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



 
 JOHNSON & JOHNSON'S RECALL OF CHILDREN'S TYLENOL AND OTHER CHILDREN'S 
          MEDICINES AND THE PHANTOM RECALL OF MOTRIN (PART 2)
=======================================================================

                                HEARING

                               before the

                         COMMITTEE ON OVERSIGHT
                         AND GOVERNMENT REFORM

                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             SECOND SESSION

                               __________

                           SEPTEMBER 30, 2010

                               __________

                           Serial No. 111-111

                               __________

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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             BILL SHUSTER, Pennsylvania
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 September 30, 2010...............................     1
Statement of:
    Sharfstein, Joshua M., M.D., Principal Deputy Commissioner, 
      Food and Drug Administration...............................    76
    Weldon, William C., chairman and chief executive officer, 
      Johnson & Johnson; and Colleen Goggins, worldwide chairman, 
      Consumer Group, Johnson & Johnson..........................    22
        Goggins, Colleen.........................................    30
        Weldon, William C........................................    22
Letters, statements, etc., submitted for the record by:
    Goggins, Colleen, worldwide chairman, Consumer Group, Johnson 
      & Johnson, prepared statement of...........................    32
    Sharfstein, Joshua M., M.D., Principal Deputy Commissioner, 
      Food and Drug Administration, prepared statement of........    80
    Towns, Hon. Edolphus, a Representative in Congress from the 
      State of New York:
        Information concerning a previous hearing................    48
        Letter dated March 23, 2009..............................    35
        Memo dated May 28, 2009..................................    72
        Letter dated April 21, 2009..............................    88
        Prepared statement of....................................     4
        Prepared closing statement of............................   104
    Weldon, William C., chairman and chief executive officer, 
      Johnson & Johnson, prepared statement of...................    25


 JOHNSON & JOHNSON'S RECALL OF CHILDREN'S TYLENOL AND OTHER CHILDREN'S 
          MEDICINES AND THE PHANTOM RECALL OF MOTRIN (PART 2)

                              ----------                              


                      THURSDAY, SEPTEMBER 30, 2010

                          House of Representatives,
              Committee on Oversight and Government Reform,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 10:07 a.m. in 
room HVC-210 Capitol Visitor Center, Hon. Edolphus Towns 
(chairman of the committee) presiding.
    Present: Representatives Towns, Cummings, Kucinich, Clay, 
Watson, Norton, Van Hollen, Issa, and Chaffetz.
    Staff present: John Arlington, chief counsel--
investigations; Kevin Barstow, investigative counsel; Kwame 
Canty, senior advisor; Linda Good, deputy chief clerk; Carla 
Hultberg, chief clerk; Marc Johnson and Ophelia Rivas, 
assistant clerks; Chris Knauer, senior investigator/
professional staff member; Steven Rangel, senior counsel; 
Leneal Scott, IT specialist; Christopher Staszak, investigative 
counsel; Gerri Willis, special assistant; Ashley Wilson and 
Alex Wolf, professional staff members; Lawrence Brady, minority 
staff director; John Cuaderes, minority deputy staff director; 
Jennifer Safavian, minority chief counsel for oversight and 
investigations; Adam Fromm, minority chief clerk and Member 
liaison; Kurt Bardella, minority press secretary; Benjamin 
Cole, minority policy advisor and investigative analyst; Seamus 
Kraft, minority director of new media and press secretary; 
Justin Franco, minority press assistant and clerk; Tom 
Alexander, minority senior counsel; Ashley Callen and Sery Kim, 
minority counsels; and Christopher Bright and Molly Boyl, 
minority professional staff members.
    Chairman Towns. The committee will come to order.
    Johnson & Johnson's Recall of Children's Tylenol and other 
Children's Medicines and the Phantom Recall of Motrin.
    Good morning, and thank you all for being here. This is our 
second hearing on the disturbing recall of children's medicine 
by Johnson & Johnson. At our first hearing, we learned that 
J&J's April 30th recall of children's Tylenol, children's 
Motrin, children's Benadryl and Tylenol Infants' Drops was the 
largest recall of children's medicine in history. More than 135 
million bottles of children's medicines were recalled.
    We also learned that there wasn't just one recall. We heard 
testimony about rolling recalls, a phantom recall, a plant 
shutdown and management firings. Since then we have obtained 
additional documents which raise troubling questions about both 
the accuracy of J&J's earlier testimony and the extent of the 
phantom recall.
    When Johnson & Johnson learned it had a problem with one of 
its adult Motrin products in 2008 and 2009, the company hired 
contractors to go into stores and buy the product off the 
shelves--without saying it was a recall--so that the public and 
the news media would not know what was really happening. When 
J&J was asked about this phantom recall at our first hearing, 
and about the behavior of its contractors, we were basically 
told that J&J did not know what the contractors were doing.
    However, documents subsequently obtained by the committee 
show that J&J dictated how the phantom recall would be carried 
out. Internal emails and other documents indicate that J&J 
clearly knew what it was doing and why.
    For example, referring to the problems with Motrin that 
resulted in the phantom recall, one McNeil executive said, ``We 
are just trying to prevent a recall and a lot of expended 
dollars.'' In another email, a McNeil executive referred to the 
phantom recall and said, ``This was a major win for us, as it 
limits the press that will be seen.''
    Finally, it appears the president of the company gave the 
go-ahead for the phantom recall, saying, ``let's make this 
happen as soon as possible.''
    Perhaps we can clear up this apparent discrepancy between 
J&J's testimony in May and the documents that have come to 
light since that time. J&J has said the FDA knew about and 
approved the phantom recall. But FDA says that isn't true. Both 
sides will have an opportunity to tell their side of the story 
today.
    But even if the FDA was technically aware of it, that does 
not excuse what Johnson & Johnson did. Johnson & Johnson had 
both the legal and moral obligation to do the right thing and 
they did not.
    There are also new questions. Our investigation has 
uncovered documents that show J&J hired the phantom recall 
contractors to perform work related to children's Tylenol. In 
light of what we know now about the phantom recall of adult 
Motrin, I think J&J has a duty to fully explain how it handled 
problems with children's medicine.
    Finally, the troubling issues about rolling recalls and 
phantom recalls that this hearing examines makes one point 
very, very clear: Even if the FDA had been notified about the 
Motrin problem, the agency did not have the legal authority to 
order a recall. This needs to be rectified. The FDA needs 
mandatory recall authority, which we have been pushing for. I 
think most people would be surprised to learn that the FDA, the 
agency that is responsible for ensuring drug safety, has no 
power to order a company to recall its defective drugs.
    This is why I introduced a bill that would give the FDA 
mandatory recall authority. Hopefully, we can avoid future 
phantom recalls and empower the FDA to take action to protect 
the American people. Both Johnson & Johnson and the FDA will be 
asked questions today. And I hope they are prepared to give us 
the answers that we need to make certain that the drugs that 
are on the shelf are safe.
    On this note, I yield 5 minutes to the gentleman from 
California, the ranking member, Congressman Issa.
    [The prepared statement of Hon. Edolphus Towns follows:]
    [GRAPHICS NOT AVILABLE IN TIFF FORMAT] 
    
        Mr. Issa. Thank you, Mr. Chairman. And thank you for 
holding this important second hearing on the failure of FDA 
regulators, FDA regulators of the Johnson & Johnson failure to 
protect the American people.
    I think it is critical for us today to understand that 
Johnson & Johnson and its subsidiaries do not get a pass for 
failing to meet the high standards expected of their company 
through their long history. That failure will mar Johnson & 
Johnson's image for many years to come. No matter how much they 
correct it, they will live with the repercussions of their 
failures.
    But the American people will also, at the end of these 
hearings, recognize that government has failed to do its job. 
FDA's explanation appears to include seemingly false statements 
to this committee in April of this year. Given the documents 
received by the committee, it demonstrates the FDA was in fact 
aware of Johnson & Johnson's quiet recall of Motrin products, 
something they led us to believe they were not.
    Even if we gave them additional authority for mandatory 
recalls, if they were complicit in a silent recall, then to 
what end would that new authority be? Mr. Chairman, fundamental 
concerns of this committee are making government do its job. In 
the case of the FDA, that means making sure that those who 
regulate our food and drug supply are careful, thorough and 
honest. Regrettably, the pattern emerging at FDA is one of 
carelessness, deficiencies and untruthfulness.
    Now that this committee has sufficient evidence of FDA 
failure, we must be committed to following up that 
investigation and its needed reforms. New authority may be part 
of it. But no amount of authority makes up for failure to do 
the job you already have authority for and responsibility.
    Mr. Chairman, there are differences in views today on where 
this committee should focus its oversight. Well-intentioned men 
and women on both sides of a partisan aisle often disagree, 
with the best of intentions. When we find agreement on our 
oversight responsibility, we should pursue them together. That 
is the case with the FDA, and many other issues before this 
committee.
    In 2007, White House Chief of Staff Rahm Emanuel, then-
Congressman from Chicago and head of the Democratic 
Congressional Campaign Committee, described the important role 
that this committee plays to ensure responsibility and 
accountability of government. He said ``We, the Democratic 
Party, want to be the party that is fettering out waste and 
fraud, and the Oversight Committee is the point of the spear 
for us.''
    Similarly, this committee's former chairman, my colleague 
from California, Mr. Waxman, noted that Congress does not 
always fulfill its duty to the American people to provide 
oversight of the administration. He said, ``Congress has failed 
to meet this constitutional oversight responsibility. On issue 
after issue, the Congress has failed to conduct meaningful 
investigations of significant wrongdoing.''
    I happen to agree with Mr. Waxman and Mr. Rahm Emanuel. 
These are constitutional obligations and we must vigorously 
meet those responsibilities.
    Fortunately, the chairman and I are pursuing a common 
investigation. It leads us to two sides and two failures. The 
public has a right to know how Johnson & Johnson got to this 
point; how they are going to get their reputation back, by 
earning it with high quality products that meet or exceed all 
standards. That is important, and it should be bipartisan.
    Mr. Chairman, today we also have to remember that our first 
part of our name, Government Oversight Reform Committee, 
implies exactly what it means. We are overseeing government. 
Yes, we are also seeing when government fails in its 
interaction with business. We must, though, remember that our 
authority is to oversee and then reform.
    I for one, in 2005, had the opportunity to oversee the 
Mineral Management Service and show that they were a 
dysfunctional organization, too cozy with those that they 
oversaw. Unfortunately, in the years that followed, we didn't 
have reform. And in 2010, the American people paid a high price 
for that failure to reform.
    When it comes to the FDA, we have seen the same thing, at 
least in this circumstance. We cannot fail to do that reform. 
We cannot wait for the American people to pay with their lives.
    With that, I yield back.
    Chairman Towns. I thank the gentleman for his statement. I 
want you to know that we are going to live up to our name, 
Oversight and Government Reform. I want you to know that.
    Now I call on the gentleman from Maryland for 3 minutes, 
Congressman Cummings.
    Mr. Cummings. Thank you very much, Mr. Chairman. Mr. 
Chairman, I thank you for convening this very important 
followup hearing to consider the safety of medications for 
children and families. I am extremely troubled by what appears 
to be an egregious pattern of behavior on the part of Johnson & 
Johnson and their subsidiary, McNeil Consumer Healthcare.
    As I listened to Mr. Issa, I must say that I am also, I 
think we need to reserve judgment. Because the FDA, the 
Principal Deputy Commissioner Sharfstein, will be testifying. 
And I know him to be a very, he was head of Baltimore's health 
department and I can think of no one with more integrity and 
who puts more effort into protecting the safety of our fellow 
citizens.
    Now, the Johnson & Johnson Web site states that ``The 
values that guide our decisionmaking are spelled out in our 
credo. Put simply, our credo challenges us to put the needs and 
well-being of the people we serve first.'' Living these values, 
McNeil Consumer Healthcare and Johnson & Johnson were lauded 
for their efforts recalling Tylenol and temporarily stopping 
advertising when lives were on the line due to cyanide 
contamination in 1982.
    The recent events could not be more different. One day 
after our last hearing, GlaxSmith Brands recalled PediaCare 
because the products were manufactured by McNeil Healthcare, 
even though McNeil officials had said that they did not 
manufacture products for other companies. Yet, it doesn't stop 
there. In June and July 2010, McNeil Healthcare twice expanded 
their original January 15, 2010 recall because of TBA 
contamination, a pesticide and flame retardant.
    Why exactly were these items not identified 6 months prior 
in the original recall? Perhaps most disturbing, McNeil's 
consumer healthcare and Johnson & Johnson conspired to put 
profits first. There is no other conclusion that simply can be 
drawn. McNeil hired contractors to simply act like regular 
customers when conducting a soft market withdrawal of tainted 
Motrin from over 4,000 convenience stores in more than 40 
States. Any product that needs to be recalled through a phantom 
or regular recall should not be in the hands of consumers and 
is probably unsafe.
    Revealing the true motivation for these events, McNeil 
President Peter Luther wrote on May 27, 2009, ``Given our 
current financial situation, I hope we are not going to really 
double our costs to do this. Let's make this happen as soon as 
possible.'' Minutes later, J&J vice president for sales, Gary 
Benedict, responded via email that he wanted more information 
on the situation that day.
    These actions clearly show that McNeil and Johnson & 
Johnson knew the product was not safe and that they chose to 
make profits their first consideration over the safety of their 
constituents. With that, I look forward to the testimony, Mr. 
Chairman. And I yield back.
    Chairman Towns. Thank you very much. I thank the gentleman 
from Maryland for his statement.
    I now yield 3 minutes to the gentleman from Utah, 
Congressman Chaffetz.
    Mr. Chaffetz. Thank you. Thank you, Mr. Chairman, for 
calling this hearing and thank you all for being here today.
    Obviously, the American people rely upon the FDA to make 
sure that our country and our people and our children are safe 
and secure. We also rely upon big brand names, people like 
McNeil and Johnson & Johnson to provide good, quality products 
that families, mothers can use with their children.
    Yet despite the hearing earlier this year, there are some 
very concerning issues that have come to light. I am very 
disappointed that the FDA has evidently not given us access to 
the people on the ground in Puerto Rico in particular that have 
first-hand knowledge of what is happening. I simply do not 
understand why the San Juan district director is not made 
available as she would provide the most, the best, most 
comprehensive type of information given the direct nature in 
which she has been involved. And I think we need to further 
explore that, Mr. Chairman.
    Then within Johnson & Johnson, I want to read some quotes 
from emails. If you spend time in your testimony giving us 
platitudes and reading things that some corporate 
communications person wrote, I think you are going to see a 
frustrated group of members. When we read quotes, and these are 
quotes from within Johnson & Johnson to other Johnson & Johnson 
employees: ``FDA is really bending the rules in this case, the 
Motrin caplet case, because of the fact that we stopped 
distribution a while ago.'' In another email, ``Regarding FDA 
documents, all my conversation with the FDA director, Ms. 
Torres, here in Puerto Rico, have been off the record since I 
cannot quote her. This happens due to my good relationship with 
her. That's why we are doing something very different.''
    In another email, ``The district director is already 
sticking her neck out, as her boss in Washington is more in 
favor of a recall.'' We need some answers from Johnson & 
Johnson, and we need some answers from the FDA. Because the 
candor has not been there. It has not been there.
    This committee has an obligation to the American people to 
get to the bottom of this. And there is some funny business 
happening here, and nobody is happy about it. Please, don't 
just read some testimony that gives us platitudes. Answer these 
questions. They are serious. And there are millions of 
Americans that are relying upon the answers to these questions.
    But based on the evidence that we are starting to see more 
and more of, it looks like there was much too much of a cozy 
relationship that does not give the confidence to the American 
people to buy your products and to insist and make sure that 
the FDA is actually doing its job.
    I yield back.
    Chairman Towns. I would like to thank the gentleman from 
Utah for his statement.
    I now yield 3 minutes to the gentleman from Ohio, 
Congressman Kucinich.
    Mr. Kucinich. Thank you, Mr. Chairman.
    I want to associate myself with the remarks of Mr. 
Chaffetz. We don't know if it is in this case, but there are so 
many areas where regulators and the regulated have a cozy 
relationship, which works to the detriment of the American 
people. We need only to look to the BP Oil catastrophe to have 
that underlined boldly.
    And sadly, there are many other examples. We will find out 
if that is the case here.
    But I want to caution some of my colleagues about how we 
define the work of this committee. Because on one hand, some of 
my colleagues would reject a beneficial role for government in 
people's lives. And on the other hand, when a regulatory agency 
does attempt to assert government responsibility for corporate 
misconduct, that is not recognized. This committee is not just 
oversight of the government, it is oversight of misconduct in 
the private sector. And there is plenty, rather, it is 
oversight of corporate conduct in the private sector. And there 
is plenty of misconduct in the corporate sector.
    Now, why does it happen? Well, it happens for a lot of 
reasons, mostly greed. Why doesn't the government always come 
forward quickly and call corporations on it? There are a lot of 
reasons why that happens. One of the reasons is because 
corporations assert enormous influence on this government 
because of their campaign contributions. That is the clear 
fact, incontrovertible evidence to that effect.
    So we have a problem with the system. Within the context of 
the system, the American people have a problem in being able to 
trust corporations, and in this case, Johnson & Johnson is 
going to have to answer a lot of serious questions about why 
they should continue to merit the public's trust, when 
apparently they concealed from public awareness information 
that was vital to protecting people's health.
    Finally, Mr. Chairman, I understand the bill that you are 
preparing for this Congress. I think we should start also 
considering another dimension of corporate responsibility, and 
that is that if we are able to establish that a corporation 
knowingly avoided their responsibility to inform the public 
about a material matter that could create serious injury or 
death, that corporation's corporate charter should be canceled, 
and that we should instruct the Justice Department to take 
steps to do just that, in cooperation with the attorneys 
general in various States. If you have any conduct that hurts 
people, and people rely on you to do the right thing, and you 
don't do the right thing, you should actually be put out of 
business.
    Thank you, Mr. Chairman.
    Chairman Towns. I thank the gentleman from Ohio for his 
statement.
    Now we will turn to our first panel. Our first witnesses 
are Mr. William Weldon and Ms. Colleen Goggins. William Weldon 
is the chairman and chief executive officer of Johnson & 
Johnson. Ms. Colleen Goggins is worldwide chair of the Johnson 
& Johnson Consumer Group. She also testified at the committee's 
first hearing. Welcome, both of you.
    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. Let the record reflect that the witnesses 
answered in the affirmative. You may be seated.
    The rule is here that of course you have 5 minutes to give 
a summary. We have your statement for the record. And of 
course, there is a light that comes on and when you have 1 
minute left, the yellow light comes on. Then of course at the 
end is a red light and the red light of course mean stop.
    Mr. Weldon, if you would start and then after that, you, 
Ms. Goggins.

