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JOHNSON & JOHNSON’S RECALL OF CHILDREN’S

TYLENOL AND OTHER CHILDREN’S MEDICINES

HEARING

BEFORE THE

COMMITTEE ON OVERSIGHT

AND GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED ELEVENTH CONGRESS

SECOND SESSION

MAY 27, 2010

Serial No. 111–104

Printed for the use of the Committee on Oversight and Government Reform

(

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html

http://www.house.gov/reform

(II)

COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM

EDOLPHUS TOWNS, New York, Chairman

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

JIM COOPER, Tennessee

GERALD E. CONNOLLY, Virginia

MIKE QUIGLEY, Illinois

MARCY KAPTUR, Ohio

ELEANOR HOLMES NORTON, District of

Columbia

PATRICK J. KENNEDY, Rhode Island

DANNY K. DAVIS, Illinois

CHRIS VAN HOLLEN, Maryland

HENRY CUELLAR, Texas

PAUL W. HODES, New Hampshire

CHRISTOPHER S. MURPHY, Connecticut

PETER WELCH, Vermont

BILL FOSTER, Illinois

JACKIE SPEIER, California

STEVE DRIEHAUS, Ohio

JUDY CHU, California

DARRELL E. ISSA, California

DAN BURTON, Indiana

JOHN L. MICA, Florida

JOHN J. DUNCAN, JR., Tennessee

MICHAEL R. TURNER, Ohio

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

BRIAN P. BILBRAY, California

JIM JORDAN, Ohio

JEFF FLAKE, Arizona

JEFF FORTENBERRY, Nebraska

JASON CHAFFETZ, Utah

AARON SCHOCK, Illinois

BLAINE LUETKEMEYER, Missouri

ANH ‘‘JOSEPH’’ CAO, Louisiana

——— ———

RON STROMAN, Staff Director

MICHAEL MCCARTHY, Deputy Staff Director

CARLA HULTBERG, Chief Clerk

LARRY BRADY, Minority Staff Director

(III)

C O N T E N T S

Page

Hearing held on May 27, 2010 ............................................................................... 1

Statement of:

Goggins, Colleen, worldwide chairman, Consumer Group, Johnson &

Johnson .......................................................................................................... 61

Sharfstein, Dr. Joshua M., Principal Deputy Commissioner, Food and

Drug Administration, accompanied by Deborah M. Autor, Director of

the Office of Compliance, Center for Drug Evaluation and Research,

Food and Drug Administration, and Michael A. Chappell, Acting Associate Commissioner for Regulatory Affairs, Food and Drug Administration ................................................................................................................. 12

Letters, statements, etc., submitted for the record by:

Connolly, Hon. Gerald E., a Representative in Congress from the State

of Virginia, prepared statement of .............................................................. 46

Goggins, Colleen, worldwide chairman, Consumer Group, Johnson &

Johnson, prepared statement of .................................................................. 64

Issa, Hon. Darrell E., a Representative in Congress from the State of

California:

Letter from McNeil Consumer Healthcare .............................................. 56

Prepared statement of ............................................................................... 10

Kucinich, Hon. Dennis J., a Representative in Congress from the State

of Ohio:

FDA inspection report ............................................................................... 77

Inspection report ....................................................................................... 81

Memo dated May 10, 2010 ........................................................................ 79

Sharfstein, Dr. Joshua M., Principal Deputy Commissioner, Food and

Drug Administration, prepared statement of ............................................. 17

Towns, Chairman Edolphus, a Representative in Congress from the State

of New York, prepared statement of ........................................................... 3

(1)

JOHNSON & JOHNSON’S RECALL OF CHILDREN’S TYLENOL AND OTHER CHILDREN’S

MEDICINES

THURSDAY, MAY 27, 2010

HOUSE OF REPRESENTATIVES,

COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM,

Washington, DC.

The committee met, pursuant to notice, at 10:04 a.m., in room

2154, Rayburn House Office Building, Hon. Edolphus Towns (chairman of the committee) presiding.

Present: Representatives Towns, Cummings, Kucinich, Tierney,

Clay, Watson, Connolly, Quigley, Norton, Davis, Speier, Issa, Westmoreland, Bilbray, Jordan, Chaffetz, Luetkemeyer, and Cao.

Staff present: John Arlington, chief counsel—investigations;

Kevin Barstow, investigative counsel; Adam Hodge, deputy press

secretary; Carla Hultberg, chief clerk; Marc Johnson and Ophelia

Rivas, assistant clerks; Jenny Rosenberg, director of communications; Leneal Scott, IT specialist; Christopher Staszak, senior investigative counsel; Ron Stroman, staff director; Gerri Willis, special

assistant; Alex Wolf, professional staff member; Lawrence Brady,

minority staff director; John Cuaderes, minority deputy staff director; Rob Borden, minority general counsel; Adam Fromm, minority

chief clerk and Member liaison; Kurt Bardella, minority press secretary; Stephen Castor, minority senior counsel; and Ashley Callen,

minority counsel.

Chairman TOWNS. The committee will come to order.

Good morning and thank you for being here.

Any time we give our children or grandchildren medicine, like

this bottle of Children’s Tylenol that was included in the recall, we

expect it to be safe and we expect it to help the children get better,

not create problems for them.

When questions are raised about whether children’s medicine is

safe, parents need immediate answers. Almost every household in

this country has these children’s products in their medicine cabinets. And everyone has the same question this morning: Are these

products safe, and what are we doing to ensure safety and to make

certain that this does not happen again?

While we do not want to cause unnecessary alarm, we also cannot ignore the troubling facts before us.

Less than a month ago, a Johnson & Johnson company known

as McNeil Consumer Healthcare recalled over 40 variations of children’s medicine, including such widely used products as Children’s

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Tylenol, Children’s Motrin, Children’s Benadryl and Tylenol Infants’ Drops.

This recall was carried out because of production problems at

McNeil that affected the quality, purity and potency of the medicine. McNeil received dozens of consumer complaints about foreign

particles in children’s medicine, which were later confirmed by

McNeil.

In addition, tests at the plant show that three batches of Infant’s

Tylenol were found to be ‘‘super potent,’’ meaning that they contained an overdose of the active ingredient.

McNeil’s production of children’s medicine was shut down by the

company and a month later it still is shut down. The FDA is currently investigating any possible links between the recalled medicine and adverse health effects on children who took that medicine.

The FDA is also currently reviewing reports of children who died

to determine if there is any connection between those deaths and

this recall. At this point, the FDA is not aware of any connection

between the recalled medicine and the death of any child.

One document the committee received from the FDA refers to the

case of a 11⁄2-year-old girl who died. That document reads, ‘‘coroner’s office called to report the death of a 11⁄2-year-old female that

is suspected to be related to a Tylenol product.’’

Just last night, the committee obtained from the FDA even more

disturbing information. According to an FDA document, McNeil

knew there was a potential problem with one of its Motrin products

that was on the market in 2008, but rather than issue a public recall, McNeil allegedly sent contractors out to stores to buy the

product back and told the stores ‘‘not to mention’’ a recall.

After the FDA confronted McNeil about this, McNeil officially enacted a recall on the affected products.

If true, this ‘‘phantom recall’’ attempt by McNeil could have endangered the public and warrants further investigation by this

committee.

We need to know what health risks are associated with this recall. We need to know whether this is an isolated issue, or part of

a widespread problem with the safety and production of children’s

medicine at McNeil. We need to know what Johnson & Johnson is

doing to get to the bottom of this. And we need to know what the

FDA is doing to ensure the safety of children’s medicine and

whether the FDA has the resources it needs to carry out its mission.

Both Johnson & Johnson and the FDA will be asked very difficult questions today and I hope they are prepared to give us the

answers that will assure safety of these medications.

This is our first hearing on this issue, but there may be more.

We will follow this road until we have all the answers and the

questions raised by the American people are answered.

There is nothing this committee will investigate that is more serious than the health of our children. I can assure you that, as

chairman of this committee, and I know on this matter I also speak

for the ranking member when I say this, we will use all of our authority to find out what went wrong and do everything that we can

to ensure that it does not happen again.

[The prepared statement of Chairman Edolphus Towns follows:]

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Chairman TOWNS. On this note, I yield 5 minutes to the ranking

member of the committee, Congressman Issa, from the great State

of California. Mr. Issa.

Mr. ISSA. Thank you, Mr. Chairman. And you are right, you

speak for both of us when you say we will use all efforts of this

committee and all power of this committee to ensure this does not

happen again.

Johnson & Johnson has owned the McNeil Consumer Healthcare

Division since 1959, so for, one, from this day forward, I will say

Johnson & Johnson and not talk about a subsidiary that has been

owned by a company for so long.

Before I came to the Congress, I was a manufacturer. I understand ISO 9001; certainly a good, but lesser standard than what

we expect medical items and food items to be held to. But there is

no question that my manufacturing techniques were less than I

would have expected if I were going to put a product in my mouth.

Producing electronics, you want it to work and you want it to

work reliably. You want it to work consistently and you want it to

never hurt anyone. But my company knew that we would produce

a product that from time to time would be installed poorly. We

knew that from time to time we would have a bad transistor, resistor, or diode. We did not produce to aviation specs because, to be

honest, an alarm going off because of a malfunction was less of a

problem.

But today we are talking about a market leader, a leader who

had so much confidence of the American people that we never question their products or their services; whose creed was all about

safety and reliability. And they have disappointed us.

We are not the committee of manufacturing. We are not the committee of jurisdiction directly over healthcare products or, for that

matter, any of the manufacturing sector in this country. That is for

other committees. What we are is the committee that oversees Government’s overseeing of its responsibility.

Today we have before us the FDA. And much like the National

Transportation Safety and other parts of the Department of Transportation, we have an agency who has done their job. They have

delivered report after report of problems and they have come to a

final conclusion before coming to this committee of a massive recall.

So like Akio Toyoda, we would hope that Johnson & Johnson

comes ready to say this is a mistake that will not happen again;

that the company will in fact change how it does business so significantly as to never be before us again.

But as to the FDA, I am encouraged that they have done their

job, but I am disappointed that it took so long. As with the national

transportation questions that we had before Secretary LaHood,

today I will be interested to know what changes at FDA would

allow for, if you will, shortcuts to this conclusion. How do we find

that a manufacturing technique that is below standard is corrected

more quickly? How do we ensure that there are no backdoor or, if

you will, unannounced recalls? And how do we ensure that the

FDA has all of the authority and financing that it needs to ensure

the American people that not just a 120-year-old company, well regarded and able to pay for all the cost of their mistakes, but that

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every piece of over-the-counter or prescription medicine or, for that

matter, food, whether domestic or foreign import, as so much is

today, is safe?

I am deeply concerned, Mr. Chairman, that Johnson & Johnson

is the tip of the iceberg. If one of the most reliable and responsible

organizations in America and a company with great connections to

the community can fail us, then what about those aspirins and

other products that are more and more being imported from outside our country, from factories that are harder to reach and people

who do not even speak our language when we go to inspect them?

So although today is about Johnson & Johnson, and I hope the

second panel does their job of explaining why they will not be in

front of us again, I am most interested in the first panel. What do

we need to do, as the Committee on Oversight and Government Reform, to ensure that you are able to do your job worldwide, safely,

so the American people can sleep knowing that these kinds of

medicines, no matter where they are made in the world, will be absolutely safe from this day forward?

I thank the chairman and yield back.

[The prepared statement of Hon. Darrell E. Issa follows:]

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Chairman TOWNS. I would like to thank the gentleman from

California for his statement and, of course, I want you to know that

I agree with you.

I would like to just recognize the Brooklyn Friends School who

is here. Thank you very much for joining us this morning.

Mr. ISSA. Could you please stand up? You can’t be recognized

when you are—there we go.

Chairman TOWNS. Brooklyn Friends School. Thank you so much

for joining us this morning.

We turn now to our first witness. Dr. Joshua Sharfstein is the

Principal Deputy Commissioner of the Food and Drug Administration. He is our witness today from the FDA, but he is accompanied

by Deborah Autor and Michael Chappell, who will not be making

opening statements, but are here to provide any additional expertise that may be helpful to the committee. Deborah Autor is the Director of the Office of Compliance at the Center for Drug Evaluation and Research at the Food and Drug Administration and Michael Chappell is the Acting Associate Commissioner for Regulatory Affairs at the FDA.

It is committee policy that all witnesses are sworn in, so if you

would stand and raise your right hands while I administer the

oath.

[Witnesses sworn.]

Chairman TOWNS. You may be seated.

Let the record reflect that the witnesses answered in the affirmative.

Dr. Sharfstein, being the only person making opening statements, let me start with you.

STATEMENT OF DR. JOSHUA M. SHARFSTEIN, PRINCIPAL DEPUTY COMMISSIONER, FOOD AND DRUG ADMINISTRATION,

ACCOMPANIED BY DEBORAH M. AUTOR, DIRECTOR OF THE

OFFICE OF COMPLIANCE, CENTER FOR DRUG EVALUATION

AND RESEARCH, FOOD AND DRUG ADMINISTRATION, AND

MICHAEL A. CHAPPELL, ACTING ASSOCIATE COMMISSIONER

FOR REGULATORY AFFAIRS, FOOD AND DRUG ADMINISTRATION

Dr. SHARFSTEIN. Great. Mr. Chairman and members of the committee, thank you for having this hearing. I am Joshua Sharfstein,

the Principal Deputy Commissioner of the U.S. Food and Drug Administration. I am a pediatrician and I am the former Health Commissioner of Baltimore, MD.

I want to talk to you about what happened at McNeil, what FDA

has done, and I want to answer your questions.

I am joined, as you mentioned, by Deb Autor, who is also a

former prosecutor at the Department of Justice and a finalist for

the Service to America medal; and by Mike Chappell, who is a 38-

year veteran of FDA.

The FDA has authority over drug manufacturing both to enforce

general good manufacturing practice requirements and to require

companies to comply with their own rules.

McNeil Consumer Healthcare makes a variety of over-thecounter products for the U.S. market from four manufacturing facilities in the United States and Canada. Over the last several

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years, FDA has had growing concerns about the quality of the company’s manufacturing process, reflected in unsatisfactory inspections and recalls. FDA inspected the company’s facilities with an

increased frequency and, in February 2010, the agency convened

the management of its parent company, Johnson & Johnson, to express concern about a pattern of noncompliance. This is a story of

an agency that identified a problem, confronted a company, and

eventually forced major changes to protect the public.

I would now like to walk you through some of the key events.

Prior to 2009, FDA investigators identified several problems with

good manufacturing practices at facilities run by McNeil. These

problems included laboratory controls, equipment cleaning processes, and a failure to investigate identified problems. The company generally fixed these problems and the agency inspected the

firm regularly.

At its Fort Washington facility, McNeil makes a wide variety of

over-the-counter products, including a large number of over-thecounter liquid products for children.

In May and June 2009, FDA identified several violations, including McNeil’s failure to meet its own standard for quality in one of

its ingredients in over-the-counter liquids. McNeil’s standard for

this ingredient, known as microcrystalline cellulose, required that

there be no gram negative bacteria. McNeil purchased the cellulose

in partial lots that had not tested positive for this objectionable

bacteria, but the vendor had tested other partial lots from the same

master lot and had found a certain bacteria called Burkholderia

cepacia. According to its standards, McNeil should not have used

any of the partial lots from this master lot.

In reviewing the situation, FDA scientists at the time concluded

that the risk to the public was remote. All of the drugs that were

used had tested negative for the bacteria, all the final product had

tested negative, and FDA agreed with the company’s assessment

that this bacteria would be very unlikely to grow in the final product.

Yet, because the company had not kept to its standard, it represented a significant violation of manufacturing processes and the

company initiated a recall of almost 8 million bottles of finished

product.

A few months later, in Puerto Rico, where McNeil makes a large

number of over-the-counter pills for the U.S. market, FDA became

aware that the company had received reports of products from this

facility having a musty odor. Yet, McNeil had not fully investigated

these reports for about a year and did not notify FDA, despite the

requirements that such reports be referred to the agency within 3

days.

FDA inspectors urged McNeil to conduct a complete investigation, which eventually identified the source of the odor to be a

chemical called TBA, which was in the air because of a pesticide

used on the wood of the pallets to store empty medication bottles.

McNeil initiated a series of recalls as the scope of the problem became clear.

The risk to the public by this problem included potential temporary non-serious reactions, including nausea, stomach pain, vomiting, and possibly diarrhea. Very little is known about this chemiVerDate 11-MAY-2000 11:05 Mar 23, 2011 Jkt 000000 PO 00000 Frm 00017 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\63140.TXT KATIE PsN: KATIE
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cal called TBA, but in the small quantities transferred to the products, it was not thought to pose a serious risk for long-term health

problems.

On January 15, 2010, FDA issued a warning letter expressing serious concerns about the company’s control over the quality of its

products and the company’s failure to aggressively investigate and

correct quality problems. FDA noted in this public warning letter

that neither upper management at Johnson & Johnson nor McNeil

had assured timely investigation and resolution of the issues.

