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EXAMINING CONCERNS REGARDING FDA’S 

PROPOSED CHANGES TO GENERIC DRUG 

LABELING 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRTEENTH CONGRESS 

SECOND SESSION 

APRIL 1, 2014 

Serial No. 113–132 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

(II) 

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, Missouri 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

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 

(III) 

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) 

(V) 

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 .......................................................................................... 2 

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

New Jersey, opening statement .......................................................................... 4 

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

California, opening statement ............................................................................. 5 

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

prepared statement .............................................................................................. 6 

WITNESSES

Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, 

U.S. Food and Drug Administration ................................................................... 7 

Prepared statement .......................................................................................... 9 

Answers to submitted questions ...................................................................... 128 

Michael D. Shumsky, Partner, Kirkland & Ellis, LLP ......................................... 41 

Prepared statement .......................................................................................... 43 

Ralph G. Neas, President and CEO, Generic Pharmaceutical Association ........ 48 

Prepared statement .......................................................................................... 51 

Answers to submitted questions ...................................................................... 139 

Allison M. Zieve, General Counsel, Public Citizen ............................................... 66 

Prepared statement .......................................................................................... 68 

SUBMITTED MATERIAL

Material submitted by Mr. Pitts ............................................................................. 85 

(1) 

EXAMINING CONCERNS REGARDING FDA’S 

PROPOSED CHANGES TO GENERIC DRUG 

LABELING 

TUESDAY, APRIL 1, 2014 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON HEALTH, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 3:01 p.m., in room 

2322 of the Rayburn House Office Building, Hon. Joseph Pitts 

(chairman of the subcommittee) presiding. 

Members present: Representatives Pitts, Burgess, Shimkus, 

Gingrey, Lance, Guthrie, Bilirakis, Pallone, Green, Barrow, 

Christensen, Sarbanes, and Waxman (ex officio). 

Also present: Representative Braley. 

Staff present: Clay Alspach, Chief Counsel, Health; 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; Chris Sarley, Policy Coordinator, Environment & Economy; Heidi Stirrup, Health Policy Coordinator; John 

Stone, Counsel, Health; Tom Wilbur, Digital Media Advisor; Ziky 

Ababiya, Democratic Staff Assistant; Eric Flamm, Democratic FDA 

Detailee; Karen Lightfoot, Democratic Communications Director 

and Senior Policy Advisor; and Karen Nelson, Democratic Deputy 

Committee Staff Director for Health. 

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

OF PENNSYLVANIA 

Mr. PITTS. The subcommittee will come to order. The chair will 

recognize himself for an opening statement. 

One of the great successes in healthcare in the past 30 years has 

been the introduction and widespread use of generic drugs, saving 

patients and taxpayers trillions of dollars. Today, nearly 85 percent 

of drugs dispensed in the U.S. are generics. This success has been 

possible because consumers and prescribers have confidence that 

generic drugs approved by the FDA are the ‘‘same’’ as their brand 

name counterparts, not only in terms of their chemical composition, 

but also with respect to their safety and effectiveness. 

This principle of ‘‘sameness’’ is the backbone of the 1984 HatchWaxman Act, which provided the pathway for generic drugs to 

come to market. A generic product has the same benefits and risk 

2 

as the brand name drug and, therefore, the same labeling is required. Ever since enactment, FDA has logically held that this is 

an ongoing requirement that extends beyond the date of approval. 

However, on November 13, 2013, the FDA issued a proposed rule 

that would allow manufacturers of generic drugs to unilaterally 

change their safety-related labeling, deviating from the brand. Both 

FDA’s legal and policy rationale for this change is dubious at best. 

Currently, a generic can only change its label when the branded 

drug does so and FDA approves the change. In that case, all 

generics are then required to adopt the same new labeling in a 

timely manner. This system does not obviate the need for generics 

to bring new safety-related information to the agency as soon as 

possible. 

Ostensibly, the proposed change is designed to help speed newly 

acquired safety information about drugs to the consumer. However, 

FDA has not explained how this rule would actually improve communication of drug safety information to prescribers and patients 

other than establishing a Web site on which they will post the various labeling proposals. 

The only outcome I see if the rule is enacted is mass confusion. 

The FDA-approved labeling would essentially become just one in a 

crowd. The proposed rule undermines the ‘‘sameness’’ requirement 

in Hatch-Waxman and will result in situations where multiple 

FDA-approved, therapeutically equivalent products will have different safety-related labeling prior to the FDA determining whether such changes are even necessary or appropriately tailored. 

Not only is the proposed rule in direct conflict with the plain language of the statute, but it directly contradicts numerous FDA 

statements and assertions over the years that consistent drug labeling is necessary if consumers and prescribers are to have confidence that generic drugs are as safe and effective as the reference 

brand name product. 

Finally, FDA has admitted that the proposed changes will open 

generic manufacturers up to greater liability under state tort lawsuits. The added cost of litigation will also cause generic prices to 

rise exponentially. 

I thank all of our witnesses for being here today to discuss these 

important issues. I look forward to your testimony, and I yield the 

remainder of my time to Dr. Burgess. 

[The prepared statement of Mr. Pitts follows:] 

PREPARED STATEMENT OF HON. JOSEPH R. PITTS

The subcommittee will come to order. 

The Chair will recognize himself for an opening statement. 

One of the great successes in health care in the past 30 years has been the introduction and widespread use of generic drugs, saving patients and taxpayers trillions 

of dollars. 

Today, nearly 85% of drugs dispensed in the U.S. are generics. 

This success has been possible because consumers and prescribers have confidence 

that generic drugs are approved by the FDA as the ‘‘same’’ as their brand name 

counterparts-not only in terms of their chemical composition, but also with respect 

to their safety and effectiveness. 

This principle of ‘‘sameness’’ is the backbone of the 1984 Hatch-Waxman Act, 

which provided the pathway for generic drugs to come to market. A generic product 

has the same benefits and risks as the brand name drug and, therefore, the same 

3 

labeling is required. Ever since enactment, FDA has logically held that this is an 

ongoing requirement that extends beyond the date of approval. 

However, on November 13, 2013, the FDA issued a proposed rule that would allow 

manufacturers of generic drugs to unilaterally change their safety-related labeling, 

deviating from the brand. Both FDA’s legal and policy rationale for this change is 

dubious at best. 

Currently, a generic can only change its label when the branded drug does so and 

FDA approves the change. In that case, all generics are then required to adopt the 

same new labeling in a timely manner. This system does not obviate the need for 

generics to bring new safety-related information to the agency as soon as possible. 

Ostensibly, the proposed change is designed to help speed newly acquired safety 

information about drugs to the consumer. However, FDA has not explained how this 

rule would actually improve communication of drug safety information to prescribers and patients other than establishing a Web site on which they will post the 

various labeling proposals. 

The only outcome I see if the rule is enacted is mass confusion. The FDA-approved labeling would essentially become just one in a crowd. 

The proposed rule undermines the ‘‘sameness’’ requirement in Hatch-Waxman, 

and will result in situations where multiple FDA-approved, therapeutically equivalent products will have different safety-related labeling prior to the FDA determining whether such changes are even necessary or appropriately tailored. 

Not only is the proposed rule in direct conflict with the plain language of the statute, but it directly contradicts numerous FDA statements and assertions over the 

years that consistent drug labeling is necessary if consumers and prescribers are to 

have confidence that generic drugs are as safe and effective as the reference brand 

name product. 

Finally, FDA has admitted that the proposed changes will open generic manufacturers up to greater liability under state tort lawsuits. The added costs of litigation 

will also cause generic prices to rise exponentially. 

I thank all of our witnesses for being here today to discuss these important issues, 

and I look forward to your testimony. 

Thank you, and I yield the remainder of my time to 

—————————————————————. 

Mr. BURGESS. Thank you, Mr. Chairman. And again, Dr. 

Woodcock, thank you for joining us this afternoon. 

For the past 30 years since the passage of the Hatch-Waxman 

amendments to the Food, Drug, and Cosmetic Act, a framework 

based on sameness between generic and brand name labeling has 

existed. Those amendments to the Food, Drug, and Cosmetic Act 

successfully created a safe and effective means by which safety information is relayed to the public. The Food and Drug Administration’s proposed rule has the potential to upend three decades of stability, and unfortunately, upend the stability in a process that is 

working and working well. Allowing generic manufacturers to update safety labels unilaterally will lead to a fragmented system 

where confusion will abound. Multiple versions of important safety 

information existing for the same drug will result in confusion for 

patients and providers alike. 

As a doctor, when I prescribe a drug, brand or generic, I want 

to know what the indications and risks are, I want to know that 

a generic is truly a generic with the same indications and the same 

side effects of the brand. If I am not sure, then why not just prescribe the brand drug and never mind about the cost savings? 

Mr. Chairman, if patients and doctors don’t have the certainty 

the benefits of utilizing generics, including cost savings could very 

well be at risk. Confusion extending to patients and pharmacists 

will accomplish nothing and could lead to an increase in issues 

with prescribing medication and the overall health of our beneficiaries. This appears to be the latest in a string of proposed rules 

4 

in which the Administration is seeking a solution for a problem 

that simply does not exist. Safety is paramount. 

I thank the chairman for holding the hearing and I will yield 

back the balance of my time. 

Mr. PITTS. The chair thanks the gentleman and recognizes 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, for having this hearing. 

The issue regarding generic drug labeling and its impact on patient safety is an important one and merits a thoughtful discussion. 

Hatch-Waxman is a true success story, one of the many that my 

colleague, Mr. Waxman, has been part of in his great career here. 

And because of this groundbreaking law passed 30 years ago, the 

drug market has transformed. 

Today, more than 80 percent of all drugs dispensed are generic 

drugs. In fact, for 45 percent of generics sold, no branded product 

is currently on the market. So I think we all agree that this is a 

good thing for patients and payers. 

But despite this reality, the FDA’s regulation over the way in 

which generic drugs are labeled has remained unchanged, and I believe that in order for consumers and doctors to have confidence in 

the drugs that they take and prescribe, the FDA should facilitate 

a process which ensures that the responsibilities upon drug manufacturers reflect the current marketplace. 

Last November, FDA proposed a regulation that would allow 

makers of generic drugs to update safety labels independently 

without waiting for FDA approval to reflect new information on 

safety issues. This is identical to the process that brand name 

drugs use to communicate safety issues as timely as possible. This 

proposal is also the result of a troubling decision by the Supreme 

Court in 2011 that generic drug manufacturers cannot be held liable under state tort law for an inadequate labeling, and therefore, 

patients who have been injured by inadequately labeled drugs have 

no recourse in court. 

Being able to hold manufacturers accountable for maintaining 

adequate labeling through the court system is an important added 

layer of a consumer protection. And what you will hear directly 

from the law’s author is that Congress never intended to give generic drug companies immunity from liability. In fact, prior to 

2011, they did not get immunity. And so I appreciate that FDA’s 

proposal would address this interest. I agree that something needs 

to be done. 

Today, we will hear from critics about the consequences of the 

proposed regulation, in particular, that it will lead to over-warning, 

higher generic drug prices, and the potential for some companies 

to even stop making certain drug products. These are bold claims 

so I am interested in better understanding the basis for their 

views. 

I believe the FDA has taken a critical step forward for patient 

safety but I do have questions about FDA’s approach. One issue in 

5 

particular is that of sameness. Hatch-Waxman established the important principle of sameness for generic drugs relative to their 

branded counterparts and this principle is significant in many 

ways, not the least of which is to ensure consumer confidence that 

generic drugs are just as safe and efficacious as brand name drugs. 

So I am interested in learning more about FDA’s consideration of 

the sameness principle, in particular, how such temporary differences in labeling as a result of this proposal may impinge on the 

benefits afforded by sameness. 

And, Mr. Chairman, this is a proposed rule, like with all other 

regulations, FDA will and should take a serious look at the many 

comments that they are sure to receive. But I want to make no 

mistake about it; I do support their efforts. In today’s marketplace, 

consumers must have confidence in the generic drug industry and 

I look forward to our witnesses’ testimony and I thank them for 

their participation. 

And I would yield back at this time. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the ranking member of the full committee, Mr. Waxman, for 5 minutes for an opening statement. 

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

Mr. WAXMAN. Thank you, Mr. Chairman. 

Ordinarily, you would go to your side of the aisle? Oh, I see. OK. 

It has been 30 years since enactment of the Hatch-Waxman generic drug law. This law has been a tremendous success if I don’t 

say so myself. Over 80 percent of prescriptions in the United States 

are generic. Consumers and payers have saved over $1 trillion over 

the last decade alone. 

Today, we are looking at one aspect of this law, and in particular, in light of the proposed rule by the Food and Drug Administration, to give generic drug manufacturers the same rights and 

responsibilities as brand name drug manufacturers to temporarily 

update safety information in their labeling without waiting for 

FDA approval. 

The proposed rule, if finalized in its current form, would be an 

important step forward for patient safety. It would remove obstacles to getting new safety information about drugs to doctors and 

patients at the earliest possible time. It would also restore the 

added incentive provided by state tort liability for generic manufacturers to comply with their obligations to conduct robust post-market monitoring and to keep their drug labels accurate and up-todate. And it would restore the ability of patients harmed by taking 

an inadequately labeled generic drug to pursue redress through the 

courts just as they were able to do before the Pliva v. Mensing Supreme Court decision in June 2011. 

Now, critics of the proposed rule have argued that it will lead to 

over-warning. They have argued that it will result in higher generic drug prices. They have argued that it will drive generic drug 

companies out of business or cause them to stop making certain 

products. And they have argued that it conflicts with the sameness 

required in the Hatch-Waxman Act. 

6 

I don’t believe those claims. We have heard the exact same 

claims about over-warning and drug company economic distress 6 

years ago when the Supreme Court decided in Wyeth v. Levine 

cases. The Court ruled that the FDA regulation did not shield drug 

manufacturers from state failure-to-warn tort liability, but since 

then, we have not seen any of these dire predictions come to pass. 