 STATEMENTS OF WILLIAM C. WELDON, CHAIRMAN AND CHIEF EXECUTIVE 
  OFFICER, JOHNSON & JOHNSON; AND COLLEEN GOGGINS, WORLDWIDE 
          CHAIRMAN, CONSUMER GROUP, JOHNSON & JOHNSON

                 STATEMENT OF WILLIAM C. WELDON

    Mr. Weldon. Chairman Towns, Congressman Issa and members of 
the committee. I am Bill Weldon, chairman and chief executive 
officer of Johnson & Johnson.
    I appreciate the opportunity to appear before you today to 
describe our efforts to address the serious quality issues at 
McNeil Consumer Healthcare.
    As you know, I was unable because of back surgery to 
testify at the committee's hearing in May. I was grateful for 
the opportunity to meet with both the chairman and Congressman 
Issa shortly afterwards to discuss our response to the recalls.
    It is essential that we work closely with Congress, the FDA 
and others to restore the public's confidence in McNeil 
Consumer Healthcare's products. Mr. Chairman, I know that we 
let the public down. We did not maintain our high quality 
standards. And as a result, children do not have access to our 
important medicines.
    I accept full accountability for the problems at McNeil, 
and I will take full accountability for fixing these problems.
    After we found a substantial quality issue at McNeil, we 
instituted a broad precautionary recall of all liquid 
children's products manufactured in Fort Washington. And even 
though our medical experts and the FDA agreed that the health 
risk was remote, we believed it was the right thing to do for 
patients.
    We also commenced a complete re-examination of McNeil's 
manufacturing processes. We are working hard to restore the 
public's trust and confidence in Johnson & Johnson and to 
strive to ensure that something like this never happens, ever 
again.
    I have spent my entire professional career at Johnson & 
Johnson. I was honored to be appointed chairman and chief 
executive officer in 2002. I am very proud to lead Johnson & 
Johnson and our dedicated, hard-working professionals. We are 
working hard to bring our important pediatric products back to 
the market responsibly.
    Indeed, I am pleased to announce that consumers will soon 
begin to see McNeil liquid pediatric products back on the 
shelves. During the work of October 4th, we will begin shipping 
one of McNeil's children's medicine products to our customers. 
Although available only in limited quantities at first, almost 
1 million bottles, these will be available for release next 
week. We expect to distribute a total of 4 million bottles in 
the United States by the end of the year.
    As Colleen Goggins testified in May, it is important for 
consumers to know that the April 2010 recall was not undertaken 
on the basis of reports of adverse medical events. When we 
first found the issues that led to the April 2010 recall, we 
stopped shipping the products, shut down the plant and issued a 
broad precautionary recall of all liquid medicines. We have 
kept McNeil's Fort Washington facility shut down and we are 
completely revamping the facility to bring both equipment and 
procedures up to the high standards that we set for ourselves 
around the world.
    The facility will not reopen until we are confident that we 
can make McNeil products to the high quality standards that the 
public, Congress and the FDA rightfully expect of us. Across 
McNeil, Johnson & Johnson is investing more than $100 million 
on facilities, equipment and other improvements.
    McNeil retained an independent third-party consultant with 
expertise in manufacturing and quality systems. McNeil also 
appointed a new vice president of quality assurance, a new vice 
president of operations, a new plant manager at Fort 
Washington, and a new head of quality for the Fort Washington 
plant.
    Since the hearing in May, these efforts have accelerated. 
As Ms. Goggins promised during the May hearing, we submitted a 
comprehensive action plan to the FDA in July. We have 
established new quality officers for each of our three business 
segments. Quality and manufacturing report to a single point, 
with oversight of our operating companies. This person reports 
directly to me.
    I have also personally visited many of our manufacturing 
facilities to reinforce the importance of quality.
    In your letter inviting me to testify, you raised questions 
about the recall of two lots of eight-caplet Motrin vials. The 
documents that we provided to the committee show that McNeil 
informed FDA officials about our plans for an in-store 
assessment and then a retrieval of any of the eight-caplet 
Motrin vials that remained available for sale. I do think the 
McNeil personnel were trying to be transparent with the FDA. 
McNeil also notified its customers that it would be sending in 
personnel to remove the products.
    Nonetheless, based on what I have learned since the May 
hearing, including the points that this committee brought to 
light, it is clear to me that in retrospect, McNeil should have 
handled things differently. And going forward, if similar 
situations arise, they will be handled differently.
    Mr. Chairman, I am committed to working cooperatively with 
the committee and the FDA to get the McNeil products back on 
the shelves for the people who rely on them. We look forward to 
earning back the trust of all those who have depended upon 
Johnson & Johnson to take care of themselves and their families 
for decades. I would be happy to answer your questions.
    [The prepared statement of Mr. Weldon follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
        Chairman Towns. Thank you very much, Mr. Weldon, for your 
statement.
    Ms. Goggins.

                  STATEMENT OF COLLEEN GOGGINS

    Ms. Goggins. Chairman Towns, Congressman Issa and members 
of the committee, I am Colleen Goggins, the worldwide chairman 
of the Consumer Group of Johnson & Johnson.
    I appreciate the opportunity to appear before you today, as 
I did in May, to discuss our efforts to address the quality and 
process issues at McNeil Consumer Healthcare.
    Because my May testimony contains considerable detail 
concerning McNeil and the recent recalls, I will be brief in my 
testimony today.
    Since my prior appearance before this committee, we have 
continued to work very hard to address the problems at McNeil. 
As Mr. Weldon stated, McNeil submitted to the FDA a 
comprehensive action plan [CAP], in July. The CAP applies to 
all the manufacturing facilities McNeil operates to supply the 
U.S. market, not just the Fort Washington facility that remains 
closed. The CAP is part of our ongoing dialog with the FDA to 
improve product quality, improve quality systems and enhance 
training.
    Under the CAP, we have engaged leading experts on 
manufacturing processes, and we have also dedicated Johnson & 
Johnson's own experts to our efforts at McNeil.
    Mr. Chairman, I understand from your letter inviting me to 
appear today that you have questions concerning my testimony 
about the Motrin caplets recall in 2009. I regret if my 
testimony created any confusion. And I hope that I can clear up 
any confusion today.
    By way of background, I learned that the committee was 
interested in the Motrin recall for the first time during the 
morning session of the May hearing. We quickly gathered what 
information we could prior to my testimony in the afternoon. 
And during my testimony, we committed to providing additional 
information to the committee, which we have now done.
    At the hearing in May, I told the committee that I believed 
there had been discussions with the FDA about our plans for the 
third-party contractor in connection with the Motrin caplets. I 
believe that the documents we have now obtained and provided to 
the committee reflect these discussions and McNeil's efforts to 
be transparent and act in good faith with the agency.
    As I tried to make clear in my testimony, I had no 
knowledge at the time of the May hearing of any instructions 
that may have been given to any contractor. Since the May 
hearing, the company located and provided the committee a copy 
of instructions given by McNeil to its contractor on the Motrin 
matter. In those instructions, McNeil directed the contractor 
to purchase the product without engaging in discussions with 
store personnel.
    Having now seen those documents, I believe McNeil should 
have handled things in a more straightforward manner with the 
retail stores. We as a company have learned from this process 
and appreciate the committee's help in highlighting these 
concerns.
    As I said at the outset, we have committed to deal 
aggressively and effectively with the quality and process 
issues we have at McNeil. Although we still have work to do, I 
do believe we are living up to that commitment. I would be 
happy to answer any questions you or the other committee 
members might have.
    [The prepared statement of Ms. Goggins follows:]
    [GRAPHIC NOT AVAILABLE IN TIFF FORMAT] 
    