On February 19, 2010, in the wake of that warning letter, senior

compliance staff from FDA’s Center for Drug Evaluation Research

and the field organization called a meeting with senior officials

from McNeil and its parent company, Johnson & Johnson.

Attendees included the president of McNeil, the company group

chairman for over-the-counter drugs at Johnson & Johnson, as well

as a number of quality assurance executives from both companies.

This was an extraordinary meeting. FDA requested that senior

officials from Johnson & Johnson attend the meeting over the

heads of the McNeil executives so that they would be on notice regarding FDA’s rising concerns about whether McNeil’s corporate

culture supported a robust quality system to ensure the purity, potency, and safety of its products. FDA raised concerns about multiple recalls based on the recent inspections and expressed concern

that there was a pattern of failure to report material information

to FDA in a timely manner. FDA told the company that significant

immediate steps were needed to address issues of compliance and

quality.

We learned that the company was taking major steps to address

these issues, but we told them we would not take their word for

it; they would expect close oversight ongoing.

In April, FDA returned to McNeil’s facility in Fort Washington.

This was an inspection that was scheduled sooner than usual because of the history of compliance problems.

Days before the inspectors arrived, McNeil shut down manufacturing because of particulates found in a number of liquid medications, including acetaminophen, cellulose, nickel, and chromium.

We identified a range of violations, including failure to meet its

own specifications for bacteria and particulates and, for one Tylenol

product, the possibility of higher than expected concentrations of

Tylenol.

In reviewing the situation, FDA scientists concluded the risk

posed to the public by these problems was remote. We did not find

evidence that McNeil used raw materials that its tests found to be

positive for bacterial contamination and that all finished lots tested

negative. The particulates would be expected to pass through the

gastrointestinal tract. And while there was a potential for higher

concentrations of Tylenol per dropper, none of the final products

tested with high levels.

Although the public health risk from these quality problems is

low, these problems should never have occurred, and the manufacturing failures at the facility that caused them were unacceptable.

Following requirements assures that products are consistent in

their safety and effectiveness, and failure to follow these proceVerDate 11-MAY-2000 11:05 Mar 23, 2011 Jkt 000000 PO 00000 Frm 00018 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\63140.TXT KATIE PsN: KATIE
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dures risks more serious problems and undermines consumer confidence.

On April 30th, McNeil announced a voluntary recall of over 136

million bottles of liquid infants’ and children’s products.

The agency is now closely monitoring the implementation of a

corrective action plan that includes changes to McNeil’s quality

system, organizational changes, and senior management oversight.

FDA will take steps to ensure that when this facility begins to

manufacture again, it will be able to produce safe products. We are

also considering additional enforcement actions against the company, which may include seizure, injunction, and criminal penalties.

I wanted just to say one word about adverse events. It is understandable that many Americans, hearing about these large recalls,

are wondering whether or not their children were put at risk. In

assessing this question, FDA considers two sources of information:

first, our assessment of the manufacturing problems themselves

and, second, adverse event reports to the agency.

As I discussed earlier, FDA analyzed the various manufacturing

problems. Based on the circumstances in each case, our experts believed the risk for any child in the United States was remote.

We also looked and are looking at adverse event reports reported

to the agency. We receive these reports and often request and review medical records, coroner’s reports, and other supplementary

data sources.

In one case we had a report of a 6-year-old child where the child

died as a result of an infection from Burkholderia cepacia, the

same bacteria that was found in the lot of the ingredient. FDA actually got hold of the medications used by this child and tested

them, and we conducted extra inspections to see whether there was

a connection between this death and the product. In fact, all the

samples tested negative and FDA believes that there was not a

connection in that particular case.

When we have adequate information, we review the reports to

determine what role, if any, the medication played in the development of an adverse event. We can find the medication had no role

in the adverse event, that the activity as a drug could cause a serious side effect, or that a quality problem may have contributed to

the outcome.

So far, FDA does recognize that some of the reports may reflect

the side effects of the medications, but we have no cases with evidence that a product quality problem contributed to a significant

adverse health outcome for children. We are continuing to receive

information about certain cases and we will update the public and

the committee should our assessment change.

Let me close by noting that every investigation presents an opportunity for FDA to improve our effectiveness in protecting public

health. In this case, we have learned more about the importance

of corporate structure for compliance. When we do not get a response that we are comfortable with from a subsidiary, FDA will

not hesitate, as we did not in this case, to go over their heads to

the corporate parent. FDA will be developing new procedures to

use what we learned at one facility in guiding our inspections of

other facilities run by the same company.

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We have also gained experience with two issues that we are

working on at the agency: how to improve our recall process and

how to strengthen enforcement. FDA Commissioner Dr. Margaret

Hamburg has called for FDA’s enforcement to be vigilant, strategic,

quick, and visible. A range of activities are underway at the agency

to bring this vision to reality, including strengthening our criminal

enforcement of FDA’s laws. We will continue to work with Congress

to secure additional authority to assist us.

Let me just mention in this regard we believe that transparency

in our enforcement activities is very important, both so people can

see what we are doing and to make sure that we are accountable.

As part of our new program performance effort at FDA, called

FDA-TRACK, we are going to be posting monthly the numbers of

different kinds of enforcement actions that FDA is taking, and as

part of our transparency task force we have proposed making public every inspection, when it is happening and what the outcome

of that inspection is, and we are getting public comment on that.

I would end by saying that this episode reminds us that a vigilant FDA is essential to drug safety in the United States. FDA inspectors identified serious problems at McNeil, called the company

to account, and forced major changes to protect the public. On behalf of the many FDA staff who worked on and are continuing to

work on this issue, I appreciate the opportunity to make this statement and I look forward to your questions.

[The prepared statement of Dr. Sharfstein follows:]

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Chairman TOWNS. Thank you very much, Dr. Sharfstein, for your

statement. Let me just begin by saying this. Does the FDA need

more enforcement authority or funding to be able to respond to

issues like this recall?

Dr. SHARFSTEIN. Thank you. I think that it is instructive to think

about the food safety bill a little bit, because in the food safety bill

there are some provisions that Congress is looking at granting the

FDA over food that we don’t currently have over drugs, and those

include authority to require certain types of quality systems and

preventive controls, mandatory recall authority, access to records

by companies, and civil money penalties.

So those are some areas where we don’t have a position at this

point, it hasn’t worked its way through the system. With respect

to drugs, I would point those out, that those are in the food safety

bill. The administration is supporting those for foods.

Chairman TOWNS. Let me ask this. Can you say with complete

certainty that no children who took the medicines that were recalled last month were harmed by them?

Dr. SHARFSTEIN. No, I cannot say that with complete certainty.

I think we are continuing to get information and there were remote

risks that were potentially possible. But from what we know, we

do not have evidence at this point of children who did have serious

problems. But because there was a remote risk, it was the right

thing to do the recall.

Chairman TOWNS. But are you still looking to see in terms of

whether or not this occurred?

Dr. SHARFSTEIN. That is correct, we are. And there are certain

reports that we have gotten that we are in the process of thoroughly reviewing.

Chairman TOWNS. How serious were the problems at McNeil’s

plant in Fort Washington that the FDA most recently discovered?

How serious were they?

Dr. SHARFSTEIN. I think as manufacturing problems go, they

were serious. There was a range of different problems. They had

not responded to the complaints that they had gotten of particulates in the product; they had missed the fact that some of their

ingredients came from a lot that had had contamination, even

though the previous year they knew this to be an issue. There were

a wide range of findings that indicated to us that there were serious manufacturing quality problems at the facility.

Chairman TOWNS. What went wrong that caused one of the largest makers of children’s medicine to recall millions? Was it quality

control? What do you think might have happened here?

Dr. SHARFSTEIN. I think that is a great question and it can be

answered at different levels. I think one level you answer it is exactly like you said, it is quality control, that there were quality control problems. At another level you have to ask why, why did a

company with a reputation and record of McNeil and Johnson &

Johnson have those quality control problems?

And we think it is a very important question for you to be looking at. It is something we need to understand better. We think it

may relate to the corporate compliance and corporate structure.

And we note that the company has made major changes in that

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when we confronted them with the very serious compliance problem that they were having.

Chairman TOWNS. Could you sort of describe to us what you are

doing now to work with Johnson & Johnson to make sure that they

correct the problems that exist?

Dr. SHARFSTEIN. Sure. Well, this facility in Fort Washington is

now not manufacturing. There is a complete plan for standing it

back up that the company is going to be presenting to FDA. I think

it is fair to say that we have very good cooperation from the company now; that they are really looking for the agency’s seal of approval before they get going, and I am sure you will hear that from

them on the next panel. In addition to what we are working on

there, we are also reviewing the record and considering whether

other types of enforcement action are appropriate.

Chairman TOWNS. Dr. Sharfstein, tell me what the FDA believes

McNeil did as described in these FDA documents that we received.

Dr. SHARFSTEIN. Can you say that again? I am sorry.

Chairman TOWNS. On the screen there, Doctor.

Dr. SHARFSTEIN. Oh, I see.

Chairman TOWNS. On the screen.

Dr. SHARFSTEIN. What do we believe actually happened here?

Chairman TOWNS. Yes.

Dr. SHARFSTEIN. This is something that is troubling to the agency. I am not sure we know the complete full story, but basically

there was a problem with how Motrin tablets dissolve and whether

or not patients would get the right dose. The company notified FDA

that they were going to be evaluating whether there was product

on the shelves to recall.

Then we were alerted, I believe, by one of the State Boards of

Pharmacy that instead of just looking to see whether or not there

was medication to recall, the company had a contractor that was

going out and trying to buy up all the medicine when they went

into the store, and the information said you should simply act like

a regular customer while making these purchases, there must be

no mention of this being a recall of the product. If asked, simply

state your employer is checking the distribution chain of this product and he needs to have some of it purchased for the project.

I don’t think we really fully understood exactly what was going

on. It was troubling to us and, when FDA found out about this, we

insisted that an actual recall occur. And we did think that it reflected poorly on the company, and it was one of the things that

FDA brought to their attention during this extraordinary meeting

that happened in February.

Chairman TOWNS. Thank you. After the recall, FDA recommended consumers buy drugstore alternatives for their children.

The vast majority of those drugstore products are made by Perrigo,

a company in Michigan that had ongoing quality control problems.

When was the last time FDA inspected the plant in Michigan that

makes infants’ and children’s problems? Do you know when it was

inspected last?

Dr. SHARFSTEIN. I do. I may ask Deb Autor to answer that because she oversees the compliance efforts at the Center for Drugs.

I believe there were several inspections in the last couple years.

32

Ms. AUTOR. I don’t have the exact dates here, but there have

been several inspections in the last few years. I believe there have

been two in 2010, but I would have to double-check those facts.

Chairman TOWNS. But you agree with the fact there have been

some issues with quality control?

Ms. AUTOR. Yes, there have been some issues at Perrigo.

Chairman TOWNS. OK, on that note, I yield to the ranking member for 5 minutes.

Mr. ISSA. Thank you.

Ms. Autor, I would like to followup. Is it appropriate for the FDA

to recommend an alternative at all? Basically, if you say don’t do

that or, baby doctor, if you prefer, isn’t it really appropriate for the

FDA to simply deal with its knitting and say don’t take that, and

not intervene in alternatives?

Dr. SHARFSTEIN. Well, the challenge is——

Mr. ISSA. I know there is an irresistible urge to answer people’s

questions; I am in that business. But isn’t it in fact inappropriate

for any government entity to make a recommendation unless it is

an authorized recommendation? It doesn’t appear as though there

is any mandate for that.

Dr. SHARFSTEIN. I think that Dr. Hamburg and I see FDA as a

public health agency that has to be responsive to the needs of clinicians and patients, and it very frequently happens that there is a

shortage of one medication, and we have a whole shortage team

that works with manufacturers and professional societies to give

recommendations in the event of a shortage for what can be used

as an alternative. I think it is wrong to say this brand is the right

one to use, but when people don’t know what is available, for the

FDA to say we want you to know this medication is available and

is a potential alternative, I think that is information that the clinical community really wants to hear from FDA.

Mr. ISSA. And I have no problem with the clinical community.

When you speak doctors to doctors, I certainly appreciate that. My

only question was where is the line. I think all of us want to know

where is the line when it is ultimately to the public, to the uninformed public. As you said, a brand name would be inappropriate,

but a chemical description, I gather, is what you are saying would

be appropriate, which would cover potentially multiple brands?

Dr. SHARFSTEIN. Right.

Mr. ISSA. OK.

Ms. Autor, one that I know falls more squarely on you, in this

case, I don’t want you to say you have an investigation or you

don’t, but is there a potential criminal liability for some of the acts

that went on?

Ms. AUTOR. I think what I can say at this point is that the Center for Drugs has referred this to FDA’s criminal investigative unit,

and then they have to judge where to go from there.

Mr. ISSA. OK. I will take that as a yes, that there is at least the

potential, and that everyone who is out there providing food and

drugs should be aware that the scenario we just saw in the future,

or perhaps in this case, could lead to criminal actions or indictments. At least not saying in this case, but that should be fair

warning to people who are watching this hearing.

33

Ms. AUTOR. And I think, as Dr. Sharfstein said, the agency is

working to increase our enforcement on the criminal side and to

connect carefully what we do on the criminal side with what we do

on the civil side so that we can maximize the effectiveness of those

tools.

Mr. ISSA. Yes, Doctor.

Dr. SHARFSTEIN. I think that is an excellent point. We very much

want to send that message. Dr. Hamburg, the Commissioner, gave

a major address on enforcement, where she called on companies to

make sure they had excellent compliance programs, and just this

week someone sent me an email about a course and report that is

being marketed, where it says bigger, tougher, faster, preparing for

the new FDA. When the inspector comes calling, will you be ready?

And it is all about sending a message to industry. This is within

industry they are marketing this, that FDA is significantly

strengthening its oversight and companies have to learn how to put

quality systems in place. This is the kind of thing we like to see.

We don’t like to see these kinds of recalls; we like to see compliance. That is our goal. And seeing the industry really coming together, getting the message, that is very important to us.

Mr. ISSA. Now, Doctor, your being here today goes far beyond the

McNeil division of Johnson & Johnson, so let me ask a slightly different question. In the ordinary course, you try to visit facilities

here in the United States once every 2 years. But, more and more,

non-prescription drugs are being produced in China and other very

far away places, and those places, in many cases, have a standard

of simply lying on their paperwork. We have had that in a number

of other areas.

How do you propose that the FDA be able to ensure that a foreign manufacturer in a country where we have a fairly opaque ability to go beyond what the papers presented at the factory, that we

can rely on those test results and, as such, the medicine that comes

from them?

Dr. SHARFSTEIN. It is an excellent question. The safety of imports

is extremely important to us, and Dr. Hamburg has raised these

very similar sorts of concerns in some major speeches, and we had

a hearing in the Energy and Commerce Subcommittee on health

not too long ago, where this got a fair amount of attention. It is

a concern for us and there are certain things that we need to be

able to do better. Included among those is holding each person in

the supply chain accountable, and there are some tools that would

allow us to do that. In addition, we need to significantly expand

our coordination with other agencies.

We now have two foreign offices in China that coordinate with

other agencies. For example, if Australia does an inspection that

we have confidence in, then we can go to another plant in Australia

and can have confidence in that inspection. We also need to

strengthen and work——

Mr. ISSA. So what you are saying is part of your procedure would

be to learn to inspect the inspectors, to qualify countries or inspection techniques so that we can be somewhat reciprocal.

Dr. SHARFSTEIN. That is absolutely true both for our major partners in the developed world, but also we want to strengthen the indigenous inspecting capacity, and there is a big effort to do that in

34

countries like China and India. So it is a very complex problem and

there are a lot of solutions.

Mr. ISSA. Let me just ask one final question. And if it goes long,

I would ask that it be answered for the record. Every day, 45-foot,

53-foot containers of non-prescription drugs come in the country.

Currently, our import authorities open only a fraction of those containers and, when they do, they open them to see if it is an aspirin,

and not much more.

Do you believe here today that the Congress should begin creating both the authority and the mandate for at least sample inspection of 100 percent of these types of imports if they come from

countries that you have not certified the certifiers?

Dr. SHARFSTEIN. I believe that Congress and the FDA need to

work together to really address the question of import safety. I am

not sure 100 percent testing is the answer. I think we need to have

100 percent accountability across the supply chain and a strong import border presence, but it has to be addressed comprehensively.

Mr. ISSA. OK. I would like you to answer for the record, then,

the key question of if it comes from a country in which you have

not achieved that level of confidence, no part of the supply chain

can change the fact that if any one of those bottles is bad and there

has been no sampling, you will not have that public confidence.

So I would like you to tell us how you are going to get that confidence if you didn’t get it in the country of origin and now it is

sitting in a container in the United States or going through the

supply chain. And I ask you to answer that for the record.

Dr. SHARFSTEIN. Happy to do that.

Mr. ISSA. Thank you.

Thank you, Mr. Chairman.

