and I were talking earlier that 

criminals are always sort of one step ahead of you. 

Mrs. ELLMERS. Sure. 

Ms. WOODCOCK. So we need to keep encouraging that innovation. 

Mrs. ELLMERS. Thank you, Dr. Woodcock. 

And, Mr. Rannazzisi, I think we have—there is a lot of discussion of clarity and process on how things are moving forward. You 

know, we are hearing repeatedly that registrants are very concerned about the lack of clarity. However, you have outlined that 

this is something that the DEA is working on. And you say that 

you, and I am going to quote you, that you give the opportunity for 

the registrants to come forward, that there is plenty of opportunity 

for them. 

112 

Is there a process for appeal of a decision by the DEA? And can 

you describe that, if a registrant is found to have been revoked, 

their DEA ability to produce suspended or revoked? 

Mr. RANNAZZISI. I believe they could take it to district court. 

Mrs. ELLMERS. You believe or you—— 

Mr. RANNAZZISI. They could take it to the district court. 

Mrs. ELLMERS. OK, when we are talking about the hearing process, I know my colleague across the aisle, Mr. Green, was referring 

to some of the hearing procedures, and there seems to be a lot of 

discrepancy on timing of how long a hearing would take. Can you 

tell us what the average time is? I know my colleague had said 

that he had heard of a time frame, and there again, I don’t know 

exactly the number. But you basically said you weren’t sure where 

that number came from. Can you tell us? 

Mr. RANNAZZISI. I don’t believe that was for a hearing; I believe 

that was for—I think that was for scheduling. The timeframe it 

takes for scheduling action. 

Mrs. ELLMERS. To schedule? 

Mr. RANNAZZISI. Yes. 

Mrs. ELLMERS. OK. 

Mr. RANNAZZISI. For a hearing, again, it depends on if it is an 

immediate suspension order with an order to show cause or just a 

plain, ordinary—— 

Mrs. ELLMERS. So to that point, how long would you say that it 

does take a hearing to be scheduled? And then I know my time 

is—— 

Mr. RANNAZZISI. When we do an immediate suspension order 

with an order to show cause, the date of the hearing is on the order 

to show cause, and I believe if it is within 30 days. 

Mrs. ELLMERS. OK. Within 30 days. Thank you so much. 

My time has expired. 

Mr. PITTS. Chair thanks the gentlelady. 

Now recognize the gentleman from Florida, Mr. Bilirakis, for 5 

minutes for questions. 

Mr. BILIRAKIS. Thank you, Mr. Chairman. I appreciate it very 

much. 

And again, thank you for your testimony. Thank the panel. 

Mr. Rannazzisi, numerous seniors in my district are complaining. 

They call my office on a regular basis because they can’t get their 

pain medications, and the pharmacists have stated that DEA is 

placing arbitrary and vague quotas on wholesalers and pharmacies. 

I also hear that DEA is telling pharmacists not to fill prescriptions that raise red flags, but has given no guidance about these 

red flags. I want to give you an opportunity to respond. 

But considering DEA’s mission to ensure an adequate, uninterrupted supply of controlled medications for patients’ needs, what is 

DEA doing to address the impacts on patients that these confusing 

policies are causing? 

And I know we have touched on this earlier. But if you could 

elaborate, I would appreciate it. 

Mr. RANNAZZISI. To start, actually, last year we were down in 

Florida, and we trained, I think, 1,400 pharmacists on what their 

role is as far as corresponding responsibility and how they review 

prescriptions. And we talked about the red flags, and we are trying 

113 

to do that in every State. The fact is that we do not want patients 

to go without their medication, true pain patients that need their 

medication. We don’t want that. But there is no quota—— 

Mr. BILIRAKIS. Tell me what you are doing about it? Because, I 

mean, we get calls on a regular basis. 

Mr. RANNAZZISI. There are no quotas set by DEA concerning how 

much downstream drug goes from the wholesalers to the pharmacies. The wholesalers are required to report suspicious orders. 

They should know their customers, they should do due diligence. 

But they have certain things that they must do to reconcile an 

order before it is sent downstream. The pharmacies that are ordering those drugs, again, have a corresponding responsibility to ensure that the prescriptions they are filling are legitimate, are valid, 

are for legitimate medical purpose. 

That is exactly what happened in Sanford. In Sanford, Florida, 

those two pharmacies that were stripped of their registration, they 

were not doing any corresponding responsibility, and there are 

wholesalers that were sending drugs to them, were not doing their 

due diligence. 

And they were filling hundreds of thousands of tablets per year. 

And most of those prescriptions were not for legitimate medical 

purpose. They were also filling prescriptions for doctors that didn’t 

have a valid DEA registration. 

See, the problem is, is corresponding responsibility has a quite 

a few different components to it. And this has been in place for 40- 

plus years. 

Mr. BILIRAKIS. Let me go on to the next one. Thank you for that 

answer. 

Does DEA meet the chronic pain patients groups and others to 

ensure—do they meet with chronic pain patients groups and others 

to ensure that agencies understand the need and concerns of patients? And yes or no, and please elaborate. 

Mr. RANNAZZISI. If we were asked to meet with a pain patient 

group, yes, we would. 

Mr. BILIRAKIS. How often are you asked? 

Mr. RANNAZZISI. We meet with treatment groups, for instance, 

American Association of Opiate—AATOD. AATOD. We meet with 

them. We meet with physicians’ groups. We meet with pharmacy 

groups. Specific patient groups when they request. 

Mr. BILIRAKIS. What is discussed during those meetings? Give 

me an example. 

Mr. RANNAZZISI. We meet with—for instance, AATOD, we give 

them a trend analysis of what is going on in drug diversions, what 

drugs are being used. Then we ask them, what are you seeing? 

It is the same thing with community groups. We go into the communities all the time. In fact, I am doing a community function 

with doctors, pharmacists, and community leaders in Weymouth, 

Massachusetts, next month. 

Mr. BILIRAKIS. Thank you very much for the answer. 

Dr. Woodcock, Zohydro is a new extended-release opioid approved 

for the market by FDA but without any requirement for abuse deterrents. I find this disturbing because FDA has taken a number 

of steps to make sure opioid drugs would have these deterrents. 

114 

FDA has even blocked generics from entering the market because 

they lacked abuse-deterrent properties. 

Some brand name drug makers have changed their drug to include abuse deterrents, saying their previous versions were unsafe. 

28 State attorneys general sent a letter to FDA asking to reconsider the position on Zohydro. Your own advisory council did not 

favor approving this drug, from what I understand. 

The drug company’s own literature says an adult could overdose 

on two capsules, a child could die from swallowing just one, an addict can easily crush it and receive a dangerous and potentially lethal high. 

Why would you approve a drug with 5 times as much 

hydrocodone as Vicodin with no abuse-deterrent properties? 

Ms. WOODCOCK. Well, first of all, there is only one drug that we 

have approved, and it is on the market, it is a high-potency opioid 

that has abuse-deterrent properties. All other opioids on the market do not have abuse-deterrent properties—— 

Mr. BILIRAKIS. But why was that drug approved? 

Ms. WOODCOCK. Pardon me? 

Mr. BILIRAKIS. Why was that drug approved? 

Ms. WOODCOCK. Zohydro? 

Mr. BILIRAKIS. Yes. 

Ms. WOODCOCK. All right. Zohydro is a single ingredient, highpotency opioid. You can’t take—you said Vicodin. You can’t take a 

lot of those if you have severe pain because it has acetaminophen 

in it, and it will be toxic to your liver, and acetaminophen is a very 

big cause of liver failure, OK, and liver transplants. Because people 

are getting too much acetaminophen. So we need high-potency 

opioids for people who have severe pain. 

Mr. BILIRAKIS. But why wouldn’t we make sure that it has abuse 

deterrent prior to approval? 

Ms. WOODCOCK. Abuse deterrence is really in its infancy, unfortunately. We have approved one product with abuse-deterrent properties. Those are quite limited, abuse-deterrent properties. I don’t 

want to talk about that further. But they are present, OK. But we 

have a long way to go, and almost all the opioids on the market 

do not have abuse-deterrent properties. 

Mr. BILIRAKIS. OK. Thank you very much. 

I yield back the balance of my time. 

Mr. PITTS. Chair thanks the gentleman. 

Now recognize the gentleman from Virginia Mr. Griffith for 5 

minutes for questions. 

Mr. GRIFFITH. Let me pick up on some of what my colleague was 

just talking about. Because a number of people are having difficulty, particularly at their pharmacies, based on some of the new 

rules or regulations that have come out. 

In fact, I was standing in my local pharmacy waiting to get some 

drugs for my son a couple of months back, and there was a lady 

there getting some medication for her mother, and a local judge get 

something medication for his wife, who just had surgery, and the 

pharmacist, while I was standing there, had to inform both of them 

that they had used their allotment under the DEA’s new regulations of those particular types of drugs, and they would have to 

come back next week. 

115 

Now, wasn’t a problem for the judge. He was coming in, you 

know, a little early so that he didn’t have that pressure, and that 

she would have the medication she needed. 

But for the lady who was getting drug for her mom, it was very 

stressful. She said, my mother needs this medication. I promised 

them I would look into it. 

What do I tell them? I mean what are we doing to make sure 

that these folks are heard from and that the drugs are available 

when there is a valid prescription for a valid patient who presents 

that to a pharmacist? 