When we enacted the Hatch-Waxman bill in 1984, we did not 

give generic drug companies immunity from liability. In fact, the 

industry did not get immunity until 2011 when this Pliva case was 

decided. The tremendous growth of generic drugs from ’84 to 2011 

proved that the generic drug industry can flourish without immunity from state liability. 

The one issue for which I do have some limited sympathy is that 

of sameness. Sameness is fundamental to Hatch-Waxman. Generic 

drugs are the same as their brand counterparts. They are proved 

based on demonstration that they are chemically the same and 

have the same effects in the body. And because they are the same, 

they are required to have the same labeling as the brand at the 

time of approval. 

It is also important that the labels remain the same thereafter. 

But this does not mean that there can be no differences. There can 

be differences for brief periods of time when labeling updates need 

to be made, just as there can be because of differences in inactive 

ingredients or indications. In fact, the existing regulatory policy 

under which brands may update their safety labeling without waiting for FDA approval also results in temporary differences between 

the brand and generic label. These temporary differences occur 

during the time between when the brand makes its label change 

and the time when FDA approves it and then the generic manufacturer actually makes conforming changes. Few would argue that 

the current process violates the sameness requirements. 

FDA has tried in its proposal to minimize these differences to the 

extent possible. Experience will tell us whether the mechanics of 

the process FDA has proposed will need to be improved. If refinements are needed, I hope the FDA will make them. But I applaud 

FDA for releasing this proposal now and urge the agency to finalize 

it quickly after reviewing and taking into account all the comments. I believe the rule will result in even greater consumer trust 

and confidence in the generic industry, trust and confidence that 

I am very proud to share. 

I thank the chairman for holding this hearing. I look forward to 

the testimony of the witnesses. I yield back the time. 

Mr. PITTS. The chair thanks the gentleman. 

All the other members’ opening statements will be made part of 

the record. 

[The prepared statement of Mr. Upton follows:] 

PREPARED STATEMENT OF HON. FRED UPTON

In a bicameral letter sent earlier this year, my colleagues and I raised important 

questions and concerns regarding the Food and Drug Administration’s recent proposed rule on generic drug labeling, and today I hope we can learn more about the 

agency’s rationale. There are significant concerns regarding the legal basis for the 

proposed rule and its consequences on patients and providers. 

First, there is the question of whether FDA has the authority to even make this 

proposal. Since the passage of the Hatch-Waxman Act three decades ago, the agency 

7 

has adamantly asserted that a generic drug must have the same labeling as the 

brand-name product and that this ongoing requirement is based in statute. In 2011, 

the Supreme Court agreed. With this proposed rule, FDA is taking a different view 

of the statute. If the law does actually need to be changed for whatever reason, the 

authority to do so belongs to Congress. 

Second, we want to find out why the FDA proposed this rule and who was involved in the decision-making process. FDA stated in the proposal that the generic 

market has matured and that manufacturers no longer have sufficient incentives to 

conduct post-market surveillance, evaluation, and reporting. They cited the need to 

get new safety-related information to patients faster and that allowing generic companies to change their labeling prior to FDA-approval would ensure that such companies actively participated in the process. Yet in their response to our letter from 

January, FDA cited no evidence that generics are not actively participating already 

and no evidence that there are public health concerns justifying such a fundamental 

shift in well-established policy. The agency made very contradictory statements in 

its brief to the Supreme Court just three years ago. What changed? 

Finally, and most importantly, we need to understand how this proposal would 

impact patients and providers both in terms of confusing warnings and raising the 

costs of generic drugs. Generic drugmakers like Perrigo in southwest Michigan provide medicines that countless Americans depend on. In fact, more than 80 percent 

of prescriptions are currently filled with generic drugs. But the FDA’s proposed rule 

could drive the costs up for the drug manufacturers, patients, and the government. 

Simply, this proposed rule reverses years of successful practice and is built on 

questionable legal terms. 

I look forward to hearing from FDA and understanding the need for and rationale 

behind this proposed rule. I yield the remainder of my time to 

——————————————. 

Mr. PITTS. We have two panels before us today, and on our first 

panel we have Dr. Janet Woodcock, Director of the Center for Drug 

Evaluation and Research, U.S. Food and Drug Administration. 

Thank you for coming today, Dr. Woodcock. Your written testimony will be made part of the record and you will have 5 minutes 

to summarize your testimony. 

So at this time, the chair recognizes Dr. Woodcock for 5 minutes 

for an opening statement. 

STATEMENT OF JANET WOODCOCK, M.D., DIRECTOR, CENTER 

FOR DRUG EVALUATION AND RESEARCH, U.S. FOOD AND 

DRUG ADMINISTRATION 

Dr. WOODCOCK. Thank you, Mr. Chairman, and members of the 

subcommittee. 

I am Janet Woodcock, Director of the FDA’s Center for Drug 

Evaluation and Research. And I appreciate the opportunity to testify. 

I am happy to discuss FDA’s proposed rule that would provide 

generic drug makers with the same opportunity as brand drug 

makers to update their labels when they have new safety information. They would also be able to distribute the revised label before 

FDA reviewed it by submitting a Changes Being Effected supplement. It is known as a CBE supplement. This would be dissemination of new drug safety information to health professionals and patients. 

Now, this is a proposed rule. The comment period closed about 

2 weeks ago and we are now reviewing comments. While I am free 

to discuss the proposal, I am not able to discuss what we may or 

may not do further. 

FDA-approved generic drugs are copies of brand drugs. They 

have the same safety and effectiveness as brand drugs for their approved indications. They are held to the same quality standards as 

8 

brand drugs, and generic drug makers right now have the same obligation to monitor their drug safety as the brand drug makers do. 

But currently, only the brand drug makers can update their label 

with new safety information and distribute the revised label before 

FDA reviews the change. They do this by submitting a CBE supplement. Generic drug makers must wait to change their labels until 

the FDA approves the brand name change. 

In today’s world when over 80 percent of all U S. prescription 

drugs dispensed are generics and brand drug makers may drop out 

of the market after generics are approved, FDA believes it is time 

to provide generic drug makers with the means to promptly update 

their labels. In fact, for over 400 drugs, the only marketed drugs 

are generics and we expect that this number will increase over 

time. 

The proposed rule, if finalized, would allow the generic drug 

makers to use the same process that brand drug makers use to update their safety information. It would ensure that all manufacturers marketing the drug, other generics as well as the brand, would 

be promptly advised of the new safety information. 

And we also propose to establish a dedicated web page where 

FDA would post information about these proposed changes submitted in CBE supplements for all drug and biological products so 

that healthcare providers and patients could have access to this information while FDA is reviewing it. 

FDA would make an approval decision on the proposed change 

for the generic drug and the corresponding brand drug at the same 

time so that after FDA approved a change, the brand and generic 

drugs would all have the same FDA-approved label. After FDA approves a label change for the brand drug, the proposed rule would 

set up a 30-day time frame in which the generic drug makers 

would submit conforming changes to their label. Right now, the situation is FDA currently advises generic drug makers to update 

their drug labels at the very earliest time possible after a change 

to the innovator, and the time in which they actually do update 

that varies quite a bit. 

So in light of that range of time frames where generic drug makers currently submit supplements, the proposed procedures would 

likely minimize the current variation between brand and generic 

labels that is in existence right now and would cause I think less 

confusion because there are no time frames stipulated by FDA and 

there are often considerable delays before all the generic drug labels are dated. Therefore, any confusion that might be caused by 

different labels would be reduced by this proposal. 

In conclusion, I want to emphasize that this proposed rule, if finalized, is intended to improve the communication of important 

drug safety information to both prescribers and patients. 

Thank you and I look forward to answering questions. 

[The prepared statement of Dr. Woodcock follows:] 

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Mr. PITTS. The chair thanks the gentlelady and I will begin the 

questioning and recognize myself 5 minutes for that purpose. 

Dr. Woodcock, in 2011 in a brief submitted to the Supreme Court 

in Pliva v. Mensing, FDA argued on the merits, and both the majority and dissenting opinions agreed that a generic manufacturer 

could not unilaterally change its labeling without violating the 

plain language of Hatch-Waxman. FDA has taken this position for 

more than 20 years over the course of various administrations. 

FDA argued in the 2011 brief that generics do however have a 

duty to provide adequate warnings and that they discharged this 

duty by promptly contacting the agency about new safety information so that FDA can make an informed decision about any labeling 

changes the agency determines are warranted. 

Without citing any evidence in the proposed rule or in the agency’s response to the bicameral letter we sent in January, FDA now 

speculates that generic companies will stop meeting their post-market requirements under the law. Despite all their previous assertions to the contrary and despite the fact that they took the exact 

opposite position in 2011, FDA is now claiming that the HatchWaxman Act does not in fact preclude a generic company from unilaterally changing their labeling to strengthen warnings, that they 

should now be able to do so because the market has matured. 

Dr. Woodcock, the market has not matured all that much since 

2011. What really prompted the FDA’s decision to fundamentally 

change its position on these matters and what role did plaintiffs’ 

lawyers play in the process? 

Dr. WOODCOCK. What prompted FDA to look into this rule was 

partly by the court ruling that pointed out a disparity in the obligations between the generics and the innovator drugs. And in today’s 

world, a world where the generics are more than 80 percent of all 

prescriptions dispensed to patients in this country, we feel the 

standards should be the same, the standards for manufacturing, 

the standards for safety and efficacy, the standards for overseeing 

safety, and the standards for reporting to FDA. So we wanted to 

have a level playing field, have the same standards, and correct 

this inconsistency. 

Mr. PITTS. Now, in February of 2013 while FDA was drafting 

this proposed rule, agency officials met with several plaintiffs’ lawyers, including at least one representative from the American Association for Justice, also known as the Association of Trial Lawyers 

of America. In fact, according to FDA’s public calendar, one of the 

agency participants in this meeting was Daniel Siegelman from the 

office of the Commissioner, who is himself a former prominent 

member of trial bar. Would you please provide the Committee with 

the minutes from this February 2013 meeting? 

Dr. WOODCOCK. We will get back to you with what we have. 

Mr. PITTS. Would you commit to working with the Committee to 

provide any other communications between agency officials, including Mr. Siegelman and representatives of the American Association 

for Justice relating to the proposed rule or other approaches that 

were considered? 

Dr. WOODCOCK. Certainly. 

Mr. PITTS. Now, I am going to read a statement from a separate 

brief submitted to the Supreme Court by Ranking Member WaxVerDate Nov 24 2008 11:05 Feb 26, 2016 Jkt 037690 PO 00000 Frm 00027 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-132 CHRIS
22 

man and ask you to comment. ‘‘It is clear that a generic and a 

brand name label must be the same and that a generic firm cannot 

unilaterally change its label. To permit individual generic drug labels to differ significantly from their brand name counterparts, particularly with respect to safety information, would thwart the 

sameness goal reflected in the Hatch-Waxman amendments.’’ Dr. 

Woodcock, did the agency agree with this statement in 2011 and 

does the agency agree with this statement today? 

Dr. WOODCOCK. All right. Certainly with all due respect to Mr. 

Waxman, who has obviously authored the legislation, I would like 

to dispel the notion that the labels are the same now with respect 

to safety information. 

We have looked at this and it is not just the CBE–0, but when 

we, say, do a class labeling, say, for the NSAIDs, we put a box 

warning in, some major safety change is put into drug labels, there 

is a time frame that can be considerable under which the generics 

submit conforming labeling. And during that time frame, those labels are different. 

And in fact, I would submit to you from a practical point of view 

as I administer the program, these drug labels are dynamic and 

may change up to maybe 10 years, 15 years. I think our latest is 

38 years after a drug has been on the market, we are still discovering safety information. That needs to get onto the label as quickly as possible. The generic copies may take quite a long time, 

months, perhaps a year or so before they make conforming changes 

to their label. And then of course that takes much longer to get out 

there in circulation because the print nature of the package insert. 

So, while in principle they are the same, because of the dynamic 

nature, they are not literally and exactly the same right now. And 

the proposed rule, if it were enacted, would actually narrow down 

that time, that disparity, that temporary difference. And after FDA 

would approve, maybe we would not put the safety label in or 

maybe we would decide that the safety update goes on a drug label, 

then all the manufacturers of that drug would have to change and 

the generics would have 30 days in which to do that. 

Mr. PITTS. The chair thanks the gentlelady and now recognizes 

the ranking member, Mr. Pallone, 5 minutes for questions. 

Mr. PALLONE. Thank you, Mr. Chairman. 

Dr. Woodcock, Mr. Neas, who is here today representing the generic drug makers, argues that FDA should focus on assuring patient safety and not on preemption of state tort law. I agree with 

the FDA that state tort law complements FDA oversight and enhances patient safety. My reading of the FDA proposed rule is that 

its primary purpose is to realign FDA post-market safety monitoring and labeling requirements with the realities of the current 

marketplace and increase the speed at which new drug safety information gets to doctors and patients. 

So I just wanted to ask you initially is that a fair reading of the 

purpose of the proposed rule and if you wanted to comment on 

that? 

Dr. WOODCOCK. That is correct. With over 80 percent, as we have 

all said, of drugs taken by Americans today being generic drugs 

and many of the generic drugs not having an innovator copy on the 

market, the goal is to make sure that the whole system is searchVerDate Nov 24 2008 11:05 Feb 26, 2016 Jkt 037690 PO 00000 Frm 00028 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-132 CHRIS
23 

ing for safety problems and promptly updating labels when they 

are found. 

Mr. PALLONE. So another criticism made by Mr. Neas is that requiring generic manufacturers to make unilateral labeling changes 

will lead to a flood of unnecessary and different labeling changes 

and confuse doctors and patients. And he also claims that companies will exaggerate the risks of their drugs leaving patients to 

avoid taking needed medications. 

I know that in the lead up to the Wyeth vs. Levine case, brand 

drug companies made similar predictions of over-warning if the Supreme Court were to rule again preemption, as it did. 

So I guess, couple things. First, has FDA found that drug companies commonly over-warn? 