Chairman TOWNS. The gentleman’s time has expired.

I now yield 5 minutes to the gentleman from Maryland, Mr.

Cummings.

Mr. CUMMINGS. Thank you very much, Mr. Chairman.

Dr. Sharfstein, it is very good to see you again. And I say this

without reservation: When you served as the Health Commissioner

for Baltimore, where I live, you did an outstanding job. You did it

with excellence and integrity. And I have full faith and confidence

in you. So I wanted to say that before I got into these questions.

Dr. SHARFSTEIN. OK. Thank you.

Mr. CUMMINGS. There appears, Dr. Sharfstein, as I listen to your

testimony, that McNeil was involved in a culture of mediocrity. It

seems that the FDA had one standard and McNeil had another,

and I am trying to figure out where the two meet. In other words,

it sounds like the standard at McNeil, they said, OK, we got a little

taint here, a little problem there, but we will still mix it up, it will

be all right. FDA says, no, that is not good enough. And then you

said something that was very interesting. You said there might be

a need to take further action. You said further action may be required.

I am trying to figure out how that all comes together. When you

have a company that seems to be, over and over again, be it by

negligence, intent, greed, or whatever, skirting the system, but you

have the FDA saying we have this standard, how does that work?

How does that come together? You follow what I am saying?

35

Dr. SHARFSTEIN. Sure. Absolutely. And there is a real parallel to

Baltimore because in Baltimore we inspected restaurants at the

Health Department, and we would sometimes find problems, and

there is always a balance between cooperation, working cooperatively with the business, and taking action; and most of the time

we would find a problem and the business would jump and fix it,

and then we were done.

But every so often there was a restaurant that we would have

a significant problem with and we eventually got to the point

where, for some people, we took away their license to run a restaurant in Baltimore, their ability to do that. It is a balance.

And I think if you look at this experience with McNeil, you see

that. FDA is pointing things out, McNeil is sort of correcting them,

waiting a little bit of time in some cases to tell us about problems,

and over time FDA is ratcheting up the oversight like we would do

in Baltimore, where we would say, wait a second, this should have

been corrected in a restaurant, and we are going to have to go back

again, and eventually we are going to have to bring them in and

eventually we are going to bring them to the administrative judge.

That is basically what FDA is doing.

And the story of this whole episode is that FDA increased the

pressure, brought in the corporate executives and wound up forcing, I think you will hear, very major changes in the company’s approach to quality.

We are going to use this as an opportunity to see what we can

improve. But I think overall it is a tough balance that the FDA has

to strike.

Mr. CUMMINGS. Let me ask you this. In your testimony you state

that in February 2010 FDA took the extraordinary step, you said,

of meeting with the management of Johnson & Johnson to express

your concern about a pattern of noncompliance. Why was this

meeting considered so extraordinary?

Dr. SHARFSTEIN. What was extraordinary about it were two

things. First of all, we went over the heads of the whole company.

McNeil is a pretty big company, but we went to the actual corporate central head of the entire major company to express this

concern. That is one reason why it is extraordinary.

The second thing is usually we meet about specific problems, and

this was a meeting about a culture of compliance, that we had seen

so many problems at different facilities, and problems that really

concerned us, that we really were calling them on their whole quality system, and it led to major changes, I think you will hear, at

the company. People were moved in their positions or removed

from their position. They have a whole new layer, I believe you will

hear. And I think those were the two things that made it extraordinary, that we went over their heads and that we talked about the

culture of compliance at the company, not just individual problems.

Mr. CUMMINGS. Now, how did Johnson & Johnson react to what

you said? They were present at the meeting, were they not?

Dr. SHARFSTEIN. They were, yes.

Mr. CUMMINGS. OK. What was their reaction?

Dr. SHARFSTEIN. My understanding is they took it quite seriously. They heard that this was not a usual kind of meeting for the

FDA to have. They had gotten one of the fastest warning letters

36

ever from what happened in Puerto Rico. We issued a warning letter and the warning letter itself mentioned the fact that there was

a failure of oversight by not just McNeil and Johnson & Johnson.

And I think, based on the changes they committed to at that point,

we got the sense that they had heard our concern, although we

made it very clear that we weren’t going to take their word for it.

Mr. CUMMINGS. And what does all of this say about a corporation? Apparently, you have gone pretty far with this corporation.

What does this say about this corporation? Have you drawn a conclusion?

Dr. SHARFSTEIN. Well, you know, most of the companies that

FDA deals with do comply, and there are some great examples out

there of terrific compliance programs. This is a company that had

a major problem with compliance, and it was a problem that

crossed different domains, different facilities, and was a systematic

problem at the company. That is something FDA needs to be able

to identify and address with the company, with its senior leadership, and we have to be willing, and I think in this case I think

we did, really, call them to account for it.

Mr. CUMMINGS. Thank you, Mr. Chairman.

Chairman TOWNS. Thank you. Thank you very much.

I now yield 5 minutes to the gentleman from Utah, Mr. Chaffetz.

Mr. CHAFFETZ. Thank you.

Thank you all for being here. In a moment, Ms. Goggins, from

Johnson & Johnson, is about to testify, and in her written testimony she says, ‘‘The health risks due to consumers from the recalled products were remote.’’ Is that true or false, from your opinion?

Dr. SHARFSTEIN. I think that is also FDA’s understanding right

now.

Mr. CHAFFETZ. Next thing she says, ‘‘Second, McNeil has no indication of a serious adverse medical event caused by any of the

issues referenced in the recalled announcement.’’ In your opinion,

is that accurate?

Dr. SHARFSTEIN. Well, I can’t speak to what McNeil knows. FDA

does not have evidence of that kind of severe event, although we

are continuing to investigate certain cases.

Mr. CHAFFETZ. She says, ‘‘Third, no raw materials that tested

positive for objectionable bacteria were ever used in the manufacture of McNeil’s pediatric products.’’ Is that true?

Dr. SHARFSTEIN. I would say that is sort of true, maybe with an

asterisk.

Mr. CHAFFETZ. Sort of true?

Dr. SHARFSTEIN. Yes. I would say——

Mr. CHAFFETZ. What is sort of true?

Dr. SHARFSTEIN. You know, with a footnote, the footnote being

they did use raw materials from lots that had tested positive.

There were some negative tests for the parts of those lots that they

used, but FDA does not consider that an adequate assurance of

safety.

Mr. CHAFFETZ. ‘‘And, finally, McNeil rejected the products that

it found had excess active ingredient.’’ Would you agree with that

statement or disagree with that statement?

37

Dr. SHARFSTEIN. Again, I would say I agree with a footnote.

When they knew those particular lots had excess ingredients, they

rejected it. But I think we felt that they didn’t test other parts of

that area to be sure that there wasn’t a problem, another ingredient that was shipped.

Mr. CHAFFETZ. Now, my understanding is——

Dr. SHARFSTEIN. Let me just see if Deb wants to clarify that?

Ms. AUTOR. Yes. Just to clarify that, with the potency issue,

what happened was that McNeil made a change in their manufacturing process, the size of the vat they were using, without testing

whether the product would adequately mix once that change was

made. So they produced 11 batches using that new process.

Three of them tested to be super-potent. They threw away those

three, but, from our perspective, there is no assurance that the

other eight wouldn’t have the same potency issues. They did some

testing, they didn’t find potency, but, because the process hadn’t

been tested, there was potential that there were potency problems

in the other batches even though they hadn’t tested that way.

Mr. CHAFFETZ. I appreciate the efforts of the FDA and I love the

fact that they are ahead of the ball, but having found no serious

adverse reaction, is the FDA overreacting to this? I mean, there are

775 serious side effects, so where in the spectrum is this in what

you are usually dealing with? How severe is this problem?

Dr. SHARFSTEIN. Well, let me answer that in a couple ways. The

side effects were reported about the medications, and we think that

some of them were linked to the actual medications used, not the

quality problems. And I think the number of adverse events we

probably have to separate a little bit from the quality problems.

We consider these quality problems to be quite significant, and

we want to fix them before it becomes a point where we are counting the problem in hospitalizations and injuries, instead of in bottles recalled.

Mr. CHAFFETZ. What is a mom supposed to do? You have had

hundreds of millions of products recalled. How many of those have

actually made it beyond the store shelf and actually into somebody’s cupboard and they are sitting the? What is a mom supposed

to do at home?

Dr. SHARFSTEIN. We had some in our house. I think we recommend that people throw out the ones that they have. You can

find out which ones they are from the Web site and other information, and that they can go to the store and get alternatives.

Mr. CHAFFETZ. So if you have any of these products on your

shelf, you are supposed to actually go back to the store? When you

say the Web site, how does that work? Is there a lot number on

the bottom that they can go check on the FDA Web site?

Dr. SHARFSTEIN. There is, yes. McNeil has actually set up a

phone number for people to call to get instructions. They may answer better how they are handling that part of it, but there are instructions for people to be able to turn back their medication.

Mr. CHAFFETZ. And, finally, were any of you at those meetings

in February?

Dr. SHARFSTEIN. I think that Ms. Autor was the one who called

for the meeting, but I don’t think any of us were at the meeting.

Mr. CHAFFETZ. OK.

38

All right, thank you, Mr. Chairman. Yield back.

Chairman TOWNS. Thank you very much.

I now yield 5 minutes to the gentleman from Ohio, Mr. Kucinich.

Mr. KUCINICH. Thank you.

Dr. Sharfstein, in your testimony you reference a 2010 report

which identified a 6-year-old child who died. Now, prior to the

child’s death, according to this report, the child had been given several products manufactured at the facilities in question. Did any of

those products that the child took contain a harmful bacteria?

Dr. SHARFSTEIN. No, as far as we know. Those were tested, and

we did not see any of the bacteria.

Mr. KUCINICH. And what was the cause of death?

Dr. SHARFSTEIN. I want to be sure whether we have this. I think

there that is still an open coroner’s investigation, so I am not sure

they have a final cause of death. It may have been infection.

Mr. KUCINICH. When was the death?

Dr. SHARFSTEIN. January.

Mr. KUCINICH. Have you seen an toxicology screens from this autopsy report? Have you seen the autopsy report?

Dr. SHARFSTEIN. I am not sure that we have the final autopsy

report. If the coroner’s investigation is open, we probably don’t

have the final report. I understand that there was this bacteria

found in multiple tissues.

Mr. KUCINICH. Which bacteria was found in multiple tissues?

Dr. SHARFSTEIN. Burkholderia cepacia.

Mr. KUCINICH. And was that bacteria found in any of the samples that the FDA picked up of the products that were recalled?

Dr. SHARFSTEIN. No. No. That bacteria was not found in the

products that this child apparently consumed; it was not found in

any finished product that we know of. But it was the same bacteria

that was involved in the ingredient issue that the company had.

Mr. KUCINICH. So does the FDA have a pathologist on its staff?

Dr. SHARFSTEIN. I couldn’t tell you 100 percent.

Mr. KUCINICH. Do you outsource pathology reviews?

Dr. SHARFSTEIN. Well, we do have medical officers who would be

qualified to review pathology reports.

Mr. KUCINICH. Are they certified in terms of pathology? Are they

pathologists or do they just review pathology reports?

Dr. SHARFSTEIN. I would have to get back to you on that exact

question. But we do have people who are qualified to review pathology and judge whether or not we are concerned about a link between a product and a particular death.

Mr. KUCINICH. Why was the report even included in testimony

if it doesn’t seem to rise to the level of significance, according to

your answers here?

Dr. SHARFSTEIN. Well, I used it as an example of how seriously

we take reports like this. I mean, we went out, we tested the products. We actually went back and reviewed the records again at

each of the facilities that were involved, because they had taken

products from the two facilities. It is really two lines of evidence

that we use: one is our assessment of the manufacturing problem

and the other is a thorough investigation of the adverse event reports that we get, and that was an example of one.

39

Mr. KUCINICH. When is something, by your consideration, the result of an adverse event that is well understood to be a contraindication of taking of a drug and, on the other hand, an adulterated product? How do you make the distinction?

Dr. SHARFSTEIN. It is a good question. It partly depends on the

specific situation. So, for example, in some of the cases that were

reported, there were toxic levels of the medicine, a variety of medicines, and there was a history of the child maybe getting extra

doses. That is a known problem for certain over-the-counter medicines.

Mr. KUCINICH. When will you get the autopsy report on this 6-

year-old child who died? Do you expect to get it?

Dr. SHARFSTEIN. Will we? Oh, yes, I believe so.

Mr. KUCINICH. Can you share it with this committee?

Dr. SHARFSTEIN. I am sure we would do that, yes.

Mr. KUCINICH. And could I ask you, to your knowledge, does anyone who is at the FDA, have they ever gone over and worked for

Johnson & Johnson or McNeil? Is there anybody over there at

Johnson & Johnson or McNeil who used to work for the FDA?

Dr. SHARFSTEIN. I couldn’t say for sure, but I would guess probably there are people who have.

Mr. KUCINICH. And is there anyone who used to work at Johnson

& Johnson or McNeil who now works for the FDA?

Dr. SHARFSTEIN. I don’t know that for sure, but it is possible.

Mr. KUCINICH. OK.

Thank you, Mr. Chairman. No further questions.

Chairman TOWNS. Thank you. Thank you very much.

I now yield 5 minutes to the gentleman from Ohio, Mr. Jordan.

Mr. JORDAN. Thank you, Mr. Chairman.

I want to thank you all for being here with us today.

Just to be clear for the record and kind of picking up where Mr.

Chaffetz was, the cause and effect, has there been any determination that any adverse event was caused by product from McNeil or

Johnson & Johnson?

Dr. SHARFSTEIN. By the product, not the product quality issue?

Yes, I believe that there are adverse events that are known to be

caused by the product. There are a lot of adverse events that happen in medicine, and often they are linked to the actual pharmaceutical itself because all medicines have risks and benefits. But

not anything linked to the product quality issues that we are talking about here.

Mr. JORDAN. OK. I just wanted to be clear on that. Have you

looked at any of the recalled product? Have you tested that to see

if there is the bad stuff in there, any of the product that has been

taken off the shelf?

Dr. SHARFSTEIN. We did in the course of some of these investigations of individual adverse events, but generally, other than that,

we generally don’t do that.

Mr. JORDAN. And why not? I mean, in this situation why not?

Dr. SHARFSTEIN. Well, we believe that if there needs to be a recall because of the testing that has been done demonstrates a problem, then it should just be recalled, there is no need for us to do

it.

40

Mr. JORDAN. No need to check it out? OK. If I follow the time

line right, you did the warning letter in January, you had the inspection of the Pennsylvania facility, I believe, in April, and then

you have had the recalls and the stoppages and everything else.

And you had the meeting where it seemed like you indicated at

that meeting, though you all weren’t there, that you felt that it was

positive and productive.

I mean, I contrast what we are hearing about here and what we

have seen with, frankly, what we are hearing about in the Gulf

Coast with MMS, I guess it is, the Mineral Management Service,

and their relationship with the industry. It seems to me this process is working much better than what we are seeing and hearing

about in another area of government. Do you think the process is

working appropriately?

Dr. SHARFSTEIN. I think, as I testified, if you look at what happened here, you had a team, actually both part of Mr. Chappell’s

organization and Ms. Autor’s organization, career inspectors that at

FDA who are very vigilant with this company, identified the problem, called them to account, and it led to major changes to protect

the public.

Mr. JORDAN. OK. OK.

Mr. Chairman, I yield back. Thank you.

Chairman TOWNS. I thank the gentleman for yielding back.

I now yield to the gentlewoman from Washington, DC, Ms. Eleanor Holmes Norton, 5 minutes.

Ms. NORTON. Thank you very much, Mr. Chairman.

Dr. Sharfstein, listening to your testimony and the action taken,

I want to commend you for what looks like effective action by an

administrative agency. I would like to ask you about this notion of

super-potency. I think about when my kids were young. If I had

read that something I was giving them was found by FDA to have

something called super-potency, I would have been immediately

fearful. I would like to know what it takes for a product to be

super-potent, and as a physician, former Public Health Commissioner, whether you think such potency could result in health effects at some later point. What does it mean?

Dr. SHARFSTEIN. Sure.

Ms. NORTON. How did it manifest itself?

Dr. SHARFSTEIN. It is an excellent question. There is a range of

the amount of material in a drug that we expect to be in a particular dose, and in this case I think it was up to about 108 percent

we expect to be there. And when they tested certain lots, they

found up to 124 percent of what they were expecting. So let’s say

there is supposed to be 100 milligrams in there. Any particular lot

we would say it is acceptable, it doesn’t have to be exactly milligrams, it could be up to 108. But what they found was up to 124.

Now, they threw out those lots, but we weren’t assured that some

of the ones that did ship were OK because of what Ms. Autor said

about their new process.

So what happened was, both at FDA and at the company, we

looked, we assessed whether or not this problem, if it had been

there—we don’t have proof that anything shipped that was superpotent, but if it had been there, would that have posed a risk; and

that evaluation was done by physicians within FDA and by doctors

41

within McNeil, and for a number of reasons the conclusion was this

would not have posed a risk.