Mr. RANNAZZISI. We talk to the pharmacists about this. The 

pharmacists are being told by their distributors that DEA is setting 

up a quota. There is no quota, there has never been a quota when 

it comes to distributors. I defy anybody to show me where there is 

a quota. 

The fact is, we ask the distributors to know their customers and 

ensure that the drugs they are sending downstream are you know, 

if it is a suspicious order, that it is reconciled before it is sent. But 

there has never been a quota to, going downstream from wholesaler to pharmacy. The pharmacists are reporting this. That is 

what they are being told, but we are not telling them that. 

Mr. GRIFFITH. Well, can you figure out why it is that has happened? I mean, are you all making the distributors worry about it? 

So that if this particular pharmacy deals mostly, not exclusively, 

obviously, but mostly with older patients, because it has been there 

in one form or another on Main Street in Salem, Virginia, for about 

a hundred years, and so a lot of their folks are people that have 

been in the community for a long time. Some of them are fourth 

generation, et cetera. But some of them are also older, which 

means you are going to have, probably, more of those prescriptions. 

I think maybe that you all need to talk with the distributors 

again make sure that if it, you know, is a long-term situation, that 

drugstore may be a little higher than the CVS down the street just 

because they have been there forever. So their population by definition is going to be an older population. 

Mr. RANNAZZISI. And I understand that, and DEA does not want 

anybody to go without their medication, if they are a legitimate patient. But the problem is I have no control to tell a distributor to 

distribute to a pharmacy. 

And the fact is that, if they just complied with the act and complied with the regulations, there wouldn’t be a problem. 

Mr. GRIFFITH. Well, clearly, there is confusion somewhere. And 

I hope you will work with us to get that resolved. 

Let me move to another subject now, involves the DEA, and also 

may involve pain medication. Most people are unaware of this, and 

let me state right up front, I do not support recreational use of 

marijuana. But, believe it or not, Virginia has the oldest medical 

marijuana law on the books. It was passed in 1979. Either with the 

hope that the DEA was going to come around and say these are 

certain legitimate uses, or in the hopes of encouraging the DEA to 

do that. But it was passed in 1979. It’s 182251.1. And right now, 

it—as I think is the proper way to deal with medicinal marijuana, 

it requires a valid prescription from a valid physician, and then it 

has to be taken to the pharmacist to be filled. 

116 

Virginia set the construct up, and they did it just for cancer and 

glaucoma. Because in 1979, that is all the evidence would have justified. So they were trying to work within the construct of the Federal law and the DEA. Needless to say, no doctor in his right mind 

or her right mind is going to prescribe it, because that would get 

them in all kinds of trouble with the DEA. 

But when is the DEA going to take a look at medicinal marijuana? Forget the crazy laws, as I sometimes call them, that California has passed and some other States that make it open. But a 

law that would allow the legitimate use of marijuana, smoked 

marijuana as well, not just the pill form, for purposes of relieving 

people on any number of areas, but particularly on cancer and 

glaucoma. Because we know that has been—that science has been 

out there for decades. 

Mr. RANNAZZISI. Well, I think I will answer it and then I am sure 

my colleague would love to answer it as well—— 

We have a—maybe not. 

We have a—— 

Mr. GRIFFITH. Our impediment is the DEA won’t allow it. 

Mr. RANNAZZISI. Well, a petition process where a person could 

petition the Government to schedule, reschedule, or move through 

the schedules any drug. 

Now, in the case of marijuana, there are several factors. But one 

is it is based on approval as a medicine, and FDA has looked at 

this twice now, I believe, and the science is not there. There is no 

scientific evidence that shows that smoked marijuana is beneficial 

as a medicine. 

Mr. GRIFFITH. Well, and let me say, because my time is running 

out. I haven’t ever used marijuana recreationally or otherwise. But 

I will tell you that I have numerous constituents who feel that it 

has been of assistance to them, and I tell a story when I go out 

and talk to people. 

Decades ago, I went to—I knew somebody who was having a 

problem with cancer, and the story was told to me at the time by 

some of his friends that the doctors put on his chart ‘‘Nobody goes 

in this room from 11:00 to 12:00, and then bring his food at 12:00.’’ 

Because the doctors recognized that that would give him some relief. 

He was trying to stay alive as long as he could so he could see 

his 2-year-old child a few more days. Every day he could get was 

important. I am telling that story in a high school group, what I 

call my high school town halls. This kid raises his hand up, and 

I thought it was going to be some question about, what about recreational use? And he says to me, ‘‘They did that for my daddy too.’’ 

And I was in a different part of my district, and my district is 

about 4 hours long; there are no way they could have been anyway 

close, plus the kid was way too young. It wasn’t the same deal. So 

we have got doctors out there who are recognizing it. 

Further, I would submit there is a Washington Post article that 

says that it is difficult to get permission to even do the scientific 

studies because of the DEA. 

So I ask you to work on that, because that is a serious issue, and 

the American people support it for legitimate use, not abuse. Not 

recreational, but for legitimate use. 

117 

I yield back. 

Mr. PITTS. Chair thanks the gentleman. 

Now recognize the gentleman from New Jersey, Mr. Lance, 5 

minutes for questions. 

Mr. LANCE. Thank you, Mr. Chairman. 

Good afternoon to you both. 

I don’t want to beat a dead horse. I agree with Congresswoman 

Ellmers on the issue of the sunscreen, and I hope quick action can 

be taken, and I would personally benefit. I am in a situation where 

the sun is poison to me. And I presume that—I like going to the 

dermatologist about as much as I assume you like hearing us bark 

at you this afternoon, and I want to work with you so that we 

might bring these European components to market here in a safe 

and effective way, Dr. Woodcock. 

On a completely different issue. I would like to ask you a couple 

questions about special protocol assessments. It is my understanding that Congress intended that these agreements should be 

binding on both parties except when a substantial scientific issue 

has come to light, after an agreement has been reached and testing 

has begun. 

Dr. Woodcock, could you explain to the committee what type of 

scientific evidence would be so substantial as to cause the FDA to 

rescind a special protocol assessment for a drug that was otherwise 

safe and which had met all of its end points? 

Ms. WOODCOCK. Certainly. Well, in some cases, for example, we 

would learn for a class of drugs that there was a new safety problem, and say for the nonsteroidal, anti-inflammatory agents, we 

learned, as you recall with Vioxx and others, that they caused cardiovascular events, myocardial infarction or so, and if we had said, 

you don’t have to study that in depth in the premarket assessment, 

and then subsequently we learned that that whole class of drugs 

caused that problem, we would be remiss in approving that drug 

unless that safety problem had been addressed. 

OK. Now, similarly on the efficacy side, the special protocol assessment has at what end points, how you study the drug and 

what end points you use, and often we use surrogate end points of 

different kinds or intermediate clinical end points or whatever. 

And if we find that, in the interim, there is evidence that comes 

to light that that end point may no longer be valid and actually 

predict what we are looking for, then we might say we cannot any 

longer for any applicant rely upon that end point because its validity has been brought into question. 

However, I would say that out of—we have entered into almost 

a thousand agreements since 2007. And we have only rescinded 10 

over that whole time. 

Mr. LANCE. As a matter of public policy, I do think the FDA 

should be accountable for continued diligence in identifying issues 

that bear on the continued enforceability of an SPA agreement, and 

then notifying the sponsor of such issues within a reasonable period of time after the FDA has become aware of a new situation. 

Is my understanding correct as to how that system works? 

Ms. WOODCOCK. I am not sure it is a system. But I totally agree 

with you that is what we should do. 

118 

Mr. LANCE. Thank you. I hope to work with you in a more extended way on this issue, and I appreciate your attention to the 

matter. 

And, Mr. Chairman, I yield back a minute and 20 seconds. 

Mr. PITTS. Chair thanks the gentleman. 

Now recognize the gentleman from Pennsylvania, Dr. Murphy, 5 

minutes for questions. 

Mr. MURPHY. Thank you, Mr. Chairman. I yield my time to you. 

Mr. PITTS. All right. Thank you. 

Mr. Rannazzisi, with respect to scheduling, is it your understanding that you cannot speak to, at the very least, the goals of 

the MOA that DEA and FDA are trying to achieve? 

Mr. RANNAZZISI. The MOA will give us the opportunity to share 

information, both proprietary and information pertaining to our different databases, on just about anything in the process. Not only 

scheduling, but other things as well, and that is something that 

has never been in place before. So that memorandum of understanding, will give us the opportunity to move information back 

and forth under agreement of how it should be maintained. 

Mr. PITTS. Dr. Woodcock, is that your understanding? 

Ms. WOODCOCK. Absolutely. And I would like to add that I think 

it will be extremely beneficial in some—we work closely with DEA, 

but we are not able to share certain information, which impedes, 

say, in the premarket realm, us working as closely as we would 

like. 

Mr. PITTS. Thank you. 

Will you both commit to working with the committee to provide 

this information, as much information as possible, by the end of the 

week to ensure that we can consider your efforts as we work on our 

legislation? 

Ms. Woodcock? 

Ms. WOODCOCK. Yes, as much information as possible, certainly. 

Mr. PITTS. Mr. Rannazzisi? 

Mr. RANNAZZISI. I would agree with that. 