Dr. WOODCOCK. Well, we have existing precautions against that. 

Our regulations that we passed a few years ago called the physician labeling rule, which modernized the drug package insert, has 

specific caveats about doing such things and requires certain levels 

of evidence before you just put warnings in the label. Many of you 

may not have looked at a drug label, but long ago, they were what 

we called the laundry list. There were just long lists of things that 

might happen to you. And the modern drug label has eliminated 

much of that because it is not informative. 

Mr. PALLONE. Did the FDA see a worrisome increase in overwarning after Wyeth v. Levine? 

Dr. WOODCOCK. Not to my knowledge. 

Mr. PALLONE. And the FDA believes that this concern about the 

over-warning, do you think that is warranted? 

Dr. WOODCOCK. I think it is important to stress that these warnings are temporary. They are put up there because something has 

been discovered and the company feels there is a reasonable link 

to the drug. Then after that occurs, right now with the innovator, 

we take a look at that and we gather up whatever evidence there 

might be and we may have studies or other things that are brought 

to bear. And then FDA makes a decision about whether that is actually going to be approved FDA labeling or not. And the same 

would be true here with this proposal. 

Mr. PALLONE. All right. Let me ask you about the Mensing decision. Were generic drug companies subject to failure-to-warn liability before Mensing? 

Dr. WOODCOCK. Well, first of all, may I remind everyone I am 

not a lawyer; I am a physician. But I understand that for many 

years prior to the Mensing decision, the generic drug manufacturers were generally considered to be potentially liable for failing to 

warn of important drug safety information. And during that time, 

they grew to about 75 percent of the U.S. retail prescription market. In other words, the industry thrived during that time. 

Mr. PALLONE. So is it fair to assume that finalizing the FDA rule 

essentially will bring the generic industry’s liability situation back 

to something similar to what they faced before the Mensing decision in 2011? 

Dr. WOODCOCK. I think that is a reasonable assumption that I 

would again argue that I am not very qualified to opine on that. 

Mr. PALLONE. I mean because we have all heard that—well, I 

guess the GPhA commissioned a study looking into the economic 

24 

impact of the FDA rule, and it concluded that finalizing the FDA 

rule will lead to new liability protection costs for the generic drug 

industry of about $4 billion a year, and yet the cost attributable to 

the FDA rule sound like they may be, you know, really not different from the liability cost the industry faced prior to Mensing. 

So, I don’t. I am questioning the value of the study. You don’t have 

any comment? 

Dr. WOODCOCK. It requires a lot of assumptions to make those 

conclusions. 

Mr. PALLONE. All right. Thank you, Mr. Chairman. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentleman from Florida, Mr. Bilirakis, 5 minutes for questions. 

Mr. BILIRAKIS. Thank you, Mr. Chairman. Thank you, Dr. 

Woodcock. I appreciate it very much. Thanks for your testimony. 

First question, depending on the drug, there could be a dozen generic products for the same brand drug. From a public health stand 

point, don’t you believe that the multiple different versions of labeling will lead to confusion among doctors? 

Dr. WOODCOCK. Well, in fact, the state is now when FDA makes 

a label change to the innovator, there will be multiple different 

versions because the generic drugs will be changing. We have seen 

the drug makers will change their label over a period of time. Some 

would change their label to conform very rapidly; others may take 

a year or so. So that is the current situation. 

Mr. BILIRAKIS. OK. Next question: the FDA frequently issues 

guidance documents better informing industry of FDA’s expectations. How many guidance documents has FDA issued related to 

updating of generic drug labeling in the past decade? Can you give 

me that information? 

Dr. WOODCOCK. I can’t but I could get back to you on it. 

Mr. BILIRAKIS. Please do. 

Isn’t it true that the FDA currently has the regulatory authority 

to set specific time frames within which a generic company must 

update their labeling to conform to the brand name equivalent, and 

doesn’t FDA have the authority to take regulatory action against 

any company that doesn’t comply with the agency’s requirements? 

Dr. WOODCOCK. For the second part of your question, do we have 

the ability to take action? Yes, I believe we do. And for the first 

part of your question, that is part of this rule. The proposed rule 

stipulates a time frame in which the generics would have to conform. So we do have that ability. We show that by proposing this 

rule. 

Mr. BILIRAKIS. OK. If FDA feels as though it is not getting adequate post-market safety information from companies—— 

Dr. WOODCOCK. Yes. 

Mr. BILIRAKIS [continuing]. As required under the law, isn’t it 

the agency’s responsibility to better enforce these requirements to 

ensure that it does? 

Dr. WOODCOCK. Well, I think that is a more complicated question. It is a very complicated question. This proposed rule is about 

giving companies the ability to rapidly change their label and communicate information that they have found, all right. Generic drug 

companies do not frequently submit new safety information to the 

FDA. 

25 

What we usually audit companies for is their required apparatus 

that they have to monitor for safety and to report to us to make 

sure that they operate those functions. For example, for a generic 

drug where there was no innovator on the market anymore, we 

would really like to know that the generic drug companies were out 

there watching and seeing what is happening with their drug and 

telling us if they come across any new safety problems. 

Mr. BILIRAKIS. OK. Thank you. 

I yield back, Mr. Chairman. Thank you. 

Mr. PITTS. The chair thanks the gentleman and now yields to the 

ranking member of the full committee, Mr. Waxman, 5 minutes for 

questions. 

Mr. WAXMAN. Thank you, Mr. Chairman. 

I feel like I am in a Woody Allen movie when they asked about 

Marshall McLuhan and the man in the back of the line said I am 

Marshall McLuhan and everything you said is absolutely wrong. 

Well, I am Henry Waxman from the Hatch-Waxman and I am here 

to set the record straight. 

I submitted a brief to the Supreme Court and I stated generic 

and brand name labels must be the same because, after all, the generic drug has to be the same as the brand name drug so the warning labels have to be the same. But that was in the context of the 

existing FDA regulation that said the brand name companies could 

change their label if they know something more that they ought to 

tell the consumer, but the generic companies could not change their 

label and they couldn’t act unilaterally. 

So I was making the point that even within that context, generic 

manufacturers should be subject to the state failure-to-warn tort liability. That was my argument. The Court didn’t accept it. The 

Court said you have FDA regulations and what we were arguing 

was not consistent with them. Now you are proposing a new regulation. 

My amicus also contained the statement that to permit generic 

labels to differ significantly from their brand counterparts, particularly with respect to safety information, would thwart the sameness goal reflected by the Hatch-Waxman Act. So I still believe that 

to be true. However, I don’t think allowing a temporary period of 

time in which the labels may be different thwarts the sameness 

goals. 

For example, you have existing regulations called CBE–0, and 

that allows the brand name company, when they learn some problem, to change their label even if FDA doesn’t approve it. FDA may 

later approve it. They have to send it to FDA, but they can act on 

their own unilaterally. That would mean the warning label would 

be different than on the generic drug, isn’t that right, Dr. 

Woodcock? 

Dr. WOODCOCK. That is correct. And also the generics may take 

various amounts of time even when FDA has approved a label 

change to conform their own label. 

Mr. WAXMAN. So we have a period in time I would like to be kept 

at a minimum before the labels are the same but there is a difference in time, and no one would argue that that violates the 

Hatch-Waxman Act. 

Dr. WOODCOCK. Yes. 

26 

Mr. WAXMAN. Sameness in labeling is important but also finding 

out about new problems is important. You mentioned an example 

to Mr. Bilirakis. What if the generic was based on a brand that is 

no longer on the market? 

Dr. WOODCOCK. Yes. 

Mr. WAXMAN. Would we prohibit a generic that learns about 

problems from doing anything to warn the public about these problems? I think that was one of the issues that you had in mind in 

proposing this new regulation, isn’t that right? 

Dr. WOODCOCK. That is correct. And increasingly, the innovator 

companies are concentrating on innovation—— 

Mr. WAXMAN. Yes. 

Dr. WOODCOCK [continuing]. And dropping their drug or withdrawing it from the market or even withdrawing their application 

after the drug goes generic because they can’t compete or they don’t 

want to compete in that space. 

Mr. WAXMAN. Yes. 

Dr. WOODCOCK. And so there the generics are responsible. They 

must stand behind that drug because there is no one else watching 

the safety of that medication other than, of course, the FDA. 

Mr. WAXMAN. The FDA but the generic manufacturers which 

may be the only manufacturers of the drug are more likely to hear 

about the problems for which they need to warn the public and 

hopefully they will give that to FDA. But they are the ones that 

are making the drug that could be harmful unless people understand the warnings that should go with it, isn’t that right? 

Dr. WOODCOCK. That is correct. And most of the reports we get— 

we get about 1 million reports a year about drug safety problems 

and about 80 percent of those are from the manufacturers. 

Mr. WAXMAN. Yes. OK. 

So I think there needs to be sameness in labeling. I think that 

is critical, but equally important is ensuring the patients know 

they will have the same right to access courts whether they are injured by taking a generic drug as they would if they took a brand 

drug. We don’t want to scare consumers to think, oh, if I take a 

generic, I may be taking something that is not as safe. That has 

always been the brand name industry’s claim, that it is not the 

same; it is not as safe. But of course if they are the same and the 

warnings are the same, then the consumers should relax. And we 

want to get to that same labeling. 

Mr. Neas and Mr. Shumsky claimed that the proposed rule fundamentally violates the sameness principle and that it undermines 

the statutory and regulatory framework for approving and overseeing generic drugs. How do you respond to that, Dr. Woodcock? 

There are differences that occur now between brand and generics. 

When brands use their existing CBE–0 process to update their 

safety labeling, what you would be doing is giving the generic that 

same opportunity. Do you think that this is going to mean that we 

are going to have less sameness in drug labeling? 

Dr. WOODCOCK. I believe the portions of the rule that call for the 

webpage and then call for all the labels to be conformed within 30 

days will result in less differences among brand and generic labels 

in the future if this rule were to be made final. 

Mr. WAXMAN. That is a good objective. 

27 

Thank you, Mr. Chairman. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentleman from New Jersey, Mr. Lance, 5 minutes for questions. 

Mr. LANCE. Thank you, Mr. Chairman. And good afternoon, Dr. 

Woodcock. 

This is a very complicated topic. As I understand the recent Supreme Court decisions, there is a question legally as to whether the 

proposed rule complies with those decisions. I certainly want the 

public to be as safe as possible, and at the same time, I don’t want 

the public to be confused. Do you see any potential of a conflict between safety, which we all desire, and confusion among the public 

on this issue? 

Dr. WOODCOCK. Well, as we have been talking about a little bit, 

I believe if the proposed rule were implemented, it would reduce 

confusion caused by differing labels because there would be more 

conformity of labels. 

Mr. LANCE. As I read the underlying statute, it appears to me 

to be clear and it is my own opinion that what is proposed may go 

beyond what is currently in the underlying statute. And obviously, 

agencies try to administer underlying statutory law to the best of 

your ability given your responsibilities in the executive branch. 

Would it have been better for the agency to come to us here to Congress to ask for an amendment if you thought that you needed to 

move forward in the way you are apparently moving forward? 

Dr. WOODCOCK. It is hard for me to speculate on that. I am not 

a lawyer. I would say that—— 

Mr. LANCE. That speaks well of you. Some of us are lawyers. 

Dr. WOODCOCK. Well, I don’t, opine as a lawyer. I am not one. 

However, I will say that we have been administering this program 

a long time. The generic drug labels are actually different in many 

areas, some of which have been stipulated by Congress. For example, pediatric—— 

Mr. LANCE. Yes. 

Dr. WOODCOCK [continuing]. Exclusivity and et cetera, et cetera. 

And they are different in their safety information due to the time 

frame often it takes and due to the fact that the generic industry 

does not often update their label in a timely manner. 

Mr. LANCE. Thank you. I would hope that on issues like this the 

executive branch and the legislative branch could work together 

and often where you stand on an important issue of public policy 

is based upon where you sit and sitting in the legislative branch 

of government and having reviewed the underlying statute and certainly having a great respect for those who wrote the statute, including Mr. Waxman, I tend to view the opinion of Mr. Shumsky 

and others as how I would read the underlying statute. I realize 

it is extremely complicated. But I would prefer if the executive 

branch and the various agencies might come to us if an amendment would clarify the situation and certainly statutory law from 

my perspective serving in the Congress is the bedrock by which 

agencies proceed, recognizing as I do that the safety and health of 

the American people is preeminent. 

Thank you, Mr. Chairman, and I yield back the balance of my 

time. 

28 

Mr. PITTS. The chair thanks the gentleman and at this time recognizes the gentlelady from Virgin Islands, Dr. Christensen, for 5 

minutes for questions. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman. Welcome back, 

Dr. Woodcock. 

Dr. Woodcock, FDA describes both the existing and the proposed 

CBE–0 processes as an exercise of enforcement discretion, and that 

sounds like either the agency is deliberately flouting the will of 

Congress or the law is so badly written that FDA can only make 

it work by ignoring parts of it. Yet I know that FDA uses enforcement discretion in many areas of regulation with good effect. 

Could you put your use of enforcement discretion in the CBE regulations into context? Could you explain how the agency uses it 

elsewhere and its oversight of drugs or other FDA-related products 

and why you have chosen to use it in this instance to allow drug 

manufacturers to rapidly update their safety information? 

Dr. WOODCOCK. Well, first of all, I understand that originally 

when the CBE–0 regs were written, that was how it was described 

a long time ago. Maybe I was in high school. But I think that what 

I understand from our lawyers now is that we regard this as—the 

statute of course sets the framework, as has just been pointed out, 

that regulations are implementing of that framework. We regard 

this as implementing, interpreting part of the statute. So I am not 

sure we regard this in today’s legal world as enforcement discretion. 

But we do use enforcement discretion in many areas. For example, one of the most poignant is probably our dealing with the 

shortage issues where we are getting products from around the 

world for critical medical needs that are being not met for our population. After we verify that they are correctly manufactured and 

of high quality, we will have them imported into the United States. 