    Chairman Towns. Thank you very much.
    Let me thank both of you for your statements, and of 
course, for being here.
    Let me begin with you, Mr. Weldon. In your prepared 
statement to the committee, you talk about a March 23, 2009 
field alert that was sent to the FDA about the defective 
Motrin. This is the product that was taken off the shelves 
during the phantom recall.
    That field alert says a third party has been contracted to 
perform an in-store assessment. That does not say anything 
about contractors going into stores and not communicating about 
a recall and buying all the affected products. Then on April 1, 
2009, just about a week after McNeil told the FDA it would 
perform an assessment, a McNeil executive emailed your 
contractors with instructions for the phantom recall. And those 
instructions say, ``purchase all of the product,'' and ``do not 
communicate to store personnel any information about this 
product.'' We also have an email dated April 16, 2009, where an 
employee of one of your contractors informs McNeil that the 
phantom contractors had already completed 250 visits to stores.
    Mr. Weldon, don't these documents show that the phantom 
recall had already been performed in over 200 stores before you 
made any mention to the FDA about these, the defective Motrin?
    [The information referred to follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Mr. Weldon. Yes, it does, sir. May I offer some thoughts on 
this?
    Chairman Towns. Delighted.
    Mr. Weldon. I think your comments are absolutely accurate 
and correct. And I think this is one of the areas where we have 
benefited by the guidance of the committee. If you look at the 
document in March, we were notifying the FDA that we were going 
to go and audit stores. When we went out in April, April 1st, I 
think it was, to your reference, we audited stores and also 
purchased product.
    April 21st, I think we notified the FDA of exactly what we 
had done and what we were planning on doing and completing this 
by July 15th, I think it was. Unfortunately, we did not notify 
the FDA that we would be purchasing this product. That was a 
mistake we made. We firmly admit that. We also hope that people 
would understand that if we went into an account and there was 
a minimal amount of product there, and it did not present a 
safety hazard to anybody, but actually did not dissolve and 
give pain as quickly as we would like it to have been, as it 
should have, we would take that product off the market.
    We made a mistake. We should have notified them that we 
would be taking these products, if it was small amounts, off 
the shelves. So you are absolutely correct that we made a 
mistake. But we feel we did keep people informed as to the 
actions we were taking.
    Chairman Towns. Thank you very much. I really appreciate 
your explanation.
    Ms. Goggins, when you testified before this committee 4 
months ago, you indicated that Johnson & Johnson did not intend 
to hide anything about the phantom recall, and that Johnson & 
Johnson did not know what the phantom contractors were doing.
    You also said that the affected Motrin was sparsely 
distributed. However, we now have documents that show McNeil 
wrote instructions for the phantom recall. And it is clear that 
McNeil's executives were fully aware of the phantom recall 
while it was going on.
    We also know that the phantom recall was not sparse, 
because it involved at least 40 States. Can you explain this 
discrepancy?
    [The information referred to follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Ms. Goggins. I am sorry, sir, it contained at least 46, you 
said?
    Chairman Towns. Forty States.
    Ms. Goggins. Forty States, I am sorry, thank you. When I 
testified in May, sir, what I was aware of at the time was, as 
I said, we verified that the FDA was aware that we were as of, 
the SN1 office of the FDA was aware that we had hired 
contractors and we were going into stores and we were 
retrieving product. We have since determined that was since the 
April 21st filing of the field alert report.
    At the time, I was not aware of any retrieval actions going 
on, I don't believe, and I had not seen any instructions to 
contractors until the excerpted instructions, I think, were 
exhibited that day during the hearing.
    To Mr. Weldon's point, I think that we would agree that 
were we to do this over, we would certainly be more 
transparent, particular with the store personnel. But I don't 
believe there was ever any intent to mislead or deceive the 
FDA, sir.
    Chairman Towns. When you say they were notified, what 
process did you use to do that?
    Ms. Goggins. To the point that Mr. Weldon made, and I 
believe in our testimony, the FDA was notified by a field alert 
report submitted on April 21st. And I believe there was ongoing 
correspondence between that date and the agreed-to date for the 
termination of that work, which was July 15th.
    Chairman Towns. Thank you very much. My time is expired.
    I now yield 5 minutes to the gentleman from California, the 
ranking member, Congressman Issa.
    Mr. Issa. Thank you, Mr. Chairman.
    I am going to continue along that line, because our 
documents appear to be again, a little different than what I am 
hearing. I have a McNeil document dated March 23, 2009, to Ms. 
Torres. But very clearly it says, ``attached please find the 
third followup to the field alert report for Motrin caplets 
submitted November 26, 2008.''
    So now, really, the FDA was well informed November 26, 
2008, is that correct?
    Ms. Goggins. Yes, the first field alert report was filed in 
November 2008.
    Mr. Issa. So let's put it in perspective, Mr. Weldon had 
said. There was a stealth recall, phantom recall, remaining 
product purchased back because it was less than effective as 
prescribed. And I understand that's just as good a reason to 
get something off the market as anything else. But it was not 
something that you took it and you were poisoned, you took it 
and you were hurt. But you took it and your headache didn't go 
away, right? That is pretty much it. OK.
    So this product that the FDA is aware doesn't work, 
dissolve, do its job properly, the FDA is aware of it November 
26th. So you have pieces of November, all of December, all of 
January, all of February, almost all of March. And then in 
April, March, April, the product is actually removed.
    So in retrospect, one, it should have been removed quicker 
once you knew it didn't work. Two, Mr. Weldon, you have already 
said, and so have you, Ms. Goggins, that if you had to do it 
over again, you would do it in a more general recall way. But I 
am trying to understand why the FDA was so slow in going 
through to make a decision and why, in earlier testimony, they 
sort of say, well, we didn't find out, we didn't know, when in 
fact they knew for month after month and emails show that there 
was dialog.
    I am going to ask you two a tough question. Because 
although I am very disappointed in Johnson & Johnson, I said it 
in the first hearing, I say it again, this is not what we 
expected from a company with your history. But it happened. You 
didn't do your job well in a number of quality areas.
    Let me ask you, is your relationship ordinarily supposed to 
be so cozy as to have months of discussion and informal back-
channel and then be allowed to have, if you will, an 
undocumented recall? Is that what should be happening? Is that 
what we should expect from the FDA or tolerate? Both of you, 
please.
    Mr. Weldon. Congressman Issa, I think my response to that 
would be that, I asked the same question about our 
organization. Is there a way we could do this faster? It seemed 
like exactly the same question you are asking, it seemed like 
it took a protracted period of time. And I think in the future, 
we try and accelerate that, to see if we can do it faster, to 
get the product off the market.
    As far as relationships and things like that, I think it is 
important that there is dialog between the FDA, in this case, 
and our company to ensure that we are doing the right thing. So 
I can't comment exactly on the discussions that went on, or the 
relationship. But I think it is very important and very normal 
that there would be a dialog before action is taken.
    Mr. Issa. I am going to followup with another question, 
because you can never take a CEO out, once he has been one. 
When I looked at your reorganization, your July plan, I begged 
two questions. First of all, you have single line 
accountability from quality to quality to you. Should have been 
that way to begin with.
    But in our research, there was a period of time at McNeil 
where they were clearly trying to cost down QC. Today, who 
controls the decision of how much money the QC portion of any 
of your companies can spend? In other words, who is responsible 
for making sure they are fully funded and not part of an edict 
to lower costs?
    Mr. Weldon. Congressman, respectfully, I would like to 
maybe clarify one point. We have gone back and looked at the 
period between 2006 and 2009. And at best, the cost on quality 
at McNeil were flat. Actually, they increased during that 
period of time. And the head count was constant also. There was 
not a reduction.
    Mr. Issa. That came out in the first hearing. What I am 
looking at is in your plan going forward. Because our 
responsibility is to fix the FDA going forward, but it is also 
to have confidence in companies like yours. Who determines if 
there are sufficient funds today? Does a plant manager, a 
division CEO, chief operating officer, chief financial officer? 
If the quality control people do not believe they have the 
resources, whether it is a new tool, advanced technology in the 
production line or actual personnel, how is that done today so 
that we can know that those cost efficiencies are not being 
looked at by somebody far away and too many chains between 
them?
    Mr. Weldon. Yes, sir, that would be determined by the 
quality people directly to the individual who reports to me and 
myself. And we have let it be known that we will not get in the 
way of cost. We want to make sure we are investing 
appropriately in quality and that decision will be made 
directly up to and including myself.
    Mr. Issa. OK, and then if you can, quickly, Fort 
Washington, when it reopens, tell me how it is going to be 
different, different in a way that the American people can 
believe in product that eventually comes from there.
    Mr. Weldon. Sir, I would like to say we are working closely 
with the FDA, external consultants and our own people to 
invest, as I mentioned, $100 million across the McNeil 
facilities. We are going to make that the start of the art 
facility. It will not be opened up until we are sure it is 
state-of-the-art. I would like to say it will be the best in 
the world. That is what we would like it to be.
    But I guarantee it will be state-of-the-art and people can 
have the highest degree of confidence. We will not ship a 
product out of there until we have been able to satisfy the 
expectations of the people who will use our products.
    Mr. Issa. Thank you. Thank you, Mr. Chairman.
    Chairman Towns. I recognize the gentleman from Maryland for 
5 minutes.
    Mr. Cummings. Mr. Weldon, on August 19th, in an online 
article in Fortune Magazine suggested that McNeil had 
exceptional quality control measures until 2002, the year you 
assumed the position of chairman and chief executive officer. 
The article suggests that the cost-cutting had a significant 
impact on the quality control staff and procedures across the 
company. Are you familiar with that article?
    Mr. Weldon. Yes, sir.
    Mr. Cummings. Further, the article is critical of your 
ability to manage the consumer products business we are 
discussing today. Is it possible that cost-cutting contributed 
to the culture that created the quality issues?
    Mr. Weldon. Sir, I do not believe the cost-cutting 
contributed to this.
    Mr. Cummings. Well, do you think the cost-cutting, do you 
think the cost-cutting culture may have inadvertently created a 
situation in which phantom recalls and processes that did not 
put consumer safety first could occur?
    Mr. Weldon. No, sir. Could I elaborate on that?
    Mr. Cummings. I only have 5 minutes. I do want you to 
answer, though, briefly.
    Mr. Weldon. OK, I said no, sir, I do not believe, I do not 
believe that cost-cutting nor financials were put ahead of the 
quality for patients at any of our facilities.
    Mr. Cummings. Mr. Weldon, in your testimony you stated that 
McNeil believed that the phantom recall was an expeditious way 
to remove the remaining caplets from the convenience store 
shelves. If the product was not good enough or safe enough to 
sell, why would it be good enough for consumers to keep it in 
their homes, in their medicine cabinets?
    Mr. Weldon. Sir, first of all, I think we had looked at 
this closely and determined there was no risk, no safety 
hazard, no risk to patients who consumed these products. We 
thought it was a way to expeditiously get the product out of 
the market. And I think it was in May that we sent a letter to 
the customers, notifying them of this action and telling them 
that we wanted to remove the products that were in the 
facilities.
    Mr. Cummings. Why do you think they conducted this phantom 
recall?
    Mr. Weldon. Sir, that I can't address. I would not quite 
characterize it that way. But I do believe that we kept people 
informed. I think that we just talked about the document in 
April, in March saying that we were going to be acquiring or 
retrieving the product during that period of time.
    But shortly thereafter, we notified the FDA of our actions, 
our intent, and that we would have this product off the market 
in July. And we executed against that plan.
    Mr. Cummings. I notice that Mr. Issa spent some time I 
guess sort of halfway complimenting you on making changes. I 
think Ms. Goggins talked about changes that you all had made. 
And you have made some significant changes, have you not?
    Mr. Weldon. Yes, sir, and I think it is the guidance of the 
committee that has helped us see some of the changes and some 
of the issues that we really did need to make at the Fort 
Washington facility. And we have taken it beyond that to help 
ensure that we have actually learned and grown and continue to 
learn across Johnson & Johnson.
    Mr. Cummings. Well, let me ask you this question about how 
much you have learned and grown. Mr. Weldon, both you and Ms. 
Goggins have stated that you have addressed the issues with 
McNeil Consumer Healthcare by changing the senior leadership. 
Yet Mr. Peter Luther, you know him?
    Mr. Weldon. Yes, sir.
    Mr. Cummings. The current president of McNeil, remains in 
place. It seems disingenuous to suggest that you changed 
leadership to fix the problem, when key people involved in the 
decisions to conduct the phantom recall, and I know you don't 
call it a phantom recall, I call it a phantom recall, remain in 
place. Can you comment on whether Mr. Luther is competent to do 
what is needed to fix the problem, when he was involved in the 
problem originally?
    Mr. Weldon. Yes, sir, and I do appreciate the way you refer 
to the recall. I appreciate that.
    Mr. Luther has been a long-serving Johnson & Johnson 
employee. He has been a good employee for a very extended 
period of time. Mr. Luther also is very committed to improving 
and revamping the facility, and he is very committed to doing 
that. We are looking forward to the results of what he is 
doing. So yes, I think Peter Luther is a good employee who will 
contribute to rectifying this problem.
    Mr. Cummings. And so the same folk that were around when 
the problem took place, you then put it in their hands to fix 
the problem, is that it? And I think you said, in a very, very 
sincere way, that you were looking to get the public's trust. 
And we all know in order to get the public's trust, you need 
people in place that people trust, the consumers trust. To me, 
that doesn't make very much sense, and then put the person who 
was in charge when the problem came up back in charge. You 
follow me?
    Mr. Weldon. Yes, I do, sir, and think we all, as I said, 
share accountability in this. I think that Mr. Luther was in 
charge, but I think that you can see that there were many 
changes that were taken that were in the quality area, the 
manufacturing area, to ensure that we have the best 
representation.
    As I said, Mr. Luther has been a long-serving employee who 
has done a very good job for us. But he is also committed to 
and has been very instrumental in making sure that we are 
revamping and improving the facility. So I think there is 
accountability that is shared across the organization. I think 
that the players that we needed to replace have been replaced.
    Mr. Cummings. Thank you, Mr. Chairman.
    Chairman Towns. Thank you very much.
    I now yield 5 minutes to the gentleman from Utah, 
Congressman Chaffetz.
    Mr. Chaffetz. Thank you, Mr. Chairman.
    Ms. Goggins, with the Motrin phantom or silent recall or 
retrieval, was it McNeil's understanding that until July 2009, 
the FDA was not requesting a recall? Is that correct?
    Ms. Goggins. Yes, that is our understanding, sir.
    Mr. Chaffetz. Had the FDA wanted or even suggested a recall 
at the time a problem was discovered, would you have issued a 
recall?
    Ms. Goggins. In fact, I believe that the FDA told us in 
that time period that they wanted to classify our retrieval as 
a recall and we filed the forms almost immediately.
    Mr. Chaffetz. What percentage of the product shipped was 
actually recalled? Do you have any idea?
    Ms. Goggins. I am estimating it is about 1 percent of the 
product shipped was recalled, sir.
    Mr. Chaffetz. Mr. Weldon, you said in your testimony that 
the right thing to do was an imperative for you. I am having a 
hard time with the directive from the CEO's office and the way 
you feel personally with what happened on the ground. Were any 
of the personnel fired, relieved of their duties, dismissed, 
demoted? What happened to all these employees that were 
involved here from your operation?
    Mr. Weldon. I can't comment. I know some people have been 
relieved of their responsibilities and there are some new 
people in the facilities, yes. But I don't know all the direct 
information.
    Mr. Chaffetz. Ms. Goggins.
    Ms. Goggins. Yes, to elaborate on Mr. Weldon's point, we 
have a new, at McNeil we have a new head of manufacturing, we 
have a new head of quality. And the two largest plants that we 
have, our Las Piedras plant and our Fort Washington plant. We 
have new people both in manufacturing and----
    Mr. Chaffetz. Was anybody fired?
    Ms. Goggins. Yes. Yes, that is my point.
    Mr. Chaffetz. Mr. Weldon, I believe you when you personally 
say you want to do the right thing. But I have a hard time 
rectifying what was actually happening on the ground within 
your organization. You said you wanted to take personal 
responsibility for it.
    Let me read this excerpt from March 24, 2009 emails from 
Paul DePaulo, and pardon if I am mispronouncing these names, to 
Daniel--I can't pronounce his last name, Fegas, I guess is his 
name. ``The FDA is really bending the rules in this case, the 
Motrin caplet case, because of the fact that we stopped 
distribution a while ago.'' Doesn't that imply that there was 
some encouragement from Johnson & Johnson to bend the rules?
    Mr. Weldon. Again, I can't directly know what was meant by 
that. It says, the email says exactly what it says. I think 
that what we are looking at here is the ability to dialog and 
make the right decisions.
    Mr. Chaffetz. And you say that, but then when you say the 
FDA is really bending the rules, and that is coming from a 
Johnson & Johnson employee to another Johnson & Johnson 
employee, it doesn't look as if you are doing ``the right 
thing'' to do.
    Let me read another email. ``Regarding FDA documents,'' 
this is from Eddie Carillo to Carolyn Prezalli, again, I am 
slaughtering their names, ``Regarding FDA documents, all my 
conversation with the FDA director, Ms. Torres, here in Puerto 
Rico, have been off the record, since I cannot quote her. This 
happens due to my good relationship with her, and that's why we 
are doing something very different.''
    Is that inappropriate mode of conduct? I mean, does this 
regularly happen above and beyond this one instance, where you 
are having off the record discussions? That the relationship is 
so cozy? Is this common practice? Is this something you 
condone? Is this an exception?
    Mr. Weldon. No, we don't condone it, sir. I can't comment 
for the conversation that go on across the organization. What I 