Mr. PITTS. Well, that concludes the questions. 

Mrs. ELLMERS. Mr. Chairman, do you mind if—— 

Mr. PITTS. I yield to Ms. Ellmers. 

Mrs. ELLMERS. Mr. Rannazzisi, I just have one question that just 

is burning in my mind. As we have had these discussions on the 

process that the DEA is taking, I guess I just don’t understand why 

we are not going after the bad actors, those physicians who are the 

ones who are writing the prescriptions to those patients. We know 

they are out there. What is the DEA doing about the physicians 

who—because, look, I am in the medical community. I know it exists. And I know that I have known doctors who have abused this 

system. Where is the progress there? 

Mr. RANNAZZISI. Absolutely. Well, when we started initially with 

the Internet, we went after the physicians, the physicians that 

were prescribing over the Internet. 

But the problem evolved. As soon as Congress passed Ryan 

Haight, they immediately started opening rogue pain clinics. It 

closed down the Internet, and rogue pain clinics flourished. First 

in Florida, then in Georgia, Tennessee, Missouri, Kentucky—— 

119 

Mrs. ELLMERS. OK, to that point, and I understand. Because— 

you are pointing out a—we kind of went on an explosion. But, you 

know, we all live in small—I live in a very small community. I live 

in a small community where I know this is happening. 

Mr. RANNAZZISI. Yes. 

Mrs. ELLMERS. What is the DEA doing in those communities 

where you know they exist? 

Mr. RANNAZZISI. We have right now 66 task forces, State, local, 

and Federal task forces, that are working with HHS, OIG, and FBI 

and other agencies, and we go after these doctors. 

But the problem is, there are so many bad clinics right now. We 

are kind of overwhelmed, just as the States are. If you look at what 

is happening in Georgia, there are a lot of bad actors out there. 

And we are doing our best to keep up with them. 

As it spreads, as it spreads, for instance, in Texas, we are just— 

you are overwhelmed by the numbers. And these are not clinics 

that provide medical care. These are things that distributing—— 

Mrs. ELLMERS. Pain. And to that point, and then we will finish 

here so that we can move on. But, you know I do believe there is 

value in making an example of a physician, a physician’s office that 

repeatedly abuses the system and continues to be that cycle. 

Because, unfortunately, what we have learned is that those who 

are in the community and they are drug seeking and drug shopping, they network very well. They know who the physicians are 

that will write those prescriptions, and I would just imagine that, 

you know, maybe even just taking a step backward and just looking at it in a more singular level, especially in some of our rural 

communities, that that might go a long way. 

Mr. RANNAZZISI. That is exactly why the administrative—the immediate suspension order is so important. Because I could stop the 

hemorrhaging by issuing the immediate suspension order, and, 

quite frankly, the burden is a lot less than charging the bad actor 

with a crime. Not that he won’t be charged. But if I want to stop 

the hemorrhaging, I use the immediate suspension order to stop 

him from doing it. Then working with the State backtrack, and hit 

him with a criminal charge. 

So, yes, it happens, but it takes time. All of these cases take 

time. It is not distributing heroin or LSD. Those are illegal per se. 

It is distributing a legal substance illegally. 

Mrs. ELLMERS. Well, thank you, sir. 

And thank you to the chairman for allowing me to use the remainder of his time. 

Mr. PITTS. All right. Chair thanks the members. 

Mr. Pallone has a U.C. request. 

Mr. PALLONE. Thank you, Mr. Chairman, I have to just ask 

unanimous consent to submit into the record a comment letter on 

H.R. 4069 from the Drug Policy Alliance. I believe you have it. 

Mr. PITTS. Without objection, so ordered. 

[The information follows:] 

120 

121 

122 

Mr. PITTS. That concludes the questions of the members here at 

this point. We will send follow-up questions to you. We ask that 

you please respond as soon as possible. 

And the subcommittee will take a 5-minute recess as we set up 

for the second panel. Subcommittee is in recess. 

[Recess.] 

Mr. PITTS. We will ask the witnesses to please take their seats. 

On our second panel today we have five witnesses, Dr. Nathan 

Fountain, Chair, Medical Advisory Board, Epilepsy Foundation; 

Mr. John Gray, President and CEO Healthcare Distribution Management Association; thirdly, Mr. D. Linden Barber, Partner and 

Director, DEA Compliance Operations, Quarles and Brady; 

fourthly, Ms. Wendy Selig, President and CEO of the Melanoma 

Research Alliance; and Mr. Scott Faber, Vice President of Governmental Affairs, the Environmental Working Group. 

Thank you all for coming. Your written testimony will be made 

part of the record. You will each be given 5 minutes to summarize. 

And, Dr. Fountain, we will start with you. You are recognized for 

5 minutes. 

STATEMENTS OF NATHAN B. FOUNTAIN, CHAIR, PROFESSIONAL ADVISORY BOARD, EPILEPSY FOUNDATION OF 

AMERICA; JOHN M. GRAY, PRESIDENT AND CHIEF EXECUTIVE OFFICER, HEALTHCARE DISTRIBUTION MANAGEMENT 

ASSOCIATION; D. LINDEN BARBER, PARTNER AND DIRECTOR, DEA COMPLIANCE AND LITIGATION PRACTICE, 

QUARLES & BRADY, LLP; WENDY K.D. SELIG, PRESIDENT 

AND CHIEF EXECUTIVE OFFICER, MELANOMA RESEARCH 

ALLIANCE; SCOTT FABER, SENIOR VICE PRESIDENT FOR 

GOVERNMENT AFFAIRS, ENVIRONMENTAL WORKING GROUP 

STATEMENT OF NATHAN B. FOUNTAIN 

Mr. FOUNTAIN. Thank you. 

Thank you, Chairman Pitts and Ranking Member Pallone, for allowing the Epilepsy Foundation to provide comments to H.R. 4299 

today. 

I am a neurologist at the University of Virginia and also director 

of the comprehensive epilepsy program there. But I am reporting 

the Epilepsy Foundation today—representing the Epilepsy Foundation today as the chair of the professional advisory board. The Epilepsy Foundation is the largest patient advocacy group in the 

United States for epilepsy, indeed, in the world. 

And the two facts to start with, at least before our earlier discussion, I thought were sort of not in dispute, was first that DEA has 

progressively taken longer to schedule drugs after approval by the 

FDA. So the information that was quoted earlier is that in a referenced publication that we can provide if it is not in my written 

comments, is that between the years 1997 and 1999, the average 

drug approval by DEA, so the time to scheduling, was 49 days, so 

about a month and a half. In the period between 2009 and 2013, 

that increased to 237 days, or about 8 and a half months. So from 

1 and a half months all the way to 8 and a half months. 

123 

This second point that I think is at least clear to me is that DEA 

has always agreed with FDA’s recommendations for scheduling, at 

least according to the same published analysis I referred to before. 

I think we heard that as well. 

The epilepsy community is so sensitive to this issue because antiepileptic drugs, or anti-seizure medications, the medications that 

people with epilepsy have to take each day, have progressively 

been more frequently scheduled by the DEA. If you went back to 

older drugs for epilepsy, they weren’t an issue. But newer drugs, 

because of various reasons, are now scheduled by the DEA. 

So the most recently approved seizure medication was approved 

by the FDA on October 22, 2012 and received scheduling and approval for marketing by DEA on January 2, 2014, an astounding 

14 months later, according to FDA news. And I think if I understood their comments, that was even 11 months after it arrived at 

the DEA from FDA. So I think probably by any measure a very 

long time. 

Some brief background information about epilepsy illustrates 

why this delay is so important to Americans. Epilepsy is any condition that predisposes to spontaneous, recurrent seizures. You can 

imagine it happens by many different insults to the brain, such as 

a stroke or head trauma. But in fact it most often is caused by 

some microscopic change in the brain or some genetic predisposition to seizures in people who are otherwise perfectly fine and perfectly normal. 

Seizures are an electrical storm of the brain. The kind of seizure 

that people are most familiar with is a generalized tonic-clonic or 

grand mal seizure, when someone stiffens up, falls to the ground, 

and jerks rhythmically all over for a few minutes. They are then 

unconscious for a little while and, over the course of about an hour, 

return back to normal. 

But the electrical storm of the brain can start in just one spot. 

Seizures can arise focally in just one area, and the most common 

focal area they arise is in the temporal lobe. The temporal lobe, behind your temple here, controls consciousness and awareness, and 

during temporal lobe seizures, people don’t fall down and jerk all 

over, but instead stare off, unaware of what is going on around 

them. 

They are awake, but they are confused and don’t know what is 

going on, and that means that they may continue to do behaviors 

they are doing but they don’t do it correctly. So, for example, if 

they are ironing, they may continue to iron, but unfortunately they 

may pick up the hot side of the iron, and iron with that, burning 

their hand. If they are cooking with boiling water, they may put 

their hand, immerse it into the boiling water to pick something up 

because they are confused about what they are doing. If they are 

chopping something, they continue to chop and chop their own fingers. So it can a very dramatic and difficult thing for people with 

this kind of seizure, which is the most common type. 