Mrs. CHRISTENSEN. Thank you. Well, whether it is enforcement 

or not, I think the whole process seems consistent with one of the 

overriding purposes of the food and drug law, to protect patient 

safety. 

Also in his testimony, Mr. Neas notes that generic manufacturers 

only have access to information about their individual products 

saying that FDA is the only entity with access to all safety information and is the only body in a position to decide whether a labeling change is warranted. How do you respond to those points? 

Dr. WOODCOCK. Well, what we are talking about here is sort of 

early notification. That can be done now by the innovator to change 

their label in advance of an FDA decision. And what we are proposing is that the generic industry should be able to change their 

label in advance of an FDA decision. After we get a safety signal 

and, we may evaluate it through our Sentinel system, we may do 

a literature search, seek data from other sources, and generally deliberate and finally make a final decision. You know, should this 

be a box warning? Should it be a precaution? Is it a contraindication or is it just another warning? Or maybe, as was raised earlier, 

it isn’t adequately linked and should not be on the label. 

Mrs. CHRISTENSEN. Yes. 

29 

Dr. WOODCOCK. Once we make that decision, we then are proposing here that we tell everyone all at once you should change 

your label to conform to the FDA decision. 

So, yes, FDA would weigh in at the end of the day on this but 

what we will do now, and as a clinician you are aware of this, and 

it is frustrating somewhat but FDA will put out safety information 

that says we are looking at this. 

Mrs. CHRISTENSEN. Yes. 

Dr. WOODCOCK. We just don’t know what it means yet. But people became very unhappy that we weren’t notifying them that we 

were evaluating this issue, so if it is an important safety issue, we 

actually put out a drug safety alert and say we are evaluating this. 

We don’t know what the truth is yet, but we will keep you informed and let you know when we have made a decision. 

Mrs. CHRISTENSEN. Thank you. And I agree basically. And as the 

proposal notes, not only do generic drugs now comprise over 80 percent of drugs sold but they constitute 94 percent of the market for 

those drugs for which generics are available. So many of them may 

not have a preponderance on the market. Some are likely to have 

much more than the brand. And as the rule makes clear, FDA continues to reserve for itself the final decision regarding proper labeling. 

Thank you, Dr. Woodcock. 

Dr. WOODCOCK. Thank you. 

Mr. PITTS. The gentlelady yields back. 

The chair recognizes the gentleman from Illinois, Mr. Shimkus, 

for 5 minutes for questions. 

Mr. SHIMKUS. Thank you, Mr. Chairman. Welcome, Dr. 

Woodcock. Good to see you again. 

In proposing significant changes to prescription drug labeling requirements in December 2000, FDA, under the Clinton Administration, found ‘‘the use of labeling and product liability and medical 

malpractice lawsuits, together with increasing litigation cost has 

caused manufacturers to become more cautious and include virtually all known adverse event information regardless of its importance or plausibility relationship to the drug.’’ Do you agree with 

this statement or is this no longer a concern of the agency? 

Dr. WOODCOCK. That was the practitioners’ labeling rule, the 

label modernization that you are talking about. And in there we 

put in some standards that prevent putting in the label events that 

are not really causally linked where we don’t see a causal association. So we were basically putting people on notice that we did not 

think that those types of events, that laundry list, should get into 

a drug label. And the modernized drug labels do not have that feature. 

Mr. SHIMKUS. So it is no longer a concern of the agency? 

Dr. WOODCOCK. It is always a concern but we have put in safeguards to make sure the modernized labels—— 

Mr. SHIMKUS. OK. 

Dr. WOODCOCK [continuing]. Don’t contain that. 

Mr. SHIMKUS. All right. Before proposing the 2000 rule, the FDA 

held multiple focus groups and conducted a national survey of 

healthcare providers. Prior to issuing the proposed rule in November of 2013, did the FDA discuss these changes with physicians? 

30 

Dr. WOODCOCK. Yes. Well, the physicians were part of the focus 

groups. We had a public—— 

Mr. SHIMKUS. No, I am talking about this current rule that you 

are proposing. 

Dr. WOODCOCK. Oh, this one. Oh, I am sorry. No. 

Mr. SHIMKUS. Did the FDA meet with any pharmacists to hear 

their thoughts? 

Dr. WOODCOCK. No, not to my knowledge. 

Mr. SHIMKUS. Did you meet with any of the branded drug companies? 

Dr. WOODCOCK. Not to my knowledge. 

Mr. SHIMKUS. What about the generic drug companies? 

Dr. WOODCOCK. Not to my knowledge. I did not. 

Mr. SHIMKUS. Did the FDA meet with the trial lawyers? 

Dr. WOODCOCK. My understanding is that this is the case. However—— 

Mr. SHIMKUS. So in 2000 you met with all these groups? 

Dr. WOODCOCK. That is correct. 

Mr. SHIMKUS. So you didn’t meet with physicians, you didn’t 

meet with pharmacists, you didn’t meet with branded drug companies, you did not meet with generic drug companies, but you met 

with the trial lawyers? 

Dr. WOODCOCK. Well, after the—— 

Mr. SHIMKUS. I think you have already testified it is yes. 

Dr. WOODCOCK. After the court decision I sat down with the staff 

at the Center for Drug Evaluation and Research and we went over 

options for dealing with this disparity in the treatment of the two 

groups. And we went ahead and drafted this rule. I was not 

aware—— 

Mr. SHIMKUS. So let me get back. So the answer is yes? 

Dr. WOODCOCK. My understanding is—— 

Mr. SHIMKUS. You can just say it. Come on. Get it out. 

Dr. WOODCOCK. Part of the agency did meet with the trial lawyers, yes. 

Mr. SHIMKUS. Thank you. Because in your responses earlier, you 

talked about how innovator drugs, right—— 

Dr. WOODCOCK. Yes. 

Mr. SHIMKUS [continuing]. Who may not be in the market anymore and you have the generic drug—— 

Dr. WOODCOCK. Yes. 

Mr. SHIMKUS [continuing]. But it is funny you are using that as 

an explanation but you didn’t discuss this with innovator drugs 

and you didn’t discuss this change with the generics. So even in 

your answers to our questions today, you are using what you would 

think would be support from and inclusive process of an evaluation 

of a new rule without talking to these two groups. 

So let me ask you this question. What role did the trial lawyers 

play in complying in the development of this new rule? 

Dr. WOODCOCK. To my knowledge, none, because, as I said—— 

Mr. SHIMKUS. Wait, wait. You met with them, you changed the 

rule, and you are saying they had no role in developing this new 

rule? 

Dr. WOODCOCK. Right. I was trying to explain that. 

Mr. SHIMKUS. I know. I am trying to believe it. 

31 

Dr. WOODCOCK. Well, I am explaining factually what happened, 

all right. The Center for Drugs, I asked our staff here at the Center 

for Drugs to look at this finding which pointed out we did not have 

a level playing field of sameness between the innovators and the 

generic drug firms. They developed a list of options. We picked the 

option we wanted to pursue and it was really a matter of feasibility 

and execution and we developed that rule. The personnel in the 

Center for Drugs did not meet with the trial lawyers—— 

Mr. SHIMKUS. And you understand why we have questions about 

this rule if you met with just the trial lawyers and you didn’t meet 

with any of the folks that are involved in this sector? 

Dr. WOODCOCK. Certainly. 

Mr. SHIMKUS. All right. Thank you. I yield back my time. 

Mr. PITTS. The chair thanks—— 

Mr. WAXMAN. Mr. Chairman, I ask unanimous consent that the 

gentleman be given an additional minute so I can ask him to yield 

to me. 

Mr. PITTS. Do you want to have me recognize Mr. Sarbanes? 

Mr. SHIMKUS. No, the ranking member is asking for unanimous 

consent for me to be given another additional minute so I can then 

yield to the ranking member. 

Mr. PITTS. All right. The chair recognizes the gentleman for one 

minute. 

Mr. SHIMKUS. I would be happy to. And I would then yield to Mr. 

Waxman. 

Mr. WAXMAN. Whoever you met with before is interesting but 

don’t you now have to have comments from everybody with a proposed rule and take those comments into consideration? 

Dr. WOODCOCK. Certainly. The folks we met with before were 

about parts of the label that would really impact them and this is 

more of a procedural issue. But we put together a procedure. We 

instantiated it in this proposed rule and we have received over 100 

comments from a wide range of groups and we will be evaluating 

those comments. 

Mr. WAXMAN. Thank you. 

Mr. SHIMKUS. And reclaiming the rest of the minute, I understand that now you are going to receive comments. However, historically, you met with everyone involved in this sector. You now 

issue a new proposed rule with only meeting with the trial lawyers. 

I think that raises cause of concern and the reason why many of 

these questions are going to for what purpose and there is a question on intent. 

And I yield back my time. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentleman from Maryland, Mr. Sarbanes, for 5 minutes for 

questions. 

Mr. SARBANES. Thank you, Mr. Chairman. Thank you, Dr. 

Woodcock. You are one of the best witnesses we get up here and 

I appreciate your testimony. 

I am sort of baffled at what the objection could be to the proposed rule and looking forward to the second panel to elucidate 

that for me. It seems eminently reasonable what you are trying to 

do. I think that it strikes exactly the right balance that we would 

want to see between the objectives, aspirations, and the success of 

32 

the Hatch-Waxman Act and then having to deal with practical obstacles that that framework encounters over time. So it makes a 

lot of sense what is being proposed. 

And Congressman Waxman got right to the point I was going to 

make which is I gather now that comments have been in as of 2 

weeks ago, right? 

Dr. WOODCOCK. Yes. 

Mr. SARBANES. And those include a lot of perspective from consumer groups out there, people that are concerned about safety 

issues, presumably, isn’t that the case? 

Dr. WOODCOCK. Yes, there are comments from consumers, consumer groups. 

Mr. SARBANES. It seems to me this notion that if a trial lawyer 

has a positive opinion of the proposal, that somehow that should 

taint, undermine, or eliminate the concerns that the broad public 

has about seeing this kind of proposal. In fact, my view would be 

that they are largely reflecting the opinions and perspective of the 

broad public and those people who could be potentially damaged if 

you don’t have a proper framework in place. So it is good to hear 

that those comments include organizations that would represent 

that kind of perspective on safety. And we look forward to seeing 

how the rule will roll out from here. 

I was curious before the Mensing case, before this decision that 

appeared to protect or did protect the generic manufacturers from 

failure-to-warn cases at the state level, which was only a couple of 

years ago. Before that, as industry was developing, presumably 

they were getting more engaged in monitoring based on the exposure and liability that they properly had vis-a-vis the public and 

consumers. Would that be accurate to say? 

Dr. WOODCOCK. Yes. And as far as sameness, they have the same 

requirements for monitoring the recipients of their drug or any reports that they get of problems with their drug and reporting those 

to the FDA so that is the same as for the innovator industry. 

Mr. SARBANES. You mentioned that you think probably there are 

some assumptions and the projection that this will result in a $4 

billion hit to the generic drug industry as a result of having this 

liability there. I will be interested to hear testimony that backs 

those kinds of assumptions up because I am skeptical of them, as 

I think you are, and certainly Congressman Waxman has indicated 

his skepticism about that. 

I am a very intrigued by your testimony that not only does the 

proposed rule not add to the sameness problem—— 

Dr. WOODCOCK. Yes. 

Mr. SARBANES [continuing]. That has been discussed but in fact 

it would help to remedy—— 

Dr. WOODCOCK. Yes. 

Mr. SARBANES [continuing]. Some of the problems that there has 

been with sameness because there hasn’t been in place the kind of 

timelines that would push the generic manufacturers to come in to 

conformity on a more expedited basis. 

Dr. WOODCOCK. That is correct. 

Mr. SARBANES. So you have sameness issues now that are kind 

of initiated from the innovator brand side of the equation. You may 

now get situations where the sameness, you know, that sort of 

33 

glitch gets initiated from the generic side. But all told, what you 

are proposing, as I understand it, is a structure that will lead to 

more sameness, to use that sort of odd phrase, than less. And so 

that will be actually an improvement over the current situation, is 

that correct? 

Dr. WOODCOCK. That is correct. We would anticipate that the 

amount of disparities between the generic label and innovator label 

will decrease with this proposal because it will put in a 30-day 

clock for conformance to the labels. 

Mr. SARBANES. Terrific. Thank you very much, and I yield back. 

Mr. PITTS. The chair thanks the gentleman. Because we have a 

just heard there may be some confusion over various views on this 

proposed rule, let me take this time to request unanimous consent 

to insert the following documents into the record: AARP letter to 

Commissioner Hamburg dated March 13, 2014; ‘‘The FDA’s Proposed Generic Drug Labeling Rule: An Economic Assessment’’ by 

Alex Brill, February 5, 2014; a letter from FDA to Congressman 

Kevin Yoder, January 29, 2014; March 6, 2014, letter from 24 

members of the Pharmaceutical Supply Chain to Commissioner 

Hamburg; of the labels on generics drugs, ‘‘The FDA Should Take 

the Lead on Making Drug Warning Labels Consistent,’’ LA Times, 

article, March 12, 2014; committee letter to Commissioner Hamburg regarding the proposed change to generic drug labeling policy 

dated January 22, 2014; and the FDA’s response dated February 

26, 2014; a letter dated March 14, 2014, to Commissioner Hamburg 

from Minority Health Groups; and finally, a letter dated March 13, 

2014, to Commissioner Hamburg from Patient Advocates. 

Without objection, so ordered. 

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

Mr. PITTS. The chair now recognizes the gentleman from Kentucky, Mr. Guthrie, 5 minutes for questions. 

Mr. GUTHRIE. Thank you, Mr. Chairman. 

Thank you for coming, Dr. Woodcock. 

A lot of discussion on the topic of changes being effected involves 

generic drugs. It occurs to me that CBE is also an important policy 

issue in the context of biosimilars. What is the current legal status 

of CBE with respect to biosimilars and would the proposed rule 

change the current legal status of CBE with respect to biosimilars? 

