[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
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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)
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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:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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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