But the greatest risk from epilepsy is death. Death from sudden 

unexpected death in epilepsy, or SUDEP, S–U–D–E–P, sudden unexpected death in epilepsy, in which patients die for no apparent 

reason. They are typically found dead in bed, sometimes associated 

with a seizure, the same seizure they have had ten, hundreds, 

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thousands of times before. But for whatever reason in this particular seizure, they don’t awaken and they die. SUDEP. 

Matthew is an engineering student at a Virginia university—I 

am from Virginia—with intractable epilepsy. He had seizures in his 

sleep that happened several times a week. Typically they weren’t 

such a substantial problem because as far as he knew, he didn’t 

have them. They just occurred in his sleep, but eventually, they 

started to occur during the day. When they started to occur during 

the day, you can imagine all different ways its disrupted his life. 

Besides the risk of injury, there are more common ways in which 

you can imagine if you have seizures that you can’t drive, difficulty 

working and so forth. 

He was an otherwise very personable, pleasant young man. I 

have an 18-year-old son who is at the University of Virginia, a 

freshman. Could have about been my son, could have been your 

son, could have been your daughter. And as his seizures persisted, 

we tried more and more medications to treat them. Eventually, for 

those situations we consider surgery. It is a several month long 

evaluation to localize exactly where the seizure is coming from in 

the brain; if that is a safe spot to remove, then removing that spot. 

But unfortunately a couple of months into his evaluation, I got an 

email message I received too many times in which the subject line 

is ‘‘sad news.’’ And whenever that happens, my heart just sinks because I know what is coming next. So, on opening the email, it 

says, from my nurse, ‘‘Matthew’s mother called today. He was 

found dead in bed. He went to bed last night perfectly fine, but he 

didn’t come down for breakfast, I went to check. He was dead.’’ 

So you can imagine there is no more devastating thing that could 

happen to you. What could possibly be more devastating? Most of 

us would rather cut off our arm than lose a child. Right? And, of 

course, it doesn’t just happen to children and young adults. It happens to everyone with epilepsy. So the question is, how common is 

this? What is the scope of the problem? Is he just one guy in my 

thousands of patients with epilepsy? No. I am afraid not. 

Take a step back for the scope of the whole problem. Epilepsy is 

common. About 1 in 26 people have epilepsy at some time in their 

life. Earlier today there were 96 people in this room. That means 

three or four of them had epilepsy. Some of they had it as a child. 

They outgrew it. It went away. Some of them haven’t gotten it yet 

because its highest incidence is in the very young and in the elderly, as you can imagine. But that is pretty common. About 3 million 

Americans have epilepsy today. That is quite a lot of Americans. 

And about a third of these people have seizures that are not controlled with available medications. That means they persist in having seizures, despite our best efforts, like Matthew. 

I follow about 2,000 people with epilepsy in my clinic per year, 

and I get this message about twice per year. So I now have accumulated about 50, actually 52 people with epilepsy who have died, 

mostly in this manner. It is not a small problem. It is a huge problem and as a general sense affecting almost 3 million Americans; 

in a specific sense, the risk of death for those people with intractable epilepsy, at least a million. 

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Now, we started Matthew’s evaluation when the last drug I mentioned had been approved by the FDA but was awaiting scheduling 

at the DEA. That is when he died. 

Mr. PITTS. Could you please summarize, Doctor—— 

Mr. FOUNTAIN. One last sentence. So I can’t tell that you that 

Matthew would be alive if he had this drug available, but he certainly might be, as would other patients with epilepsy who desperately need these kind of treatments that have been found safe 

and effective by the FDA. Thank you. 

Mr. PITTS. Thank you. 

[The prepared statement of Mr. Fountain follows:] 

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Mr. PITTS. Mr. Gray, you are recognized for 5 minutes for your 

summary. 

STATEMENT OF JOHN M. GRAY 

Mr. GRAY. Good afternoon, and to members of the Energy Subcommittee on Health, Ranking Member Pallone and Chairman 

Pitts, I am John Gray, President and CEO of the Healthcare Distribution Management Association. I want to thank you for the opportunity to come here to talk about Representatives Blackburn 

and Marino, the Ensuring Patient Access and Drug Enforcement 

Act of 2014, H.R. 4069. 

HDMA is the national association representing America’s primary pharmaceutical distributors, the vital link we say between 

manufacturers, pharmacies and health care providers. Our industries’ prime mission is to operate the safest and most secure supply 

chain in the world. As part of the mission, the pharmaceutical distribution industry is committed to addressing the serious national 

epidemic of prescription drug abuse. Drug abuse and diversion as 

we have heard here today is a complex, challenging problem calling 

for a collaborative effort on the part of doctors, pharmacists, distributors, manufacturers and importantly State and Federal authorities. 

HDMA members are committed to working proactively with the 

DEA, local law enforcement and other regulatory agencies, to investigate potential cases of diversion and implement protocols to 

monitor and report suspicious orders. 

The supply chain is a complex one depending on numerous core 

components working closely with one another to ensure patients receive the medicines they need and to prevent the diversion to individuals who would abuse the drugs. It is sometimes difficult to find 

the balance between proactive and anti-diversion efforts while not 

inadvertently limiting access to appropriately prescribed and dispensed medications. 

We hope this legislation will address the need for balance and 

encourage some cooperation and collaboration between prescribers, 

dispensers, distributors, manufacturers, regulators and the like, 

while making sure that the legitimate patient population continues 

to get what they require for medication. All HDMA members take 

seriously this obligation to fill only legitimate and appropriate orders for controlled substances. 

However, in many instances, our members struggle with applying the Controlled Substances Act and it is accompanying regulations to the specific situation when balancing the need for preventing the diversion at the pharmacy or the doctor’s office and ensuring that the legitimate patient needs are addressed. This is one 

of the reasons why HDMA supports 4069, the legislation’s timely 

and thoughtful approach to addressing the prescription drug epidemic. And we believe it will foster, again, better collaboration, 

communication and transparency between the industry stakeholders and the regulators, especially the DEA. Our members appreciate the importance of DEA’s law enforcement activities, confronting, disrupting, and dismantling illegal drug trafficking. However, establishing a collaborative working relationship between 

DEA and our members will serve as a more effective way to curb 

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the diversion of legal medicines. We feel this legislation will improve the interaction with DEA as they engage in their regulatory 

duties to prevent the diversion of these substances. The several key 

components, the bill clarifies the regulatory environment by defining terms that will facilitate greater compliance with and consistent enforcement of the Controlled Substances Act. Another key 

provision is the bill establishes a corrective action for plan registrants working with the DEA. This concept first raised by Representative Blackburn during a hearing on drug abuse here 2 years 

ago, is intended to mirror the way the FDA interacts with and regulates pharmaceutical manufacturers. 

The bill will allow DEA-registered companies to submit corrective plans, to address and mitigate any of the agency’s concerns, we 

hope and we believe creating a more robust, transparent, time-sensitive approach to addressing diversion. Preventing this diversion 

and abuse requires a clear understanding of the regulations consistent with the CSA and prompt communication between supply 

chain members and the regulators. The provision ensures that law 

enforcement registrants will collaborate to achieve these aims. 

Finally, the bill establishes a prescription drug abuse working 

group to encourage meaningful dialogue and coordination between 

the supply chain stakeholders, law enforcement, patient advocacy 

groups, as well as State and Federal regulators. Ultimately, the 

working group will provide guidance to Congress on the most effective strategies to curb this prescription drug abuse. 

HDMA has long been working to improve the collaboration 

among industry stakeholders. We recently joined the Alliance to 

Prevent the Abuse of Medicines. The alliance is in the process of 

developing a platform of policy recommendations to address numerous aspects of the drug abuse diversion problem, and that alliance 

does support 4069. 

We recognize there isn’t a one-size-fits-all solution to this problem. There never is. But we believe pharmaceutical distributors, 

along with our other supply chain partners, are committed to a 

more coordinated and transparent approach, balancing between addressing enforcement, public health and treatment efforts. We are 

neither seeking to restrict DEA’s authority nor increase the regulatory burden on registrants. What we are seeking is clarity, consistency to ensure that the public health needs are adequately addressed in a balanced, collaborative and effective manner. In the 

end, we share the same goal, ensure patient access, sufficient, safe 

and secure supply chain of medicines for the necessary therapies 

while keeping these drugs out of hands of individuals who will 

abuse them. The anti-diversion efforts need to strike a balance between the need to reduce abuse and diversion while avoiding disruptions to legitimate patients. 

Thank you again for this opportunity to participate in the hearing, and I hope this overview was valuable to the committee. 

Thank you, Mr. Chairman. 

[The prepared statement of Mr. Gray follows:] 

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Mr. PITTS. The Chair thanks the gentleman and now recognizes 

Mr. Barber 5 minutes for an opening statement. 

STATEMENT OF D. LINDEN BARBER 

Mr. BARBER. Good afternoon, Chairman Pitts, Ranking Member 

Pallone, and members of the subcommittee. Thank you for the opportunity to testify. 

My name is Linden Barber, Partner at Quarles & Brady. I am 

a former associate chief counsel at DEA. H.R. 4069 provides much 

needed clarity in the Controlled Substances Act, and that clarity 

will foster compliance, communication and collaboration, which is 

essential to preventing prescription drug abuse and ensuring that 

patients have access to controlled medications. 

