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63–148 PDF 2011

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

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

(

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

http://www.house.gov/reform

(II)

COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM

EDOLPHUS TOWNS, New York, Chairman

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

JOHN F. TIERNEY, Massachusetts

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

JIM COOPER, Tennessee

GERALD E. CONNOLLY, Virginia

MIKE QUIGLEY, Illinois

MARCY KAPTUR, Ohio

ELEANOR HOLMES NORTON, District of

Columbia

PATRICK J. KENNEDY, Rhode Island

DANNY K. DAVIS, Illinois

CHRIS VAN HOLLEN, Maryland

HENRY CUELLAR, Texas

PAUL W. HODES, New Hampshire

CHRISTOPHER S. MURPHY, Connecticut

PETER WELCH, Vermont

BILL FOSTER, Illinois

JACKIE SPEIER, California

STEVE DRIEHAUS, Ohio

JUDY CHU, California

DARRELL E. ISSA, California

DAN BURTON, Indiana

JOHN L. MICA, Florida

JOHN J. DUNCAN, JR., Tennessee

MICHAEL R. TURNER, Ohio

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

BRIAN P. BILBRAY, California

JIM JORDAN, Ohio

JEFF FLAKE, Arizona

JEFF FORTENBERRY, Nebraska

JASON CHAFFETZ, Utah

AARON SCHOCK, Illinois

BLAINE LUETKEMEYER, Missouri

ANH ‘‘JOSEPH’’ CAO, Louisiana

BILL SHUSTER, Pennsylvania

RON STROMAN, Staff Director

MICHAEL MCCARTHY, Deputy Staff Director

CARLA HULTBERG, Chief Clerk

LARRY BRADY, Minority Staff Director

(III)

C O N T E N T S

Page

Hearing held on 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

(1)

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

MEDICINES AND THE PHANTOM RECALL OF

MOTRIN (PART 2)

THURSDAY, SEPTEMBER 30, 2010

HOUSE OF REPRESENTATIVES,

COMMITTEE ON OVERSIGHT AND GOVERNMENT REFORM,

Washington, DC.

The committee met, pursuant to notice, at 10:07 a.m. in room

HVC–210 Capitol Visitor Center, Hon. Edolphus Towns (chairman

of the committee) presiding.

Present: Representatives Towns, Cummings, Kucinich, Clay,

Watson, Norton, Van Hollen, Issa, and Chaffetz.

Staff present: John Arlington, chief counsel—investigations;

Kevin Barstow, investigative counsel; Kwame Canty, senior advisor; Linda Good, deputy chief clerk; Carla Hultberg, chief clerk;

Marc Johnson and Ophelia Rivas, assistant clerks; Chris Knauer,

senior investigator/professional staff member; Steven Rangel, senior counsel; Leneal Scott, IT specialist; Christopher Staszak, investigative counsel; Gerri Willis, special assistant; Ashley Wilson and

Alex Wolf, professional staff members; Lawrence Brady, minority

staff director; John Cuaderes, minority deputy staff director; Jennifer Safavian, minority chief counsel for oversight and investigations; Adam Fromm, minority chief clerk and Member liaison; Kurt

Bardella, minority press secretary; Benjamin Cole, minority policy

advisor and investigative analyst; Seamus Kraft, minority director

of new media and press secretary; Justin Franco, minority press

assistant and clerk; Tom Alexander, minority senior counsel; Ashley Callen and Sery Kim, minority counsels; and Christopher

Bright and Molly Boyl, minority professional staff members.

Chairman TOWNS. The committee will come to order.

Johnson & Johnson’s Recall of Children’s Tylenol and other Children’s Medicines and the Phantom Recall of Motrin.

Good morning, and thank you all for being here. This is our second hearing on the disturbing recall of children’s medicine by Johnson & Johnson. At our first hearing, we learned that J&J’s April

30th recall of children’s Tylenol, children’s Motrin, children’s

Benadryl and Tylenol Infants’ Drops was the largest recall of children’s medicine in history. More than 135 million bottles of children’s medicines were recalled.