It is a relatively small increase; it was one formulation, actually,

of the dropper for little babies. And Tylenol and acetaminophen is

actually something that, particularly in adults, you can get into

trouble and people get liver problems if they get overdoses on. But

there are a number of reasons why, for babies, actually, babies are

much less likely to get that problem, and it turns out it has to do

with the way that the chemicals metabolize in children’s livers.

So that gives you one margin of safety, and then you have a

whole other margin of safety because 20 percent isn’t a real big increase in the scheme of toxicology that you are looking for two or

three times the dose to start to get into trouble. So, for all those

reasons we felt that the risk was very, very low of a problem.

Ms. NORTON. That is comforting, particularly since we know

adults get in trouble with these medicines in adult doses, and we

know these effects can be different. I have to ask you, though, as

a physician, these medicines for children and infants are very controversial. I am looking at an ad for one of them, and it says infant’s, pediatricians’ choice. Are these effective enough to take the

risk? Every time a child has a sniffle, we ought to run for one of

these infant doses of medicines that weren’t even available until

fairly recently?

Dr. SHARFSTEIN. Well, I think for particularly small babies it is

important for patients to talk with their doctors about the use of

medications. Congressman Cummings knows that I personally have

a history with some of these products of concern, about whether

they should be used for young children, and I petitioned the agency, as the Health Commissioner of Baltimore, about them, and I

am recused from that issue at FDA now. But I do think that it is

important for patients to talk to a doctor about the use of medicines. I certainly use Tylenol and ibuprofen, acetaminophen for

children.

Ms. NORTON. For infants?

Dr. SHARFSTEIN. For infants under certain circumstances. But it

really is something that, as a doctor, I would say, particularly to

parents of small babies, that it is very important that we be in

touch. If you are giving medicine because you are worried about

your child, I would say I want to know about it so we can decide

whether that was the right response.

Ms. NORTON. Dr. Sharfstein, let me ask you about a statement

in your statement. I am looking at page 10. You say FDA is considering additional enforcement actions against the company for its

pattern of noncompliance, which may include seizure, injunction,

and criminal penalties. These are nuclear penalties. Does FDA

need more effective penalties? I don’t think you are going to go

around seizing companies, or even seizing large batches, and I

don’t think you are going to be quick to run to court to get injunctions. And we have not seen criminal penalties yet. Do you have

the graduation of penalties necessary to be effective here beyond

the effectiveness you have already shown?

Dr. SHARFSTEIN. I think that is a very fair question to ask. I will

point out that in the food safety bill Congress is looking at giving

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FDA the ability to assess civil money penalties, which would be one

of those graduated steps.

Ms. NORTON. So you have no such authority now?

Dr. SHARFSTEIN. I believe not.

Ms. AUTOR. Not for drugs, no.

Ms. NORTON. That is authority you would like to have?

Dr. SHARFSTEIN. You know, that position is sort of working its

way through the process, but the administration supports that for

food.

Chairman TOWNS. The gentlewoman’s time has expired.

Before I go on, I just want to clear up something, Dr. Sharfstein.

When my staff and the ranking member’s staff, earlier this week,

they were told that the recall consisted of 6 million bottles. I believe you said 136 million bottles? What number are we using here?

Dr. SHARFSTEIN. I understand that there was a recall of about 6

to 8 million bottles last year, in 2009. That was the 2009 recall.

But this recall was much bigger, over 100 million bottles. That is

my understanding.

Ms. AUTOR. This recall was over 136 million bottles. The recall

last year relating to the chemical contamination that Dr.

Sharfstein mentioned, by our numbers, was over 60 million; and

then the year before, the recall relating to the potentially contaminated raw material was 8 million bottles.

Dr. SHARFSTEIN. That wasn’t the year before, it was a couple

months before.

Ms. AUTOR. Yes, I am sorry, a couple months before, in August

2009.

Chairman TOWNS. Thank you very much for correcting the

record.

I now yield 5 minutes to Mr. Luetkemeyer of Missouri.

Mr. LUETKEMEYER. Thank you, Mr. Chairman.

As I have been listening to the discussion this morning, it seems

to me that we have a situation where we have gone through this

and we had a 6-year-old that passed away, but it wasn’t necessarily

due to the drugs that were in question here today. Your own FDA

report indicates that the recalled drugs pose a remote potential

problem for serious health problems, but yet McNeil found their

own problems. One of your comments a while ago, Doctor, indicated

that the operations were not up to McNeil’s standards. Can you

elaborate on that just a little bit? They have their own set of standards and you have FDA standards?

Dr. SHARFSTEIN. That is correct.

Mr. LUETKEMEYER. Are their standards higher than your standards or lower than your standards?

Dr. SHARFSTEIN. Well, part of what good manufacturing practices

are is that a company has to set its own standards. So that is

something every company has to do.

Mr. LUETKEMEYER. Are they higher than FDA standards or lower

than FDA standards?

Dr. SHARFSTEIN. Well, part of FDA’s standards is for the company to sort of work together. So part of FDA’s standards are for

the company to set standards for its product.

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Mr. LUETKEMEYER. OK. So it seems as though we have a problem here. McNeil, correct me if I am wrong, they did the recall on

their own, is that correct?

Dr. SHARFSTEIN. That is correct. We do not have mandatory recall authority.

Mr. LUETKEMEYER. So they found the problem, they realized they

had a problem, and they went out and did the recall on their own.

So it would appear to me that we have a situation where it looks

like we have a sloppy shop that found they were doing poor work,

and they are going to try to correct it themselves, and you are

working with them to do that, is that correct? Is that pretty well

framing it?

Dr. SHARFSTEIN. I think that is basically true. I think that what

was particularly troubling in this story to FDA is that there was

a pattern of FDA finding out about things late. People were complaining that the products smelled bad for a year before they told

FDA about it, and it turned out there was a chemical coming in

through the pallet. And it should not have taken a year, it should

have taken 3 days for us to hear about it.

And the recall in 2010, part of that recall was related to something that happened in 2009 that the company should have been

able to figure out. So I do think that, particularly over this period,

I believe that the company has gotten the message from FDA and

I believe that they are really improving, and I think you will hear

about that. But I do believe FDA’s oversight was very important

to that.

Mr. LUETKEMEYER. Have you found any problem with co-dosing

or taking more than the prescribed amount with the people that

you have had complaints with? Has that been a problem at all with

regards to some of the drugs you looked into with this group?

Dr. SHARFSTEIN. Well, these are over-the-counter, so they are

generally not prescribed. I do think, in general, for these types of

medicines, you know, overdosages are just generally an issue, but

nothing that I know for this that would make it a particular issue.

Mr. LUETKEMEYER. OK. But my question is, as you are looking

at some of the adverse events that you were describing here, are

in those events any instances of co-dosing? Are there instances of

over——

Dr. SHARFSTEIN. Oh, absolutely. Yes.

Mr. LUETKEMEYER. OK. Are those things, then, that are part of

whenever you get your little labeling and you get your little pamphlet that goes along with your drugs, is that information in there?

Because these are over-the-counter drugs, an individual has to read

it themselves to be able to see that they are not going to interact

with something inappropriately. Is that information there? Were

these drugs something that were not part of the prescription that

was released along with the drug itself?

Dr. SHARFSTEIN. No, I think that, in general, the drugs are labeled with their ingredients, and people should be able to see

those. It is complicated for some of these products because they

may have multiple ingredients and people may not immediately realize that if they are giving one medication and another, that they

actually have the same underlying ingredients; and that kind of

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confusion has been one of the issues in this field, and I think it is

something that FDA is working with the industry on.

Mr. LUETKEMEYER. So you are looking at further labeling or further advertisement about this?

Dr. SHARFSTEIN. You know, I probably shouldn’t go further, because this is the area that I am recused from, in part, because of

the petition that I wrote when I was the Baltimore City Health

Commissioner. But FDA is looking at the labeling and the appropriate handling of this class of medicines in the cough and cold

arena.

Mr. LUETKEMEYER. OK, with these adverse events, were any of

them with regards to taking more than the prescribed amount of

this medication?

Dr. SHARFSTEIN. More than the labeled amount? I believe yes.

Mr. LUETKEMEYER. OK. So between the two of them, co-dosing

and taking more than suggested, what percentage of the total number of adverse events would you apply to those different groups?

Dr. SHARFSTEIN. I would have to get back to you on that, I

couldn’t answer that.

Mr. LUETKEMEYER. I see my time has expired. Thank you, Mr.

Chairman.

Chairman TOWNS. Thank you very much.

I now yield 5 minutes to the gentleman from Virginia, Mr.

Connolly.

Mr. CONNOLLY. I thank the Chair and I certainly welcome all of

the concerns of members of the committee about this tragedy. It is

too bad not everybody on the committee could find their way to voting to give FDA mandatory recall authority, and that is, I think,

the crux of what we are talking about here today.

Mr. Chairman, this committee has held many important and

groundbreaking hearings in its history, none more important than

this. Why? Because 37 children are dead due to a tainted product,

a product that parents relied on; a product they trusted to be safe

both because of the brand name and the expectation that the FDA

ensured its safety through Federal regulatory and oversight statutes. Whoever is responsible, everyone involved failed those 37

families in a profound and tragic way, including us.

This story is part of a much broader and equally tragic pattern

characterized by anti-government rhetoric, laissez-faire laws and

policies, and deliberate non or lax enforcement of existing laws and

regulations, especially during the Bush administration.

In the last 6 weeks we have witnessed the unfolding drama of

multiple examples of the effects and consequences of this laissezfaire philosophy of government:

A mine tragedy in West Virginia, with a number of deaths, and

one prominent advocate of the laissez-faire approach actually reacting by stating sometimes accidents happen, even though there is

strong evidence lax mine safety enforcement had something to do

with that tragedy.

The BP oil well, which has spilled at least four times the oil

leaked in Exxon Valdez, was exempted from regulation by the Minerals Management Service from the normal National Environmental Policy Act regulations. Result: an oil slick the size of Rhode

45

Island and Delaware combined, threatening the single largest fishery and source of seafood in the United States.

No need for health insurance reform? Tell that to the breast cancer victims who were systematically targeted by the largest insurer

in the United States for recision of all coverage.

And what could go wrong with lax enforcement of oversight on

Wall Street? The steepest recession in 80 years, 8.5 million Americans losing their jobs, the largest Government bailout in American

history, and the loss of $17.5 trillion, that is trillion with a T,

worth of aggregate worth in the United States.

And now 37 children dead because a contaminated product could

not be detected and mandatorily recalled by the regulatory agency

in question in a timely fashion.

There is certainly a difference between these two philosophies of

government. One offers protections to the public through reasonable regulation and strict oversight enforcement, and the other

leads us tragically, as we have seen in these last few weeks, to

nothing short of the law of the jungle.

I yield back.

[The prepared statement of Hon. Gerald E. Connolly follows:]

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47

48

Chairman TOWNS. I thank the gentleman for his statement.

I now yield to the gentleman from Georgia, Mr. Westmoreland.

Mr. WESTMORELAND. Thank you, Mr. Chairman.

Dr. Sharfstein, I have seven grandchildren and they spend the

night with us on a regular basis, so we have a cabinet full of children’s medicine; and my wife and I, after the recall, went and

looked and saw that some of it needed to be taken out. Could you

tell me who manufactures the CVS brand infant similar medicine

or maybe the Wal-Mart equivalent brand?

Dr. SHARFSTEIN. I don’t know if I can tell you off the top of my

head. I think that there may be a number of manufacturers there.

One of them was mentioned earlier that does supply for that market, but there may be more than one.

Mr. WESTMORELAND. Because I know that a lot of times certain

companies make all the products and just put different labels on

them or have different specs. So you don’t know who actually?

Since McNeil manufactures or at least has about a 70 percent market share, would we be safe going to buy a CVS or a Wal-Mart, not

actually knowing who manufactured it? I mean, do you know that?

Dr. SHARFSTEIN. Well, FDA knows who manufactured it, I just

don’t know off the top of my head. But I think one of the things

we were talking about is that FDA does inspect those facilities too,

and FDA has not identified the kinds of problems at those facilities, and that is why they are on the market.

Mr. WESTMORELAND. OK. Do you know how many labels McNeil

manufactures for?

Dr. SHARFSTEIN. Yes, we do know that, and we know that all the

products of concern have been recalled.

Mr. WESTMORELAND. There has been some question, I guess,

about the availability of these products for this, and that is one of

the concerns that my wife had was, well, where are we going to get

it from; what is it? Is there sufficient amount of product on the

market right now to where people can feel comfortable that they

would have the medication for the young children?

Dr. SHARFSTEIN. Yes. The drug shortage team at FDA looked at

that around the time of this recall and felt like there would be adequate alternatives for the medications that had been recalled.

Mr. WESTMORELAND. And have you put out a list of what those

might be or is it anything but?

Dr. SHARFSTEIN. I think that, you know, it is what is available

in the stores, because the other ones have been pulled off. We do

have a shortage team that is looking to see and even though it

looks like there is enough across the country, if there a spot shortage in a particular location, our team can help direct the supplies

and work with the companies to direct the supplies to alleviate a

spot shortage. That is something that we were concerned about

given the fact that the facility is such a large supplier to the market.

Mr. WESTMORELAND. OK.

With that, Mr. Chairman, I——

Mr. ISSA. Would the gentleman yield?

Mr. WESTMORELAND. I will. I yield.

Mr. ISSA. I thank the gentleman.

49

Doctor, Mr. Connolly seemed to imply that the previous 8 years

before you came to this job, that the FDA wasn’t doing their job.

Do you know of any of that?

Dr. SHARFSTEIN. Well, I think that, as I testified before, we have

not identified a case of a serious adverse event linked to these

quality problems.

Mr. ISSA. No, that wasn’t my question. Mr. Connolly implied that

the Bush administration didn’t care about safety, that somehow

those 8 years were not good. You are heading as a political appointee, but you are heading an organization that, if I understand

correctly, is almost all non-political appointees, isn’t that correct?

Dr. SHARFSTEIN. That is correct.

Mr. ISSA. So how would you rate the agency, the FDA, at the

time you came from a standpoint of professionalism and consistency of inspecting with the intent of food safety, food and drug

safety?

Dr. SHARFSTEIN. Well, personally, I have been incredibly impressed with the people at the FDA. There are thousands of professionals with backgrounds in medicine, law, there are inspectors,

there are chemists; and the work they do is because they really

care about the mission of the agency. I do think that one of the

messages that Dr. Hamburg has sent as the Commissioner in the

major speeches that she is going to place an emphasis on enforcement and compliance that she believes is very important, and she

has really made the pitch to industry that it supports industry

when that happens, and that has been something that she has focused on.

Mr. ISSA. Sure. And that probably is very similar to what her

predecessor said when they came in. But I just want everyone to

understand for the record this is an organization that the vast majority of it is controlled by career professionals, scientists, physicians who do their job and within the limits of the laws and the

funding we give them, in fact do the same job whether it is a Republican or a Democratic administration. Isn’t that true?

Dr. SHARFSTEIN. You know, I am sitting here with two terrific

professionals from the agency who have worked across multiple

administrations——

Mr. ISSA. Well, then why don’t we go to those two and just answer. Do you see this as a dramatic change in the last 2 years, or

is this essentially the same organization it was 2 years ago?

Chairman TOWNS. The gentleman’s time has expired. I will yield

him an additional minute.

Mr. ISSA. Basically, because the statement was made, I just

would like the career professionals to answer if in fact this is substantially the same organization with the same mission and the

same level of care.

Ms. AUTOR. I would say that FDA, as you said, has thousands

of very hardworking career professionals who did very hard work

and do regardless of the administration. I think that we welcome

this administration’s focus on enforcement and compliance and are

glad to see that, and we will continue to do everything we can to

ensure the safety, quality, and integrity of the drug supply.

Mr. CHAPPELL. Thank you. I concur in that and also say, as Dr.

Sharfstein has said, when Dr. Hamburg arrived and reinforced the

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fact that enforcement was one of our major tools, obviously, that

was an issue that we have always dealt with and also were encouraged by that.

Mr. ISSA. Thank you.

Thank you, Mr. Chairman.

Chairman TOWNS. The gentleman’s time from Georgia has expired.

I now yield to the gentlewoman from California, Congresswoman

Watson.

Ms. WATSON. Thank you so much Mr. Chairman. I think this is

a very crucial and essential hearing that you are having today, and

we all are concerned about the 775 adverse effects that have been

reported through Dr. Sharfstein’s office and the deaths that have

occurred because of some of the products that can be purchased

over the counter. And this is directed to you, Doctor.

According to McNeil, no raw material that tested positive for objectionable bacteria were ever used in the manufacture of their

products. However, according to the Form 483 filed after the FDA’s

April inspection of the Fort Washington facility, the raw material

samples pulled from testing are not statistically significant enough

to be a representative sample of that total.

So here is the question: What does McNeil need to do to improve

their sampling methods and what kinds of bacteria were discovered

in the raw materials, and what are the health implications for children and for infants who might have consumed the contaminated

products?