History tells us why clarity is important. In 2006, DEA stopped 

issuing immediate suspensions for 8 months because a Federal 

court ruled that the way DEA issued suspensions was unconstitutional. During that critical time, Internet pharmacies were fueling 

prescription drug abuse with millions of pills, and the agency 

issued zero immediate suspensions. That is Exhibit A for why clarity in the law is so important. The CSA allows DEA to immediately 

suspend a registration based on imminent danger to the public 

health, but the act does not currently define ‘‘imminent danger.’’ 

This lack of clarity and DEA’s inconsistent approach to immediate 

suspensions has led to judicial intervention. Defining imminent 

danger will protect DEA’s ability to issue immediate suspensions. 

In 1974, a year after DEA was created, a pharmacy successfully 

challenged DEA’s immediate suspension order because the alleged 

danger was one single incident that occurred more than 7 months 

before the suspension, far from an imminent danger. More recently, 

the 2006 case I mentioned echoed that same theme, and last year, 

the DC Circuit Court of Appeals raised pointed concerns about the 

DEA’s apparent lack of a standard in applying the imminent danger definition or lack thereof when issuing suspensions. History is 

sending a message. In the absence of clarity in the law, courts will 

intervene, and they will curtail DEA’s powers. 

After the 2006 adverse decision, I became the associate chief 

counsel at DEA and was charged with fixing the immediate suspension process for the agency. As part of that, the agency took a 

disciplined approach to applying the imminent danger standard, an 

approach that is consistent with the definition of imminent danger 

in H.R. 4069. Using that approach, we issued a record number of 

immediate suspensions in 2007 and 2008. I am confident that defining imminent danger the way this bill does will not impede 

DEA’s ability to issue immediate suspensions. 

The lack of clarity in DEA’s inconsistency has unintended but 

devastating consequences for the public. Why would a pharmacist 

tell DEA about a doctor’s bad prescribing habits if DEA was going 

to use that to suspend the pharmacy’s registration, even though 

the pharmacy was no longer filling those prescriptions? This is not 

a hypothetical. The agency has issued suspensions for conduct that 

it knew was no longer occurring. Registrants get this message: 

Don’t tell DEA about a bad prescriber who is the real source of diversion because DEA might take action against you. 

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Clarity in the law will remove that fear and foster communication that helps DEA identify truly bad actors. Clarity also promotes 

access to controlled medications for patients. Without clarity, registrants often act to reduce the perceived risk of regulatory action. 

A pharmacist refuses to fill legitimate prescriptions for narcotics 

simply because dispensing a high volume of narcotics brings the attention of the agency and the supplier on the pharmacy. 

No one wants cancer patients or wounded veterans or those with 

chronic pain to go without their pain medication, but restricting access is an unintended consequence of a regulatory environment 

that lacks clarity. 

The corrective action plan section of the bill also promotes communication with the agency by assuring registrants that the agency will consider remedial actions they have taken. It is important 

to note that the remedial action section and corrective action plan 

does not apply to immediate suspensions for the reasons I discussed in my written testimony. 

Nearly a decade ago, DEA crippled elicit Internet pharmacy 

schemes. We issued a record number of administrative actions, collected record-setting civil penalties, but prescription drug abuse 

continued to rise. All along, DEA was working tirelessly to protect 

the public, and all along, the vast majority of registrants were looking for ways to cooperate with the agency. 

Members of the subcommittee, how can these efforts of the agency and industry be harnessed to effectively address medications for 

patients and to prevent diversion? The answer is with clarity. Clarity will produce compliance, communication and collaboration, and 

that collaboration will produce real results in preventing the prescription of diversion drugs and their abuse. 

[The prepared statement of Mr. Barber follows:] 

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Mr. PITTS. The Chair thanks the gentleman. 

I now recognize Ms. Selig, 5 minutes for an opening statement. 

STATEMENT OF WENDY K.D. SELIG 

Ms. SELIG. Thank you, Mr. Chairman, good afternoon, Ranking 

Member Pallone and members of the subcommittee. My name is 

Wendy Selig, and I am the President and CEO of the Melanoma 

Research Alliance, known as MRA. Thank you again for inviting 

me to testify today on behalf of my colleagues in the Public Access 

to Sunscreens Coalition, known as the PASS Coalition, in support 

of H.R. 4250. 

The PASS Coalition is a multistakeholder group that advocates 

for a regulatory pathway for new, safe and effective sunscreen ingredients. The goal of the coalition is to work collaboratively to establish a transparent and predictable process for premarket review 

of sunscreen components. MRA is a unique non-profit organization 

whose mission is to end suffering and death due to melanoma by 

collaborating with all stakeholders to accelerate powerful research, 

advance cures for all patients, and prevent more melanoma. We are 

the leading private funder of melanoma research, having awarded 

more than $51 million in cutting-edge scientific projects around the 

world. 

Mr. Chairman, as has been discussed here this afternoon, skin 

cancer is the most common form of cancer diagnosed in the United 

States, with more new cases of skin cancer than breast, prostate, 

lung, and colon cancer combined every year. Melanoma, which is 

the deadliest of the skin cancers as a result of its ability to move 

quickly and to spread to distant organs in the body, is rising dramatically across demographic groups. 

Each year, more than 76,000 Americans are diagnosed with 

melanoma, one every 8 minutes, and more than 9,400 Americans 

die, one every hour. So, in the time that we have been sitting here, 

we have lost several melanoma patients. 

We have made real strides on the treatment front, as four new 

drugs have been approved for use by the sickest of these patients. 

We commend the FDA and especially Drs. Woodcock and Pazdur 

and their colleagues for their work in this area, including landmark 

efforts in immune therapy, biomarket-driven targeted therapies, 

combination therapies, and breakthrough therapy designation to 

speed review processes. These new drugs are saving lives, and their 

approval and use are paving the way for continued investment and 

innovations that will bring about even more dramatic progress. 

Still we know that more effective options for patients are urgently needed. Everyone is at risk for developing melanoma. One 

of the risk factors, as we have been discussing today, for all skin 

cancer and specifically for melanoma is exposure to UV radiation. 

In fact, one blistering sunburn that happens during childhood can 

double a person’s lifetime chance of developing this deadly skin 

cancer. We take every opportunity to urge people to protect themselves and their loved ones by reducing exposure to UV from the 

sun, from tanning beds, and to examine their skin and watch for 

changes and see a dermatologist regularly, especially if they notice 

a change. 

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A central message is that people should use effective sunscreen 

protection all year round. As you know, FDA is responsible for ensuring the safety and effectiveness of all drugs, including evaluating medical claims related to sunscreens and sunscreen ingredients. The 2002 TEA process envisioned a 90 to 180 day evaluation 

process. Yet as we have been discussing today, FDA as not completed the review of any new sunscreen component under TEA or 

its preexisting OTC process since the 1990s. I think everyone 

agrees the current sunscreen premarket review process needs to be 

reformed. 

It is important that I point out that the sunscreens Americans 

use today can be effective for those who use them correctly. However, the latest products developed and used around the world can 

offer important steps forward and should be made available in the 

U.S. if found to be safe and effective. Finding innovative ways to 

make these products more effective and user-friendly can help ensure more people are using them properly and to maximum effect. 

Unfortunately, given the history of stalled reviews under the FDA’s 

current process, there is a strong disincentive for investment in 

this kind of sunscreen innovation for the U.S. market. 

The Sunscreen Innovation Act would codify a time frame for review and provide FDA with the authority to make a final scientific 

decision on the application instead of going through the cumbersome and delayed rulemaking process. While keeping the existing process whereby FDA makes an ultimate eligibility determination, the act says an existing advisory committee of experts will review the safety and advocacy data. It ensures that all submissions 

are reviewed within a predictable time frame. Enactment of this 

legislation would be a victory for everyone, for the FDA, for manufacturers, and, most importantly, the American people. Mr. Chairman and members of this subcommittee, I commend you for holding this hearing and to Mr. Whitfield and Mr. Dingell for taking 

the lead on this bill. 

May is Melanoma Awareness Month, just a few weeks from now. 

As the weather improves and people are once again making plans 

for outdoor activities, MRA and the PASS Coalition look forward to 

working collaboratively with you and the FDA to enact the Sunscreen Innovation Act this year, and we hope perhaps we can see 

progress on that in Melanoma Awareness Month. 

Thank you, and I’d be happy to answer any questions. 

[The prepared statement of Ms. Selig follows:] 

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Mr. PITTS. The Chair thanks the gentlelady. 

And I now recognize Mr. Faber, 5 minutes for an opening statement. 

STATEMENT OF SCOTT FABER 

Mr. FABER. Thank you, Mr. Chairman, members of the committee. EWG strongly supports the goals of the Sunscreen Innovation Act, and we look forward to working with the committee to expedite the review of sunscreen ingredients. 

I don’t think I need to spend any time describing why skin cancer is a public health crisis or how FDA has not had the incentives 

to quickly review and approve sunscreen ingredients that have 

been used in Europe, Australia and other countries. So let me just 

take a few minutes to describe some of the truly modest improvements that we would propose to this act that we think would ultimately make it a more workable piece of legislation. 

So, first, and Mr. Dingell referred to this, we believe that to be 

eligible for expedited review, that a sunscreen ingredient should 

have been used for 5 years in a country with a competent regulatory system or, as Mr. Dingell put it, roughly equal to ours. As 

currently drafted the Sunscreen Innovation Act would allow expedited review for an ingredient that has been used in any one country for 5 years. It doesn’t distinguish between any one country and 

other countries that may have similar review systems to the U.S. 

review systems. 