We also learned that there wasn’t just one recall. We heard testimony about rolling recalls, a phantom recall, a plant shutdown and

management firings. Since then we have obtained additional docuVerDate 11-MAY-2000 15:50 Mar 25, 2011 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\63148.TXT KATIE PsN: KATIE
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ments 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 goahead 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.

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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:]

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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.

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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.

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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.’’

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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.

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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

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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.

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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:]

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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 thirdparty 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

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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:]

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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?

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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?

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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

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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

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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

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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?

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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 DanVerDate 11-MAY-2000 15:50 Mar 25, 2011 Jkt 000000 PO 00000 Frm 00067 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\63148.TXT KATIE PsN: KATIE
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iel—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.

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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

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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.

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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.

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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

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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 ultiVerDate 11-MAY-2000 15:50 Mar 25, 2011 Jkt 000000 PO 00000 Frm 00073 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\63148.TXT KATIE PsN: KATIE
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mately 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

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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.

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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.

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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

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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

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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

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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.

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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:]

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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?

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Dr. SHARFSTEIN. I think that is a very fair question for the committee to ask. That report disclosed that McNeil was retrieving

product that failed specifications. And removing the product was

the right thing for McNeil to be doing. But what it didn’t say in

that report was that they were, all it said was we are going to retrieve it from the shelves, or however they phrased it. It didn’t say

that they would be telling people to act like regular customers or

not disclosing the facts when they were asked about what happened when they went out.

I think that in part because there was limited information, that

might have contributed to the delay. But I also think that FDA

should have been asking questions right away, and figured out

what the agency eventually figured out, that this really did need

to be registered as a real recall.

Chairman TOWNS. What went wrong that caused Johnson &

Johnson’s recall of 135 million bottles of children’s medicine? Is the

FDA satisfied with what Johnson & Johnson is doing to solve the

problem? Are you satisfied with Johnson & Johnson?

Dr. SHARFSTEIN. What went wrong there is sort of the notes and

the music. The notes are the specific details and the inspectional

observations. The fact that there were batches that were super-potent or batches that may have had particles or an issue with how

they investigated and responded to potential bacterial contamination.

But the music is that the company had an inadequate quality

system. And that you could see in multiple facilities. FDA is both

responding to the notes and the music, you have heard from the

testimony there are major changes at McNeil. FDA has been very

involved in ensuring that those are the right kinds of changes. And

FDA is committed to making sure when this facility is up and running that it is in compliance.

So we are comfortable with where things are now. We appreciate

the commitment of McNeil and Johnson & Johnson’s leadership to

fixing the problem. But this was a very serious problem, and we

are not going to take anything for granted.

Chairman TOWNS. Right.

Let me ask, does FDA need more enforcement authority or funding to be able to respond to issues like the Johnson & Johnson recall? This bothers me in terms of, for something like this to happen. We are concerned about safety. Does FDA need additional authority? What is the problem?

Dr. SHARFSTEIN. I think there are a couple of things. This is to

be put in the context that FDA did identify these lapses before

there was a serious health consequence. We are not finding that

there are serious illnesses or deaths linked to this problem. And

the agency, through its inspections and through multiple meetings

with the company, and aggressive, extraordinary meetings with the

company, has brought about tremendous change in this area.

Having said that, all of us want to prevent these things and we

want to be responding much faster in some cases even than what

happened here. And I think that issues of resources and authority

are very fair questions. I testified that if FDA had had mandatory

recall authority, I think things would have gone a lot different.

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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 meetVerDate 11-MAY-2000 15:50 Mar 25, 2011 Jkt 000000 PO 00000 Frm 00096 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\63148.TXT KATIE PsN: KATIE
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ing 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.

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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

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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 purVerDate 11-MAY-2000 15:50 Mar 25, 2011 Jkt 000000 PO 00000 Frm 00099 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\63148.TXT KATIE PsN: KATIE
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chases.’’ 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.

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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 sublots 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.

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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, reVerDate 11-MAY-2000 15:50 Mar 25, 2011 Jkt 000000 PO 00000 Frm 00102 Fmt 6633 Sfmt 6633 C:\KATIES\DOCS\63148.TXT KATIE PsN: KATIE
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member, 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

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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

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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.

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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?

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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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