[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
A CONTINUING INVESTIGATION INTO THE FUNGAL MENINGITIS OUTBREAK AND
WHETHER IT COULD HAVE BEEN PREVENTED
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
FIRST SESSION
__________
APRIL 16, 2013
__________
Serial No. 113-31
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
______
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
RALPH M. HALL, Texas HENRY A. WAXMAN, California
JOE BARTON, Texas Ranking Member
Chairman Emeritus JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky Chairman Emeritus
JOHN SHIMKUS, Illinois EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska ANNA G. ESHOO, California
MIKE ROGERS, Michigan ELIOT L. ENGEL, New York
TIM MURPHY, Pennsylvania GENE GREEN, Texas
MICHAEL C. BURGESS, Texas DIANA DeGETTE, Colorado
MARSHA BLACKBURN, Tennessee LOIS CAPPS, California
Vice Chairman MICHAEL F. DOYLE, Pennsylvania
PHIL GINGREY, Georgia JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana JIM MATHESON, Utah
ROBERT E. LATTA, Ohio G.K. BUTTERFIELD, North Carolina
CATHY McMORRIS RODGERS, Washington JOHN BARROW, Georgia
GREGG HARPER, Mississippi DORIS O. MATSUI, California
LEONARD LANCE, New Jersey DONNA M. CHRISTENSEN, Virgin
BILL CASSIDY, Louisiana Islands
BRETT GUTHRIE, Kentucky KATHY CASTOR, Florida
PETE OLSON, Texas JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia JERRY McNERNEY, California
CORY GARDNER, Colorado BRUCE L. BRALEY, Iowa
MIKE POMPEO, Kansas PETER WELCH, Vermont
ADAM KINZINGER, Illinois BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia PAUL TONKO, New York
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Missouri
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina
Subcommittee on Oversight and Investigations
TIM MURPHY, Pennsylvania
Chairman
MICHAEL C. BURGESS, Texas DIANA DeGETTE, Colorado
Vice Chairman Ranking Member
MARSHA BLACKBURN, Tennessee BRUCE L. BRALEY, Iowa
PHIL GINGREY, Georgia BEN RAY LUJAN, New Mexico
STEVE SCALISE, Louisiana EDWARD J. MARKEY, Massachusetts
GREGG HARPER, Mississippi JANICE D. SCHAKOWSKY, Illinois
PETE OLSON, Texas G.K. BUTTERFIELD, North Carolina
CORY GARDNER, Colorado KATHY CASTOR, Florida
H. MORGAN GRIFFITH, Virginia PETER WELCH, Vermont
BILL JOHNSON, Ohio PAUL TONKO, New York
BILLY LONG, Missouri GENE GREEN, Texas
RENEE L. ELLMERS, North Carolina JOHN D. DINGELL, Michigan
JOE BARTON, Texas HENRY A. WAXMAN, California (ex
FRED UPTON, Michigan (ex officio) officio)
C O N T E N T S
----------
Page
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 1
Prepared statement........................................... 3
Hon. Diana DeGette, a Representative in Congress from the state
of Colorado, opening statement................................. 5
Hon. Fred Upton, a Representative in Congress from the state of
Michigan, opening statement.................................... 7
Prepared statement........................................... 8
Hon. Henry A. Waxman, a Representative in Congress from the state
of California, opening statement............................... 9
Hon. Edward J. Markey, a Representative in Congress from the
Commonwealth of Massachusetts, prepared statement.............. 74
Witnesses
Margaret A. Hamburg, M.D., Commissioner, U.S. Food and Drug
Administration................................................. 11
Prepared statement........................................... 14
Answers to submitted questions............................... 114
Submitted Material
Minority memorandum.............................................. 77
Majority memorandum.............................................. 98
Letter of April 11, 2013, from the committee to the subcommittee. 101
Document binder \1\
----------
\1\ The document binder is available at http://docs.house.gov/
meetings/if/if02/20130416/100668/hhrg-113-if02-20130416.xml.