Second, ingredients that are subject to expedited review should 

have been used as sunscreen ingredients, not as cosmetic ingredients or ingredients in dietary supplements, and one provision of 

the bill does suggest that those ingredients, ingredients that have 

been used for this purposes, could be eligible for this expedited review of sunscreen ingredients in the U.S. 

Third, and perhaps most importantly, I think it is very important 

that the panel that does review these ingredients that have been 

used in the EU and Australia and elsewhere has the technical competency to review potential health risks posed by sunscreen ingredients as Dr. Woodcock said, that might result from repeated longterm exposures. And while the Nonprescription Drugs Advisory 

Committee has many experts, they may not have the expertise to 

quickly and thoroughly review all of the potential health effects 

that might result from the sorts of ingredients that we are requiring for review. 

Fourth, and we have heard a little bit about this already. We 

think that Congress should set deadlines but workable deadlines 

for FDA and this advisory committee. For example, the current 

draft, under the current draft, the expert panel would be required 

to review all of the eight pending Time and Extent Applications 

that FDA within 180 days, which seems like a herculean task. So 

while we think deadlines are important, in light of the long history 

of delay, deadlines are essential, we think those deadlines need to 

be workable and, again, that the advisory panel that reviews these 

ingredients has the technical competency to really do a thorough 

evaluation. 

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Similarly, we think the FDA should have more than 45 days to 

respond to a recommendation by the advisory panel envisioned by 

the Sunscreen Innovation Act. 

Fifth, we think that ultimately, although there is an important 

role here to be played by a panel of experts, that ultimately, FDA 

should make the final determination of ingredient safety and that 

supervisors who are reviewing CDER staff decisions should have 

the power to ask for more information, either from FDA staff or 

from the panel, not simply to decide whether or not the ingredient 

should be intercommerce or not. 

Sixth, we believe that applicants seeking expedited review should 

provide both published and unpublished data regarding the safety 

and efficacy of sunscreen ingredients, and that data should be 

shared with the public. Obviously, the current bill does envision a 

role for the public, and we appreciate that. I think we just need to 

be clear about precisely what we are asking companies to provide, 

if they are going to receive expedited review and how much of that 

is available to the public. 

And then, lastly, we think it is critically important that FDA be 

required to finalize a proposal to restrict the use of SPF claims 

greater than 50. Other countries have taken steps, including Australia and Japan and others, to restrict SPF claims greater than 

50. But we do think that FDA should be given more time than is 

envisioned in the current bill to assess the inhalation risks and 

other risks posed by aerosol sprays. FDA has started to look at this 

question. It has only begun in the last few years. It is a critically 

important health question. We think they should be given the time 

to do a thorough and a fair assessment. 

Let me just simply close by saying that we applaud Congressman 

Whitfield and Mr. Dingell for your leadership. We share the goals 

of the Sunscreen Innovation Act. We look forward to working with 

you to give FDA the help it needs to quickly review and approve 

these promising ingredients. Thank you. 

[The prepared statement of Mr. Faber follows:] 

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Mr. PITTS. Chair thanks the gentleman. 

That concludes the opening statements. 

We will now go to questioning. I will recognize myself 5 minutes 

for that purpose. 

Dr. Fountain, can you please describe the impact DEA delays 

have on patients suffering from epilepsy? 

Mr. FOUNTAIN. Well, in addition to the impact we talked about 

before, of the risk of death during the whole time seizures are active, there is a much wider and more difficult perspective. So about 

3 million Americans have epilepsy and about 1 million of them, so 

almost a million Americans, have intractable epilepsy, meaning 

they continue to have seizures despite our best efforts. So for all 

of those people, having a delay in treatment can be life-threatening, as we talked about. And that affects a relatively few people 

in a very important way. There is also a huge effect on everyone 

else. Because for the remainder of people, they need new drugs 

available soon because they are waiting for a new drug to control 

their seizures. 

Epilepsy is difficult in many ways, but one of the ways is that, 

although we now have almost 20 drugs available for the treatment 

of epilepsy, we still have this group of people that continue to have 

seizures despite our best efforts. But as each new drug is approved, 

we are able to control more and more people with epilepsy. And if 

you are in that group that is controlled, then waiting for that drug 

is a longer time that exposes you to the problems of epilepsy. 

Mr. PITTS. Thank you. 

Mr. Barber, do you believe DEA adequately factor legitimate patient access into its registration and scheduling time frames as well 

as its enforcement decisions? 

Mr. BARBER. Mr. Chairman, I will first address the issue of 

scheduling, particularly with regard to new molecular entities. The 

studies that are done by HHS are binding on DEA when it comes 

to the medical and scientific factors, and so the delay time in 

studying a new molecular entity is curious because there is no law 

enforcement data for a molecule that has not previously existed. So 

looking for issues of real diversion and law enforcement activity 

around a new molecular entity seem like they should be very brief 

because the entity has not previously existed. 

I believe that DEA does care about patient access. I am not sure 

that they necessarily take into account the unintended consequences of the significant delays that come with new molecular 

entities when scheduling. 

With respect to enforcement activity, certainly, Mr. Chairman, I 

do believe and as a long-time DEA employee—I have been gone for 

21⁄2 years—I believe the agency cares about patient access. But, 

again, it is the unintended consequences. Mr. Rannazzisi testified 

previously and knowing him, he is a pharmacist, he does care 

about patient access. I am just not convinced that the way the 

agency handles enforcement activities contemplates all of the unintended consequences in the supply chain. 

Mr. PITTS. Mr. Gray, do you have anything to add on this front? 

Mr. GRAY. I believe his assessment is correct. I think they have 

a legitimate goal. 

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I think, as you said, Mr. Rannazzisi is a pharmacist himself. But 

it is the law of unintended consequences when you apply what I 

would call enforcement tactics for illegal drugs to the legal market. 

And what happens is what has happened in the case of our members is without specific guidance and detail as far as how they are 

to interpret suspicious orders, then our members are forced into 

situations where they make decisions to terminate relationships 

with pharmacies, thereby immediately limiting that pharmacy’s 

ability to get certain Schedule II drugs. 

Mr. PITTS. Would either of you comment on how a more collaborative relationship between supply chain, stakeholders, and the 

DEA, would help in our effort to address prescription drug abuse 

and diversion? 

Mr. BARBER. Certainly, Mr. Chairman. 

I will point to a historical example that really brings this to light. 

There was a significant problem with methadone overdose deaths 

related to the 40-milligram methadone diskette. And without any 

regulation, without any new law, DEA called manufacturers and 

distributors in and asked them to voluntarily not sell the 40-milligram methadone diskette, except for narcotic treatment programs, 

not to sell it for dispensing for pain. And the manufacturers and 

distributors responded and voluntarily did that, and it reduced the 

overdose deaths related to 40-milligram diskettes, so collaboration 

absolutely actually addresses the real problem of prescription drug 

abuse. 

Mr. PITTS. Ms. Selig, Mr. Faber, Dr. Woodcock committed to 

working with the committee to improve the timelines and predictability of the Time and Extent Application, TEA, process is a it relates to new sunscreen ingredients. Do you think the TEA process 

provides an efficient mechanism by which these types of products 

can get to consumers in the U.S., and what else can be done? 

Ms. SELIG. Thank you, Mr. Chairman. I appreciate Dr. 

Woodcock’s statement, and we look forward to continuing to work 

with FDA. That said, I think that we have heard repeatedly from 

FDA, and our own assessment is we need your help here in Congress, and that is why we support this legislation, that the current 

regulatory process that the TEA system and the OTC system for 

sunscreens is based on has really been broken. And in order to not 

only clear out the backlog that exists with those eight applications 

that are pending, but to encourage innovation and to bring the 

most cutting-edge innovation to American consumers, we need your 

help with this legislation. 

Mr. PITTS. Mr. Faber, do you want to add anything? 

Mr. FABER. I will just had that this process has been in place 

since 2002, and FDA has been unable to review and improve even 

one sunscreen ingredient, and that six of the eight ingredients that 

have sought applications, have filed applications, have languished 

at FDA for more than 8 years. So I think, clearly, as we have all 

heard today, that this process is not working for consumers or for 

manufacturers. 

I do think, with all due respect to Dr. Woodcock, that we should 

not have to wait for a reformation of the sense of the monograph 

process for FDA and with the help of an advisory panel to review 

and approve some of these very promising ingredients. 

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Mr. PITTS. The Chair thanks the gentleman. My time is expired. 

The Chair now recognizes Mr. Green 5 minutes for questions. 

Mr. GREEN. Thank you, Mr. Chairman. 

Dr. Fountain, can you describe what your organization’s communication with DEA is like, and how do you think it could be improved? 

Mr. FOUNTAIN. Our communication has been limited to more or 

less the issue at hand because of the seemingly desperate situation 

that I mentioned before about how long it has taken to have the 

most recently approved, FDA approved drug scheduled by the DEA. 

In that case, the communication was sent to DEA and received a 

response 7 and a half months later, and we don’t have—I would 

have to inquire of the whole organization, but I am not aware of 

any ongoing dialogue. 