can comment on is that we would like to have, and I think we 
have worked cooperative, and I think with the FDA, to ensure 
that we have a dialog to make sure that the right things are 
done for the patients and to make sure we are behaving in a 
proper way.
    As far as being able to comment as to whether, on specific 
emails, no, sir, I can't comment on those.
    Mr. Chaffetz. Help me understand, for the record, moving 
forward, Johnson & Johnson's commitment on what is the proper 
way.
    Mr. Weldon. Johnson & Johnson's commitment on what is the 
proper way, to continue to dialog with the FDA and to ensure 
that we are looking out for the rights, for the best interests 
of patients. Sir, if I could elaborate for a little bit, I 
think that we try and establish ourselves, I think there is a 
reference that the chairman made earlier on to our credo. And 
our credo, our first responsibility is to the people who use 
our products. I stated, and I would state again that we have 
let them down. There is absolutely no doubt we let them down. 
This was not one of our best moments.
    We are going to fix it, and improve up on it. And we are 
stressing, as I said also, I have gone out to our facilities, I 
have talked to our people and I have talked to our leadership 
to ensure that we continue to reinforce the responsibility we 
have to the people who use our products. There is absolutely 
nothing more important than ensuring the safety of our products 
and the quality of our products.
    So going forward, we are committed to doing the right thing 
for patients.
    Mr. Chaffetz. Thank you. And thank you, Mr. Chairman, my 
time is expired. I will yield back.
    Chairman Towns. Thank you.
    I now yield 5 minutes to the gentleman from Ohio, 
Congressman Kucinich.
    Mr. Kucinich. Thank you very much, Mr. Chairman.
    The committee has documents that demonstrate that on 
September 18, 2009, there was a letter to health care 
professionals, like physicians, explaining the recall of 
children's and infants' Tylenol. On the third line of the 
second paragraph of this particular document, B. cepacia is 
clearly mentioned. It mentions that children with underlying 
pulmonary disease, cystic fibrosis or compromised immune 
systems are at high risk.
    Then there was another document dated September 24, 2009, 
just 6 days later, that describes the recall of children's and 
infants' Tylenol, it is from Tylenol.com, it is directed at the 
public. But there was no mention of B. cepacia and no mention 
of any conditions a child might have, like cystic fibrosis, 
that would make him more vulnerable.
    Now, this would make sense, if a patient had to go to their 
doctor to get the medicine. But because a doctor would have a 
chance to convey the hazard to a patient, but this was an over 
the counter drug. Now, and apparently, they kept the public out 
of the loop.
    So follow this pattern. We have McNeil knowing a product 
was defective, they kept it away from public knowledge. They 
hired phantom contractors who purchased the product but did not 
inform store personnel. As a matter of fact, their contractors 
were told, don't tell the store personnel. Inform the doctors, 
don't inform the public.
    Mr. Chairman, what we have here, I think, is a pattern of 
concealment. Now, one of the things I am concerned about, with 
all due respect to Mr. Weldon, your testimony presentation has 
all the earmarks of coaching from the spin doctors who help 
corporate executives put a good face on misconduct. To say, OK, 
admit, throw yourself on the mercy of the court, we did wrong. 
But wait a minute. There is a pattern of concealment here. You 
can't call that pattern a mistake. A person can make a mistake 
once. But if you keep making the ``mistake'' over and over and 
over, then somebody has to ask, well, it is just the way you do 
business, or the way you did business.
    Now, Ms. Goggins, I was present at your testimony the last 
time, and there is a transcript of your testimony. And I 
listened carefully when you said at the time of the hearing 
that you weren't aware of any retrieval actions. I have here a 
memo, which the chairman alluded to in his opening statement, 
which is to Gary Benedict, from Bob Miller. And listen to this 
memo.
    ``Gary, as you know, we've negotiated an agreement with the 
FDA not to formally conduct a recall for Motrin 8s, but rather 
conduct a `soft market withdrawal.' This was a major win for 
us, as it limits the press that we'll be seeing. We had 
committed to FDA to complete this withdrawal by July 15th. 
There have been continuing issue trying to get a PO, purchase 
order, from the marketing group, which is now putting our 
ability to meet the July 15th timeframe in jeopardy. At the 
same time as we delay this work, the cost to complete the work 
continues to increase because of the fact that the outside 
resource,'' that is the people involved in this recall, the 
phantom recallers, ``will now need more resources to expedite 
the work. We cannot extend our commitment date to FDA. It is 
now estimated this will cost approximately $400,000, which is 
approximately two times what was originally quoted.''
    And then Peter Luther has an answer here, he says, ``Group, 
where is the miss here? Given our current financial situation, 
I hope we're not going to really double our costs to do this. 
Let's make this happen ASAP.''
    Now, Ms. Goggins, since you are the head of this consumer 
group, are you trying to lead this committee to believe that 
you knew nothing about it? Apparently, from this memo, there 
was widespread discussion within your organization about 
phantom recall, about the cost of the recall, about not being 
able to get cooperation from the marketing people. You are at 
the top of this group and you knew nothing about it? Really? I 
am not talking about what is on the record here. Are you saying 
that no one ever talked to you about it? Not only do you have 
no recollection, you are sure that no one talked to you about 
it?
    Please help us.
    Ms. Goggins. Yes, I will, thank you for the opportunity. As 
I said in my opening testimony----
    Mr. Kucinich. No, answer my question. Not your opening 
testimony. What is the answer to my question?
    Ms. Goggins. I did not know at the time that I testified in 
May. I have since learned from looking at documents that there 
was a retrieval going on. I did not know that at the time of my 
testimony in May, I don't believe.
    Mr. Kucinich. Mr. Chairman, I have to tell you, this 
testimony is lacking in credibility in light of this particular 
document. Thank you, Mr. Chairman.
    Chairman Towns. I now recognize the gentlelady from 
Washington, DC, Congresswoman Norton.
    Ms. Norton. Thank you, Mr. Chairman.
    I have a question about children's medicine. We have a 
McNeil document that shows that a contaminant was discovered in 
April 2008. And another document that shows that more than 8 
million bottles had been shipped starting in March 2008. So 
when you put these two documents together, doesn't this mean 
that although your company recalled 8 million bottles of the 
children's medicine in 2009, that the fact is that you had 
discovered the problem at least a year earlier in 2008?
    Mr. Weldon. May I comment on that?
    Ms. Norton. Yes, Mr. Weldon, this is a question for you.
    Mr. Weldon. Thank you.
    I would like to maybe clarify the record in terms of what 
exactly took place. And we are talking about the B. cepacia, 
the potential bacterial contamination of the product. Just to 
maybe shed a little light on it, the way we manufacture our 
product is we order product from, let's say raw materials from 
suppliers, we then test those raw materials. We manufacture 
product, we test the product and then we release the product.
    What happened in this case is we had done that and in a 
batch of raw materials that came from a supplier, we detected 
B. cepacia. We eliminated that from our manufacturing, we want 
to be clear that none of that was used in any product that was 
manufactured or left our facility.
    We went back and checked for B. cepacia, we went back and 
checked the product. We wanted to make sure there was no risk 
as we saw to anybody that was there, anybody that would consume 
this product.
    The following year, I think you said in 2009, the FDA came 
to inspect our facility. And they found exactly what we had 
done. And they said there could be a risk that there is B. 
cepacia in the product, in the product that was delivered that 
was gone out. We had never used, I want to be clear, we had 
never used the raw materials that had B. cepacia. We felt 
confident in the work we had done that there was no B. cepacia 
in the products that we released.
    Ms. Norton. Do you believe in 2008 that those 8 plus 
million bottles that had been shipped starting in 2009, which 
your own document says get consumed very quickly, that you 
believe that none of this contaminant made its way into those 8 
million bottles?
    Mr. Weldon. That is correct. Because the raw material that 
had B. cepacia we did not use to manufacture any product. We 
eliminated that.
    The FDA's position, and in discussion we said fine, was 
that possibly there could have been in some product. So we 
recalled the product. But we were confident in the 
manufacturing process, the checks that we use, and then we have 
a thing called retain samples, where we take these and put them 
aside, of the products that are manufactured. We went and 
checked that, after we brought product back, we went and 
checked those retained samples. And there was no trace of B. 
cepacia.
    But to protect patients, and as a precautionary measure, 
and I think we also mentioned this in the communications that 
went out to the customers that we had, we said that there was a 
product there that had, that we did not know had any problems. 
We had worked closely with the FDA on this, to take the product 
off the market. And we have no, today we still have no, we do 
not feel, and we have no indication that any product that was 
ever shipped had B. cepacia.
    But because of the product we did not use, the raw 
material, there was a concern there could have been a potential 
risk. So we accepted that and withdrew the product. But we have 
never confirmed that there was any B. cepacia in any of the 
products we released. And it was never used, I am stressing, 
the raw material that had B. cepacia in it, was never used to 
manufacture a product that was shipped out of the facility.
    Ms. Norton. In any of those 8 million?
    Mr. Weldon. In any of those 8 million, yes, ma'am.
    Ms. Norton. Mr. Weldon, let me ask you another question. Is 
it not true that 8-count vials of Motrin tablets can no longer 
be found on store shelves because you no longer make them?
    Mr. Weldon. That is correct. To the best of my knowledge, 
it is correct.
    Ms. Norton. But isn't it commonly known that Motrin tablets 
were removed from store shelves because the product was 
defective?
    Mr. Weldon. Yes, ma'am. Once again, to clarify, we 
identified there was never a heath risk to patients. What we 
found is that the product dissolved more slowly than we would 
have liked it to dissolve and it was supposed to dissolve. So 
we went out and took the products off the shelf, that is 
correct.
    Ms. Norton. Well, I wonder if you could explain this 
guidance given to Johnson & Johnson, we have another document 
here, given to Johnson & Johnson and to McNeil employees in an 
internal email to tell customers that the product is not on the 
shelves because your company no longer makes it. Here is the 
email. It says the recall and the consumer will not know that 
we recalled it, a candid response to the customers is that we 
no longer make the 8-count vial.
    Mr. Weldon. Yes, I am not familiar with that specific 
document, and I am not sure if it refers to, it was referring 
to notifying our own internal employees that we no longer made 
it.
    Ms. Norton. It tells your employees what to tell the 
customers.
    Mr. Weldon. And that is correct. Again, I don't see the 
document, I don't know, but we no longer make that product, 
that is absolutely correct.
    Ms. Norton. You do have the document before you, though, I 
understand. The document says, unfortunately, the consumer Q&A 
form doesn't apply to the Motrin products, since it isn't a 
recall and the consumer will not know that we recalled it. It 
is only two lots of the product, you say. They simply won't be 
able to find it on the shelf. They will not know we recalled 
it. They simply will not know they are not able to find it on 
the shelf. Our candid response to the consumers is that we no 
longer make the 8-count vial.
    Mr. Weldon. Could I take a moment and just read this?
    Ms. Norton. Please.
    Chairman Towns. Then I will give the gentlewoman additional 
time.
    Ms. Norton. Thank you, Mr. Chairman. I thought he had the 
document and had looked at it.
    Mr. Weldon. I did, I just wasn't aware of it. I apologize.
    It says, it refers to a consumer Q&A that I am not aware 
of. But it does say that the response to the consumer is that 
we no longer make the 8-count vial. That is correct. We no 
longer make it.
    Ms. Norton. Is that the response under all circumstances, 
it should have been made, no recall, we just don't make it?
    Mr. Weldon. No, ma'am. I think there are some lessons that 
we have learned, and I think you all have helped us with this. 
I think some of the wording that we have used and the 
directions we have given have been inappropriate. I cannot 
comment on this specifically, but I can assure you that we 
would be much more transparent with our customers and the 
people that would have our products in the future.
    Ms. Norton. Well, understand that there is a difference 
between telling a consumer you no longer make a product, which 
may simply mean you decided to move onto another product, and 
telling the consumer that the product has been recalled, so 
that the consumer may know to look himself or herself for the 
product and all that goes along with recalled products.
    Mr. Weldon. Yes, ma'am, and I do appreciate your comments. 
I do think in May we did send out an announcement saying that 
we were going to be taking these products off the shelves. But 
I think your point is well taken. Thank you.
    Chairman Towns. The gentlewoman's time has expired.
    I now yield 5 minutes to the gentleman from Missouri, 
Congressman Clay.
    Mr. Clay. Thank you, Mr. Chairman. Thank you, Ms. Goggins 
and Mr. Weldon, for being here.
    There were repeated instances of alarming problems with 
Johnson & Johnson's children's medicine from 2008 to 2010. And 
in April 2008, McNeil began receiving reports that an 
uncharacteristic odor in its products was causing nausea, 
stomach pain, vomiting and diarrhea. FDA found that McNeil's 
initial investigation into these complaints was unjustifiably 
delayed and terminated prematurely. Over 100 additional 
complaints later, McNeil did not discover the root cause of the 
contamination until September 2009.
    Why did it take so long to figure out the cause of the 
contamination?
    Mr. Weldon. Yes, sir. This was an area where we have 
learned a very important lesson. And as you said, in 2008, 
there were adverse events reported that we knew, and it had to 
do with the aroma in the product and then some reported cases 
of nausea and vomiting. We investigated that to see if there 
was a microbial content or any content in the product. We found 
that there was not. And we saw that the adverse events fell 
off.
    So we knew that there was, at that point we identified that 
there would be no harm to patients. There was some gastric 
distress but no serious adverse events. The adverse events fell 
off .
    They came back in September, I guess in 2009, I am not sure 
exactly the date. We then investigated it, and I think worked 
closely with the FDA to identify. And I have to say, it was a 
very complex issue to identify a product called TBA. What had 
happened is this is a preservative. There is a preservative put 
on wooden pallets that can migrate into packaging material. It 
was something that has been very hard to identify and 
determine.
    Now, I also want to be clear: we should have determined the 
root cause in 2008. I do not want to defend our inaction there. 
I think the FDA pointed that out correctly to us, and we 
appreciate that.
    What we did do, though, in working closely with the FDA, 
was able to identify this. It was a very, very difficult 
initiative that needed to be undertaken and we were able to 
determine it. I think as the FDA said, this actually helped to 
lead to some new guidance documents from the FDA for everybody 
to benefit by.
    So I do not want to make any excuses for what we should 
have done in 2008, which was to have determined the root cause. 
As a corporation, we know today if we have adverse events we 
need to investigate. We investigate them thoroughly until we 
determine the root cause. And that is exactly what happened in 
this instance. We did not, and the FDA was absolutely correct 
in pointing that out to us. And we did identify it ultimately. 
It was a very, very scientifically challenging exercise. But 
that is no excuse. We did ultimately determine it, and I think 
in combination with the FDA, I think it is something that will 
benefit many people.
    Mr. Clay. But Mr. Weldon, it leached through the----
    Mr. Weldon. Yes, that is correct. What happens is, they put 
a preservative on a wooden pallet, which materials are shipped 
on. And the preservative can actually break down and actually, 
as you, the words you described are very accurate, leach into 
the packaging material. And that packaging material then, when 
you put the product in it and you ship the product out, can 
actually cause this musty odor, this smell. And I think it was 
something, again, I want to say that I think it was a 
combination of people working closely together to determine 
this. And I think ultimately a guidance document has gone out 
that will help many people in this area.
    Mr. Clay. Thank you for that response, Mr. Weldon. 
Regulations require drug makers to submit field reports within 
3 working days of receipt of information concerning any 
bacteriological contamination or any significant physical or 
other change or deterioration in its drug products. Yet, when 
McNeil began receiving consumer complaints in 2008, McNeil did 
not alert FDA. Further, when McNeil had test results confirming 
the contamination, these results were not shared with FDA. Why 
didn't McNeil share this information with FDA as required?
    Mr. Weldon. I cannot comment on that. I am not, I just 
can't comment. I am not aware of that specific example.
    Mr. Clay. Ms. Goggins, can you explain it?
    Ms. Goggins. I don't know which incident you are referring 
to. Are you referring to the B. cepacia, sir, or what are you 
referring to?
    Mr. Clay. OK, here, your FDA regulations require.
    Ms. Goggins. Right, absolutely.
    Mr. Clay. Well, let's go back to the first instance. Did 
you report it within 3 days?
    Ms. Goggins. Mr.----
    Mr. Clay. You can twist my words if you like. But you still 
can't get around the fact that you didn't follow the rules that 
you are required to. You can twist my words if you want. But 
why didn't you report it within 3 days?
    Ms. Goggins. I wasn't trying to twist your words, sir, I 
apologize.
    Mr. Clay. OK, well, do you understand the question now?
    Ms. Goggins. I do understand the question, and I don't, to 
Mr. Weldon's point, we are aware of the regulations for the 
FDA, and you are absolutely right, we are supposed to report 
these within 3 days to the FDA.
    Mr. Clay. And you didn't.
    Ms. Goggins. I don't know which incident you are talking 
about. If we did not, sir, we should have.
    Mr. Clay. Well, any of the incidents. You didn't report it 
in a timely fashion, within 3 days.
    Mr. Weldon. Sir, if----
    Mr. Clay. So why didn't you?
    Mr. Weldon. That I----
    Mr. Clay. Simple question.
    Mr. Weldon. That I cannot answer. I would say, though, in 
all instances, in some instances, I know that we did, I don't 
know the specific instance. If we did not, it was a mistake on 
our part and we should have, you are absolutely correct.
    Mr. Clay. My time is expired, I yield back.
    Chairman Towns. The gentleman's time is expired.
    Before we let you go, there are some terms, actually 
phrases that have been used. I want to make certain that the 
committee understands. You used the term ``soft market'' 
withdrawal. What does that really mean? Soft market withdrawal.
    [The information referred to follows:]
    [GRAPHIC NOT AVAILABLE IN TIFF FORMAT] 
        