Dr. SHARFSTEIN. Sure. I am happy to address that. What McNeil

needed to do, and what they eventually did, is have a process

where if the bacteria was found in any part of a lot of this substance, that they not use the whole lot. What they started to do is

they would use part of the lot that tested OK, but the sampling

wasn’t good enough to assure that. So they have now a new policy

they don’t take any of the lot, and that is the right policy to have.

Ms. WATSON. Did we pull those products off the shelves, or did

they pull them off the shelves?

Dr. SHARFSTEIN. Yes, they did.

Ms. WATSON. OK. And representatives from Johnson & Johnson

have stated that McNeil is committed to not restarting operations

until it has taken the necessary corrective actions to ensure the

safety and quality of their products. What do you think are the

most critical changes that McNeil needs to make before the American people can trust the integrity of their medicines again?

Dr. SHARFSTEIN. That is an excellent question. I think there is

a broad answer to that question, which is that McNeil needs to put

in a very strong quality system that has some very important basic

components to it, where not only will things be done correctly, but

they have a strong way of catching if there is a problem, investigating what that problem is, and immediately solving that. And that

approach is what FDA is going to really insist on to be in place before the facility starts manufacturing again.

Ms. WATSON. I see. Now, do you have the authority to pull these

products off the shelves? I wasn’t clear with the testimony that preceded.

51

Dr. SHARFSTEIN. FDA does not have the authority to require recalls. Now, under certain circumstances we can go to court and get

seizures and injunctions and other things, but in terms of a mandatory recall authority for drugs, FDA does not have that authority.

Ms. WATSON. The process of going to court is, in some cases,

time-consuming.

Dr. SHARFSTEIN. Absolutely.

Ms. WATSON. How can we help with FDA? I have another issue

and we had a hearing yesterday that deals with mercury amalgams. I don’t want to get into that; that took us 5 hours. But I

want to know what authority we can provide to you so that we can

take these questionable products off the shelves. Lives are at stake

here and you have testified to——

Dr. SHARFSTEIN. Well, one of the things to note is that in the

food safety bill Congress is looking to give FDA mandatory recall

authority over foods; also authority to put in place, require certain

types of preventive standards to prevent problems; access to

records, easier access for FDA to records at companies; and civil

money penalties.

Ms. WATSON. Let me just interject this question. You are saying

authority over foods. Can we add another line saying anything that

is ingested or digested through the mouth?

Dr. SHARFSTEIN. I think that would be up to Congress.

Ms. WATSON. That would go beyond just foods.

Dr. SHARFSTEIN. Right. That would be up to Congress.

Ms. WATSON. OK. As a doctor, would that clarify what you need

to understand we can do? I want to make it easier for you to indicate.

Dr. SHARFSTEIN. I appreciate the question tremendously.

Ms. WATSON. And we make the policy, so——

Dr. SHARFSTEIN. Right. No, absolutely. The administration hasn’t

worked out a final position on this with respect to drugs, but the

administration does have a position with respect to foods, and

these are the types of things that the administration is looking at

with respect to foods, and there is no question that it is relevant

for drugs.

Ms. WATSON. OK, I am going to have my staff write a letter to

you and we are going to suggest this language, and then you can

take it the rest of the way.

Dr. SHARFSTEIN. Thank you very much.

Ms. WATSON. Thank you very much. My time is up.

Chairman TOWNS. We will leave the record open for it.

I now yield 5 minutes to the gentleman from California, Mr.

Bilbray.

Mr. BILBRAY. Thank you, Mr. Chairman.

Doctor, let me first thank you very much for a very measured response, a very measured and thoughtful approach to this issue. I

think it is so quick for us to want to go from one radical extreme

to the other, and I appreciate the fact that I think some people

would say your experience here, I think your experience in the real

world, doing local health gives you that measure of moderation and

consistency, and I think that really helps the entire process.

One of the things that I really want to focus on is that we have

talked about how do we respond to this and, as you said, we sort

52

of addressed the issue before it became chronic, before it became

a crisis. As we look at the way we can improve this, I have some

questions about your auditors when they go in. How do you assign

the inspectors to do these inspections for the facilities?

Dr. SHARFSTEIN. They come out of the district office. FDA has a

number of district offices around the country and they have a staff

of inspectors, so the firms are inspected by their local district office

professional inspectors.

Mr. BILBRAY. OK. Does the same inspector go back and inspect

these facilities each time, or is there a rotation? Do you know how

they allocate personnel toward certain facilities?

Dr. SHARFSTEIN. I am going to maybe ask Mike Chappell, who

oversees all the inspectors, to answer that question.

Mr. CHAPPELL. Well, thank you. In response to your question, we

make sure that the individuals that conduct these inspections have

the proper level of training and experience. Indeed, if they are at

a firm where there are some significant problems, they also are

able to call upon expertise both within the inspector group and also

other places in the agency. We don’t have a policy that the same

investigator can’t go into the same firm; oftentimes they do. But in

many of the cases of these large firms, there will actually be a

team of inspectors that will go in just due to the sheer size of the

firm.

Mr. BILBRAY. So, in other words, you have a policy that you may

have an inspector go in with a general oversight, but if he finds

specific concerns, he can then call in sort of a delta team that specializes to help him focus on some of the concerns and bring the

level of expertise up a little bit on those specific issues?

Mr. CHAPPELL. Yes, exactly. That is exactly it. If there is a specific manufacturing process or a specific issue that we have other

people with greater expertise or experience, they are available to

be called in for these inspections, yes.

Mr. BILBRAY. Now, when we talk about the inspectors and their

relationships with the facility itself, what is the policy and what is

the practical application of communication contact with the facility

or individuals who operate the facility by the inspectors other than

during inspection, other than during the official process of review

and inspection of the facilities, as we say, off-campus contacts?

What is the policy and what is the reality in what level of contacts

off campus or out of the inspection process do these inspectors have

with operators or owners of these facilities?

Dr. SHARFSTEIN. I would say that there is quite a lot of communication between the company and its district office, and maybe,

Mike, if you want to talk about some of the examples. If they find

problems in the facility, for example, it is not during an inspection,

there are certain types of problems, they have to notify the district

office about.

Mr. CHAPPELL. Just to make sure I understand your question,

are you talking about an inspector or investigator that is not conducting an inspection, that has no relationship with that company

as it relates to an inspection or investigation?

Mr. BILBRAY. Yes. I am really looking at, Doctor, one side to look

through the official communications. But what I am saying is what

is the policy about unofficial contacts that may not be directly reVerDate 11-MAY-2000 11:05 Mar 23, 2011 Jkt 000000 PO 00000 Frm 00056 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\63140.TXT KATIE PsN: KATIE
53

lated to the responsibility of the inspector to the facility, but outside of official contact? What kind of policy do you have specific to

those contacts outside of official——

Dr. SHARFSTEIN. I see. I am sorry, I may have misunderstood the

question.

Mr. BILBRAY. That is OK.

Dr. SHARFSTEIN. You are asking about like after-hours contacts,

that sort of thing?

Mr. BILBRAY. Right.

Dr. SHARFSTEIN. I thought you meant outside of the inspections,

but not outside of the job.

Mr. BILBRAY. I understand that.

Dr. SHARFSTEIN. He means outside the job.

Mike, do you want to?

Mr. CHAPPELL. Well, I can certainly say there is professional integrity that we expect of our investigators, and if they are involved

in activities with company officials as it relates to some type of relationship, such as a job seeking, etc., we have standards for that

prohibits that kind of activity.

Mr. BILBRAY. OK. I appreciate that.

You know, Doctor, I had the pleasure for a decade of supervising

an environmental health department doing this kind of inspection

and an Air Resources district doing this kind of inspection, and

there are two schools of thought, and I think too often people take

the punitive approach that my air district was involved in for too

long, rather than a cooperative; and one thing I was very impressed with our environmental health people was they saw their

job was to help the private sector stay within the law, stay within

the safety boundary, rather than what I ran into with a lot of my

air guys that were looking, the cop mentality of trying to catch people crossing the line and being punitive rather than cooperative.

And I know people will attack you for trying to work with the private sector at staying within the framework, but I think we all remember busting people or finding fault is not the answer, but to

avoid the problem, and I appreciate your efforts.

Chairman TOWNS. The gentleman’s time has expired.

Mr. BILBRAY. Mr. Chairman, could I allow the doctor to comment

on that?

Dr. SHARFSTEIN. Sure. I would say I absolutely agree with that,

and that was the approach we had in Baltimore. It is very important to work cooperatively where you can, and we, in Baltimore, actually had a Web site where we posted common questions so that

people could get information. We weren’t counting success by the

number of closures, but we wanted to have success by compliance;

and that is the same thing at FDA. Actually, one of our transparency recommendations parallels that, that FDA should be more

aggressive in telling the regulated community about the kinds of

problems that we find so that people can correct them in advance,

not whether we can find them at every place.

Mr. BILBRAY. Thank you very much, Mr. Chairman.

Chairman TOWNS. The gentleman’s time has expired.

I now yield 5 minutes to the gentleman from Missouri, Mr. Clay.

54

Mr. CLAY. Thank you, Mr. Chairman. Let me thank you and the

ranking member for holding this hearing on a serious matter of

public health and public safety.

Maintaining the highest standard for manufacturing medicine is

essential to the safety of the American consumers. Let me ask Dr.

Sharfstein. I have two children, 9 and 16. Do you advise me, as

well as the rest of the people listening and viewing this hearing,

to stay away from these products, from Johnson & Johnson, from

Motrin, from Tylenol, and whatever else you found to be problematic?

Dr. SHARFSTEIN. We are advising that people throw out the recalled products, yes.

Mr. CLAY. What about just the brand itself?

Dr. SHARFSTEIN. I don’t think we would go that far, because we

are looking at each of the different issues at the different facilities.

But there is a pretty big list of products that we are staying people

to stay away from right now.

Mr. CLAY. You know, looking at the observation from your first

report and then from your report in April 2010, it appears that you

observed many of the same deficiencies again. Is this a correct assessment?

Dr. SHARFSTEIN. I think that there were some similarities, but

we found some new ones in April 2010 that were extra concerning.

Mr. CLAY. In your opinion, how seriously did McNeil take its response to your inspections?

Dr. SHARFSTEIN. I think that what happened over this period is

FDA was intensifying its scrutiny and that really culminated in

this February meeting, which was an extraordinary meeting with

the senior leadership of the parent company, where FDA really

said there is a problem of compliance at your company; and our

sense is they took that very seriously and have made some major

changes to how they oversee quality across this particular company. You know, we wish it hadn’t come to that, but I think it was

necessary for FDA to really talk to the company about the company’s overall compliance problems.

Mr. CLAY. Now, it is my understanding that reports of suspicious

odors were made as early as 2008. Is that correct?

Dr. SHARFSTEIN. That is correct.

Mr. CLAY. And how long did it take McNeil to begin a comprehensive response to these complaints?

Dr. SHARFSTEIN. At least a year, I think.

Mr. CLAY. A year?

Dr. SHARFSTEIN. That is correct.

Mr. CLAY. OK. So they didn’t take the report seriously. They

didn’t take the complaint seriously.

Dr. SHARFSTEIN. FDA’s view is that they should have reported

that to the agency and that they didn’t at that time, and then,

when they did report it to us, it required a lot of oversight by FDA

for them to realize the scope of the problem, and eventually that

led to a significant recall. And because of their failures in that regard, FDA sent them a warning letter on January 15th of this year

that not only called attention to the problems, but called attention

to the failure of corporate oversight.

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Mr. CLAY. So, in FDA’s opinion, their response was not timely,

nor appropriate.

Dr. SHARFSTEIN. That is correct.

Mr. CLAY. Do you believe that Johnson & Johnson’s participation

in recalling the contaminated product was effective?

Dr. SHARFSTEIN. I believe that they have gone about the recall,

particularly this most recent recall, very vigorously, and they have

made a lot of information available to the public about it.

Mr. CLAY. What new regulations do you believe should now be

enacted to protect American consumers from the contaminated

medicines we are investigating today? What else can we do?

Dr. SHARFSTEIN. One of the things we have been talking about

are some of the authorities that are being looked at under the food

safety bill for food that relate to things like mandatory recall authority, easier access to records to FDA, civil money penalties.

Those are things that have been discussed.

Mr. CLAY. Do you believe that contamination of this magnitude

has implications for possible terror threats?

Dr. SHARFSTEIN. I don’t know if I can answer that question without thinking about it some more. In general, this is really a product

quality issue that we see and have seen for a while, and FDA believes it is important, just in general, that products be made according to the best specifications so that they are safe and effective

as possible, and it is really product quality that is driving our

strong work in this area.

Mr. CLAY. And how often do you check quality with the manufacturers?

Dr. SHARFSTEIN. It depends on the company and it depends on

their record. And this is a company that got extra scrutiny from

FDA because of our concerns.

Mr. CLAY. Thank you.

I yield back.

Chairman TOWNS. The gentleman’s time has expired.

Before we move to the next questioner, let me yield 30 seconds

to the gentleman from California.

Mr. ISSA. I thank the gentleman. To clarify the record, I would

ask unanimous consent to be able to place in the record a letter

from the McNeil Consumer Healthcare Division in which they say

call 888–222–6036. I won’t put this in the record, but if you do that

rather than throwing away medicine, you return it and you are

paid $15 on this check. So I would just ask that be placed in the

record and that it be clear that the recall does cause this division

to pay for healthcare products returned to them.

Chairman TOWNS. Without objection, so ordered.

[The information referred to follows:]

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Chairman TOWNS. I now yield 5 minutes to the gentlewoman

from California, Congresswoman Speier.

Ms. SPEIER. Thank you, Mr. Chairman.

Along those same lines, let me ask FDA do you have this telephone number on your Web site to alert the consuming public that

they can contact McNeil and get reimbursed?

Dr. SHARFSTEIN. I believe we do. I believe that we link to all of

McNeil’s materials.

Ms. SPEIER. Well, I am not talking about linking, but actually

having a notice on your Web site to call this number and that you

can then get a reimbursement.

Dr. SHARFSTEIN. I would have to——

Ms. SPEIER. And if you don’t, I think you should.

Second, I think it is very important for the consumers to be told

that they shouldn’t throw away these prescription drugs that then

get into the water system; that they should properly dispose of

them in a manner that will not have it being leached into the

water system and then creating more problems down the road.

So I want to talk about the elephant in the room. And I think

the elephant in the room is that you don’t have recall authority.

This has been a voluntary recall by McNeil of 43 of their products,

correct? So if they had chosen not to recall those products, you

would have had to go to court in order to effectuate that result. Is

that correct?

Dr. SHARFSTEIN. And it would have been challenging to do it

through court, actually.

Ms. SPEIER. So you probably wouldn’t even have been able to do

it through the court.

Dr. SHARFSTEIN. We would have had some ability to do some of

it through court, but I think in this case McNeil and Johnson &

Johnson agreed to do the recall. But I think that part of the issue,

if you look across this whole time period, is that from the point of

wanting to have a recall, there were some delays, and I think that

it is a fair question to ask about mandatory recall authority.

Ms. SPEIER. So you don’t have mandatory recall authority. If they

had chosen not to recall those products, those products would still

be on the shelves today. Is that a fair comment?

Dr. SHARFSTEIN. I think that probably is a fair comment, yes.

Ms. SPEIER. All right, so, Mr. Chairman, I think that is an issue

that really needs to be addressed.

Second, if you look at the behavior of McNeil over the course of

these 2 or 3 years, it reminds me of a kid in school who continues

to get Ds, no one basically takes an action, the kid never goes to

the principal’s office until 3 years down the road, and very little action occurs. So my question is really about fines. Since your real

power is somewhat limited, outside of suggestions and negotiations,

what kind of fines can be imposed? Can you close them down for

10 days? What hammers do you have to utilize in your regulatory

function?

Dr. SHARFSTEIN. I think I may ask Deb Autor to answer that

question. I can tell you we do not have civil money fines for these

kinds of violations, so there are criminal penalties that would require going to court to get. But in terms of the ability to assess civil

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money penalties, which is part of the food safety bill, we don’t have

that in this area of drugs.

Ms. SPEIER. OK, maybe that is part of the problem, that getting

compliance is more difficult because there is no hammer on any of

these companies. There is no downside risk not to ignore what FDA

is requiring because you don’t have any financial impact.

Dr. SHARFSTEIN. Well, I think the story here is that we got their

attention and there were major changes that were made over the

course of this process even under the existing law.

Ms. SPEIER. I agree.

Dr. SHARFSTEIN. But having said that, I think you are asking a

very fair question, which is, with other tools, could FDA have gotten their attention faster and sooner and had a quicker result. I

think those are fair questions to ask. They are being asked in the

context of food safety as well.

Ms. SPEIER. And especially since you don’t have the power for

mandatory recall. How else do you get anyone’s attention?

So if Ms. Autor.

Ms. AUTOR. Yes, thank you. Just to add on to what Dr.