And I know that biosimilars, though none have been approved by 

the FDA yet, but when they are, will they have CBE or not? 

Dr. WOODCOCK. This rule does not pertain to that because those 

would be under the Public Health Service Act and they are not considered generics like the generics are. So that is a separate issue. 

Mr. GUTHRIE. Completely separate, thank you. 

In your testimony throughout the day, you stated four or five 

times that this rule would address the need for outdated generic 

labels to be updated. While that may be so, that was not the basis 

for why the FDA issued the proposal. In fact, I have been told that 

the goal was not even addressed in the proposed rule. What is the 

agency’s stated rationale for proposing this rule change and if updating outdated generic labels is really the goal, can’t you address 

those administratively or with better enforcement? 

Dr. WOODCOCK. Well, the goal of this, at least my goal and the 

Center for Drugs’ goal was to update what we felt was a disparate 

34 

playing field for the brand industry and the generic industry where 

the generic industry has really grown up to be taking care of much 

of the healthcare of your constituents in this country. The drugs 

they get at their pharmacy are generic drugs. And so that was the 

goal from my point of view. 

We are looking at updating old labels and this isn’t just a fault 

of the generic industry; it is a fault of the innovator industry, too. 

Drug labels need to be modernized and the modernization effort 

that was talked about earlier only went back to, I think, 2003. 

Mr. GUTHRIE. Yes. 

Dr. WOODCOCK. And so we are looking at updating globally the 

drug labels in general. 

Mr. GUTHRIE. Is your FDA pilot project Sentinel, is that focused 

on that? Is that what that is, the Sentinel system? 

Dr. WOODCOCK. Sentinel system is using electronic health 

records to learn and look at safety signals that we get. So that is 

what Sentinel is about. We have electronic health records of 150 

million people and we can look in there and find out what happens 

when they took a drug and find out whether a side effect is real. 

We are doing a different pilot on modernizing drug labels that have 

become out-of-date. 

Mr. GUTHRIE. OK. And I have one last question. Ranking Member Waxman discussed the brief he filed with the Supreme Court 

in 2011. My understanding of that brief a different approach than 

the one ultimately included in FDA’s rule proposed was raised. I 

believe the brief suggests that FDA should formalize the process by 

which a generic manufacturer could provide the FDA with any new 

information they obtained regarding safety hazards associated with 

their products and that they could be held liable if they failed to 

do so. Why does the FDA feel that that was an inadequate approach and why you have to go this direction? 

Dr. WOODCOCK. I am sorry but I am unfamiliar with what mechanism that they were supposed to update their labels. 

Mr. GUTHRIE. Yes. I have a quote from the brief. ‘‘Provide the 

FDA with any new information they obtain regarding safety hazards associated with their products.’’ 

Dr. WOODCOCK. Yes, well, generics have always supposed to have 

been able to do that. So this is simply a mechanism. This is really 

a procedural rule that allows a procedure that was always available to innovator to be made allowed to be available to generics as 

well. 

Mr. GUTHRIE. OK. Thank you. I yield back. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentleman from Texas, Mr. Green, for 5 minutes for questions. 

Mr. GREEN. Thank you, Mr. Chairman. And I am glad you are 

here, Dr. Woodcock. 

I think the three main criticisms of the proposed rule is that it 

would restore tort liability to generic manufacturers, which I don’t 

know if that was the intent but one criticism if the proposed rule 

restores the tort liability, which critics argue would lead to warning 

and significant higher generic drug rates. 

Two, the rule undermines the sameness principle that generic 

and brand name drugs have to be the same, including their labelVerDate Nov 24 2008 11:05 Feb 26, 2016 Jkt 037690 PO 00000 Frm 00040 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-132 CHRIS
35 

ing and therefore undermines the entire Hatch-Waxman justification. 

And three, the rule would lead to a multitude of different labels 

confusing doctors and patients and undermining confidence in generic drugs. 

Frankly, I don’t mind if somebody is producing a drug, they 

ought to have some responsibility for it so I don’t have that big a 

concern about the tort liability. But the other two I do have some 

concern about. It undermines the sameness principle that HatchWaxman did and also the multitude of labeling. 

Dr. WOODCOCK. Well, as I explained earlier, right now, there are 

different versions of the label because the innovator will change 

their label. Even after FDA approves that label, it takes some time, 

for some cases a year, maybe 2 years for some of the generics, not 

all of them, to change their label. So there are differences out there 

between the innovator and generic labels that are disparities now. 

And this proposal that we have would reduce the time of confusion 

if you want to call it confusion. 

Mr. GREEN. OK. But then the sameness principle issue that was 

brought up? 

Dr. WOODCOCK. I feel that the sameness applies and if you are 

a consumer or patient I think that you would want to know that 

the drug is the same as far as its chemical composition, as far as 

its pharmacology, and as far as the manufacturers standing behind 

that drug, all right, and doing the safety surveillance and the monitoring and keeping their label up-to-date no matter whether they 

are innovator or a generic manufacturer. 

The sameness as a literal point of view that labels need to be exactly the same, they are not exactly the same and there are a number of reasons, for example, the pediatric exclusivity, there may be 

certain constituents that are slightly different that is allowed. 

There may be other carveouts to the label due to new indications 

that the innovator has that the generic doesn’t have. And there are 

these differences due to the safety changes in other label updates 

that actually the generics don’t necessarily update in a timely manner. 

Mr. GREEN. Well, Mr. Chairman, I think consumers actually do 

look at labeling, too, not just physicians obviously, for the prescription. 

Dr. WOODCOCK. Yes. 

Mr. GREEN. And I will give you an example. Zyrtec is something 

that has been successful but now it has lost its exclusivity and 

there is a generic available for it that I noticed still has the same 

compounds as Zyrtec. So consumers also look at it other than physicians. 

And I yield back my time. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentleman from Georgia, Dr. Gingrey, 5 minutes for questions. 

Mr. GINGREY. Mr. Chairman, thank you. And, Dr. Woodcock, 

good to see you. 

What is wrong with the current process that the FDA has defended as being necessary to bring orderly change to the labeling 

when it is warranted? What is wrong with the current—— 

36 

Dr. WOODCOCK. As the universe has changed and time has 

changed, the generic industry is now in charge of much of the 

healthcare. It delivers most of the dispensed prescriptions in the 

United States. 

Mr. GINGREY. Well, I know the doctor from the Virgin Islands 

mentioned that a little earlier, that maybe 85 percent of the drugs 

that are dispensed today are generic. Is that what you are getting 

at? 

Dr. WOODCOCK. Yes. And, in fact, in that situation those manufacturers who are marketing those drugs, they need to be monitoring those drugs for safety. The people who market the drugs will 

get the reports, all right? 

Mr. GINGREY. Let me ask you this just a yes-or-no answer. The 

approach the FDA now proposes will result in an orderly process 

that gets evidence-based appropriately tailored labeling changes to 

prescribers in the best possible manner. 

Dr. WOODCOCK. Yes. 

Mr. GINGREY. It does, right? In this proposed rule—and, listen, 

I just came from another committee hearing where I was praising 

the trial attorneys, but this proposed rule sure seems to me to be 

led by the trial attorneys. I am following up on what the gentleman 

from Illinois, Mr. Shimkus, said. And as a physician like me, I hope 

that you would disagree with this implication that the FDA trusts 

the trial bar to be the chief stewards of public health policy. 

Dr. WOODCOCK. The impetus behind this rule was to have a level 

playing field in a situation where now the generic manufacturers 

make most of the drugs that your constituents take. And that they 

have the same opportunity to react to the reports that they get of 

safety problems and rapidly modify the labels and bring them to 

FDA’s attention. There are about 420 drugs right now that have no 

innovator on the market and so it will only be the generic manufacturers to whom those reports would come or to the FDA directly. 

Mr. GINGREY. Under the proposed rule, I understand that generic 

innovator—now, innovator is the same as the brand—— 

Dr. WOODCOCK. Yes, sorry. 

Mr. GINGREY [continuing]. The original drug that the company 

brought. I understand that generic and innovator companies could 

propose labeling changes through the CBE process and that the 

agency would post all of these suggested changes on your Web site 

on the FDA Web site before you would approve them. That is correct, isn’t it? 

Dr. WOODCOCK. Yes. 

Mr. GINGREY. And for multi-sourced drugs, those that are the 

exact same, they are made by both the innovator and the generic 

companies, isn’t it possible that each manufacturer could have different warnings posted for the same risk? 

Dr. WOODCOCK. It is possible, but of course that would enable us 

to move very quickly. We get these now from innovators and they 

do a CBE–0 or we may hear from practitioners, we may have it reported to us, we may get it from the literature. We quickly evaluate 

those and we put out an FDA drug safety alert. I am sure you are 

familiar with these. Sometimes we say we are just looking at this 

issue. We don’t know the answer yet. 

Mr. GINGREY. Yes. 

37 

Dr. WOODCOCK. So we are an actor in this as well but we need 

to be made aware of what the manufacturers know. 

Mr. GINGREY. Yes. Well, it seems like to me it would be confusing for doctors and patients, let’s say, to go online, up-to-date 

WebMD, you pick it, and find different warnings and contraindications for the exact same drug. I don’t see how that benefits public 

health when that happens. 

Dr. WOODCOCK. Well, right now, of course there are drug safety 

controversies, as you know. And there is much on the blogosphere, 

on WebMD and everything else about different reported papers 

with this cardiovascular risk, this risk. Generally, FDA will put out 

a safety alert and say we are evaluating this issue. Here is what 

we know so far. Here is what we don’t know. We will let you know 

when we have definitive information. When we do, then we would 

require all the manufacturers have the same label when we 

had—— 

Mr. GINGREY. Well, that is good news in my concluding 10 seconds because I was going to ask isn’t it the FDA’s job to referee 

these disputes and make class-wide labeling changes? 

Dr. WOODCOCK. Yes, it is, and we do that. Yes. 

Mr. GINGREY. Mr. Chairman, I yield back. 

Mr. PITTS. The chair thanks the gentleman. That concludes the 

questions of the Health Subcommittee members who are here. I am 

sure they will have written questions that they will submit. 

But at this time I would like to seek unanimous consent to permit the gentleman, Mr. Braley from Iowa, to ask questions. And 

without objection, so ordered. 

The chair recognizes Mr. Braley 5 minutes for questions. 

Mr. BRALEY. Thank you, Mr. Chairman. I really appreciate the 

Committee’s indulgence in allowing me to be part of the hearing. 

I want to follow up with a question, Dr. Woodcock, that Mr. 

Shimkus raised about input from physicians or physician groups. 

Dr. WOODCOCK. Yes. 

Mr. BRALEY. We heard from Mr. Waxman about the friend-ofthe-court brief he filed in the Mensing case. Were you aware that 

the American Medical Association, the largest physician organization in the country, also filed a friend-of-the-court brief in that 

case? 

Dr. WOODCOCK. No. 

Mr. BRALEY. OK. Assume for the moment that they did and that 

one of the concerns they raised with the Supreme Court was the 

ethical dilemma that physicians face when they are confronted 

with inconsistent rules to protect their patients who receive brand 

name drugs—— 

Dr. WOODCOCK. Yes. 

Mr. BRALEY [continuing]. As opposed to rules that protect their 

patients who purchase generic drugs. 

Dr. WOODCOCK. Yes. 

Mr. BRALEY. Is that the type of concern from healthcare providers that would be relevant to the agency in deciding whether or 

not to go forward with this rule? 

Dr. WOODCOCK. Well, we just several weeks ago closed the comment period and we got over 100 comments, some of them fairly 

38 

voluminous, so I hope we have received input from a large number 

of sectors on this, including obviously the clinical community. 

Mr. BRALEY. Mr. Lance raised concerns about similarly situated 

consumers being treated the same, but wouldn’t that be an example raised by a physician group, the largest in the country, that 

would show how these different consumers of medications can be 

treated differently and that could raise concerns? 

Dr. WOODCOCK. Well, I will say that certainly one of our issues 

is that the entities that are supplying medicine for a large number 

of patients in this country should stand behind their medicines. 

Mr. BRALEY. One of the things that came up was Sentinel systems in your testimony, and this is a common word that is used 

in trying to promote patient safety throughout the healthcare delivery system, correct? 

Dr. WOODCOCK. Yes. 

Mr. BRALEY. In fact, the Joint Commission on Accreditation of 

Healthcare Organizations uses a Sentinel event system that requires any adverse event to be reported and then followed up so 

you get to the root cause of what caused the problem and develop 

an action plan to correct it. Are you familiar with that concept generally? 

Dr. WOODCOCK. Yes, I am very familiar with it. 

Mr. BRALEY. So, don’t generic manufacturers of drugs have the 

same safety incentives as a matter of public health to warn consumers as brand name manufacturers? 

Dr. WOODCOCK. Well, I would certainly hope so. They have the 

same regulatory requirements to be monitoring for the impact of 

their drug and to find out if any new safety event happened and 

to report it to the FDA. 

Mr. BRALEY. And one of the concerns about this proposed rule 

that I would think conservatives would be very happy about is that 

it promotes personal responsibility and not shifting the burden to 

take care of patients to taxpayers through publicly funded 

healthcare systems. Isn’t that true? 

Dr. WOODCOCK. Not being a lawyer, it is difficult for me to comment on that. 

Mr. BRALEY. If we don’t have a remedy for people harmed by generic drugs and they have to go on Medicare and Medicaid, we end 

up paying for it as taxpayers, don’t we? 

Dr. WOODCOCK. That would apparently be the case sometimes. 

Mr. WAXMAN. Would the gentleman yield to me? 

Mr. BRALEY. I only have a few more minutes. 

Mr. WAXMAN. I know. I wanted to take it. 

Mr. BRALEY. One of the things that we know is there have been 

concerns raised about the cost of the proposed rule and we have 

heard testimony that 80 percent of the medications being dispensed 

are generics. The federal agency that is focused on promoting public health as part of the National Academy of Sciences is the Institute of Medicine—— 

Dr. WOODCOCK. Yes. 