A CONTINUING INVESTIGATION INTO THE FUNGAL MENINGITIS OUTBREAK AND
WHETHER IT COULD HAVE BEEN PREVENTED
----------
TUESDAY, APRIL 16, 2013
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:02 a.m., in
room 2123 of the Rayburn House Office Building, Hon. Tim Murphy
(chairman of the subcommittee) presiding.
Members present: Representatives Murphy, Burgess, Scalise,
Harper, Olson, Gardner, Griffith, Johnson, Long, Ellmers,
Barton, Upton (ex officio) DeGette, Braley, Schakowsky,
Butterfield, Tonko, Green, Dingell, and Waxman (ex officio).
Staff present: Gary Andres, Staff Director; Mike
Bloomquist, General Counsel; Sean Bonyun, Communications
Director; Matt Bravo, Professional Staff Member; Karen
Christian, Chief Counsel, Oversight; Andy Duberstein, Deputy
Press Secretary; Brad Grantz, Policy Coordinator, Oversight and
Investigations; Debbee Hancock, Press Secretary; Sydne Harwick,
Legislative Clerk; Brittany Havens, Legislative Clerk; Sean
Hayes, Counsel, Oversight and Investigations; Carly McWilliams,
Professional Staff Member, Health; Andrew Powaleny, Deputy
Press Secretary; Krista Rosenthall, Counsel to Chairman
Emeritus; Charlotte Savercool, Executive Assistant, Legislative
Clerk; Alan Slobodin, Deputy Chief Counsel, Oversight; John
Stone, Counsel, Oversight; Dan Tyrrell, Counsel, Oversight; Lyn
Walker, Coordinator, Admin/Human Resources; Tom Wilbur, Digital
Media Advisor; Phil Barnett, Democratic Staff Director; Stacia
Cardille, Democratic Deputy Chief Counsel; Brian Cohen,
Democratic Staff Director, Oversight and Investigations, Senior
Policy Advisor; Eric Flamm, FDA Detailee; Elizabeth Letter,
Democratic Assistant Press Secretary; Stephen Salsbury,
Democratic Special Assistant; and Rachel Sher, Democratic
Senior Counsel.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Murphy. Good morning. This is a hearing of the House
Energy and Commerce Oversight and Investigations Committee
entitled ``A Continuing Investigation into the Fungal
Meningitis Outbreak, and Whether it Could Have Been
Prevented.''
The subcommittee is here today because 53 people died from
a pain medication manufactured by the New England Compounding
Center, NECC. Those patients trusted that the steroid injected
into their spine or their joints to relieve chronic pain was
perfectly safe because of the confidence our Nation's
healthcare providers place in the Food and Drug Administration.
But that drug was contaminated with fungus, a form of mold that
attacks bone and nerves.
More than 700 people who received these lethal injections
continue to have symptoms. Today, they are living with the
unbearable horror of not knowing whether they will survive.
They must spend weeks in the hospital, missing work, holidays,
and times with families. They must take large doses of morphine
to ease the pain. Each day is lived under the deadly threat of
an infection that could reach their brains and kill them.
This outbreak is one of the worst public health disasters
in our country's history, and it is a terrible tragedy and an
epic failure. Sadly, the Food and Drug Administration, which is
supposed to protect the public, has spent its time passing
blame and hiding behind judicial robes rather than taking any
responsibility.
At our hearing last November, Commissioner Hamburg told
this committee that the FDA faced ``complex'' issues in taking
enforcement action against the New England Compounding Center.
Here is the truth: this outbreak begins with NECC illegally
shipping 17,000 vials of supposedly sterile drugs without
patient prescriptions. The FDA insists it could not tell the
difference between a corner drug store compounder who makes
cough syrup for a child, and a massive manufacturer illegally
shipping into 23 states.
This committee has discovered the agency had information
that should have spurred it to act and stop this rogue outfit
from continuing to operate as an illegal manufacturer of
sterile medication.
This outbreak is simply not ``complex`` nor was it a
surprise. They were under the nose of the FDA for a decade. DA
field staff and FDA headquarters repeatedly received complaints
about NECC's numerous transgressions. They even considered
additional inspections and enforcement. Ten years of warning
signs, alarm bells, and flashing red lights were ignored.