Sharfstein said, we do not have any civil money penalty authority

for violations of good manufacturing practices or drug labeling requirements. And to clarify my answer to Ms. Norton earlier, the

only context in which we have civil money penalties for drugs are

related to certain application requirements.

Ms. SPEIER. All right.

Ms. AUTOR. So it would be useful to us to have that authority.

Ms. SPEIER. OK, my time is running out.

Cost recovery. A lot of money has been spent investigating inspecting over and over and over again. How much has that cost the

taxpayers of this country and are you able to recover the costs associated with that?

Dr. SHARFSTEIN. That is a good question We would have to get

back to you on how much money exactly has been spent on it. I

think, as we said, there are a number of things that FDA is still

considering in terms of enforcement in this situation, and one of

our potential options would be to seek to get money back from the

company if certain criteria were met, and that is part of the assessment that is probably going on.

Ms. SPEIER. I thank the witnesses. My time has expired.

Chairman TOWNS. The gentlewoman’s time has expired.

I now yield 5 minutes to the gentleman from Massachusetts, Mr.

Tierney.

Mr. TIERNEY. [Remarks made off mic.]

Chairman TOWNS. Right.

I now yield 5 minutes to the gentleman from Illinois, Mr. Davis.

Mr. DAVIS. Thank you very much, Mr. Chairman. I thank you for

holding this hearing.

Dr. Sharfstein, let me ask you when troubles emerge, are found,

or concerns raised, are there any remedies that can occur prior to

recall?

Dr. SHARFSTEIN. In terms of whether we can fix the manufacturing process before the product gets recalled?

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Mr. DAVIS. Yes. I mean, if you find that there is a problem with

a product or there are concerns about a product, or allegations of

concerns about a product, what happens at that point?

Dr. SHARFSTEIN. I think there is an assessment. In some cases

the product may not have left the facility, and you don’t have to

do a recall at all; it is still there and it just never gets sold. And

then there is an assessment, if it has gotten sold, of whether it is

something that is significant enough to require a recall. And we

have a standard for that and I think one of the things we are going

to do is take a look at that. But sometimes, you know, there is a

problem and it can be addressed. We look at it, we get more information, and we realize that it doesn’t pose any risk at all and there

does not need to be a recall, but there will be fixed going forward.

So it is kind of a case-by-case determination. But there are sometimes when we don’t do a recall.

Mr. DAVIS. In the event that there is just a continuation of production activity that is out of compliance or does not meet specifications or requirements, what can happen to a company?

Dr. SHARFSTEIN. If there is repeated violation, what we have

seen so far is we call in the company, we can talk to them; we can

send them warning letters; and then they can have other enforcement actions, including court-ordered injunctions, we can seize

their products; and then eventually we can refer to criminal investigation and people can be prosecuted criminally.

Mr. DAVIS. Can you think of any instances where that has happened?

Dr. SHARFSTEIN. There have been examples where there has

been a quality problem so significant that it has led to that. Recently with a company actually in Massachusetts, there was a

major agreement that we reached, that has yet to be blessed by the

court, that relates to quality problems and I think well over $100

million is being paid by the company back to the government because of quality problems at their facility.

I think in that case and in this case it is really important to realize the critical role that FDA plays for drug safety; and I think it

is important to think of what would have happened in this case

had FDA investigators not been on the job, that we could expect

that a lot of these problems would not have been caught, that

changes at the company would not have been made, and it eventually could get to a situation where there was a very serious risk

to the public.

Mr. DAVIS. Thank you very much.

I have no further questions, Mr. Chairman.

Chairman TOWNS. Thank you very much.

Let me just make a quick statement to the Members. We will

have votes in just a matter of a few minutes, and what I would like

to do is to adjourn and come back 10 minutes after the last vote.

I can’t say exactly what time it will be because I am not sure as

to how long it will take us for the four votes, but we would take

a recess and then come back and then do the second panel.

If you would like to, fine.

Mr. ISSA. Thank you, Mr. Chairman.

Just a very, very quick followup. The gentlelady from California,

before she leaves, under the previous administration there was an

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egregious failure by the FDA, and you probably remember it either

from your time on the Hill or when you in Baltimore. We had a

spinach problem under the FDA. A bag of spinach coming from a

specific location and a specific farm was tainted. That led to a total

recall of all spinach. You may not have had authority for mandatory, but the FDA made sure that spinach was dead in America for

a period of time.

What are you doing today to ensure, under the food side of food

and drug, that if in fact a field of some fresh vegetable is tainted,

that only that field, if it can be identified. In this case the bags

were numbered; they could have named the manufacturer, or at

least the bagger, and they didn’t. What are you doing to change

that so the next time a bit of food, similar to when beef is tainted

and agriculture controls it, that only the actual tainted or likely

tainted or possibly tainted is recalled, rather than an entire fresh

vegetable segment being off the market for a period of time?

Dr. SHARFSTEIN. That is a good question and that is something

that we have thought a lot about. In fact, the transparency report

that we just posted has a whole section on the importance of FDA

being as transparent as possible about the products that are not affected by recalls. For example, when there was a pistachio recall,

FDA linked to an industry Web site of all the brands that were not

involved with the particular farm at issue.

Recently, there was a terrible outbreak that was related to Romaine lettuce. FDA worked very quickly with States and localities

and the CDC, and we identified a distributor, and we quickly were

able to narrow it down so that, when we did do a recall, it was a

relatively narrow recall.

There is a balance between the scale of the recall and the timeliness, because you need to move fast because it is often perishable

foods that you don’t want people to eat. I think we realize that we

want to be as absolutely as narrow as we possibly can when we are

warning the public about food, and I think that you can look at the

Romaine lettuce situation that just happened, that I was quite involved in, as an example of an area where we did our best to narrow it as quickly as possible and, in fact, it was very relatively narrow in how we did it, and we were able to get the products of concern off the market very quickly.

Mr. ISSA. Last question. Do you need any new authority in relation to food, such as, in the case of ground beef, every package of

ground beef that is ground outside of the store in which it is sold

has a manufacturer’s ID, date code, and so on, so that the consumer can make a decision about whether they are covered by a

code. In the case of packaged vegetables, that is also true. But in

the case of unpackaged vegetables, the master pack may or may

not contain sufficient information to find out for sure where it came

from. Is that something that you could do within your own rulemaking authority, or does Congress need to act?

Dr. SHARFSTEIN. It sounds like a question I am going to want to

get back to you on with a good answer, but——

Mr. ISSA. I think the chairman would appreciate that for the

record.

Dr. SHARFSTEIN. But I would say that FDA strongly supports

food safety legislation, and we think it is really critical for our abilVerDate 11-MAY-2000 11:05 Mar 23, 2011 Jkt 000000 PO 00000 Frm 00064 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\63140.TXT KATIE PsN: KATIE
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ity to establish the standards that are needed to protect the food

supply.

Mr. ISSA. Thank you.

Thank you, Mr. Chairman. I yield back.

Chairman TOWNS. Right. Just before we recess, let me just ask

have you checked to see whether or not the quality control staff has

been decreased?

Dr. SHARFSTEIN. At McNeil?

Chairman TOWNS. Yes.

Dr. SHARFSTEIN. I believe that one of the things that we are talking to the company about is their quality control staff; what their

qualifications are, what kind of plans they are going to put into

place. Everything related to the quality control staff FDA is working with the company to make sure it is satisfactory.

Chairman TOWNS. Just before we recess, the gentleman from

Maryland, any comments or suggestions?

Mr. CUMMINGS. No, Mr. Chairman. Thank you very much.

Chairman TOWNS. Thank you very much.

We will now recess until 10 minutes after the last vote. Cannot

tell you the exact time we will come back because we do not know

how fast the votes will move, but this panel is dismissed.

Dr. SHARFSTEIN. Thank you.

[Recess.]

Chairman TOWNS. The committee will reconvene.

Our second witness today is Colleen Goggins, worldwide chairman of the Johnson & Johnson Consumer Group.

It is committee policy that all witnesses are sworn in. Please

stand, Ms. Goggins, and raise your right hand.

[Witness sworn.]

Chairman TOWNS. You may be seated.

Let the record reflect that the witness answered in the affirmative.

Ms. Goggins, please give your opening statement.

STATEMENT OF COLLEEN GOGGINS, WORLDWIDE CHAIRMAN,

CONSUMER GROUP, JOHNSON & JOHNSON

Ms. GOGGINS. Thank you, Chairman. Chairman Towns, Congressman Issa, and members of the committee. My name is Colleen

Goggins, and I serve as the worldwide chairman of the Consumer

Group of Johnson & Johnson. In this position, I oversee the products that include the pediatric Tylenol, Motrin, Zyrtec, and

Benadryl products that were recalled by McNeil Consumer

Healthcare on April 30, 2010. McNeil is a Johnson & Johnson operating company, and I am pleased to testify on behalf of Johnson &

Johnson to present our understanding of the events.

All of the Johnson & Johnson family of companies realize that

we have a responsibility to provide consumers with the highest

quality products possible. We are proud that our products help millions of people around the world improve their health and wellbeing. In this instance, we have not lived up to that responsibility.

The quality issues in this recall are therefore a disappointment to

our chairman, Bill Weldon, to me personally, and to the thousands

of employees in the Johnson & Johnson family of companies.

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The quality and process issues that we found at McNeil, those

that led to the recall and others, are unacceptable. On behalf of

McNeil and Johnson & Johnson, I apologize to the mothers, the fathers, and the caregivers for the concern and inconvenience caused

by the recall. Johnson & Johnson embraces the work of this committee and we hope that today’s hearing will be an important step

in furthering public understanding of the recall.

Unfortunately, there has been some confusion in the media with

respect to this recall. I would like to stress, therefore, four key

points that Dr. Sharfstein also reiterated this morning. First, as

the FDA noted last month, the health risk to consumers from the

recalled products are remote. Second, McNeil has no indication of

a serious adverse medical event caused by any of the issues referenced in the recall announcement. Third, no raw materials that

tested positive for objectionable bacteria were ever used in the

manufacture of McNeil’s pediatric products. And, finally, McNeil

rejected the products that it found had excess active ingredient and

these never reached the marketplace.

Because the McNeil products are used by millions of sick children each year, we receive many questions and reports on possible

adverse events. We take all of these very seriously, assess all of

them, and specifically investigate all serious adverse event reports,

whether or not the events may have been caused by our products.

As Dr. Sharfstein indicated, the mere existence of these normal

and expected reports does not alter the medical conclusions of the

FDA and our doctors that the safety risk from the recalled products

is remote.

The recall last month was implemented because of the presence

of minute metal particles detected in a small percentage of products. To be clear, these quality issues, including the minute particles, are unacceptable to us. For that reason, McNeil implemented

a broad precautionary recall of liquid children’s and infants’ medicines on April 30, 2010.

Let me address the remote medical risks.

First, with respect to the minute particles, McNeil’s health assessment concluded that even if those products were distributed

and the particles were ingested, the particles were inert, so small,

and so few that they did not present a safety or health risk.

Second, with respect to products with an excess concentration of

acetaminophen, which McNeil rejected, McNeil’s medical experts

confirmed that even ingestion of the maximum labeled dose over an

extended period of time, with the highest identified level of excess

acetaminophen, would not present a medical concern.

Third, with respect to raw materials, McNeil tested all raw materials and rejected any containers of raw materials that tested positive for objectionable bacteria. No raw materials that tested positive were ever used in production.

Although the medical risks were remote, we recognize that the

quality and process deficiencies identified in McNeil’s Fort Washington plant must be remedied. My written testimony contains additional details on these points and a summary of the steps that

McNeil undertook and is undertaking to act quickly to implement

this broad recall and the steps that Johnson & Johnson and McNeil

are taking to address quality processes.

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In particular, we have made a number of personnel changes and

embarked on a comprehensive assessment of McNeil’s OTC facilities both before the FDA inspection in April. The Johnson & Johnson parent company is committed to providing McNeil with all the

resources and personnel needed to improve quality and to ensure

that its product and processes meet the highest standards.

Johnson & Johnson and McNeil take these issues very seriously,

and we are committed to taking the steps necessary to bring

McNeil’s operations back to the level of quality that Johnson &

Johnson demands of its companies and that the public rightly expects of us.

Mr. Chairman, I would like to close in the same manner that our

chairman, Bill Weldon, concluded his letter to the people who use

our products: We will work hard to earn back your confidence. I

would now be happy to answer your questions.

[The prepared statement of Ms. Goggins follows:]

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Chairman TOWNS. Thank you very much for your statement, Ms.

Goggins. Before I begin, I want to say that Johnson & Johnson is

a family brand, and the American people have come to rely on that

for more than 100 years. Until recently, most people would not

think twice about giving their child one of your products. In fact,

most Americans have at least one or more of your products in their

home. But I have become deeply concerned about your company.

Information I have seen during the course of your investigation

raises questions about the integrity of the company; it paints a picture of a company that is deceptive, dishonest, and has risked the

health of many of our children.

As the ranking member, Mr. Issa, said earlier in his opening

statement, I hope that you will be forthcoming today about your

company. And on that note, let me just go to a couple questions.

Is it true that excess amount of certain active ingredients were

found in your children’s medicines?

Ms. GOGGINS. Chairman Towns, it is true that lots of the product

were produced with excess amounts of the medicines, but these

never reached the marketplace. In fact, as I think Ms. Autor said

earlier this morning, we produced something like 10 or 11 lots of

product; 3 were rejected on that grounds, the other 7 were tested.

And I should say we test all of our finished products extensively;

we take samples from the beginning, the middle, and the end of

manufacturing, and we make sure they are within specification.

They were. We released them to the marketplace. When the FDA

raised its concerns, we tested the last batch which we had in our

possession. We actually tested 1,200 bottles, and not one of the

1,200 bottles was over the specified amount of active ingredient.

Chairman TOWNS. So was that a yes or no?

Ms. GOGGINS. I am sorry. That is that no product with excess acetaminophen entered the marketplace, to the best of our knowledge

in testing.

Chairman TOWNS. But it was actually found in the medicine, so

that would be a yes.

Ms. GOGGINS. It was found, but it was rejected, sir. It never

reached the marketplace.

Chairman TOWNS. Would you agree that these quality control

issues are totally unacceptable?

Ms. GOGGINS. I would absolutely agree with that, yes, sir.

Chairman TOWNS. Did you have contractors go back to stores and

buy medicine, instead of recalling the medicine?

Ms. GOGGINS. Let me explain that, sir. I think it is very important. There has been a lot of misinformation about the entirety of

this recall, and I am glad you raise that issue right now, because

I think there are misperceptions.

We did have a Motrin dissolution issue in 2009. It was for a

small product that was distributed in gasoline stations. We discussed with the San Juan district of the FDA this issue. We talked

to them about hiring a third-party contractor to go to see the

breadth of the distribution of these products. So we were in discussions with them. They knew that we had hired this third party,

and the third party did go out to make an inventory, and we discussed that with the San Juan office of the FDA. So there was

never any intent to mislead or hide anything from anyone.

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Chairman TOWNS. So the San Juan office of the FDA were aware

of the fact that you were going out to purchase——

Ms. GOGGINS. That is correct, sir. We were in discussions with

them.

Chairman TOWNS. Let me make sure that I understand. Now,

you went out and you purchased them, but the FDA was aware of

the fact that you were going to do it?

Ms. GOGGINS. Let me see if I can explain what happened.

Chairman TOWNS. Yes, help me.

Ms. GOGGINS. We had a Motrin product where the dissolution

profile, or how it is solubilized, wasn’t in specification. It is a small

product; it sold primarily in gas stations. We discussed this issue

with the San Juan office of the FDA and we agreed or we offered

to have a contract force go out and identify how much of this was

in the marketplace. The FDA was aware that we were doing that

in San Juan and we did that. I can’t tell you about the behavior

of these contractors in the market or what they said or didn’t say

or how they acted, but clearly FDA was aware of this and there

was no intent, obviously, to mislead or hide anything.

Chairman TOWNS. In other words, for the contractors to go in

and say do not mention the fact that this is a recall? You know

nothing about any of that?

Ms. GOGGINS. I know nothing about that, sir. I know only that

we were in discussions with the FDA in San Juan over the product

issue and how we were planning to handle it with a third-party

contractor.

Chairman TOWNS. Do you have any kind of documents or anything that might be able to confirm what you are saying? Because

the FDA is saying that they learned of this later on. If you were

in discussions with them, why wouldn’t they know it immediately?

Ms. GOGGINS. Chairman Towns, I can’t answer that question.

What I can do is I promise you to get back to you with the kind

of documentation what we have regarding this issue. In fact, I

would welcome the opportunity.

Chairman TOWNS. Well, I would like for you to do that for me

because——

Ms. GOGGINS. I would be happy to.

Chairman TOWNS [continuing]. I just find this very, very disturbing, the fact that they went in to purchase the products. FDA is

saying they had no knowledge of it and, of course——

Ms. GOGGINS. No more disturbing than I do, sir.