Mr. BRALEY [continuing]. And they have spent a lot of time 

studying this whole problem with preventable medical errors and 

especially medication errors. And this is a book they released in 

2007 called Preventing Medication Errors. 

39 

Dr. WOODCOCK. Right. 

Mr. BRALEY. And in here they write that in 2000, a study estimated that the cost of drug-related illnesses and deaths in the ambulatory setting in the United States was $177.4 billion. 

Dr. WOODCOCK. Yes. 

Mr. BRALEY. That is a lot of money. 

Dr. WOODCOCK. Absolutely. 

Mr. BRALEY. So if 80 percent of that marketplace is generic drugs and we would be talking about $140 billion cost associated with not 

reducing this problem and promoting patient safety. Isn’t that 

true? 

Dr. WOODCOCK. Well, I am very familiar with that book. I think 

that put in a lot of different safety problems together when they 

made those estimates. However, I would say that it is imperative 

that everyone monitor safety drugs in the outpatient and the ambulatory setting and that we improve our outcomes with patients. 

Mr. BRALEY. Well, with my 5 seconds left I just want to mention 

Sophie Howe of Ames, Iowa, a young college student who was 

harmed by a generic drug and ended up having a lot of added cost 

associated with that, including payment of her student loans that 

were accelerated when she had to drop out of school because of her 

medical complications. And I think it is the human faces behind 

this problem that we should be thinking about. 

Thank you. 

Dr. WOODCOCK. Thank you. 

Mr. BRALEY. I yield back. 

Mr. PITTS. The chair thanks the gentleman. That concludes the 

questions. 

At this time, we will have written questions that we will provide 

to you if you can please respond to those. 

Thank you very much—— 

Dr. WOODCOCK. Thank you. 

Mr. PITTS [continuing]. Dr. Woodcock, for your testimony and for 

your patience today. 

Before I call the second panel, I ask unanimous consent to recognize the ranking member of the full committee, Mr. Waxman, for 

5 minutes for a statement. 

Mr. WAXMAN. Thank you very much, Mr. Chairman. 

I know this is extraordinary to allow this but I am not going to 

be able to be here for the testimony of the next panel. 

But I did want to comment on the fact that there is a disconnect 

at this hearing because people are talking about whether the label 

is going to be the same, how long it will take to be the same and 

whether the doctors are for this or not for it. I just want to point 

out what is really going on at this hearing. 

The Supreme Court decision said that a generic drug manufacturer cannot be held liable under state law to warn people about 

the dangers of a drug that they manufacture that they know about 

because they can’t put it in the label because under the law they 

cannot change their label unless the FDA changes the label for the 

brand and the generic company. 

So in my brief to the Court I said, look, if they can’t change their 

label, then they ought to be held liable under state law for the failure to let FDA know that there is a problem for which they ought 

40 

to give some notice to the public. It seems reasonable to me but the 

Court on a 5-to-4 basis said no. The only thing that would make 

them liable is if they failed to warn by a label change. And they 

can’t make that label change, and therefore, the generic drug industry could open their champagne and drink to the success that 

they are never going to be held liable for. And that is great if you 

are never going to be held liable for them perhaps but it is not 

great for the consumers. 

The FDA has looked at this issue and said, well, wait a minute. 

We have a requirement that brand name companies warn the consumer and they can even change their label, and then while we are 

considering whether or not we are going to impose that label requirement on everybody, they could go forward with it. But the generic drug companies can’t do that. 

Now, FDA is not looking at it from a legal liability. They are just 

looking at it from patient safety. It doesn’t make sense that if a generic company discovers there is a problem, not to have them warn 

people, just as it is required by the brand name company. So they 

are changing the rules to be sure the consumer is protected, but 

in the process, it could and most likely would reverse the Supreme 

Court decision and make the generic companies liable for failure to 

warn people if they have the ability to warn them in a new label, 

just as the brand name companies have. 

So while we are talking about all these other issues, we are missing what is really at stake here. We are going to hear that, I think, 

in this next panel because Mr. Neas and others are going to argue 

this is going to cost billions of dollars in liability that they hadn’t 

had to worry about in the past. But I would submit that that 

doesn’t make sense. Before the Supreme Court case, they were liable and they had to anticipate that, but they didn’t have billions 

of dollars as a result of that vulnerability of liability. They were 

able to manage that reasonably well. And to expect, notwithstanding a report that we are going to hear about, which I very 

much doubt its validity, we are going to hear that, no, this is a big 

matter. This is going to be a huge liability for them. 

Well, whether it will or will not, they should be held to the same 

standards in order to protect the public, and I hope they are liable 

if they do something wrong by not warning people in a label 

change. Because if they have information that their drug, as they 

learn now, could harm people, they ought to make that label 

change. Certainly, the brand name companies have to do it. 

So I wanted this chance to make this statement now because I 

am not going to be able to be here to do it through questions. 

I just must say, Mr. Neas, you have got a report. I just don’t see 

it possibly being valid and it will be held up to some further questioning by this panel. But I can’t see how it is valid. It seems to 

me highly inflated. It is like all the people that come in here and 

we want to regulate them, they say this will drive us out of business. And then when the regulations go into effect, they do it for 

a fraction of the cost. So I just think that people ought to put in 

perspective what this hearing is really all about. 

And as I have now straightened everybody out about what is significant, I am going to leave you. Thank you, Mr. Chairman. 

Mr. PITTS. The chair thanks the gentleman. 

41 

Now, we will have our second panel. Please come to the witness 

table and I will introduce them in the order that they will speak. 

On our second panel today we have Mr. Michael Shumsky, partner, Kirkland & Ellis; Mr. Ralph Neas, President and CEO of the 

Generic Pharmaceutical Association; and Ms. Allison Zieve, General Counsel, Public Citizen. 

Thank you all for coming. Your written testimony will be made 

part of the record. You will each have 5 minutes to summarize your 

testimony. 

And at this point the chair recognizes Mr. Shumsky, 5 minutes 

for his opening statement. 

STATEMENTS OF MICHAEL D. SHUMSKY, PARTNER, KIRKLAND 

& ELLIS, LLP; RALPH G. NEAS, PRESIDENT AND CEO, GENERIC PHARMACEUTICAL ASSOCIATION; AND ALLISON M. 

ZIEVE, GENERAL COUNSEL, PUBLIC CITIZEN 

STATEMENT OF MICHAEL D. SHUMSKY 

Mr. SHUMSKY. Chairman Pitts, Ranking Member Pallone, and 

members of the subcommittee, thank you so much for inviting me 

to testify today. Though I filed administrative comments on these 

issues for a number of clients as part of my law practice, I would 

like to make clear at the outset that I am testifying today in my 

personal capacity and that the views I express are solely my own. 

Over the past 30 years, the Hatch-Waxman Act has generated 

trillions of dollars in cost savings. And that phenomenal success 

stems from a simple but brilliant insight. Because two drugs with 

the same chemical and biological properties will have the same 

safety profile, FDA can safely approve generic versions of a previously approved drug without requiring new independent clinical 

trials 

And it is precisely because two drug products with the same 

chemical and same biological properties will have the same safety 

profile that the statute naturally requires that generic drug labeling be ‘‘the same as the labeling approved for’’ that product’s brand 

name equivalent. In a single word, sameness is both the statute’s 

animating principle and the driving force of its success. 

FDA now wants to permit generic drug warnings that are ‘‘inconsistent with the labeling for the RLD.’’ That is the brand name 

equivalent. The agency has no power to do so. In our system of separated powers, the executive branch is bound by the laws this Congress passes. Indeed, as the Supreme Court explained the very 

same year Congress patched Hatch-Waxman, ‘‘if the intent of Congress is clear, that is the end of the matter for the agency must 

give effect to the unambiguously expressed intent of Congress.’’ By 

this standard, FDA’s proposal is indefensible. It pays no heed to 

Hatch-Waxman’s plain language which explicitly requires generic 

labeling to be ‘‘the same as the labeling approved for’’ the brand 

name equivalent. And indeed, the statute further bars FDA from 

even approving a generic drug for sale in interstate commerce if its 

labeling is not ‘‘the same as’’ the approved labeling for the brand 

name drug. 

The proposal also ignores FDA’s lengthy track record on this 

issue. Indeed, FDA has repeatedly recognized the generic labeling 

42 

must be the same as the FDA-approved branded labeling at all 

times. It did so during the first Bush Administration, during the 

Clinton Administration, during the second Bush Administration 

and in its Supreme Court brief in the Mensing case earlier in this 

Administration. 

And finally, FDA’s proposal conflicts with the Supreme Court’s 

recognition in both Mensing and in Bartlett that it is this Congress’ 

statute, not merely FDA’s regulations, that bars generics from 

using different warnings on their products. As the Court put the 

point very clearly in Bartlett, ‘‘Congress’ decision to regulate the 

manufacture and sale of generic drugs in a way that reduces their 

cost to patients but leaves generic drug manufacturers incapable of 

modifying their warnings.’’ In other words, Hatch-Waxman represents, as the Court said, ’’Congress’ decision,’’ not the FDA’s. 

I firmly believe that Hatch-Waxman’s sameness requirement is 

supported by sound public policy and that FDA’s rulemaking proposal threatens to harm the public health, but those issues are beyond the scope of my testimony today. 

I also understand that the Court’s recent decisions in this area 

are controversial, but as the Court recognized in Mensing and 

Bartlett, FDA has no power to adopt this proposal until this Congress changes Hatch-Waxman’s core principle, the sameness requirement that has made that law one of the most successful pieces 

of legislation ever passed. 

I have one minute left and I do want to highlight one thing and 

it was I think a very telling and very important exchange between 

Dr. Christensen on the one hand and Dr. Woodcock on the other. 

Dr. Christensen asked Dr. Woodcock about the origins of FDA’s 

CBE proposal, and as she made clear, that proposal originated as 

an exercise in the FDA’s view of enforcement discretion, meaning 

that the agency would not enforce the law as Congress wrote it. 

She then said, however, over time, FDA has changed its mind and 

now they interpret that to flow from the statute itself as opposed 

to the agency’s disregard for the statute. 

Let me translate that answer so that there is no mistaking what 

it was. FDA has ignored the law so long that the law has changed. 

That is a fundamental reordering of our Democratic process and a 

direct threat to the separation of powers. And I want to thank 

Chairman Pitts for holding this hearing so that we can explore 

those very important issues about the nature of our constitutional 

republic. 

[The prepared statement of Mr. Shumsky follows:] 

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Mr. PITTS. The chair thanks the gentleman and recognizes the 

gentleman, Mr. Neas, 5 minutes for an opening statement. 

STATEMENT OF RALPH G. NEAS 

Mr. NEAS. Good afternoon, Chairman Pitts, Ranking Member 

Pallone, and members of the subcommittee. Thank you for inviting 

me to testify on the FDA’s proposed changes to generic drug labeling. I am Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association. 

This year we commemorate the 30th anniversary of the HatchWaxman Act, which by any measure has been one of our most effective laws ever passed. This remarkable law initially projected to 

save maybe a few million dollars a year has saved the U.S. 

healthcare system more than $1.2 trillion over the past decade, 

$217 billion in 2012 alone. 

The quality and affordability of generic medicines is vital to public health and the sustainability of the healthcare system. The very 

heart and soul of the Hatch-Waxman Act is the sameness principle 

under which generic manufacturers must prove to the FDA that 

their version of a drug contains the same active ingredient as the 

brand product, is identical in strength, dosage form, and route of 

administration, and importantly for today’s discussion, has the 

same labeling. These requirements give consumers, doctors, and 

pharmacists confidence in the safety and effectiveness of generic 

medicines. 

The top priority for generic manufacturers is assuring patient 

safety for the hundreds of millions of people who rely on our products to live healthier and longer lives. The company’s proactively 

participate with FDA to ensure the timeliness, accuracy, and completeness of drug safety labeling in accordance with all current regulations. These manufacturers report all serious and unexpected 

adverse events to the FDA within 15 days. All others report it 

quarterly or annually. The generic industry takes these responsibilities seriously. 

Unfortunately, the FDA’s proposed rule would substantially undermine the enormously successful Hatch-Waxman Act and put 

both patient safety and healthcare savings at risk by directing generic manufacturers to make unilateral labeling changes without 

prior FDA approval. The rule creates a system whereby multiple 

different labels, including different warnings, can simultaneously 

exist in the marketplace for the same drug with the same active 

ingredient. 

Generic manufacturers only have access to the scientific and 

medical evidence for their individual products representing a fraction of the total market. They do not have access to the clinical 

trial data and other proprietary information of the brand manufacturer or current information and data from other generic manufacturers. Only the FDA has access to all the data and information. 

A generic manufacturer that unilaterally changes its label therefore does so with incomplete information. 

It is difficult to overstate the negative implications of the proposed rule on patient safety and on consumer access to affordable 

medicines. Allowing for multiple different drug labels in the market 

for the same product would upend 30 years of law and regulation 

49 

and create substantial confusion for everyone in the healthcare system. Uniform safety information provides certainty for patients and 

providers that they can rely on consistent information and inform 

their decisions in medical conversations. 

Identical labels also underscore the critical point that once generic medicines are approved by the FDA, they are proven scientifically equal to the brand medicine in terms of safety, efficacy, and 

quality. The risk of over-warning and the flood of unnecessary labeling changes is substantial. Multiple versions of critical safety information would inaccurately imply therapeutic differences between the generic drug and brand drug that do not exist. The exaggeration of risk and inclusion of unsubstantiated warnings will 

cause provider confusion and discourage the use of beneficial treatments. 

In addition to seriously jeopardizing patient safety, the proposed 

rule would also burden consumers, businesses, and state and federal governments with billions of dollars in increased prescription 

drug costs. A recent economic analysis found that the proposed rule 

would conservatively add $4 billion annually to the Nation’s already high healthcare cost, including $1.5 billion in Medicare and 

other government programs. 