    Mr. Weldon. Mr. Chairman, I have no idea what soft market 
withdrawal is. I have heard the term.
    Chairman Towns. It is used in the memos and the emails that 
we received.
    Mr. Weldon. I am not familiar with the term. I do not know 
what it means.
    Chairman Towns. Ms. Goggins, do you know what it means?
    Ms. Goggins. No. We don't use that term regularly, so I 
have not heard it before this instance.
    Chairman Towns. Why would the employees use it? Maybe it is 
the same thing as phantom recall. I am just trying to figure 
this out. Because you have seen it, you have heard it. What do 
you think it means? We don't know.
    Ms. Goggins. I agree with you, I think the language is very 
unfortunate. It is terminology we don't use. I also don't think 
it reflects accurately our priorities and the fact that we try 
to put safety of patients first. I think the use of language is 
unfortunate.
    Chairman Towns. Do you want to comment, Mr. Weldon?
    Mr. Weldon. I think, Mr. Chairman, the comment that I would 
make is that I think we have learned a lot of lessons through 
this unfortunate situation. I have said to you and to Mr. Issa 
and to the committee that we have learned and benefited by 
being here. I think we have discussed and can show you the 
changes we have made, the comments we are making, the resources 
we are investing, the people we are putting into roles. I can 
only assure you that we will do everything in our power to 
never let this happen again.
    I think that the characterization of phantom, soft, all 
kinds of things, I cannot explain to you. I wish I could, and I 
think many people use many different terms. What I can assure 
you is that we are committed to ensuring to resolve these 
problems, to fix these problems and to make sure that we are 
giving the highest quality products to patients.
    As I said earlier, and I will tell you very honestly that 
the FDA and Johnson & Johnson, the people at McNeil, have 
worked so closely together that we will be able to deliver some 
of these products in the market next week. And that is much 
faster than we ever thought we could have done. Our own 
internal expectation was that it would have been much later.
    Now, we are not able to fulfill the whole market. But I 
think because of the efforts that we have made collectively, we 
are going to be able to get these products back into the market 
for people that need them. And that is our single greatest 
concern.
    I can only commit to you, we will do the best we possibly 
can and we will do everything we can to ensure this never 
happens again.
    Chairman Towns. Mr. Weldon, let me thank you for coming to 
testify. The gentleman from Ohio.
    Mr. Kucinich. Mr. Chairman, with the unanimous consent of 
the committee, I have a followup question to Ms. Goggins to try 
to square this testimony that she just gave, based on committee 
documents that I have just received.
    Chairman Towns. Let me just say that before I recognize the 
ranking member, let me just say that I will give you 2 minutes 
to raise the issue and the question.
    Mr. Kucinich. I appreciate the indulgence of my colleagues.
    Chairman Towns. The gentleman is recognized.
    Mr. Issa. Mr. Chairman, thank you. As we go to the second 
panel, I would ask, because of the gravity of this hearing, of 
the failures at J&J and the corrective action that we are 
expecting you to do, plus the likelihood that we are going to 
have followup questions for you in writing, if you would both 
do the fairly extraordinary thing of remaining here through the 
FDA testimony as principals. We do believe that what you are 
doing is essential. We are obviously interested enough, even 
after the House is adjourned, to hold this hearing, because 
this is important that the American people know we are getting 
it right.
    So I would only ask that you do the followup written 
questions, and of course, yield back so the other gentleman can 
ask his.
    Chairman Towns. I thank the gentleman. And I also agree 
with the fact that we would really appreciate if you would stay 
and hear the testimony of FDA.
    The gentleman from Ohio.
    Mr. Kucinich. Thank you very much, Mr. Chairman. The 
committee produced a document here to Colleen Goggins from, 
among others, Peter Luther and Bob Miller, relating to the 
final remediation plan for the children's Tylenol. Now, on the 
document that I raised the question on, my last question, I 
pointed out that Bob Miller and Peter Luther were involved in a 
communication involving Motrin. And for some reason, Ms. 
Goggins, who was in the loop on the children's Tylenol, would 
lead this committee to believe that on something that 
apparently had wide circulation within her organization, she 
didn't know anything about it.
    Now, Mr. Chairman, one of two things have happened here. 
Either she was out of the loop on that, and if she was, a 
pattern of concealment from her needs to be further 
investigated, or the other part is that Ms. Goggins, you are 
not telling the truth. Now, would you like to respond to why 
you were kept in the loop on this, but you weren't kept in the 
loop on the children's Tylenol issue, but you were, as you say, 
were kept out of the loop or imply that you were kept out of 
the loop on the Motrin issue. Could you square the discrepancy 
there on your inter-office communications?
    Ms. Goggins. Yes, I will. I was not in the loop, as you put 
it, on the Motrin recall. But I was in the loop on the 
children's Tylenol recall.
    Mr. Kucinich. Why?
    Ms. Goggins. That is because we received a 483 with a 
number of observations regarding the issue of the children's 
recall in June of that year. So it was brought to my attention.
    Mr. Kucinich. But why? Were you concerned about that after 
you found out?
    Ms. Goggins. I was very concerned.
    Mr. Kucinich. Who kept you out of the loop? And why were 
they in the loop and you weren't? Because you're the head of 
the consumer products.
    Ms. Goggins. I was not in the loop, as you say, for the 
Motrin recall until I came to the committee, and then I went 
back and looked at the documents after my testimony. On the 
children's Tylenol recall, which happened when, we received the 
FDA 483 in June 2009, I was made aware of that. I was very 
displeased with that, and I maybe inserted myself in the loop, 
if you will.
    Mr. Kucinich. Thank you.
    Mr. Chairman, I am going to ask you to direct staff to call 
some of the people on this list who were involved in these 
communications because we may find out something that will be 
of benefit to the work of this committee.
    Chairman Towns. Without objection, so ordered.
    Let me thank the two of you. Thank you, again, Mr. Weldon, 
for coming, and for your testimony. I want to thank you, Ms. 
Goggins, for coming back. I really appreciate it, because as 
you can see, there is a concern here. We also want to make 
certain that when medication is on the shelf, that it is safe. 
We have that obligation and responsibility. So thank you again. 
We hope that you will remain and hear the testimony of FDA. 
Thank you for your testimony.
    We now will move to our second panel.
    Dr. Joshua Sharfstein is the Principal Deputy Commissioner 
at the Food and Drug Administration. It is committee policy, 
Dr. Sharfstein, that we swear all of our witnesses in. So if 
you would stand and raise your right hand.
    [Witness sworn.]
    Chairman Towns. Thank you. Let the record reflect that he 
answered in the affirmative. You may be seated.
    Dr. Sharfstein, you have 5 minutes to deliver your 
testimony, which will allow the Members an opportunity to raise 
questions with you. So you may proceed.