Chairman TOWNS. Right. How can this happen in a company of

your size and reputation? I mean, how could something like this

happen? Your company has had a longstanding reputation.

Ms. GOGGINS. That is a question that we have been asking ourselves, and what I can tell you is that we think it comes down to

a number of factors. It comes down to people and leadership and

processes. And what I can tell you is that we have made significant

changes in the leadership. We have actually changed six key executive positions: we have changed the head of OTC manufacturing;

we have changed the head of OTC quality; we have changed the

plant at Fort Washington; we have changed the head of quality at

Fort Washington; we have changed the head of quality at our PuerVerDate 11-MAY-2000 11:05 Mar 23, 2011 Jkt 000000 PO 00000 Frm 00076 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\63140.TXT KATIE PsN: KATIE
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to Rico plant; we have changed the head of manufacturing; and we

have reassigned people at other levels.

Chairman TOWNS. So all of your quality issues have now been

solved?

Ms. GOGGINS. Well, I would not say that, sir. What I would say

in addition is that we have undertaken a broad assessment of all

of our OTC plants; we have engaged a third-party expert to take

a look at our plants and help us do this assessment; and we have

committed to the FDA that by July 15th we will have a master

plan regarding the remediation of all of our plants as necessary.

Chairman TOWNS. Thank you.

I now yield 5 minutes to the gentleman from California, Congressman Issa.

Mr. ISSA. Thank you, Mr. Chairman.

Since you patiently sat through the first hearing, you are aware

of my line of questioning, so I am going to sort of followup, sort of

FDA you.

Ms. GOGGINS. Sure.

Mr. ISSA. You told me, in your testimony and in the chairman’s

questions, you said basically there was no safety issue in relation

to the product that got out of the plant, period. Not the product

that may have been multiple times its advertised dosage that remained in the plant as defective material, but the product that got

out of the plant, as of right now, the science—both at the FDA and

you—consider that there was no health risk from that product. Is

that correct?

Ms. GOGGINS. Yes. The FDA and Johnson & Johnson and McNeil

is aligned that the risk of a serious health event is remote and, to

date, there have been no serious health events associated with any

of the reasons for the recall.

Mr. ISSA. OK. So the recall was more about failure to live up to

your own standards and, therefore, a recall; and, of course, the potential that if you didn’t live up to your own standards, something

bad could happen. But the actual product being recalled is not dangerous to the consumer.

Ms. GOGGINS. That is correct.

Mr. ISSA. Now, ma’am, you are very good and scientific. If I understood what you said about the Advil product, the gasoline

station——

Ms. GOGGINS. Motrin.

Mr. ISSA. Motrin. Wrong brand. The Motrin. What you have is

paper two-packs that they sell at gas stations, and if you take

these you are not getting much use out of them because they don’t

dissolve properly. Is that right?

Ms. GOGGINS. That is correct, yes.

Mr. ISSA. So, in plain English, they simply wouldn’t cure your

headache, but they wouldn’t hurt you.

Ms. GOGGINS. It would take longer to cure your headache, yes,

but they would not hurt you, no, sir.

Mr. ISSA. OK, so it is not going to hurt you, just not going to

be——

Ms. GOGGINS. That is correct.

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Mr. ISSA [continuing]. As good as advertised. And you hired a

contractor to try to do it and you have said under oath you did inform the FDA, at least at their local level.

Ms. GOGGINS. Yes.

Mr. ISSA. I was a manufacturer for 20 years. Under ISO 9001,

if you find a defect, you do two things: you segregate the defects

and, of course, you go through a quality analysis to try to keep that

from happening again.

Ms. GOGGINS. Right.

Mr. ISSA. In the case of the Fort Washington facility, if that was

where these products were produced that were multiple times their

normal dosage—or was it Puerto Rico?

Ms. GOGGINS. That was Fort Washington, sir.

Mr. ISSA. Fort Washington. You segregated the product, is that

correct?

Ms. GOGGINS. We did.

Mr. ISSA. You destroyed the product.

Ms. GOGGINS. I believe so.

Mr. ISSA. And what steps were taken to prevent this from reoccurring, if you know?

Ms. GOGGINS. Yes. I honestly don’t know the answer to that.

What I can tell you is that we had a rigorous testing program to

ensure that the products were within specification before they hit

the marketplace, and we did go back and we took a look at the last

lot that we had in our possession, did extensive testing, 1,200 bottles. I can’t answer right now that we did or didn’t go back to test

the root cause.

Mr. ISSA. Now, some months ago we think famously, but we are

in Washington, so our image of what is famous may not be, but we

had Akio Toyoda sitting where you are sitting. He made commitments to us that he would use dramatic resources, on a scale not

seen before, to change his company to be the leader, not the follower, ahead of, not behind in quality. Can you make that same

commitment today on behalf of Johnson & Johnson?

Ms. GOGGINS. Yes, I can, and I think I can give you some points

that indicate there we are on the road to doing that.

Mr. ISSA. Please.

Ms. GOGGINS. As I mentioned, we have changed a number of key

personnel, both in quality and in our manufacturing organization;

we have contracted with an outside expert with pharmaceutical experience to help take a look at our plants independently and determine what needs to be done; we have undertaken on our own an

assessment of all of our plants across our North American OTC

network; we have made some changes already and, I think most

importantly, we have committed to the FDA that we will have a

comprehensive plan that we will share with them by July 15th.

Mr. ISSA. Excellent answer. I hope you live up to it. I expect,

after 100 years of your company’s good reputation, that you have

a reason to.

Let me followup with sort of a final line. Again, I said I was a

manufacturer. I am not bragging or complaining, but before I could

sell to General Motors, Ford, Chrysler, and others, I had to pass

independent QS and ISO analysis, and they came back in regularly. So in addition to my own quality folks, in addition to the auto

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companies and other companies I supplied to over the years, we

had ongoing annual and quarterly independent evaluation. Is there

a similar situation or is there a similar capability within your industry and do you employ it?

Ms. GOGGINS. I think there are two ways that we can do that,

sir. One is that we can employ the corporate quality resources at

Johnson & Johnson, and, in fact, we have brought a lot of those

to bear in the current situation; and they take an independent look

at our processes at McNeil. And the second thing is, as I have mentioned, we have engaged a third-party expert in manufacturing of

pharmaceuticals, manufacturing processes and sites, and we have

engaged them to help us take a look at our plants comprehensively.

Mr. ISSA. In closing, I would say that public confidence would be

increased, and I hope that you will consider a level of transparency

of these independent reviews and, if at all possible, that independent review be ongoing for a period of time. I, for one, applauded the

FDA for being diligent in this case. As you can imagine, I am much

more concerned about the fact that you test your products three

times as to potency and what is in it, while in fact the FDA does

not test even once products coming in by the container load from

countries and facilities they have no ability to test.

So, Mr. Chairman, I hope that as we followup in this process,

that latter will be included in our question of is our food and drug

safe under the current law if they are importer. And I yield back.

Chairman TOWNS. I thank the gentleman for his questions.

I now yield 5 minutes to the gentleman from Ohio, Mr. Kucinich.

Mr. KUCINICH. I would ask the staff to put the first exhibit up.

Ms. Goggins, you have testified that no raw materials that tested

positive for objectionable bacteria were ever used in the manufacture of McNeil’s pediatric products. Now, an FDA document, which

I have a copy of here, states McNeil’s lab determined the presence

of B. cepacia, an Avosil raw material to be objectionable, placing

the target population at risk if the contaminant was in the product.

The product is for use in infants and children; however, the firm

knowingly proceeded to partially release some of the remaining raw

material, Avosil, which was used to manufacture more product.

What is your response?

Ms. GOGGINS. My response is that is untrue. What I would tell

you is that——

Mr. KUCINICH. What is untrue, your testimony or this document

from the FDA?

Ms. GOGGINS. My testimony is not incorrect, sir. Let me clarify

the issue for you. This is one of the issues that has been in the

media and is simply incorrect. It is true that we tested one incoming lot of Avosil, which is an inactive ingredient in our children’s

products. It tested positive for an objectionable bacteria. We rejected it. We test each of our incoming raw materials; we have tested them all extensively. We have never used a product that tests

positive for objectionable bacteria in our manufacturing process.

Further, when our products are manufactured, we test them

after manufacturing for the presence of harmful bacteria. We have

also had preservative systems and other capabilities in our formulas which would, if a bacteria was in our product, preclude the

growth of that bacteria.

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We also, then, given the FDA’s concerns on this issue, went back,

retested, retained products of these products in question. None of

them tested positive for this bacteria. We then went back and we

tested the preservative systems by inoculating them with bacteria,

and the preservative systems killed all the bacteria.

So I feel very confident in saying that we did not knowingly use

the products of bacteria and we did not release them into the marketplace.

Mr. KUCINICH. Thank you.

Mr. Chairman, this memo also states at the end of an inspection,

an FDA 483 was issued for deficiencies, including failure to reject

Avosil raw material after learning of B. cepacia contamination of

raw material, Avosil, then it gives the lot number.

I submit this for the record.

Chairman TOWNS. Without objection, so ordered.

[The information referred to follows:]

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Mr. KUCINICH. Staff, put up the second exhibit.

A 6-year-old boy took medication that was manufactured at your

plants in Fort Washington and Puerto Rico. He died this year. He

tested positive for B. cepacia. I have a report here which is a

McNeil Consumer and Specialty Pharmaceuticals in-house document dated May 10, 2010, where they state that the child was taking medications that were manufactured at Las Piedras plant and

Fort Washington plant; that you apparently were in touch with the

coroner, who mentioned the child was sick from nausea and vomiting, goes on to give other details; say the child’s sputum was tested

positive for the B. cepacia complex that is the subject of this.

Do you have any knowledge of that?

[The information referred to follows:]

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Ms. GOGGINS. Yes, I do, sir.

Mr. KUCINICH. And what is your response?

Ms. GOGGINS. My response is the same as Dr. Sharfstein’s, sir,

in that we take every adverse medical event seriously. We investigated this. We did discuss this with the coroner. The products, as

Dr. Sharfstein said this morning, tested negative for the presence

of B. cepacia and, in fact, the products that the young child was

administered were not in the investigation of the B. cepacia issue.

Mr. KUCINICH. Are you aware that the Food and Drug Administration official also testified that a coroner’s report has not yet been

returned on that?

Ms. GOGGINS. Yes.

Mr. KUCINICH. No. 3, I would like the third exhibit put up.

Another 6-year-old boy with cystic fibrosis took Tylenol and tested positive for B. cepacia. As I am sure you know, children with

cystic fibrosis are particularly susceptible to B. cepacia, according

to the CDC. And I also want to submit this to the record without

objection, an establishment inspection report, McNeil Consumer

Health Division, where it confirms that a 6-year-old child tested

positive for a form of B. cepacia, and it says during the inspection

another complaint was received by the FDA; no details were given

except there was a death of a baby in reference to the use of concentrated Tylenol infants’ drops. This goes to the record.

[The information referred to follows:]

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Mr. KUCINICH. Ms. Goggins, can you tell the American people

what they should think when they learn that the FDA found that

McNeil knowingly let contaminated raw material into children’s

medicine and that a contaminant was found in at least two children, one of whom died?

Ms. GOGGINS. As I said, Congressman, we have never used contaminated raw materials in the manufacturing of McNeil pediatric

products.

Mr. KUCINICH. Mr. Chairman, that is at variance with the document that we got from the FDA, and I think the committee ought

to take further note of that. Thank you.

Chairman TOWNS. Thank you very much. I would like to thank

the gentleman for his questions and, of course, we have not made

a decision as to what we are going to do from this point on.

I now yield to the gentleman from Maryland, Mr. Cummings.

Mr. CUMMINGS. Mr. Chairman, I would yield to the gentlelady

from Washington.

Chairman TOWNS. The gentlelady from Washington, DC, Ms.

Norton, is recognized for 5 minutes.

Ms. NORTON. I thank the gentleman for yielding.

I am concerned, Ms. Goggins, about the delay here. I can understand that there could be difficulties in manufacturing, but I believe you need to clarify for the public why a delay doesn’t give the

appearance of coverup. The FDA, as you know, found, and I am

using their words now, that your investigation, or McNeil’s investigation was unjustifiably delayed and terminated prematurely.

Now, that is what concerns me, because, apparently, the complaints began with an uncharacteristic bad odor. I can see, given

the symptoms that were reported, and we understand those to be

nausea and vomiting and diarrhea. When you are talking about

children, I can tell you, as somebody who had kids, they all do that

anyway. I can understand your thinking that could have had any

number of causes. What I don’t understand is why any manufacturer hearing, if you will forgive me, that its product stunk

wouldn’t immediately see that as a justification for investigation.

Yet, I understand it took 100 complaints and that you did not discover the contamination until September 2009, although this bad

odor began in April 2008.

Why did it take you so long, particularly given the bad odor,

which seems to me should have been enough, to find what the root

cause of this contamination?

Ms. GOGGINS. Yes. You are referring to the recall that we executed between November and January regarding the contamination

by products with TBA. We did receive a number of complaints regarding these products. They were manufactured in our Las

Piedras, Puerto Rico facility. The complaints were characterized by

the consumers as a moldy and musty odor. We did engage in an

investigation of microbiology, because when we get a complaint of

musty/moldy, we assume that it is a micro issue. There was no evidence of any kind of a micro issue.

For 6 months we then received no complaints whatsoever, and

we thought the issue had gone away. And then in April, I believe,

of 2009, the complaints came back, and that is when we realized

that we needed to deepen our investigation.

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What I guess I would say about this is that this is a very unusual compound; it is not well characterized, it is not well known,

it is has not been found in the industry——

Ms. NORTON. Well, did it ever have a bad odor before? Is it that

unusual?

Ms. GOGGINS. Not due to this contaminant, ma’am, no. This is

a first.

So if I can just continue, please.

Ms. NORTON. Yes.

Ms. GOGGINS. So we found that there was only one lab in the

country that we were able to locate that could identify what this

was, and there were only two experts in the world that we would

identify, one in California and one in France, to characterize this.

We finally found what the product was. When we did, in January,

we recalled quite an extensive amount of product, about 565 lots

of product; and I think we did it out of an abundance of caution.

I would add that there has been no adverse medical events due to

the trace levels of this contaminant.

Ms. NORTON. Yes, after the fact we are grateful. But, of course,

the FDA’s concern was in the delay here. We don’t know what this

might have done had it been something more serious, particularly

since the regulations require drug manufacturers to submit field

reports within 3 days of receipt of information of bacteria contamination of some kind or, for that matter, of any change or deterioration in a drug product. Apparently, McNeil began receiving complaints in 2008, but you did not follow this 3-day requirement and

did not alert the FDA. Why didn’t you share this information immediately with the FDA? Indeed, after you had results confirming

contamination, you didn’t share those results immediately with the

FDA.

Ms. GOGGINS. You know, I must say I am sorry, I am not certain

of the chronology of these events, but what I can tell you is

that——

Ms. NORTON. You began receiving consumer complaints in 2008.

And this is why FDA found unjustifiable delay and termination

prematurely: you began receiving them in 2008; the regulations require you to report within 3 days of receipt of any information regarding bacterial contamination. Did you believe that you had to

have that confirmed in some kind of way before you alerted FDA?

Ms. GOGGINS. I can’t tell you when we did or did not alert FDA.

What I can tell you is that we did undertake a micro investigation

of it, and it was found not to have any micro contamination. Other

than that, I can’t tell you about the chronology.

Ms. NORTON. Again, I want you to know, Ms. Goggins, the concern here from the point of the consumer——

Ms. GOGGINS. I understand.

Ms. NORTON [continuing]. Is delay. Transparency helps a great

deal to ward off the notion of coverup. When FDA finds unjustifiable delay and premature termination of complaints, you say, yes,

but we essentially waited to see if it would come back; and when

it came back we decided to do it again. That is very troubling.

It seems to me, once you have 100 complaints about a bad odor

in something you are selling to the public, you ought to want to tell

the FDA immediately and you ought to want to do something very

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quickly. It didn’t happen very quickly if we are going from April

2008 to September 2009.

Thank you, Mr. Chairman.

Chairman TOWNS. I thank the gentlewoman from Washington,

DC.

I now yield 5 minutes to the gentleman from Maryland, Mr.

Cummings.

Mr. CUMMINGS. Thank you very much, Mr. Chairman.

Ms. Goggins, tell me, when did you learn that there were serious

problems at McNeil? When did you first learn that?

Ms. GOGGINS. I think we became aware, sir, that there were

quality issues probably in the first half of 2009.

Mr. CUMMINGS. OK. And, according to our investigation, you all

had a major shakeup of McNeil management. I think you have already testified to that, is that correct?

Ms. GOGGINS. We did replace a number of key quality and manufacturing individuals, yes, sir.

Mr. CUMMINGS. And can you tell me what went into that decision? First of all, who made the decision?

Ms. GOGGINS. I was part of that decision, sir, and there were

other people who were involved as well. But I was part of that decision.

Mr. CUMMINGS. And why did you make that? What was that decision? How did you come to the conclusion that you had to shake

up the management?