Complaints from patients, nurses, pharmacists, doctors, pain
clinics, hospitals, drug companies, drug distributors and even
confidential company informants, but the only healthcare entity
that didn't seem worried was FDA headquarters. Ultimately, the
FDA knew NECC was breaking the law but chose to do nothing.
In 2007, the FDA received complaints from patients getting
epidural injections of an injectable steroid manufactured by
NECC. FDA knew long ago that this very NECC product
hospitalized patients with meningitis-like symptoms. These
complaints led to FDA's first inspection of NECC, and this
time, there is no evidence that FDA even bothered to inform the
state or contact the company over this issue.
In 2011, a representative from the Institute of Safe
Medication contacted the FDA. This complaint read, ``As a
practicing pharmacist, I am shocked that such a product would
be allowed to be distributed for use in the United States.''
FDA officials found the product to be ``extremely dangerous,''
and ``they should further warn that this bag should not be
directly infused to the patient. This is unbelievable. I think
this is a disaster waiting to happen.''
After FDA headquarters approved, then rejected, sending a
warning letter to Ameridose in 2009, the current Director of
FDA's New England District Office angrily informed other
enforcement officials with FDA: ``I have told our
Investigations Branch to not bother inspecting compounding
pharmacies if we aren't going to act on the violations.''
FDA's primary mission is to protect the public health from
unsafe drug products. On numerous occasions, the agency
confronted a choice in dealing with NECC and Ameridose: take
action to protect patients or wait. Repeatedly, the FDA made a
conscious decision to do nothing. In particular, under the
watch of Dr. Hamburg, the FDA put enforcement actions against
NECC and Ameridose on hold in 2011 and through 2012, because
the FDA lawyers wanted to wait until finishing a revision of a
guidance document.
During this inspection holiday, 53 people died.
At the last hearing Congressmen Terry, Scalise, and I asked
Dr. Hamburg where in the law it said FDA could not act. The FDA
did not answer our question. We now know that there was nothing
in the law that prevented the FDA from acting because in the
last few weeks before this hearing, the FDA has conducted a
highly visible campaign of inspections. This flurry of well-
publicized activity exposes the FDA's charade. The agency
cannot argue it lacked authority to inspect NECC and Ameridose,
but now, after the outbreak, has the authority to conduct these
inspections. No law has changed. The only change is the FDA
decided to act.
During our November hearing, Dr. Lauren Smith of the
Massachusetts Department of Public Health recognized that her
agency could have done things differently. She didn't hide
behind ongoing investigations, lawsuits, or limited authority.
Instead, she admitted that her agency had moved too slowly, and
that if they had acted quickly in 2012, it could have prevented
about a third of the deadly drug from being shipped. She took
immediate personnel actions as a result of these conclusions.
The hope of this committee is that we will hear admissions
from the FDA that reflect decisive leadership, an admission of
what went wrong internally to delay inspections, warnings, and
actions. What I worry about is we will hear this morning a
continued litany of excuses, bureaucratic talk, and blame on
outside organizations.
For the sake of the families of those who died, and those
who are still sick, we will not stop in our effort to get
answers and fix this problem.
[The prepared statement of Mr. Murphy follows:]
Prepared statement of Hon. Tim Murphy
The Subcommittee is here today because 53 people died from
a pain medication manufactured by the New England Compounding
Center (NECC). Those patients trusted that the steroid injected
into their spine or their joints to relieve chronic pain was
perfectly safe because of the confidence our nation's
healthcare providers place in the Food and Drug Administration.
But that drug was contaminated with fungus, a form of mold that
attacks bone and nerves.
More than 700 people received these lethal injections.
Today, they are living with the unbearable horror of not
knowing whether they will survive. They must spend weeks in the
hospital, missing work, holidays, and time with family. They
must take large doses of morphine to ease the pain.
Each day is lived under the deadly threat of an infection
that could reach their brains and kill them.