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

    Dr. Sharfstein. Thank you very much, Mr. Chairman, Mr. 
ranking member, members of the committee. I am Dr. Joshua 
Sharfstein, the Principal Deputy Commissioner of the FDA.
    Thank you for the opportunity to testify today.
    I would like to provide a brief update on FDA's 
investigation of the serious quality lapses at McNeil and then 
address the phantom recall. First, FDA has continued to 
investigate whether any serious illnesses or deaths have been 
linked to the recall. Since the last hearing, FDA has looked 
into adverse events reported to FDA and McNeil citing the 
product subject to the recalls. This investigation covers over 
2,400 reports received by FDA for the 2-year period preceding 
the recall as well as for the 2-month period immediately 
afterward. We did not, in this process, establish any direct 
link to a serious adverse event, including death, in the 
recalled product.
    Second, FDA has worked with McNeil to improve the two 
facilities at the center of the previous recalls. In Puerto 
Rico, as has been mentioned, FDA became aware that McNeil had 
received reports of products from its Las Piedras facility 
having a musty, moldy odor, and McNeil did not conduct a timely 
investigation of the issue or file timely reports. After FDA 
personnel urged McNeil to do more, the firm identified the 
cause of the odor to be a chemical called 2,4,6-Tribromoanisole 
[TBA], a pesticide used to treat wooden pallets. FDA issued 
McNeil a warning letter very quickly on January 15, 2010, 
related to this failure, and FDA since then has issued guidance 
letters to industry. Subsequent investigations by customers 
have led to additional recalls and McNeil has informed us that 
the firm has stopped using the wooden pallets, cleaned its 
facilities and increased its oversight and qualification 
standards of its suppliers. FDA is currently conducting a 
followup inspection of the facility.
    In Pennsylvania, FDA found that the facility in Fort 
Washington had not conducted adequate investigations of product 
problems and complaints. During the April 2010 inspection, the 
firm announced it would stop manufacturing liquid products and 
conduct a major recall, as you know, because of excessive 
particulate matter, potency variability and possible microbial 
contamination. Subsequently, the firm held a series of meetings 
with FDA and identified many corrective actions the company 
would take. These corrective actions include ceasing all 
manufacturing and renovation of the Fort Washington facility, 
remediating the quality systems and using a third-party expert 
consulting firm to review all aspects of the firm's 
manufacturing and quality changes. We are continuing to review 
and provide feedback to the company.
    In addition, since the last hearing, third, all facilities 
associated with McNeil have been inspected at least once within 
the last year. FDA has found inspectional deficiencies of 
varying degrees of seriousness in all of these facilities. One 
common concern the agency has found is the failure to 
investigate and correct product problems in a prompt and 
thorough manner. McNeil has responded to these observations 
with a large-scale corrective plan. FDA is currently reviewing 
and investigating this plan to ensure that corrective actions 
are actually effective.
    Fourth, FDA has had continued discussions with Johnson & 
Johnson, the parent company of McNeil, to address the breakdown 
in leadership and oversight that led to these serious 
compliance problems. We recognize the company is taking agency 
concern seriously, and many changes have been made. We intend 
to keep a close eye on these facilities until the company earns 
our confidence back.
    In February 2010, FDA called an extraordinary meeting with 
the senior executives of Johnson & Johnson. At that meeting, 
the agency discussed a number of serious compliance problems at 
McNeil. More broadly FDA confronted these executives about 
whether McNeil's corporate culture supported a robust quality 
system to ensure the purity, potency and safety of its 
products.
    As part of that meeting, the agency raised concerns about 
what has been called the phantom recall of sub-potent Motrin 
tablets in the spring of 2009. FDA raised this concern because 
it seemed strange and concerning that the company had paid a 
contractor to go into retail stores across the country to 
purchase all available product, while acting like a regular 
customer, and not disclosing what was going on.
    In the summer of 2009, the agency told the company to 
register a real recall. Over the last several months, the 
committee has investigated this event further, using its 
authority to gather additional information from the company and 
the agency. Because of this committee's investigation, we 
understand much more about these events. My understanding comes 
from documents that have been provided to the committee by 
McNeil and FDA. I have not had access to all the relevant 
materials gathered in a related criminal investigation.
    Based on what we know now, the phantom recall raises 
important questions for Johnson & Johnson, FDA and Congress. 
The current voluntary system of drug recalls depends on 
companies providing accurate and complete information to the 
agency and recalling adulterated or otherwise violative 
products in a prompt and appropriate manner. As you and other 
members of the committee have stated, the new documents raise 
serious questions about whether the company's actions have met 
this standards.
    But regardless of the behavior of the company, it is FDA's 
job to do everything possible to protect the public. It was 
clear in November 2008 that the Motrin lots did not meet 
specifications. Yet the actual recall did not happen until 
early August of the following year. This took too long. Part of 
this delay can be attributed to several months spent checking 
whether or not any remaining product was on the shelves.
    Then in April 2009, the company sent a report to FDA 
indicating it was purchasing product from the shelves of 
retailers. This communication did not fully disclose the likely 
scale of the action or the way that the company was intending 
to proceed. In other words, it did not disclose the phantom 
part of the phantom recall. From this point, it took until July 
for the FDA to tell the company should be conducted. In July, 
FDA not only instructed the company that it should be 
registered as a recall, but then went on to confront the senior 
executives at Johnson & Johnson about what happened. In my 
opinion, however, the message that was delivered should have 
been delivered sooner by FDA.
    FDA has no legal authority to require a manufacturer to 
recall a drug product that is unsafe or is not in compliance 
with current good manufacturing process. The recall system 
depends on full and open disclosure, trust, and the industry's 
acceptance of its responsibilities. FDA urges and expects firms 
to notify the agency when it is initiating a recall, but firms 
have no legal requirement to provide this type of notification. 
If a firm does initiate a drug recall, the agency does not have 
the authority to approve the manner in which the firm conducts 
the recall, or to direct the firm to adopt a different recall 
strategy.
    Although the agency is able to accomplish most drug recalls 
with the cooperation of the drug manufacturer, there are 
instances in which firms are reluctant or unwilling to conduct 
a recall, or to do so in a timeframe that FDA believes is 
necessary and appropriate to protect public health. If a firm 
refuses to recall, FDA can pursue a remedy in Federal court, 
like a seizure, but this can be time-consuming and cumbersome. 
Under current authorities, when a product has already been 
widely distributed to hundreds of retail stores, the agency 
would have to undertake hundreds of separate seizures in order 
to ensure that all violative product has been removed from the 
market.
    Mr. Issa. Mr. Chairman, could I ask unanimous consent that 
the entire statement be placed in the record so we can get to 
Q&A? We have received it.
    Chairman Towns. Without objection, your entire statement 
will be included in the record. So if you just would summarize.
    Dr. Sharfstein. Sure, I am sorry. I just have two more 
sentences.
    The events of the phantom recall raises important questions 
about the current voluntary recall system. In this case, if FDA 
had the authority simply to order a recall to be done in the 
right way, I do not believe these events would have occurred.
    Thank you for the opportunity to testify today, and I am 
ready for questioning.
    [The prepared statement of Dr. Sharfstein follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Chairman Towns. Thank you very much. Let me thank you for 
your statement, Dr. Sharfstein.
    Let me begin by asking, did the FDA approve Johnson & 
Johnson's phantom recall of Motrin?
    Dr. Sharfstein. No. To start, the FDA doesn't approve 
recalls. It is in the discretion of the company.
    But the second thing, I think, that is very important, is 
the phantom part of the phantom recall. And this was part of my 
testimony previously. It relates to the fact that there were 
contractors going out telling people to act like regular 
customers and not really tell the truth about what they are 
doing in the stores. Based on what I know, based on the 
documents that I have reviewed, I don't see any indication that 
FDA was aware at the time that those types of activities were 
going on or approved.
    Chairman Towns. Are you familiar with the soft market 
withdrawal term?
    Dr. Sharfstein. I am not familiar with that term.
    Chairman Towns. When Johnson & Johnson sent the FDA a 
letter April 2009, talking about buying defective Motrin, why 
didn't the FDA become concerned and take action right away? 
What led to the delay?
    [The information referred to follows:]
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    Dr. Sharfstein. I think that is a very fair question for 
the committee to ask. That report disclosed that McNeil was 
retrieving product that failed specifications. And removing the 
product was the right thing for McNeil to be doing. But what it 
didn't say in that report was that they were, all it said was 
we are going to retrieve it from the shelves, or however they 
phrased it. It didn't say that they would be telling people to 
act like regular customers or not disclosing the facts when 
they were asked about what happened when they went out.
    I think that in part because there was limited information, 
that might have contributed to the delay. But I also think that 
FDA should have been asking questions right away, and figured 
out what the agency eventually figured out, that this really 
did need to be registered as a real recall.
    Chairman Towns. What went wrong that caused Johnson & 
Johnson's recall of 135 million bottles of children's medicine? 
Is the FDA satisfied with what Johnson & Johnson is doing to 
solve the problem? Are you satisfied with Johnson & Johnson?
    Dr. Sharfstein. What went wrong there is sort of the notes 
and the music. The notes are the specific details and the 
inspectional observations. The fact that there were batches 
that were super-potent or batches that may have had particles 
or an issue with how they investigated and responded to 
potential bacterial contamination.
    But the music is that the company had an inadequate quality 
system. And that you could see in multiple facilities. FDA is 
both responding to the notes and the music, you have heard from 
the testimony there are major changes at McNeil. FDA has been 
very involved in ensuring that those are the right kinds of 
changes. And FDA is committed to making sure when this facility 
is up and running that it is in compliance.
    So we are comfortable with where things are now. We 
appreciate the commitment of McNeil and Johnson & Johnson's 
leadership to fixing the problem. But this was a very serious 
problem, and we are not going to take anything for granted.
    Chairman Towns. Right.
    Let me ask, does FDA need more enforcement authority or 
funding to be able to respond to issues like the Johnson & 
Johnson recall? This bothers me in terms of, for something like 
this to happen. We are concerned about safety. Does FDA need 
additional authority? What is the problem?
    Dr. Sharfstein. I think there are a couple of things. This 
is to be put in the context that FDA did identify these lapses 
before there was a serious health consequence. We are not 
finding that there are serious illnesses or deaths linked to 
this problem. And the agency, through its inspections and 
through multiple meetings with the company, and aggressive, 
extraordinary meetings with the company, has brought about 
tremendous change in this area.
    Having said that, all of us want to prevent these things 
and we want to be responding much faster in some cases even 
than what happened here. And I think that issues of resources 
and authority are very fair questions. I testified that if FDA 
had had mandatory recall authority, I think things would have 
gone a lot different.
    Chairman Towns. Now how are you working with Johnson & 
Johnson to correct this and to make certain it doesn't happen 
again?
    Dr. Sharfstein. How are we working?
    Chairman Towns. Yes.
    Dr. Sharfstein. It is both at the individual facility level 
and at the corporate level. So we are helping them with 
individual quality issues that they had, as well as how they 
structure their quality program to make sure that the kinds of 
lapses that they had don't happen again.
    Chairman Towns. On that note, my time is expired and I now 
yield 5 minutes to the gentleman from California.
    Mr. Issa. No, let Mr. Chaffetz go ahead.
    Chairman Towns. Five minutes to the gentleman from Utah.
    Mr. Chaffetz. Thanks, Mr. Chairman.
    Thank you, Doctor, for being here. Ms. Torres, can you help 
explain to me, what is her current status? Did she get fired? 
Has she been demoted, did she get promoted, what is her current 
status?
    Dr. Sharfstein. I understand she is still the district 
director in San Juan, Puerto Rico.
    Mr. Chaffetz. So you found that she has done nothing 
inappropriate, she acted just the way she should have, you are 
totally comfortable with the way she acted?
    Dr. Sharfstein. No, I would say that this is a matter that 
is under investigation. We are looking at what happened here. 
As I testified, things should have happened sooner on FDA's 
part. It is something that we are looking at. And based on what 
we find and conclude, that could lead to different changes at 
FDA.
    Mr. Chaffetz. Is there an opportunity for this committee to 
interact with her? Is there any reason there is a hesitation on 
the part of FDA to make her available for questioning by the 
committee?
    Dr. Sharfstein. Well, as you know, I think that, I know at 
least the minority staff had requested to speak with her. And 
FDA declined. FDA declined at the instruction of the Department 
of Justice, Because she is a witness, a central witness, in a 
related criminal investigation.
    Mr. Chaffetz. When you say related criminal investigation, 
is that related to Johnson & Johnson in this case or related to 
some other group or product?
    Dr. Sharfstein. I believe it is related to this.
    Mr. Chaffetz. Related to this. Is it your common practice 
or recommendation to not make field staff and people who are 
closest to these situations available to the committee?
    Dr. Sharfstein. My view, as a former staff member of this 
committee, is that Congress should get as much information as 
possible.
    Mr. Chaffetz. So is it your personal recommendation that 
she should be made available?
    Dr. Sharfstein. Well, but I also recognize the importance 
of the integrity of a criminal investigation.
    Mr. Chaffetz. Why would a criminal investigation be slowed 
down by her appearing before this committee, or even simply 
meeting with staff from both the Republican and Democratic 
sides of the aisle?
    Dr. Sharfstein. I don't think that is a judgment that FDA 
should make. What we did is we turned to the Department of 
Justice and their career prosecutors and we got instructions 
from them. They said basically that it would be a problem. That 
is why. But I am not a lawyer, I don't know these cases, so I 
can't really comment. But basically we are relying on the 
Department of Justice.
    Mr. Chaffetz. I think there is a frustration, if I can 