Mr. GREEN. And as you know from my questions of the DEA, I 

have problems with that. I think the DEA needs to be more transparent in dealings with patients, doctors and companies regarding 

scheduling and registration decisions. I think it needs to have a 

predictable time frame for making these decisions, and I think the 

decisions need to be made more quickly, and I hope we can pass 

our bill to fix it. 

Mr. Faber and Ms. Selig, H.R. 4250 could be seen as ceding to 

FDA decisionmaking authority to an advisory committee, although 

it does provide the FDA with some authority to reject that decision. 

As far as I know, this would be unprecedented use of the advisory 

committee. I would like to get both of your reactions to the description in the bill. 

Mr. FABER. As I said earlier, I do think that there needs to be 

some very modest improvements made to the Sunscreen Innovation 

Act that would give FDA more time to review the recommendation 

of a technically competent advisory panel and that the FDA should 

have the final say regarding the safety and efficacy of a sunscreen 

ingredient. I think one of the important changes is that there is an 

appeals process envisioned in this bill where the supervisory staff, 

CDER staff, could ultimately overrule a staff decision. That supervisor should have the power to ask staff for more information, to 

ask the panel for more information, and not simply be in the position of having to approve the panel’s recommendation. 

Mr. GREEN. Would the PASS Coalition be willing to work with 

the committee and the FDA to improve the legislation to get a bill 

that would work for all of us? 

Ms. SELIG. Absolutely. The coalition has been attempting to work 

with everybody involved throughout this process and has had multiple conversations and meetings with all stakeholders and will absolutely continue to do that. 

I think that the bill as drafted would be a great step forward, 

and we envision, obviously, and from the perspective of melanoma 

patients and from the public in terms of our recommendation to the 

American people about using safe and effective sunscreen and 

using it properly, we definitely want to make sure that these products are reviewed in an appropriate regulatory environment by the 

FDA to be both safe and effective. 

That said, the current process doesn’t work. One reason that we 

have been told that it has been so difficult is because of the reguVerDate Mar 15 2010 13:37 May 11, 2015 Jkt 037690 PO 00000 Frm 00179 Fmt 6633 Sfmt 6633 F:\113-137 DEA, FDA REGS 2ND SCAN REQ 5-7-15\113-137 DEA, FDA REGS PENDING
176 

latory rulemaking process. So I think the proposal that is in the 

legislation is aimed at trying to get out from under that so that we 

can move these things forward in an appropriately timely manner 

and get back to innovating in this country, as opposed to watching 

the rest of the world have access to more innovation than we are 

having here. So we absolutely will work with everybody to try to 

make this bill better, but we definitely want to see the legislation 

move toward. 

Mr. GREEN. Mr. Gray, prescription drug abuse is on the rise and 

represents significant growing public health threat. Congress and 

relevant Federal agencies in public and private have responsibilities to address this epidemic and ensure the health and safety of 

the American people. What in your opinion is the appropriate role 

of prescription drug distributors in the fight to eliminate and prevent this prescription drug abuse? 

Mr. GRAY. Well, my members, we have 34 companies that deliver 

over 98 percent of the prescription drugs in this country, so we are 

a logical choice to look at where the drugs are coming through and 

going to. We have the ability, as we do every day, to monitor the 

ordering of Schedule II drugs to every pharmacy and clinic in the 

country. We keep that data. We give it weekly to the DEA. And, 

in fact, that has been one of the conundrums we face is each distributor submits their data to the DEA. The DEA collects the entire picture but does not share even a redacted version of that entire picture. So one distributor may know what they give to a certain pharmacy, but they don’t know the other wholesalers, what 

they are providing that pharmacy. So it is not a complete picture. 

The information is there. Our members have the technical capability to create that information. And our goal here is to be able 

to work collaboratively with DEA as a partner in this problem to 

say, does your information show what our information is, that this 

pharmacy is over its limits? Great. Cut that pharmacy off. And unfortunately, that is not the relationship we have today. 

Mr. GREEN. Thank you, Mr. Chairman. I am out of time. 

Mr. PITTS. Chair thanks the gentleman. 

I now recognize the vice chair of the full committee, Mrs. 

Blackburn, for 5 minutes of questioning. 

Mrs. BLACKBURN. Thank you so much, and I want to stay with 

Mr. Gray and follow on with Mr. Green’s questioning, because as 

Mr. Rannazzisi said several times, DEA doesn’t have quotas for the 

distributors, so it is up to the distributors to basically model how 

they are going to interact with the pharmacies on this product. So 

looking at the answer you just gave, is there anything else you 

would add into how these distributors are modeling their activity 

on the distribution of these drugs? And then I would like for you 

to talk for just a second about why this is problematic for our 

smaller pharmacies. 

Mr. GRAY. Well, let’s go back on that story line we were just talking about. When our members submit their suspicious orders on a 

weekly basis, DEA collects that data. They collect data from all 

wholesalers. Imagine it as a piece of pie. They see the pharmacy 

as a piece of pie. They will see the 360 degrees of that piece of pie. 

They see everything going in the door of that pharmacy with respect to Schedule II drugs. The particular distributor, who DEA 

177 

may be questioning—and you can correct me if I am wrong on this, 

Linden—but the DEA sees the whole picture. That particular distributor sees only their slice of the pie. They do not see what other 

distributors are doing. 

Mrs. BLACKBURN. So let me ask you. Would it be helpful then if 

the DEA were to periodically give a report back to those distributors as to where they are seeing patterns that are troublesome? 

And Mr. Barber, you may want to weigh in on this since you basically were involved in taking action. 

Mr. GRAY. It would certainly help because I know, in many cases, 

talking to my members, is that they will approach the regional office of DEA and say, ‘‘We have got a pharmacy here, pharmacy X; 

pharmacy X to us has suddenly seen an increase in ordering. This 

is out of their normal historical trend. Mr. DEA agent or Ms. DEA 

agent, should we cut that pharmacy off?’’ 

And the answer most typically back is, ‘‘Well, that is a business 

decision the wholesaler needs to make on their own, and then we 

will essentially fundamentally let you know if you were wrong after 

the fact.’’ 

So you are right. He was right. There are no quotas, but again, 

that creates the conundrum and the problem because not having 

quotas gives DEA the flexibility to take enforcement action I think 

without any kind of clarity to the wholesalers as to whether or not 

they are making the right business decision in terminating that 

pharmacy. 

Linden, I don’t know if you have a different opinion. 

Mr. BARBER. Mrs. Blackburn, I have looked at some of the DEA 

information that they have provided the industry. One of the 

things that we hear over and over again from the agency is there 

is an average number of pills that a pharmacy uses, but a pharmacy that fills 50 prescriptions a day uses a lot less drugs than a 

pharmacy that fills 500 prescriptions a day, and being above arrange is meaningless because if you have a normal distribution 

curve, half of your customers are going to be above average, and 

so it would be very helpful to industry if there was trending and 

modeling done not just by the industry, but by the agency who has 

all of the information. 

Mrs. BLACKBURN. OK. Mr. Barber, in your testimony, you focused a little bit on the importance of clarity of the law, and are 

there some specific areas that you think we should highlight in 

working with the DEA on how they should be more clear with the 

registrant? 

Mr. BARBER. Certainly, and I think your bill takes a great first 

step in creating the environment that is necessary by clarifying 

what ‘‘imminent danger’’ means and what ‘‘consistent with the public health and safety’’ means. At an industry conference recently, 

a DEA official told the industry that it means whatever DEA says 

it does. That is not really helpful when you are trying to comply 

with the law. There are other areas where I believe that oversight 

can be helpful, particularly in the regulatory environment. The 

agency will talk about things like due diligence by distributors on 

customers and yet you won’t find the term ‘‘due diligence’’ anywhere in DEA’s regulation. And so areas like that require clarificaVerDate Mar 15 2010 13:37 May 11, 2015 Jkt 037690 PO 00000 Frm 00181 Fmt 6633 Sfmt 6633 F:\113-137 DEA, FDA REGS 2ND SCAN REQ 5-7-15\113-137 DEA, FDA REGS PENDING
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tion and notice and comment rule making because it is those types 

of initiatives that actually will prevent prescription drug abuse. 

Mrs. BLACKBURN. Thank you. 

I yield back. 

Mr. PITTS. Chair thanks the gentlelady. 

Now recognizes the ranking member emeritus Mr. Dingell for 5 

minutes for questions. 

Mr. DINGELL. Mr. Chairman, thank you for your courtesy. These 

questions are for Ms. Wendy Selig of the Melanoma Research Alliance. They will only require yes or no answers. 

Ms. Selig, do you believe that skin cancer is a public health crisis 

in this country today? Yes or no. 

Ms. SELIG. Yes. 

Mr. DINGELL. Ms. Selig, is it correct that one American dies of 

melanoma every hour? Yes or no. 

Ms. SELIG. Yes. 

Mr. DINGELL. Ms. Selig, is exposure to UV radiation a major risk 

factor for skin cancer? Yes or no. 

Ms. SELIG. Yes. 

Mr. DINGELL. Now, Mr. Faber. This is for Mr. Scott Faber. Mr. 

Faber, your organization has extensive experience in this area. Do 

you agree that sunscreens which provide balanced UVA and UVB 

protections help lower the risk of getting skin cancer? Yes or no. 

Mr. FABER. Yes, sir. 