It should be no surprise that 19 organizations representing those 

populations that most rely on access to affordable generic drugs 

and representatives from virtually every sector of the pharmaceutical supply chain, most importantly pharmacists and pharmacy 

organizations representing more than 100,000 pharmacists and 

45,000 pharmacies, have submitted letters to the FDA raising their 

significant concerns that the proposed rule could jeopardize patient 

access and patient safety. 

Unfortunately, neither the FDA nor the Office of Management 

and Budget conducted a robust cost-benefit analysis as OMB is required to do to examine the economic implications of this rule in 

increased healthcare costs. 

I am here today with a simple message. We can do better. GPhA 

fully supports a streamlined, efficient, and transparent process for 

timely submission in updating their safety information for generic 

drugs for healthcare providers and the public. A key element of any 

new system must include timely FDA review of all available clinical data and safety signals, including the nonpublic data of the 

NDA holder. 

Underlying this process should be one bedrock principle: Generic 

drug labels must be FDA-approved; it must be based on scientific 

evidence. Such a system would advance our shared goals of protecting the public health and improving patient safety. Congress 

should ensure that the FDA has sufficient resources to do so. We 

would welcome the opportunity to work with others in the 

healthcare system in a multi-stakeholder collaboration on this matter. The FDA should hear from patient advocates, pharmacists, 

physicians, payers, not just trial lawyers, and others in the supply 

chain who could offer expertise, experience, and perspective. 

The sustainability of our healthcare system depends on the continued access to affordable generic medicines. We will work hard 

to make sure that any changes to labeling rules and regulations 

50 

protect patient safety, align with federal law, and do not hinder patient access to more affordable generic medicines. 

Thank you, Mr. Chairman. 

[The prepared statement of Mr. Neas follows:] 

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Mr. PITTS. The chair thanks the gentleman and now recognizes 

Ms. Zieve 5 minutes for an opening statement. 

STATEMENT OF ALLISON M. ZIEVE 

Ms. ZIEVE. Thank you, Mr. Chairman. 

I am general counsel of Public Citizen and director of Public Citizen Litigation Group. Our office submitted the citizen petition that 

the FDA granted in part by issuing the proposed rule that we are 

discussing today. 

Since 1984, despite considerable changes in the market, FDA 

regulation of generic labeling has remained substantially unchanged. Since 1985, at the request of Pharma and other specific 

brand name manufacturers, the FDA has allowed the brands to 

make safety-related labeling changes without prior approval. The 

concerns that motivated the FDA to adopt these changes being affected or CBE option 30 years ago—the need to promptly inform 

patients and physicians and the interest and efficiency and resource management—apply equally today. 

FDA continues to lack the resources to be the primary instigator 

of post-approval labeling changes and cannot timely pre-approve 

every safety update. Therefore, today, with generics comprising 

such a large percentage of all prescriptions filled, to fulfill the goal 

of timely labeling updates to physicians and patients, the CBE 

process must be available to generic manufacturers as well. 

The majority of labeling changes are initiated by manufacturers, 

not by the FDA, and based on publicly available adverse event reports and medical literature. The brand name manufacturer drops 

to a small percentage of the market very quickly after generics 

enter the market and often stop selling the drug altogether. More 

than 400 unique drugs fall into this category. In these instances, 

if generic manufacturers are not actively monitoring and proposing 

safety updates, no manufacturer is doing so at all. But at the same 

time, it is undisputed that critical safety information may come to 

light after entry of the generic onto the market and after exit of 

the brand-name product. 

The concern that the proposal will result in confusing or inconsistent labeling is unwarranted, I think, based on unfounded worstcase scenarios and belied by current practice. For the past 30 years 

brand labeling has been different from generic for months, or as 

Dr. Woodcock testified, up to a year even in some cases after the 

brand updates the labeling. We have seen no evidence of confusion. 

And despite this sameness concern of Hatch-Waxman, variations 

of labeling are built into current regulations and have been for 30 

years such as the listing of different formulations or a different indication. Sameness has never been a literal requirement of the law. 

Yet again, physicians and pharmacists have not complained of 

confusion. In fact, the National Physicians Alliance submitted a 

comment to the FDA 2 weeks ago saying that confusion is not their 

concern. Their concern is updated safety information. 

Finally, the manufacturers have argued, and I think this is the 

real objection, that the proposed rule, if finalized, will expose them 

to liability for failure to warn. They argue that the proposed rule 

will increase the cost of generic drugs and insurers may refuse to 

insure them and that some manufacturers may even decline to 

67 

enter the market. But both recent history and current reality prove 

these theories wrong. Until 2011, generic drug manufacturers faced 

the same liability risk that they would under the revised rule because until the Court’s decision in Pliva v. Mensing, generic companies could be and sometimes were sued for failure to warn and 

many cases were resolved favorably to the patient. Even today, 

some lawsuits, although far fewer, are brought in cases where the 

generic has failed to make a required update. So the proposal 

would not create a new cost but one borne and managed very well 

by the industry until just 30 years ago and still borne fully today 

by brand name manufacturers. 

It is important to keep in mind—I think this has gotten lost 

today—that lawsuits for failure to warn, when meritorious, occur 

because a patient suffered injury due to the lack of an adequate 

warning. Thus, the many lawsuits about metoclopramide, for example, people took a drug for reflux and developed the neurological 

disease tardive dyskinesia, which is often permanent. Adverse 

event reports and studies documented this problem for years but 

the brand name company did not revise the labeling and the 

generics said nothing. 

Of course, the manufacturer is not responsible every time a patient is injured but sometimes the manufacturers, including generic 

manufacturers, turn a blind eye and the current system allows the 

generic manufacturers to do this. The result is more injury and 

more cost because immunizing a company from liability does not 

make the patient’s costs go away. They are carried by the patients, 

the health insurance, and taxpayers. For this reason, by giving generic manufacturers the tools and incentives to update safety labeling, the proposed rule will be to a cost savings, savings in medical 

care for the patients who will not be injured because they and their 

physicians are armed with updated information about safety risks. 

Thank you. 

[The prepared statement of Ms. Zieve follows:] 

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[The supplemental information provided with Ms. Zieve’s statement is available at http://docs.house.gov/meetings/if/if14/20140401/ 

101823/hhrg-113-if14-wstate-zievea-20140401.pdf.] 

Mr. PITTS. The chair thanks the gentlelady. I will begin questioning. I recognize myself for 5 minutes for that purpose. 

Mr. Shumsky, in responding to the bicameral letter sent to the 

agency in January, FDA decided not to answer the question whether the other sameness requirements included in Sections 505(j) of 

the Food, Drug, and Cosmetic Act extended beyond the date of approval. Now that FDA has taken the position that the statute does 

not in fact require sameness in labeling after the date of approval, 

could it now be argued that the sameness requirements for 

strength, dosage, route of administration only apply at the time of 

approval as well? Is this not an absurd result? 

Mr. SHUMSKY. Mr. Chairman, thank you for the question. And I 

think it really hits the nail on the head. It does demonstrate the 

real absurdity of FDA’s proposal because once you take the position 

that sameness doesn’t mean the same for labeling, there is no principle basis for saying that sameness does mean the same for 

strength, dosage, route of administration, or any of the other requirements in the statute. 

Mr. PITTS. Can you please explain why FDA cannot make this 

change without congressional action? 

Mr. SHUMSKY. Sure. There are several reasons, all of which were 

recognized by the Supreme Court originally in its Mensing decision 

in 2011 and then its Bartlett decision just this past term, in 2013. 

The central statutory provision at issue here is Section 505(j) of 

the original statute, which specifically says the generic product labeling must be the same as the labeling approved for the brand 

name drug. There are a couple of other provisions in the statute 

that are equally relevant. One requires the secretary, which is the 

secretary of HHS whose vested authority and the Commissioner of 

food and drugs when it comes to drug approval determinations, it 

requires the secretary to reject an abbreviated new application, 

that is a generic drug application, where its labeling is not the 

same as the branded drug. 

And finally, there is a more recent provision of the statute which 

specifically says that there are certain limited exceptions to the 

sameness requirement. And we have heard about a couple of them 

where an inactive ingredient in a product like its coating is different than the brand manufacturer, there are some specific exceptions. None of those exceptions apply to warning or safety-related 

information and there is a further provision of the statute which 

says that for certain permissible exceptions, differences between generic and branded labeling will not be considered misbranded if 

certain criteria are met, but that language in the statute specifically excludes—in other words, it says ‘‘but not changes to the 

warning section of the labeling,’’ which I think represents Congress’ 

explicit recognition that a generic drug which bore different warnings than its branded drug would be misbranded. 

Mr. PITTS. Now, some have stated that the proposed rule would 

simply return the legal landscape for generic drug manufacturers 

with respect to failure-to-warn cases to where it existed prior to 

2011. Therefore, generic manufacturers would assume the same 

77 

type of liability they had before the Supreme Court’s decision. Is 

this an accurate assessment? 

Mr. SHUMSKY. I don’t believe that it is, Mr. Chairman. Prior to 

2011, no federal court of appeals had held the generic drug manufacturers could be held liable for failure to warn. To the contrary, 

one court had addressed that question. In 2008, the Third Circuit 

Court of Appeals, which is based in Philadelphia, ruled that state 

failure-to-warn lawsuits targeting generic drug products were preempted. And prior to the Supreme Court’s 2009 decision in Wyeth, 

that was the definitive word in the federal judiciary, in the federal 

court system on generic liability. Two decisions came after Wyeth, 

which did expose generic drug manufacturers to liability, one of 

them was called Mensing out of the Eighth Circuit, the other was 

called Demahy out of the Fifth Circuit. And as we all know, the 

Supreme Court promptly reversed both those decisions. 

Mr. PITTS. I have one more question I want to ask. Currently, 

there is a period where the brand and generic drug labeling differs. 

Usually, this occurs when a brand makes a labeling change on 

their end and the generic drug manufacturer has to make conforming changes. How is this scenario envisioned under the proposed rule different in nature and scope from what currently takes 

place? 

Mr. SHUMSKY. Sure. It is a totally different situation. Start with 

the language of the statute, which says the generic drug has to 

have the same labeling that FDA has approved for the brand. And 

so there will be a period of time where a brand manufacturer executes one of these CBE–0 changes. FDA then has to consider it and 

approve it before a generic can implement it. This proposed rule 

has nothing to do with that scenario. This rule says a generic on 

its own acting unilaterally can go out, decide it doesn’t think that 

the branded warning is good enough anymore and put a warning 

onto its product that the brand hasn’t considered and that the FDA 

hasn’t reviewed. It is an apples-and-oranges situation. 

Mr. PITTS. The chair thanks the gentleman. My time is expired. 

The chair now recognizes the ranking member, Mr. Pallone, 5 minutes for questions. 

Mr. PALLONE. Thank you, Mr. Chairman. 

I wanted to ask Ms. Zieve. Today, we have heard a lot about liability and I think it will be important to begin our questions of 

this panel about the role it plays in this context. So for the benefit 

of our members, could you describe for us the role that tort liability 

plays regarding product safety generally, and more specifically, in 

promoting the safety of drugs and other FDA-regulated products? 

And could you describe some of the kinds of harm that have been 

the subject of failure-to-warn lawsuits? 

Ms. ZIEVE. Thank you, Mr. Pallone. 

I will start by quoting to you from what the Supreme Court has 

said about state failure-to-warn suits in the drug context. The 

Court wrote ‘‘state tort suits uncover unknown drug hazards and 

provide incentives for drug manufacturers to disclose safety risks 

promptly. They also serve a distinct compensatory function that 

may motivate injured persons to come forward with information. 

Failure-to-warn actions in particular enforce the FDA’s premise 

78 

that manufacturers, not the FDA, their primary responsibility for 

their drug labeling at all times.’’ 

I think one sort of prominent example of some of the public 

health benefits beyond for the individual plaintiff comes through 

the Vioxx cases where a tremendous amount of information came 

to light only because of the personal injury suits, information that 

not even FDA had, and it really helped to move that process forward and eventually to get a very dangerous drug off the market 

and find out what had happened in that case. 

There are unfortunately a number of examples of drugs, branded 

and generic, that have caused serious safety problems. Unfortunately, only, according to one study, about half of serious problems 

are discovered in the first 7 years after new drug is on the market. 

So even after the generic comes on the market, we are still finding 

new safety risks. 

I mentioned metoclopramide, which was marketed under the 

brand name Reglan, in my opening remarks. Another example is 

Accutane. This one is sort of particularly heartbreaking because 

the patients who were injured were teenagers. They took the drug 

for acne. It is purely aesthetic, right, but it is very important to the 

teenagers. They take this, and unfortunately, it can cause bowel 

disease that requires in some cases surgery and it can really 

change their lives permanently and in devastating ways. 

And there was information for years and adverse event reports 

and medical literature that this drug could cause this serious problem and the brand name did nothing. And again, the FDA does not 

have primary responsibility for labeling updates. It can’t. It doesn’t 

have the resources. That is the premise of the Food, Drug, and Cosmetic Act and of the regulations. But the brand name manufacturer said nothing and the generics said nothing because they don’t 

have to. 

When the FDA finally ordered a labeling change for Accutane to 

warn of this serious problem, the brand promptly removed it from 

the market. So today, this is a drug that has had serious risks 

added throughout its I think it is 20 or 30 years now on the market 

and the only products of Accutane sold today are the generic so nobody has responsibility for that labeling today. 

Mr. PALLONE. And let me get to my second question. In my opening statement I mentioned that I am sympathetic to the questions 

surrounding sameness, which is the guiding principle in HatchWaxman. How do you respond to the claim that the FDA proposed 

rule fundamentally violates this sameness principal and will undermine the statutory and regulatory framework for approving and 

overseeing generic drugs? 

Ms. ZIEVE. Well, I am glad you didn’t say sameness requirement 

because, as I mentioned, sameness has never been a requirement. 

The FDA regulations have a section that lists exceptions to sameness and these have been uncontroversial. The most relevant one 

is actually during the period after a brand makes a CBE change. 