express it, at least from this Member, that she should be made 
available, the other staff that are there in the field office 
should be made available, in the spirit of full disclosure and 
what is happening. I am a bit troubled by this Elaine, and 
again, I am slaughtering people's names here, Elaine Bobo, is 
that how you pronounce her name? She is the FDA spokesperson. 
Very recently she said, it appeared in the Wall Street Journal, 
Associated Press and Reuters, ``Any effort to suggest that the 
FDA had knowledge of the phantom recall is based on quoting 
documents selectively and out of context and ignores other 
evidence as to what occurred. McNeil's own written account of 
its communications with the FDA does not support the conclusion 
that McNeil disclosed the activities associated with its 
phantom recall to the FDA.''
    I have a problem believing that. And I am troubled when the 
FDA puts out such a dramatic statement. And yet, we have a 
whole host of information here that suggests otherwise.
    Dr. Sharfstein. I would be happy to try to clarify that and 
explain.
    Mr. Chaffetz. Sure.
    Dr. Sharfstein. What I believe people were alleging, or 
there were questions coming to the agency, was that we knew 
about the surreptitious nature of the recall, the phantom part 
of the phantom recall, that people were out there acting like 
regular customers, not telling the truth when asked. There 
isn't, in anything that I have seen or anything before the 
committee, evidence that FDA knew about that. And so I think 
that is what she was responding to.
    Mr. Chaffetz. When we use the term recall, that has some 
very specific implications. It is a term, right? It is a very 
specific term that has a great deal of definition to it in the 
world of FDA and certainly the companies that you interact 
with. So if a company came and said, we are conducting a 
recall, you would have a pretty good sense of what they are 
going to do, right? Am I off base in saying that?
    Dr. Sharfstein. Not all recalls are the same. They then 
have to file a form, which goes through all the specifics, and 
there can be a fair amount of variability in a recall.
    Mr. Chaffetz. So I am looking at this field action report, 
which is dated April 21, 2009. And part of what was submitted 
said, the product from the subject lots found in the stores was 
removed during the visits. Visits to the remaining retailers 
will be completed by July 15, 2009, to remove any product from 
the subject lot that is found. It didn't say they were doing a 
recall, it said they were going back, and I am not trying to 
excuse their action, we just heard testimony from them saying 
we didn't do this right.
    Dr. Sharfstein. And I want to be clear. FDA was informed of 
exactly that on April 21st.
    Mr. Chaffetz. Then how does the FDA spokesperson come out 
and say, we didn't know anything about this?
    Dr. Sharfstein. I think the difference is that what she was 
referring to, what she is saying FDA didn't know, and I still 
don't see any evidence of, is didn't know about the 
surreptitious, lying part of the recall.
    Mr. Chaffetz. It wasn't a recall.
    Dr. Sharfstein. Well, the event. And that is still not in 
the documents, where people are being instructed to say things 
that aren't true.
    Mr. Chaffetz. We all agree. But what my concern is----
    Dr. Sharfstein. And that is not in that document.
    Mr. Chaffetz. What I would appreciate your looking back and 
considering is that the FDA's statement was very strong, 
saying, oh, no, you cannot construe--there was evidence that 
you should have looked deeper into that. When they say they are 
not doing a recall, then I think the FDA has some obligation to 
probe a little bit further, maybe ask a few questions. And you 
admitted that they came to the party late in this regard.
    Let me read a couple quick quotes, Because I cited them 
earlier. This is from internal J&J documents. ``FDA is really 
bending the rules in this case because of the fact that we 
stopped distribution a while ago.'' So for the FDA to go take a 
real strong stance and say, oh, we knew nothing about this, but 
then we have documents back from March 24, 2009 saying the FDA 
is really bending the rules.
    Dr. Sharfstein. Here is what I can explain I think that one 
means, because I am familiar with that. That was referring to 
the fact that we weren't ordering a recall without even a 
check. That is my understanding of that document. When he says 
because, basically a product that is violative and on the 
market should be recalled.
    But the company came to us and said, we don't think any is 
out there. They said that to us, even though their own 
documents here indicate, I believe, that they knew there was 
some out there. But they said very specifically, and in fact if 
you look at the March 23rd FAR, they were saying, there is none 
out there, there is none out there. They used that argument. 
And FDA's district office said, well, if there is none out 
there, you don't need to do a recall. He interpreted that as 
bending the rules, but in fact, our regulations permit if there 
is none out there not to have a recall.
    Mr. Chaffetz. Mr. Chairman, let me just make this last 
comment and I will yield back. I think it is irresponsible for 
the FDA to put out a public statement when the documentation 
shows that it wasn't a ``recall,'' that there is a criminal 
investigation in place, that there are internal documents that 
demonstrate there were many discussions with the FDA. I think 
you have plenty of reasons to not attack the committee for the 
testimony that we were able to draw out during the previous 
testimony, but you essentially came out just a couple, 
literally days ago, and attacked the credibility of what this 
committee is trying to do. And really what we are trying to do 
is inform the public and let them participate in this and come 
to their own conclusion.
    There was plenty of evidence from multiple sources that did 
not warrant the strong statement that came from the FDA. That 
is part of my point. I would appreciate your consideration in 
looking into that moving forward.
    I yield back the balance of my time.
    Chairman Towns. I thank the gentleman for his questioning. 
I now yield to the gentleman from Maryland, Congressman 
Cummings.
    Mr. Cummings. Thank you very much. First of all, I want to 
thank the gentleman who just asked questions. I thought he 
asked a great set of questions. As I was looking at the 
document that he was referring to, Dr. Sharfstein, there is a 
sentence here that said, ``the assessment performed 
demonstrated that on a statistical basis, a low amount, 
approximately 1 percent of the batches, is essentially still at 
the retail level.'' Are you familiar with that?
    Dr. Sharfstein. Yes.
    Mr. Cummings. What did that say to you all? So you didn't 
think it was that much out there?
    Dr. Sharfstein. That is correct. In fact, the month before, 
in the March version of the same document, it actually said it 
is expected that none of the affected lots are available at the 
store level. And at the same time, there are several documents 
that have emerged through the committee's investigation that 
they were expecting to find more. And in fact, they found more. 
And I will read you one of the emails that was on April 16th, 
prior to the submission of that. It said, ``we found 264 units 
of the impacted lots, which would project there is potentially 
5,280 units across the 5,000 stores, or 6.3 percent of the 
total product manufactured and shipped.''
    Now, it goes on to say why she thinks----
    Mr. Cummings. But this was not information that you all had 
at the time?
    Dr. Sharfstein. As far as I can see in the documents, this 
information was not shared with the FDA.
    Mr. Cummings. Dr. Sharfstein, buried in the field alert 
report dated April 21, 2009, there is a brief statement that 
``The product from the subject lots found in stores was removed 
during the visits.'' How would the FDA normally interpret a 
statement like that? And how would most companies normally 
remove product from stores if they were conducting a product 
recall? And how would the FDA and general public be informed?
    Dr. Sharfstein. I think that is an excellent question. I 
spoke last night to the head of enforcement in the Office of 
Regulatory Affairs at FDA. He said that he had looked at that 
report and that line. He said it was an unremarkable line. That 
is the kind of thing that companies do as part of recalls, they 
go out and they get the product.
    But what is remarkable is the phantom part, that they were 
concealing it when they went out. That is not in there. He 
said, that is remarkable. What is in the report is not 
remarkable.
    Mr. Cummings. So let me make sure I know what you are 
talking about. As you heard, McNeil instructed their 
contractor, Inmar, to ``simply act like a `regular customer' 
while making these purchases.'' They are also told ``there must 
be no mention of this being a recall of the product.''
    So when you say you didn't know about the phantom part, 
that is what you mean?
    Dr. Sharfstein. That is exactly right.
    Mr. Cummings. I see. So just for clarification, then, you 
thought they, apparently there is a situation where something 
was not dissolving properly and no one was under the 
impression, that is FDA, that it could be harmful to somebody 
that would buy it, is that a fair statement?
    Dr. Sharfstein. Not pose a safety problem, but it wouldn't 
necessarily be as effective as it should be.
    Mr. Cummings. Say that again?
    Dr. Sharfstein. We didn't think that it caused a safety 
problem.
    Mr. Cummings. Right.
    Dr. Sharfstein. We agreed that it might not be as effective 
as it should be, because it was less medicine in the pill, 
basically.
    Mr. Cummings. Did you know they were going into 40 States 
to do this phantom recall?
    Dr. Sharfstein. All we knew, I don't know if I can answer 
that completely, other than to point to that document, that is 
what we were told, that they were going to retrieve it. But I 
think that what is clear, and this is where I believe that FDA 
could have done better, is that document doesn't say a whole 
lot. We should have been asking questions, then, to really 
understand more. We eventually did ask those questions, we 
eventually did find out about the phantom part of the recall. 
Then the agency called the company to account for it, and that 
is why we are here.
    Mr. Cummings. Dr. Sharfstein, let me ask you this. So you 
are admitting that the FDA did not do all it should have done, 
is that right?
    Dr. Sharfstein. That is correct.
    Mr. Cummings. But we don't want to take light off of the 
fact that McNeil and J&J could have done better, too, is that 
right?
    Dr. Sharfstein. I think fundamentally, the responsibility 
is with the company to have handled their quality problems in a 
much different way. And FDA did respond and did identify these 
problems. I think we always have to ask ourselves whether we 
could have done so faster.
    Mr. Cummings. And that leads me to my final question, how 
do we know that we now have an FDA and a Department that deals 
with this that would deal with it differently and would deal 
with it in a way that would cause that trust to come to 
citizens of our country who might be buying the product?
    Dr. Sharfstein. That is a fair question. I think I would 
point in part to all the work that we have done with these 
companies since this came to light. And I would also say that 
Dr. Hamberg, the Commissioner and I are absolutely committed to 
strengthening the enforcement and the oversight of FDA. I 
actually invited here today our new head of enforcement, Dara 
Corrigan, a former acting HHS inspector general. This is her 
first week on the job, and I asked her to come to understand 
what had gone on in this case and the need, as she works and 
establishes leadership over this part of FDA, the need for us 
to do everything we can.
    Mr. Cummings. Could she raise her hand, so we will at least 
know who you are talking about? There you are. Welcome, 
congratulations.
    Thank you, Mr. Chairman.
    Chairman Towns. Let me also welcome you. Thank you.
    I now yield 5 minutes to the gentlewoman from Washington, 
DC, Congresswoman Norton.
    Ms. Norton. Thank you, Mr. Chairman.
    Dr. Sharfstein, I was really interested in Mr. Weldon's 
answer to my question regarding the children's medicines and 
the 8 million bottles. I would like your opinion. This was my 
question to him, predicated on the McNeil documents that showed 
contamination growth identified in children's medicine in April 
2008. And I wanted to know from him whether or not he should 
have recalled, not in 2009, but earlier. And he indicated that 
they had looked at those samples and that there was no 
contaminant in those samples. Is that your view?
    Dr. Sharfstein. It is true, it basically relates to what I 
would call a super-lot of this substance, meaning a huge batch, 
and the sub-lots. So the super-lot was known to have some 
contamination in it. I understand that the company knew that 
this certain sub-lots that were contaminated, they didn't use. 
Other sub-lots they tested and didn't find a problem and they 
used those.
    But FDA's view was that testing alone is not, doesn't give 
you enough confidence of safety if the whole super-lot has had 
a problem.
    Ms. Norton. So what should be done?
    Dr. Sharfstein. So what should have been done was basically 
recall it. And that is why it eventually got recalled. But this 
isn't just FDA's view, this is what we believe that their good 
manufacturing practices required. And it relates to the concept 
that you can't test quality into something. If you know that 
something is of poor quality, you can't keep testing it to find 
the little part to use. If there is a problem overall, you 
can't use it.
    Ms. Norton. And I would think especially with children's 
medicine of various kinds. I must say that what it does show is 
that a company will act, I think quite normally, absent 
regulations. It will draw the presumption in favor of itself. I 
noticed that on page 5 of your own testimony you say something 
that I would regard as a truism: the current voluntary system 
of drug recall depends on companies providing accurate and 
complete information to the agency and recalling adulterated or 
otherwise violative products in a prompt and appropriate 
manner.
    The voluntary system would assume all that to be the case. 
But I must say that it makes the same kind of assumption that 
was made for 10 years about the financial system, that 
voluntarily letting them go without regulations will do it. And 
the same way, this voluntary recall notion is not only an 
oxymoron, I don't see how we can continue to abide it and 
expect companies to act any way but the way people do, to 
protect themselves, to protect their shareholders. The only way 
to pierce that is with some kind of form of regulation. If we 
haven't learned that from financial reform, and now we have to 
learn it from children's medicine, we will never learn it.
    I want to ask you about the phantom recall of defective 
Motrin. Do you believe, Dr. Sharfstein, that the companies 
adequately informed FDA about the defective Motrin issues 
beginning in November 2008?
    Dr. Sharfstein. We knew there was a defective Motrin issue, 
the company did inform us that there was a defective Motrin 
issue November 2008. I do not think that we were adequately 
informed about what the company knew about whether it was still 
on the shelves. Because at the same time the company was 
telling FDA they didn't think any was on the shelves, they were 
internally expecting to find some on the shelves. So I don't 
think that was adequate information to the agency. I think that 
may have been one of the contributing factors to the delay.
    Ms. Norton. And of course, although they have a duty to do 
that, since it is only a voluntary duty, there was nothing you 
could do about it.
    Dr. Sharfstein. And I also don't believe, based on the 
information that I have available, that the company informed 
FDA about the phantom part of the phantom recall, the 
surreptitious nature, the act like a regular employee, don't 
tell people what you are doing, part of the recall. I do not 
see in any of these documents that FDA was informed about that 
at that time.
    Ms. Norton. I see my time is expired. Thank you, Mr. 
Chairman.
    Chairman Towns. I now yield 5 minutes to the gentleman from 
California, the ranking member of the committee, Congressman 
