[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]




 
 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


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              COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM

                   EDOLPHUS TOWNS, New York, Chairman
PAUL E. KANJORSKI, Pennsylvania      DARRELL E. ISSA, California
CAROLYN B. MALONEY, New York         DAN BURTON, Indiana
ELIJAH E. CUMMINGS, Maryland         JOHN L. MICA, Florida
DENNIS J. KUCINICH, Ohio             JOHN J. DUNCAN, Jr., Tennessee
JOHN F. TIERNEY, Massachusetts       MICHAEL R. TURNER, Ohio
WM. LACY CLAY, Missouri              LYNN A. WESTMORELAND, Georgia
DIANE E. WATSON, California          PATRICK T. McHENRY, North Carolina
STEPHEN F. LYNCH, Massachusetts      BRIAN P. BILBRAY, California
JIM COOPER, Tennessee                JIM JORDAN, Ohio
GERALD E. CONNOLLY, Virginia         JEFF FLAKE, Arizona
MIKE QUIGLEY, Illinois               JEFF FORTENBERRY, Nebraska
MARCY KAPTUR, Ohio                   JASON CHAFFETZ, Utah
ELEANOR HOLMES NORTON, District of   AARON SCHOCK, Illinois
    Columbia                         BLAINE LUETKEMEYER, Missouri
PATRICK J. KENNEDY, Rhode Island     ANH ``JOSEPH'' CAO, Louisiana
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

                      Ron Stroman, Staff Director
                Michael McCarthy, Deputy Staff Director
                      Carla Hultberg, Chief Clerk
                  Larry Brady, Minority Staff Director


                            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


 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 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 1\1/2\-year-old girl who died. That document 
reads, ``coroner's office called to report the death of a 1\1/
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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[GRAPHIC] [TIFF OMITTED] T3140.004

[GRAPHIC] [TIFF OMITTED] T3140.005

    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 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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    [GRAPHIC] [TIFF OMITTED] T3140.007
    
    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-the-
counter products for the U.S. market from four manufacturing 
facilities in the United States and Canada. Over the last 
several 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-the-counter 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 chemical 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 procedures 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.
    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 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.
    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.
    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 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?
    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 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?
    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.
    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.
    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.
    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 
super-potent, but if it had been there, would that have posed a 
risk; and that evaluation was done by physicians within FDA and 
by doctors 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 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.
    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 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 
laissez-faire 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 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:]

[GRAPHIC] [TIFF OMITTED] T3140.021

[GRAPHIC] [TIFF OMITTED] T3140.022

    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.
    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 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.
    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 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 related 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.
    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.
    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 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?
    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 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 ability 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 well-being. 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.
    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.
    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.
    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 Puerto 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.
    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 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.
    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:]

    [GRAPHIC] [TIFF OMITTED] T3140.031
    
    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:]

    [GRAPHIC] [TIFF OMITTED] T3140.032
    
    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:]

    [GRAPHIC] [TIFF OMITTED] T3140.033
    
    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.
    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 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 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.
    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.
    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, 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.
    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 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.
    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.]
    [Additional information submitted for the hearing record 
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