Mr. DINGELL. Mr. Faber, to confirm, do people in Europe, Canada, and elsewhere, have access to more new innovative sunscreen 

products than do consumers in the United States? Yes or no. 

Mr. FABER. Yes. 

Mr. DINGELL. Very quickly, why is that? 

Mr. FABER. Because our FDA has failed to provide a process that 

allows expedited review of promising sunscreen ingredients. 

Mr. DINGELL. I have been observing that they are sitting on 

those regulations like a hen on a porcelain doorknob. 

Mr. FABER. Yes, sir. 

Mr. DINGELL. Now, Mr. Faber, is it correct that FDA has not 

acted on applications for several chemicals that offer strong UVA 

protection but are already in use in the European Union and in 

Australia? Yes or no. 

Mr. FABER. Yes, sir. 

Mr. DINGELL. Mr. Faber, do you believe that the American people 

deserve access to these promising sunscreen technologies as long as 

they are proven to be safe and effective? Yes or no. 

Mr. FABER. Absolutely. Yes, sir. 

Mr. DINGELL. Mr. Faber, do you agree that the legislation is 

needed to improve FDA’s review of sunscreen ingredients? Yes or 

no. 

Mr. FABER. Yes, sir. 

Mr. DINGELL. Mr. Faber, you have been before this committee on 

a number of occasions, and I have always appreciated your wisdom 

and assistance. 

Thank you to our panel. 

It is clear to me that skin cancer is today a major public health 

crisis in this country, and legislation is needed to improve FDA’s 

179 

review of new sunscreen ingredients, which they are sitting most 

tranquilly by. 

The Sunscreen Innovation Act is one way to do so. I look forward 

to working with all of my colleagues to improve this legislation in 

whatever bipartisan manner may be necessary so it can be signed 

into law this year. 

I would point out that each hour, there is going to be an American somewhere dying of melanoma and skin cancer, and it does 

seem that maybe the Congress can assist the Food and Drug to 

come to a proper conclusion of addressing the concerns that we 

have about keeping Americans safe and affording them the same 

privileges and protections that are given in Europe, where there 

have apparently been no backlash, no problems about the question 

of safety with regard to these pharmaceuticals. 

Ladies and gentlemen of the panel, thank you. 

Mr. PITTS. The chair thanks the gentleman. 

Now recognize the gentleman from Kentucky, Mr. Whitfield, 5 

minutes for questions. 

Mr. WHITFIELD. Thank you, and I certainly agree with all the 

comments made by Mr. Dingell and particularly that relating to 

the porcelain knob. I like that. 

Let me just say this, Mr. Faber, thank you for your testimony 

and for coming up with some concrete suggestions on ways to improve the legislation, and Ms. Selig, I really do want to thank you 

and the Melanoma Research Alliance as well as the task group for 

sort of leading the charge on this issue. I was wondering, had you 

been aware of the suggestions that Mr. Faber made today before 

he made them today? 

Ms. SELIG. I think recently, yes, and we really appreciate the 

constructive effort to help everybody come up with a product that 

Congress can move forward with quickly. 

Mr. WHITFIELD. I wish that the PASS group would get together 

with Mr. Faber’s organization and see if we can come up with some 

improvements, and then maybe both sides of the aisle working together, we can move this legislation. And I know that Dr. 

Woodcock and others at the FDA have indicated they want to do 

something, so maybe we can help them make the decision on what 

should be done. So if you all would do that and get back with us, 

we would appreciate it. 

Mr. FABER. Absolutely. 

Mr. WHITFIELD. I yield back now. 

Mr. PITTS. The Chair thanks the gentleman. 

I now recognize the gentleman from Virginia, Mr. Griffith, 5 minutes for questioning. 

Mr. GRIFFITH. Thank you, Mr. Chairman. 

Mr. Gray, I am up here trying to problem solve and figure these 

things out because you may have heard my example earlier when 

I was standing in my local pharmacy, and they were under the impression, DEA witness testified that that was incorrect, that there 

is no quota, and you have said that as well, but the distributors 

have to watch it and be careful, and they don’t really know when 

it is they are going to get in trouble with the DEA. 

Mr. GRAY. Correct. 

180 

Mr. GRIFFITH. So here is what I have come up with that may be 

affecting—and I represent a fairly rural district that has a lot of 

small pharmacies. We have fewer mom-and-pop pharmacies than 

we used to, but still serve a fairly rural, somewhat suburban, but 

fairly rural community, and that is that apparently it may be true 

that at some of the smaller pharmacies, they only use one distributor. Has that been your experience, that maybe some of the 

small pharmacies use one distributor for their drugs? 

Mr. GRAY. You know, I think that will depend upon the where 

and the when. I mean, I would say, and this is just anecdotal, that 

is probably true the more rural that it is. More than likely it is one 

wholesaler involved. 

But that being said, there is a growing secondary and tertiary industry. When pharmacy cannot get product, they go into those 

markets to get that product. So it very well may be that they are 

actually dealing with other wholesalers that may or may not be reporting data to the DEA. It is very possible. 

Mr. GRIFFITH. The concern that I have is that maybe they are 

being flagged, and the distributor is saying, OK, we can’t send you 

any more because you are getting more than the distributor, you 

know, next valley over or down the road, depending on the size of 

the pharmacy. And if you are only using one, that is going to flag. 

As you said, the DEA gets the whole picture, but each distributor 

only sees what they are doing. 

Mr. GRAY. Correct. 

Mr. GRIFFITH. And so they can see a pharmacist perhaps that is 

using one wholesaler or distributor getting more drugs than some 

of his contemporaries nearby, but they may be using two distributors, but the first distributor is never going to know that they are 

getting two sources or three sources versus just the one. 

Mr. GRAY. Well, the layer of complexity to that is then it depends 

upon the demographics of that pharmacy and the patient population because the pharmacy in your district may have historically 

a number of pain patients. They may be near pain clinics. They 

may be hospitals or cancer clinics. And so it does vary. This is a 

difficult target because it does vary by pharmacy, by the location, 

by the demographics of the pharmacy, by the business model, 

where it is relative to other health care delivery systems in the 

area. So it is not as black and white as you might think, and that 

is where any amount of clarity we can get from the DEA as a 

wholesaler will be of extraordinary help. 

Mr. GRIFFITH. And so that is why you feel that they ought to 

share some of that information so that you all can get the big picture, too. Not that we want to help the bad guys. 

Mr. GRAY. That is right. 

Mr. GRIFFITH. And so you think that perhaps the information 

sharing that is envisioned by 4069 would be a good thing? 

Mr. GRAY. I think it would be an excellent thing. 

Mr. GRIFFITH. And you think that this might help my pharmacy 

back home? 

Mr. GRAY. I think it would help your pharmacy back home because whatever that wholesaler, whoever it was, made that decision, made it because they know the historical purchasing and delivering with that pharmacy, and they probably saw an uptick deVerDate Mar 15 2010 13:37 May 11, 2015 Jkt 037690 PO 00000 Frm 00184 Fmt 6633 Sfmt 6633 F:\113-137 DEA, FDA REGS 2ND SCAN REQ 5-7-15\113-137 DEA, FDA REGS PENDING
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pending upon the time of the year or whatever. And the way it is 

played now, is if there is an uptick, then that is defined in the 

wholesaler’s mind, that is suspicious. And the immediate reaction 

is if it is suspicious, you must terminate, and then talk with the 

appropriate people. So the decision always is to terminate first 

when in doubt. 

Mr. GRIFFITH. Now, in this case, they didn’t apparently terminate long term. Is that what the normal is, or just say no more for 

this month, or this cycle? 

Mr. GRAY. Well, good point. It should be for a finite set of time. 

In fact, we submitted a series of questions on two occasions to the 

DEA in the last 24 months. Do not have answers to those questions. One of them actually addressed that issue. For example, we 

asked a group of our members, said is 90 days, is 120 days, what 

is the appropriate amount of time before a wholesaler should reinstitute sales to that? What is the appropriate move on the trend 

line of the purchase order of that pharmacy to make that decision? 

Unfortunately, to this date, we have no answers. We have got no 

guidance from the agency. 

Mr. GRIFFITH. It is a difficult answer, and so I certainly don’t 

want to be critical of the DEA trying to control medications that 

shouldn’t be out there on the street and making sure that they are 

not going to folks who shouldn’t have them. At the same time, we 

want to make sure that the Judge’s wife that I mentioned earlier 

and that this lady whose mother desperately needed that medication are able to get it. So it is a balancing act. I appreciate that, 

and of course, being a legislator by nature and at heart, having 

served here not so long, but served a long time in Virginia, I recognize that it is the role of the legislative body to help enact that and 

move things forward, so I hope that we can get some form of 4069 

passed. 

And, Mr. Chairman, I yield back. 

Mr. PITTS. The Chair thanks the gentleman and also thanks the 

witnesses for your testimony, for answering our questions. There 

will be follow-up questions. We will provide those to you in writing. 

We ask that you please respond as promptly as possible. I will remind members they have 10 business days to submit questions for 

the record, and that means members should submit their questions 

by the close of business on Monday, April 21. Very important 

health and public safety issues raised today. Thank you very much. 

Without objection, the subcommittee is adjourned. 

[Whereupon, at 5:50 p.m., the subcommittee was adjourned.] 

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