Issa.
    Mr. Issa. Thank you, Mr. Chairman.
    Doctor, I earlier in my opening statement referenced your 
old boss, Mr. Chairman Waxman. Because I do think that he was 
right when he said that we had a constitutional obligation and 
we weren't meeting it. But I want to be true to his words and 
ask you, it is hard to get a notebook like this, four inches 
thick. This is the record of your agency's inspections without 
shutting down that plant. Now, you are coming here today and 
you are saying, I need new authority, I need mandatory recall 
authority. You may get it.
    But you had the ability to shut down the factory. Any time 
you found anything, you could pull the switch and shut them 
down. This is how many times you visited and visited and 
visited under Chairman Waxman's tenure, your working on the 
committee.
    But more importantly, under the Bush administration, this 
was not dealt with. Of course, it was the same people. Under 
your administration, this was not dealt with. This was the 
record of failure before we got to the recall.
    Now, you haven't been on the job more than about 2 years, 
but I assume you have read your regulatory procedure manual, 7-
3, which talks about your recall procedures, statutory recall 
procedures? OK. Let's go through it by the numbers and make 
sure we understand. Your people in Puerto Rico were 
participants in a stealth recall. The evidence shows that they 
understood product was being taken.
    I will agree with you, subject to criminal investigation 
that is going on, that they may not have known that it was 
being bought without saying that in fact it was being recalled. 
But of course, remember, your people had agreed that it wasn't 
a recall, and yet they were agreeing that it was going to be 
removed from the shelves.
    So while the FDA was aware product was being assessed and 
removed from the shelf, they were not asking for a recall. They 
were not in fact doing what they already have a responsibility, 
according to your manual, which was to agree to public 
statements, etc.
    Now, if they didn't have the right to do a recall but they 
knew product was being recalled, then they did not participate 
in how that recall that wasn't a recall was going to be done. 
In fact, if anything, while the knew that product was being 
removed by a third party contractor, they didn't ask, they 
didn't tell, like the three monkeys that you see, hear no evil, 
see no evil, speak no evil. They failed to do their job, 
Because they had an obligation and a manual that told them how 
to do that.
    Isn't that correct, that the fact that they didn't know how 
it was being removed and didn't ask, and did not assert any of 
the procedures in your manual?
    Dr. Sharfstein. Let me thank you for your questions and I 
respect the importance of oversight.
    Mr. Issa. And I would like a yes or no on that. Did they in 
fact, according to the evidence, know product was being removed 
from the shelf and did not assert, in any documents you have, 
remember, Because of the criminal investigation, we are almost 
opaque relative to the FDA.
    Dr. Sharfstein. The FDA did assert that this needed to be a 
recall in July. But it did not happen before that. And one of 
the things----
    Mr. Issa. But they were informed that product was being 
removed from the shelf. That is in the email. Your people--no, 
wait a second--that your people did a press release, a press 
statement, implying that we weren't doing our jobs and we were 
misleading the public, when in fact, you may not have known 
what was being said as they purchased the product, but your 
people knew they purchased the product, and there was ongoing 
dialog into that extent. Isn't that true?
    Dr. Sharfstein. It is true that we knew they were 
purchasing the product. That was----
    Mr. Issa. OK, so now you know there is a recall going on. 
Purchasing back the product is a recall, isn't it? Call it 
whatever you want, isn't it a recall?
    Dr. Sharfstein. It is a component of a recall.
    Mr. Issa. OK, so they are purchasing back the product. You 
are not doing a public statement to encourage people to return 
product so it can be bought back at those consumer areas. You 
are not doing any of the things that are in your manual. And 
yet you want us to believe it is all Johnson & Johnson.
    Dr. Sharfstein. That is not what I----
    Mr. Issa. Now, wait a second. Johnson & Johnson made bad 
product. They made product that was not working up to its 
standard. But yet you want us to believe that it is all their 
fault----
    Dr. Sharfstein. No.
    Mr. Issa [continuing]. And that Ms. Torres, who is still on 
the job but under criminal investigation, is in fact somehow to 
be given a pass here and you are to be given new authority, 
when I have four inches of authority that you didn't assert.
    Dr. Sharfstein. With all respect, that is not what I 
testified. I did not testify this was all Johnson & Johnson's 
fault. In July----
    Mr. Issa. Well, what changes have you made or are you 
prepared to make at FDA to prevent this from happening again at 
the other 14 plants in Puerto Rico, 35 plants in Puerto Rico?
    Dr. Sharfstein. Can I finish my previous thought?
    Mr. Issa. Please.
    Dr. Sharfstein. FDA identified the problem and in July was 
very clear with the company. What I testified was----
    Mr. Issa. No, no, in July, no, they were told by the 
company of this problem prior to that in the whole process.
    Dr. Sharfstein. FDA instructed the company to register this 
as a recall in July.
    Mr. Issa. That is 6 or 7 months after they were aware of 
the problem and after it was all removed from the shelf.
    Dr. Sharfstein. And I testified that instruction should 
have come earlier. But it was because of that instruction that 
it got into the FDA enforcement bulletin.
    Mr. Issa. Isn't it true that it is not on your Web site 
today, that it is not a listed recall?
    Dr. Sharfstein. That is not true.
    Mr. Issa. We looked for it, we could not find it. Would you 
please make it available to the committee?
    Dr. Sharfstein. I can give it to you right now, if you want 
it. It is in the enforcement report of November 25, 2009.
    Mr. Issa. No, I asked about your Web site, where you list 
public recalls.
    Dr. Sharfstein. This is on, I have a printout that looks 
like it is from a Web site right here, listing it. I am happy 
to show it to you. It sure looks like a printout from a Web 
site.
    Mr. Issa. I am sorry, but we do have, we will provide you 
with our Web site that it is supposed to be on that it is not 
on, and we can compare that for the record later.
    Dr. Sharfstein. I was given the report printed out from a 
Web site. So we will figure out what is going on there.
    FDA realizes that it has a critical responsibility, not 
just for the facilities in Puerto Rico, the facilities 
elsewhere in the United States, but all around the world that 
are shipping drugs and other things into our country. This is 
extremely important. That is why the commissioners made a 
priority of enforcement, and that is why we are pleased that 
there is an entire business within the private sector to train 
companies to meet FDA's specifications for compliance. It is 
both an FDA responsibility, it is also a corporate 
responsibility. We have to do everything we can in a changing 
and very difficult environment to protect the public.
    Mr. Issa. Mr. Chairman, I know my time is expired. So for 
the record, I would like a complete answer to this. And that 
is, since the discovery of this pesticide used on the wood, and 
you testified that in fact, if you will, they had failed to 
meet the responsibility, would you explain for the record why 
you did a notification to the industry of a new, novel problem 
after the fact that was discovered by Johnson & Johnson, 
reported by Johnson & Johnson and fixed by Johnson & Johnson, 
if you will, and yet you put it out to an industry that was 
completely unaware of it, and you want us to believe that 
somehow it was a failure of a company, when in fact it was a 
discovery not previously known by any of the manufacturers in 
the industry?
    I would like that completely answered for the record, 
Because I find an inconsistency between your implying that a 
terrible thing to discover had happened, but that somehow you 
guys were the cure rather than in fact, all you did was take 
their work and publicize it to an industry that otherwise would 
not have been made aware of it. I yield back.
    Dr. Sharfstein. I would be happy to answer that question 
initially, but I will leave it to you.
    Chairman Towns. There will not be a second round, so maybe 
you could answer it at this time, even though your time has 
long, long expired. But you can answer it at this moment.
    Dr. Sharfstein. It is OK, it is what I deserve for having 
been on the committee as staff. Many minutes of questions.
    What FDA objected to with respect to the smell and the TBA 
was not so much that there was a new problem that the company 
found, but they had identified a problem and not reported it 
for quite some time. And then it was the FDA pushing them to 
investigate it further that led them to discover the problem.
    So if the company had come to us and said, we have found a 
problem, we would be saying, that is terrific, you found a 
problem that may be applicable in other places, thanks for 
having a system that finds that. Instead, there were problems, 
many months went by before a report came into FDA. When that 
happened, we felt the company wasn't pursuing it diligently 
enough. FDA was on top of it.
    And as a result of that, we got those recalls. We learned 
and we informed the rest of the industry so that we could be on 
top of an emerging problem. I think it speaks to a bigger 
point.
    Mr. Issa. Mr. Chairman, I appreciate his answer and I think 
it is a good one. But it flies in the face of, when you 
discover new science, the expectation that you are going to 
report it within 3 days in a meaningful way begs the question 
of, if the FDA can't even make up its mind on the July report 
that they are still evaluating, 60 days later, and say that 
they are not prepared to talk about, I am seeing a pattern that 
we expect corporations to respond to new science discoveries in 
3 days and then so that everyone knows.
    It is very clear that we do need to have reporting. I think 
Johnson & Johnson appropriately was wrong not to at least give 
a heads up. But let's be honest. This was new science that 
needed discovery, that has benefited all the industry so that 
we make better product. And I think 3 days is a nice time to 
say, oh, we found something you might be interested in----
    Mr. Cummings. Mr. Chairman, regular order. Mr. Chairman, 
regular order.
    Chairman Towns. Let me just say this. Based on what the 
gentleman is saying, it seems like he wants to support my 
legislation. [Laughter.]
    I yield to Ms. Watson for 5 minutes.
    Ms. Watson. I do hope that is so.
    Dr. Sharfstein, Johnson & Johnson has described, as our 
chairman has rightfully dubbed the phantom recall of the adult 
Motrin products as merely an assessment to determine how much 
product was in circulation. However, we knew this is not 
accurate because they proceeded to remove the product from the 
stores without informing customers or retailers of the 
defective product.
    Is this a typical kind of thing that happens, and what 
steps should have Johnson & Johnson taken when they discovered 
the dissolution problem with the Motrin? Is this something that 
occurs often?
    Dr. Sharfstein. This is a very unusual set of 
circumstances. That is why, when FDA really understood what was 
going on, there was an extraordinary meeting with the parent 
company, Johnson & Johnson, to express concern about it.
    To your point, what should happen is when there is a 
product that is out of specification, there is a prompt 
notification to the agency and a recall, an official, 
registered recall. In this case, because they had stopped 
selling it before, they made the case to the agency that there 
wasn't out there and there might not need to be a recall. 
Although as I said, I am concerned, based on some of the 
documents the committee has found, that wasn't necessarily a 
fair representation to the agency, Because they seemed to know 
that there was stuff out there. That was one of the steps that 
led this to take a lot longer than it should have.
    But I also acknowledge that FDA could have done more to 
make this happen sooner.
    Ms. Watson. During our previous hearing on this subject, it 
was reported that from January 1, 2008 through April 30, 2010, 
that 775 adverse events had been reported for children who took 
the recalled products. At the time, the FDA could not confirm 
whether or not there was a direct causal link between these 
events and the recalled drugs.
    But I think it is important that we fully investigate the 
effects these contaminated or super-potent drugs could have on 
children. So has the FDA been investigating the adverse events 
report and if so, how? Would you elaborate a bit?
    Dr. Sharfstein. Sure. I believe that there was a team in 
the Office of Surveillance and Epidemiology that pulled all the 
adverse events for the recalled products for 2 years prior to 
the recall and then 2 years after and reviewed them, and did 
not find that there was evidence establishing a link. That was 
one of the things that was done.
    In other specific cases, FDA actually went out, where there 
was a coroner, for example, who had a sample, and was 
concerned. We tested the sample and we didn't find it in any of 
the samples.
    So everything that we could do we have done to try to 
assess this. There is a very small risk, but we did not see 
evidence in these reports that there were serious illness or 
death.
    Ms. Watson. Do you have any reasons to believe that these 
adverse events were related to the recalled medications? What 
are the most common adverse events that children have 
experienced because of the use?
    Dr. Sharfstein. Most of the adverse events are because of 
the medications themselves. We couldn't find any adverse events 
related to the problems in production. Each of those different 
kinds of medicines has their own series of adverse events that 
are on the label. Some medicines might make a child jittery, 
potentially. There are a list of things that could happen. 
Those are the kinds of reports that we got.
    In other cases, people might take, mistakenly, an overdose, 
too much of a medicine and have an adverse event related to 
that. But that is not because of the quality problem in 
production. That just happens. All medicines carry risks.
    So those are the kinds of things that were being reported 
to the agency, not things that we could track to the quality 
problems that were at issue.
    Ms. Watson. In my last 30 seconds, I am addressing the 
Chair. Mr. Chair, does your bill address this kind of thing, 
what are the adverse effects and how typical?
    Chairman Towns. Yes.
    Ms. Watson. Would your bill address that, is there a 
provision?
    Chairman Towns. It will address it. It also is still open 
for amendment and suggestions.
    Ms. Watson. Very good.
    Chairman Towns. We need co-sponsors.
    Ms. Watson. I yield back. You will have one.
    Chairman Towns. Thank you very much. Let me thank the 
gentlelady for her comments.
    And let me just say to you, Dr. Sharfstein, thank you so 
much for your testimony. I also want to thank Mr. Weldon and 
Ms. Goggins for staying and listening to your testimony. I 
think you are the appropriate person to do this, because you 
are a pediatrician, aren't you?
    Dr. Sharfstein. I am.
    Chairman Towns. So you are the right person to talk to in 
reference to this issue. I want to thank you for that.
    I also want to let the Members know that the record will be 
open for several days. We have not come up with the amount of 
days but there are certain questions, of course, that Members 
wanted to submit for the record. Of course, we will leave it 
open to get those questions.
    Again, I want to thank you for being here. I want to thank 
all the Members for their participation. On that note, the 
committee stands adjourned.
    [The prepared closing statement of Chairman Edolphus Towns 
follows:]
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    [Whereupon, at 12:20 p.m., the committee was adjourned.]
    [Additional information submitted for the hearing record 
follows:]
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