Ms. GOGGINS. I think the fact that we were not happy with our

quality processes based on some of the things that we saw both in

terms of recalls and in terms of some of the FDA observations that

we got in a Form 483. And I think we were also concerned about

some of the issues that have been raised here today.

Mr. CUMMINGS. When Dr. Sharfstein was testifying, I was trying

to get a clarification. You know, it is one thing if you go to McDonald’s and you get a sandwich and it has a worm in it, God forbid,

and then McDonald’s says, you know, what? It is no big deal; it

can’t do you any harm. That is one standard. But the standard is

there should never have been a worm in the sandwich.

I know that is a little extreme for those people who haven’t eaten

their lunch, but what I am saying to you is that I am wondering

if there is a different standard. First of all, it sounds like McNeil

didn’t even adhere to its own standard, let alone FDA’s. Would you

agree?

Ms. GOGGINS. I would say, sir, that we have a very high standard, because I think consumers expect a lot of us, and I think we

did not adhere to that high standard on the quality standpoint.

That is why we enacted this broad recall.

Mr. CUMMINGS. Can we put a pin in that right now? Where you

are right there. And should consumers expect the high standard?

Ms. GOGGINS. They should, sir, and our intention is to remediate

our plants to the highest possible standards.

Mr. CUMMINGS. Now, Ms. Goggins, can Johnson & Johnson tell

the American people today with complete certainty that no children

who took these recalled medicines were harmed by them?

Ms. GOGGINS. What I can do is reiterate what Dr. Sharfstein said

this morning, that we believe that the risk of a serious medical

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event is remote and there have been no serious medical events associated with the reasons for the recall of these products.

Mr. CUMMINGS. Now, you said that you all had some concerns

and you heard Dr. Sharfstein’s testimony; it sounds like he had

some concerns with regard to the way things were going along. It

is one thing if it is one incidence, but there is another thing when

there appears to be a pattern of these things. Is that one of the

things that concerns you?

Ms. GOGGINS. I think the number more than the pattern, sir.

There were a different number of plants and different number of

products and different number of medicines involved and different

number of issues. But the number concerned me, yes.

Mr. CUMMINGS. And what were the top three issues that went

into your decision to bring in new management? Just curious.

Ms. GOGGINS. Well, as I said, I think that the——

Mr. CUMMINGS. Give me the top three.

Ms. GOGGINS. Top three?

Mr. CUMMINGS. So the public can hear what went on when you

all decided to make this change, so that hopefully they can have

some confidence when they buy these products.

Ms. GOGGINS. I think it was the number of quality issues we

had, the quality issues themselves, and the fact that the FDA had

made observations that we were disappointed in.

Mr. CUMMINGS. Now, would you agree that government has a

role in making sure that products that end up in the medicine cabinets of the public are safe?

Ms. GOGGINS. I would. Like most Americans, I have a great deal

of respect for the FDA. I think they have an important mission, an

important operation, and they have been very professional in their

dealings with us, so, yes, I agree with you.

Mr. CUMMINGS. Now, a little bit earlier there was a statement

by one of the witnesses from the FDA that this matter had been

referred for possible criminal prosecution. Did you hear that?

Ms. GOGGINS. I did, yes.

Mr. CUMMINGS. And are you concerned about that?

Ms. GOGGINS. Sir, my major concern right now is remediating

our plants to the highest possible level of quality and getting products back on the marketplace for the consumers who need them.

Mr. CUMMINGS. And the Fort Washington plant, that is basically

closed down right now?

Ms. GOGGINS. It is closed down right now, yes.

Mr. CUMMINGS. And when do you expect that to reopen?

Ms. GOGGINS. I don’t know, sir. What I can tell you is that we

will not reopen that plant until we meet our own and the public’s

and the FDA’s standards for high quality and safety.

Mr. CUMMINGS. Thank you very much.

Thank you, Mr. Chairman.

Chairman TOWNS. Thank you very much. I thank the gentleman

from Maryland.

I want to, Ms. Goggins, go back to this contractor business. Now,

the contractors, what were they contracted to do and who contracted them? Explain all this to me, because it is just not clear

to me.

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Ms. GOGGINS. I can tell you what I know, and then I promise you

I will come back to you with more information. The product in

question is sparsely distributed, as I understand it, primarily in

gas stations. So I think the idea was to go in and identify how

much product there was on the shelves. But beyond that, I don’t

know, sir. We did contract them, but, as I said, I am told that we

contracted them in discussions and with the knowledge of the San

Juan office of the FDA.

Chairman TOWNS. So I guess what I am saying, were they instructed to go out and buy if they found——

Ms. GOGGINS. I can’t answer that, sir, nor can I answer the question of what they are alleged to have said. I don’t know the answers to that.

Chairman TOWNS. Well, I would like for you to get back to us on

that, because these contractors, I just find this very disturbing.

Ms. GOGGINS. As do I.

Chairman TOWNS. OK. So, in other words, you don’t know who

actually contracted them or what their role and responsibility was?

You don’t know any of that at this time?

Ms. GOGGINS. I know only that I imagine we contracted them,

sir, and we did so, as I am told, with the knowledge of the FDA.

Chairman TOWNS. Were they instructed to do certain things?

Ms. GOGGINS. I can’t tell you right now what they were instructed to do or not, sir.

Chairman TOWNS. The quality control, do you have the same

amount of people in the quality control unit today as you had 4

years ago or 3 years ago or 8 years ago? What is the situation with

quality control?

Ms. GOGGINS. I believe that, at the Fort Washington plant, our

headcount is basically flat. I do know that between 2006 and 2009

we increased our spending 17 percent, and I know that we have increased it again this year.

Chairman TOWNS. This document, that was actually just brought

to my attention, says this: You should simply act like a regular customer while making these purchases. There must be no mention of

this being a recall of the product. If asked, simply state that your

employer is checking the distribution chain of this product and

needs to have some of it purchased for the project. It is a demonstration project and we want to purchase some for the demonstration project.

Is this accurate?

Ms. GOGGINS. As I said, sir, I have no idea. What I can tell you

is that I have no idea of whether or not that is true or not, and

I also have no idea of the context, sir. I have no idea. All I know

is that we did hire a third-party contractor, and I do know that we

did it with discussions with the FDA and they were aware of it.

Chairman TOWNS. Well, let me put it this way. If this is true,

does it bother you?

Ms. GOGGINS. Again, I don’t know the context, sir. I don’t know

the context. I would have to understand the context. I don’t believe

there was any intent to mislead or hide anything, so I don’t know

the answer to that. So I can’t answer that.

Chairman TOWNS. I am really trying to finish this, but, I tell you,

there are some unanswered questions here that are very troubling.

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On that note, I yield to the ranking member, Congressman Issa.

Mr. ISSA. Thank you, Mr. Chairman. First of all, I would like to

ask unanimous consent that all Members have 5 legislative days

in which to ask additional questions, supplement or provide information.

Chairman TOWNS. Without objection, so ordered.

Mr. ISSA. Thank you.

This email I think speaks for itself. What we don’t have here is

we don’t have the individuals behind that. Can I ask that you use

your authority to investigate the email, we will certainly give you

a copy if you don’t have it, and get back to us in detail with either

the individual and statements that they would make for us subject

to our interrogatories, if we choose, and at least their side of the

story? Because on the face of it all, I look at this and it appears

as though people acting on your behalf, working for one of your

subsidiaries, did ask for this information, and we would appreciate

knowing for sure the individuals, assuming they are still working

with you. If they are not, then provide us the information and we

will contact them directly.

My understanding from our investigators is that there was a cutback, not on your watch, but at this facility, in 2006, a reshuffling

of where quality personnel were located. Do you know anything

about that?

Ms. GOGGINS. No, I do not. What I can tell you is what I referenced earlier, that in fact the headcount is flat from 2006 until

now, and, in fact, spending was up 17 percent from 2006 to 2009

and is up again this year.

Mr. ISSA. OK. I guess there were a lot of questions about deaths

of I hear a number as high as 37. To date, are you involved in any

litigation in which you are the defendant, where someone is alleging that your products, those 37, if you will, your Tylenol series

products have led to the death or severe injury of some child?

Ms. GOGGINS. Not to my knowledge. But let me just say that I

would not necessarily know that, and I would ask you if we could

get back to you after we talk to our legal group.

Mr. ISSA. I would appreciate if you would respond in writing.

I guess, last, you use imported products like all companies at

times, is that correct?

Ms. GOGGINS. I believe we do, yes.

Mr. ISSA. My understanding is the source of the smelly pallets

could well have been imported wood. Is that correct? Or at least

not mainland United States.

Ms. GOGGINS. We believe that our supplier of packaging components did use wood from Latin America that was treated with this

ingredient, yes.

Mr. ISSA. OK, so I just want you to run us through. I have dealt

with import and production from all over the world and in other

parts of the world. What did you do after this extensive research,

finding only two people in the world that could do it, but you got

to the fact that you had a problem? What did you do relative to

the vendor for the future? In other words, what corrective action

was in your quality loop relative to not having this happen again?

Ms. GOGGINS. One thing, the main thing we did, sir, was not just

for the McNeil organization, but for Johnson & Johnson in total,

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we mandated that we would only use material that came in on

heat-treated wooden pallets, which precludes the use of this fungicide, or plastic pallets, where you don’t use it at all.

Mr. ISSA. And I guess last, presently the Federal Government

has had a series of problems here in the United States, more of

them related to the vitamin industry of imported vitamins from

outside the United States, but some related to non-prescription

drugs. If you were sourcing vitamins, ingestible products, non-prescription drugs from completely outside of your own production,

outside of the United States and outside of factories you control,

how often would you test them and how often would you visit the

facilities, and what level of transparency would you require in

order to bring that product to the American people?

Ms. GOGGINS. You know, what I can do is perhaps draw an analogy to what we do now with raw materials; and I imagine our

standards would be exactly the same. We require all of our suppliers to give us a certificate saying that they have tested the product

and it meets the specification that is required from them. That

being said, when the products arrive at our own facilities, we retest

them for identity, for potency, for microbial contamination. Then,

when we use them in the final goods, we do test them again.

Mr. ISSA. I would appreciate that. Although we don’t make it a

practice to look at any one private company when we write legislation, this committee is very interested in the question of drug and

food safety, and as imports increase, both raw materials that you

may be checking, but finished product that come in from overseas

complete in the container, it became apparent in the earlier FDA

portion that it is not tested to that level; that the inspection of your

facilities seven times in 5 years does not occur in an aspirin factory

in China.

So I would appreciate the input you could give as we begin looking at how we should instruct the FDA and other agencies to inspect similar products coming in from around the world where we

have no such luxury as to send inspectors seen times in 5 years.

Ms. GOGGINS. We would be happy to provide that.

Mr. ISSA. Thank you.

Thank you, Mr. Chairman. I yield back.

Chairman TOWNS. The gentleman from Maryland is recognized

for 5 minutes.

Mr. CUMMINGS. Thank you very much, Mr. Chairman. I won’t

even take 5 minutes.

I understand that you are basically retraining folks. Is that retraining completed or is that ongoing?

Ms. GOGGINS. No, it is ongoing. We have already started to undertake training programs.

Mr. CUMMINGS. And what kind of things are you emphasizing in

this retraining?

Ms. GOGGINS. We are emphasizing a commitment to quality; we

are emphasizing adherence to good manufacturing practices and a

number of other things. I would say that our program definition

isn’t complete yet, and one of the things we are doing with the

third-party experts we have hired, the independent experts, is we

are putting together a comprehensive plan which we will share

with the FDA on July 15th.

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Mr. CUMMINGS. Now, I am chairman of the committee on the

Coast Guard, and one of the things that they do in the Coast

Guard is whenever they have a problem, they take that problem

and they use it as a learning tool. Is that part of this process?

Ms. GOGGINS. It could well be, sir. It is a good idea.

Mr. CUMMINGS. Yes, it is helpful that way, because I noticed that

you ended your testimony saying that you all wanted to make sure

you earned the trust of the public. It seems to me that if there is

a training process, that in order for it to be effective, not only effective with regard to changes within the corporation, but also effective with regard to the public having confidence, it seems as if you

would have to almost certainly show these new folks or the old

folks, whoever is there, whoever you are training, what has happened and how those things should not happen again. So I would

make that very, very strong suggestion.

I just want to go back. I tell you, I am curious. I wish I could

have been a fly in the room when you fired all these people. How

many people did you all fire?

Ms. GOGGINS. You know, I can’t give you the exact number of

people who are no longer in their positions.

Mr. CUMMINGS. But you were there, weren’t you?

Ms. GOGGINS. I was not there, no, sir.

Mr. CUMMINGS. Oh, I thought you just told me you were in the

meeting.

Ms. GOGGINS. No, no. I was involved in the decision to fire these

people, I was not there myself.

Mr. CUMMINGS. Oh. Oh. So you weren’t in the room; you helped

to give the order.

Ms. GOGGINS. I was part of the discussion, yes, sir.

Mr. CUMMINGS. OK. All right. I am sorry. But were a number of

people dismissed?

Ms. GOGGINS. Yes. We have a number of new people in the most

senior positions in both our quality and our manufacturing organizations.

Mr. CUMMINGS. And do you know whether a lot of these people

are from in-house or a lot of them outside?

Ms. GOGGINS. No, they were all our employees, sir.

Mr. CUMMINGS. They were already employees?

Ms. GOGGINS. They were all our employees.

Mr. CUMMINGS. Is that your normal procedure, when you have

a problem, you bring people from within, not anybody from outside?

Ms. GOGGINS. No, we do both. We hire people both inside and

outside in different jobs, depending on the qualifications. Then we

also bring fresh pairs of eyes in, as we have done in this case, with

an independent third-party consultant.

Mr. CUMMINGS. Just one last thing. I asked you about the Fort

Washington plant. What are you all doing now to try to reopen it?

In other words, what is the process there? First of all, you plan to

reopen it, do you not?

Ms. GOGGINS. We do plan to reopen it, yes, sir.

Mr. CUMMINGS. OK. And what is the process there?

Ms. GOGGINS. The process right now, I guess there are two major

prongs to the process. One is we are undertaking a massive assessment ourselves of not only the Fort Washington plant, but all the

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other plants in our OTC network in North America; and the second

is we have brought in this third-party expert who has a lot of pharmaceutical experience to help independently tell us what we should

do. Our plan is to combine those two assessments and discuss the

master plan for remediation with the FDA by July 15th.

Mr. CUMMINGS. And the last thing, when you all were meeting

and firing these people, making the decision to fire them, I take it

that this was embarrassing, this is an embarrassing episode to you

all, is it not?

Ms. GOGGINS. The entire episode is extremely embarrassing to

Johnson & Johnson. We take our commitment to our consumers

and quality and safety very seriously, and all of the people of Johnson & Johnson and McNeil are deeply troubled by what has been

found and we are all deeply committed to remediating it.

Mr. CUMMINGS. Well, I look forward to seeing the results of your

efforts to remediate.

With that, Mr. Chairman, I yield back.

Chairman TOWNS. Thank you very much. I thank the gentleman

from Maryland for his questions.

Ms. Goggins, and let me just say FDA, what we have heard

today is not too reassuring or comforting.

The initial story was bad enough: On April 30th, Johnson &

Johnson announced the largest recall of children’s medicine in history. But it turns out there wasn’t just one recall. What we have

heard about today is rolling recalls, a phantom recall, a plant shut

down, and management firings.

I think there are still unanswered questions.

J&J told the committee staff that this most recent recall involved

only 6 million bottles. That is what they told staff. That’s a huge

number. But today we learned from the FDA that it was almost 20

times that, namely, 136 million bottles.

J&J testified that there was no attempt to hide anything. But we

uncovered a J&J document showing that they told their contractor

not to say this is a recall, just buy up everything.

J&J says that none of its contaminated products has had any adverse health effects. But the FDA testified today that the issue of

whether any of these products caused deaths is still being investigated.

This is an issue of trust. When parents and grandparents give

these medicines to their children, they want to be confident that

they are not harmful. Johnson & Johnson has the duty to ensure

their safety and the FDA has the duty to enforce that duty.

One thing we know now is that the FDA needs mandatory recall

authority. They should not have to persuade a company to recall

suspect products. I intend to introduce legislation, Mr. Ranking

Member, to give FDA that authority, and I hope you will join me.

FDA should also have the power to order a halt in drug production.

At this point, there are still many unanswered questions. We intend to look further. We will hold the record open to get additional

information and to have some of the questions that we raised answered and then, based on that, we will make a decision as to what

we will do from this point on.

On that point, I yield to the ranking member.

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Mr. ISSA. Thank you, Mr. Chairman. I won’t have a closing statement. I would just join with you in offering to work on bipartisan

legislation to provide FDA additional tools, including mandatory recall capability.

I yield back.

Chairman TOWNS. I thank the gentleman for his statement and

his willingness to work along with me.

On that note, the committee now is adjourned.

[Whereupon, at 1:57 p.m., the committee was adjourned.]

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