The difference between the status quo today and after what I hope 

will be the FDA finalization of the rule is that that period of difference, that temporary deviation, may be instigated by the 

generics just like today it is instigated by the brands. And the FDA 

79 

has fashioned the rule to make sure that this temporary exception 

actually works a little more efficiently than it works today. 

Mr. PALLONE. All right. I don’t know if I have enough time. I 

think I don’t have enough time for my next question now, Mr. 

Chairman. Thanks. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentleman from New Jersey, Mr. Lance, 5 minutes for questions. 

Mr. LANCE. Thank you, Mr. Chairman. 

Ms. Zieve, were you an amicus in either the Mensing or the Bartlett cases or a litigant in some way? 

Ms. ZIEVE. My office filed an amicus brief in Mensing—— 

Mr. LANCE. In Mensing. 

Ms. ZIEVE [continuing]. And filed an amicus brief in Bartlett, I 

believe on behalf of Mr. Waxman. 

Mr. LANCE. Thank you. And are you in agreement with the 

Mensing and the Bartlett decisions? 

Ms. ZIEVE. No, I think that they are wrong as a matter of legal 

jurisprudence as well as policy. 

Mr. LANCE. I see. And certainly we can debate policy but you believe the Supreme Court was wrong in both the Mensing and Bartlett decisions? 

Ms. ZIEVE. Right, I do, but I also think it is important, particularly in Mensing today that the Supreme Court look to the FDA’s 

regulations and defer to the FDA’s view of those regulations in deciding that failure-to-warn suits were preempted. The Court didn’t 

hold that Hatch-Waxman required that result but said specifically 

it was going to defer to the FDA’s view about its own regulations. 

Mr. LANCE. Thank you. 

Mr. Shumsky, your view on Mensing and Bartlett? 

Mr. SHUMSKY. I represented the petitioners in both of those lawsuits and I think the Supreme Court did a fabulous job. 

Mr. LANCE. Thank you. Thank you. And this is a situation where 

the question was litigated to the Supreme Court and the Court 

made its decision. As I stated to Dr. Hamburg and I think very 

often in these matters where you stand on issues of public policy 

is based upon where you sit, if we want to modify the underlying 

statute, Mr. Shumsky, do you believe we should ask Congress to 

do that through our statutory power? 

Mr. SHUMSKY. I certainly believe that if Congress is of the mind 

that the public policy here needs to be altered to enable the kind 

of liability the Mensing and Bartlett decisions—— 

Mr. LANCE. Yes. 

Mr. SHUMSKY [continuing]. Rejected, that Congress needs to act 

to change the statute to do that. I remain firmly of the belief that 

FDA has no authority on its own to do that. 

Mr. LANCE. Yes. 

Mr. SHUMSKY. And I would say I think there are very sound policy reasons underlying the Mensing and Bartlett decisions which 

would counsel against those changes. 

Mr. LANCE. And your testimony would indicate that in the Administration of President Bush, senior President Bush, President 

Clinton, the junior President Bush, and President Obama, at least 

at the beginning of his tenure in office, your view was the view 

80 

that was prevailing in the administrative agency. Have I got that 

right? 

Mr. SHUMSKY. Yes, Congressman, that is correct. 

Mr. LANCE. Thank you. Why in your opinion has there been a 

change at the agency regarding this matter? 

Mr. SHUMSKY. I can’t speculate on what has prompted them to 

turn around after 30 years of taking the position that these labeling changes are impermissible. 

Mr. LANCE. And, Mr. Neas, do you have an opinion on that? 

Mr. NEAS. It would be speculative. All we have, however, right 

now is that the FDA after, as Mike said, 30 years of enforcing the 

law in a certain manner under several different Democratic and 

Republican administrations made a change, and that change was 

precisely what the trial lawyers and Public Citizen recommended 

in 2011 and 2013, and they are the only ones I believe who met 

with the FDA and think that is a problem. 

Mr. LANCE. I am sorry, Ms. Zieve. You are welcome to comment. 

Ms. ZIEVE. Sorry. We didn’t meet with FDA for what it is worth. 

Mr. NEAS. Just the trial lawyers. 

Mr. LANCE. The trial lawyers, thank you. They have a perfect 

right to meet with the FDA. 

Mr. NEAS. Absolutely. 

Mr. LANCE. Let me be on the record as saying that. 

If the rule is finalized, will it likely be a matter of litigation? 

Mr. NEAS. If the rule is finalized? 

Mr. LANCE. In its current form. 

Mr. NEAS. My guess is there is a strong likelihood that it could 

be the subject of litigation from a variety of different perspectives 

and constituencies. 

Mr. LANCE. And, Ms. Zieve, what is your opinion on that? If the 

rule is finalized as it has been written, do you believe this is likely 

to be litigated? 

Ms. ZIEVE. Well, I would like to answer that in two ways. I think 

given what the industry has been saying, it is likely that they are 

going to want to litigate because they have been saying that they 

will. But I also think that the rule is perfectly permissible under 

the Food, Drug, and Cosmetic Act, including the Hatch-Waxman 

amendments to that act. 

Mr. LANCE. Yes, thank you. I realize your opinion but you believe 

it will be litigated is my question. You think it will be litigated? 

Ms. ZIEVE. Well, I believe that the industry has said that they 

are going to litigate it. 

Mr. LANCE. Yes. 

And, Mr. Shumsky, do you believe there will be litigation? 

Mr. SHUMSKY. It has certainly been discussed but no final decision has been made to the best of my knowledge. 

Mr. LANCE. Thank you, Mr. Chairman. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

the gentleman from Maryland, Mr. Sarbanes, 5 minutes for questions. 

Mr. SARBANES. Thank you, Mr. Chairman. I thank the panelists. 

I think this is the least absurd proposal to come forward from 

the FDA I have ever seen. I just wanted to mention that. 

81 

I gather there are three basic objections to this rule or critiques 

of it. One is the increased costs that it represents and I am not convinced that the report that is forecasting those increased costs is 

based on valid assumptions. But let’s assume that there will be increased cost. As an objection to the rule that should be the basis 

for not going forward, that is a dog that just doesn’t hunt because 

the American public would say it is worth some additional cost in 

the system to make sure that we are protected. And frankly, the 

cost that will be saved to whatever industry is involved, as well as 

in terms of potential damage and harm to individuals and families 

and patients out there, the cost that will be saved make it worth 

that investment if you want to look at it in those terms. So I don’t 

think the economic argument is going to carry the day here and I 

noticed that neither of you lead with that argument, Mr. Shumsky 

or Mr. Neas, probably because of that reason. 

The second objection is the notion that it will create confusion 

and I read the letter that the pharmacists, among others, submitted to Dr. Hamburg that you cited, Mr. Neas, and they don’t 

outright advocate against this rule. They advise caution and they 

say the FDA and others need to fully explore the potential unintended consequences that the rule may have on patient access and 

national healthcare costs, et cetera. And I think that that is exactly 

what FDA is doing. They are trying to consider what the potential 

consequences here would be. They are also going to great lengths 

in the rule to actually reduce the potential for confusion and even 

reduce it from where it stands now, as I understand it. So I see 

that as progress. 

That then leaves the argument about kind of the statutory interpretation. I don’t buy that either because if you subscribe completely to the notion that this sameness principle has to have total 

integrity, then you would also have to take the position that the 

brand name manufacturers should not be permitted to put these 

interim labels on their products as a matter of safety because for 

some period of time you would be violating a very strict and literal 

interpretation of the sameness concept because you would have a 

situation where you would have some drugs that are identical to 

other drugs that have different labeling on them. 

It seems to me it is a very reasonable position for the agency to 

have taken up until now that sameness ought to be interpreted in 

context of public safety, and that is why you have had a situation 

where innovators and brand-name manufacturers have been putting these interim labels on their products even though that for 

some period of time makes them different from the generic manufacturing labeling because there is an understanding that we are 

doing the best we can here to protect the public and we have to 

interpret sameness in the context. 

And I think bringing that same perspective and lens, as the 

agency is now trying to do by making it sensible for the generic 

manufacturers to also make this change in their labeling for some 

small period of time, is a perfectly sensible thing to do. And so I 

guess there are no questions in that. That is just my observation 

of the matter. 

But I continue to support fully the proposal that has been made. 

I think it is very, very reasonable and I don’t think it represents 

82 

overreaching of the enforcement or interpretive discretion and authority that the FDA has. 

And with that, I yield back. 

Mr. PITTS. The chair thanks the gentleman and now recognizes 

Mr. Braley 5 minutes for questions. 

Mr. BRALEY. Thank you, Mr. Chairman. 

Mr. Shumsky, in your opening remarks, you made clear that 

your testimony here today was in your personal capacity. Do you 

remember that? 

Mr. SHUMSKY. Yes, sir. 

Mr. BRALEY. Have you or one of your family members ever been 

harmed by a generic drug? 

Mr. SHUMSKY. I have experienced side effects associated with generic drugs. I am not sure I would characterize that or any of my 

family’s experiences as being harmed. 

Mr. BRALEY. All right. Have you in your professional capacity 

ever represented a client who claimed to have been harmed by a 

generic drug? 

Mr. SHUMSKY. No, sir. 

Mr. BRALEY. You have represented generic drug manufacturers 

in front of the Supreme Court, is that correct? 

Mr. SHUMSKY. That is correct. 

Mr. BRALEY. And were you here in my earlier comments when 

I talked about a young woman from Ames, Iowa, who had taken 

a generic drug and had a really bad outcome? 

Mr. SHUMSKY. I was, Mr. Congressman. 

Mr. BRALEY. OK. This is her picture. Her name is Sophie Howe, 

and she began having some of the same problems with a complexion medication that we heard mentioned earlier here today, 

ended up having multiple pulmonary emboli, was hospitalized with 

that, and had significant complications. At the time she was a college student at Iowa State University, and because of the complications of her injury, she was forced to drop out of school. She had 

student loans that were paid for and insured by the Federal Government that became due, and that caused her to drop out of a 

community college program in order to work full-time to pay off her 

student loans. 

So when you walk into the Supreme Court building across the 

street, you will see a sign up above that says ‘‘Equal Justice under 

Law,’’ but the actual result of the Mensing decision is to tell those 

claimants like Sophie Howe you have equal justice under the law 

if you pay more for brand name drugs because she has no remedy 

under the Court’s decision, does she? 

Mr. SHUMSKY. Not against the manufacturer of the generic drug 

product, no. 

Mr. BRALEY. Now, Mr. Neas, I want you to know that I am glad 

that generic drugs are helping American patients by giving them 

access to affordable medications where and when they need them. 

And I also believe it is just as important that the medications on 

the market are safe and that patients and providers are aware of 

any possible threat to their health. In this Mensing case we have 

been talking about, were you aware that there was a friend-of-thecourt brief filed by 43 state attorneys general talking about the 

cost-shifting result of not providing this remedy? 

83 

Mr. NEAS. I do know that the state attorneys general took a certain decision, sure, as they do. 

Mr. BRALEY. In their brief they noted, ‘‘Costs should not be shifted to taxpayer-funded healthcare programs. This implied preemption would put added pressure on state and federal budgets. Not 

only would it be a significant incentive for ensuring the safe use 

of prescription drugs be eliminated, but injuries to consumers 

would go uncompensated by the wrongdoer, and much of the resulting increase in healthcare costs would be borne by state-funded 

programs.’’ 

And, Mr. Chairman, I would ask unanimous consent for recognition that the brief was filed by the attorneys general from the 

States have Minnesota, Louisiana, Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Hawaii, 

Idaho, Illinois, Indiana, Iowa, Kentucky, Maine, Maryland, Massachusetts, Mississippi, Missouri, Montana, Nebraska, Nevada, New 

Hampshire, New Mexico, New York, North Carolina, North Dakota, 

Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, 

South Dakota, Tennessee, Utah, Vermont, Washington, West Virginia, Wisconsin, Wyoming, and the District of Columbia. 

Mr. PITTS. Without objection, so ordered. 

Mr. BRALEY. Ms. Zieve, when we are talking about this cost-shifting, are you aware that the same companies that are generic drug 

manufacturers were held accountable before the Mensing decision 

either through settlements or through claims in court for failureto-warn claims? 

Ms. ZIEVE. Yes, I am aware that there were hundreds of suits 

and at least in a few years leading up to Mensing that there were 

a large number of settlements that are confidential at the manufacturer’s request. 

Mr. BRALEY. After the Mensing decision, are you aware of any 

instance where an insurer for one of those generic drug manufacturers rebated portions of premiums that had been paid based on 

a potential assumption of liability for failure-to-warn claims among 

generic manufacturers? 

Ms. ZIEVE. I am not aware of that. I am also not aware of any 

decrease in the cost of generics to consumers because of the elimination of liability. 

Mr. BRALEY. Thank you, Mr. Chairman. I yield back. 

Mr. PITTS. The chair thanks the gentleman. That concludes the 

questions of the Members. 

The ranking member has a unanimous consent request. He will 

be recognized for that purpose. 

Mr. PALLONE. Thank you, Mr. Chairman. 

I ask unanimous consent that the Committee include in the 

record the following: a comment letter to the FDA on the rule by 

41 Members of Congress, including myself and Mr. Waxman; New 

York Times editorial in support of the FDA rule; comment letters 

to FDA on the rule, well, three, one including the patient and consumer groups and the Consumer Union; the state attorneys general 

from 30 States, and from an attorney, Brandon Bogle. 

Mr. PITTS. Without objection, so ordered. 

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

84 

Mr. PITTS. That concludes the questions from the Members who 

are present. We have another hearing going on and I am sure other 

Members will have questions. We will send those to you in writing. 

We ask that you please respond promptly. 

I remind Members that they have 10 business days to submit 

questions for the record and I ask the witnesses to respond promptly. Members should submit their questions by the close of business 

on Tuesday, April 15. 

Thank you very much for your testimony today. It has been a 

very informative hearing. 

And without objection, the subcommittee is adjourned. 

[Whereupon, at 5:13 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

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