This outbreak is one of the worst public health disasters
in our country's history. It is a terrible tragedy and an epic
failure. Sadly, the Food and Drug Administration, which is
supposed to protect the public, has spent its time passing
blame and hiding behind judicial robes rather than taking any
responsibility.
At our hearing last November, Commissioner Hamburg told
this Committee that the FDA faced ``complex'' issues in taking
enforcement action against the New England Compounding Center.
Here is the truth: this outbreak begins with NECC illegally
shipping 17,000 vials of supposedly sterile drugs without
patient prescriptions. The FDA s insists it could not tell the
difference between a corner-store compounder who makes cough
syrup for a child, and a massive manufacturer illegally
shipping into 23 states.
This Committee has discovered the agency had information
that should have spurred it to act and stop this rogue outfit
from continuing to operate as an illegal manufacturer of
sterile medication.
This outbreak is not ``complex'' nor was it a surprise.
Neither NECC nor its sister company, Ameridose, were operating
in the shadows. They were under the nose of the FDA for a
decade. FDA field staff and FDA headquarters repeatedly
received complaints about NECC's numerous transgressions. They
even considered additional inspections and enforcement actions.
Ten years of warning signs, alarm bells, and flashing red
lights were deliberately ignored. Complaints came from
patients, nurses, pharmacists, doctors, pain clinics,
hospitals, drug companies, drug distributors and even
confidential company informants. About the only healthcare
entity that didn't seem worried was FDA headquarters.
Ultimately, the FDA knew NECC was breaking the law but chose to
do nothing.
In 2007, the FDA received complaints from patients getting
epidural injections of an injectable steroid manufactured by
NECC. FDA knew long ago that this very NECC product
hospitalized patients with meningitis-like symptoms--these
complaints led to FDA's first inspection of NECC. This time,
there's no evidence that FDA even bothered to inform the state
or contact the company over this issue.
In 2011, a representative from the Institute of Safe
Medication Practices contacted the FDA about an Ameridose
medication.
The complaint read, quote, ``As a practicing pharmacist, I
am shocked that such a product would be allowed to be
distributed for use in the United States.'' FDA officials found
the product to be ``extremely dangerous.'' A member of FDA's
compounding team wrote: ``And they should further warn that
this bag should not be directly infused to the patient. This is
unbelievable! I think this is a disaster waiting to happen.''
After FDA headquarters approved--then rejected--sending a
Warning Letter to Ameridose in 2009, the current Director of
FDA's New England District Office angrily informed other
enforcement officials with FDA: ``I've told our [Investigations
Branch] to not bother inspecting compounding pharmacies if we
aren't going to act on the violations.''
FDA's primary mission is to protect the public health from
unsafe drug products. On numerous occasions, the agency
confronted a choice in dealing with NECC and Ameridose: take
action to protect patients or wait. Repeatedly, the FDA made a
conscious decision to do nothing. In particular, under your
watch, Dr. Hamburg, the FDA put enforcement actions against
NECC and Ameridose on hold in 2011 and through 2012, because
the FDA lawyers wanted to wait until finishing a revision of a
guidance document.
During this inspection holiday, 53 people died.
At the last hearing Congressmen Terry, Scalise, and I asked
Dr. Hamburg where in the law it said FDA could not act. The FDA
did not answer our question. We now know that there was nothing
in the law that prevented the FDA from acting because in the
last few weeks before this hearing, the FDA has conducted a
highly visible campaign of inspections. This flurry of well-
publicized activity exposes the FDA's charade. The agency
cannot argue it lacked authority to inspect NECC and Ameridose,
but now, after the outbreak, has the authority to conduct these
inspections.
No law has changed. The only change is the FDA decided to
act.
During our November hearing, Dr. Lauren Smith of the
Massachusetts Department of Public Health recognized her agency
could have done things differently. She did not hide behind
ongoing investigations, lawsuits, or limited authority.
Instead, she admitted that her agency had moved too slowly, and
that if they had acted quickly in July 2012, it could have
prevented about a third of the deadly drug from being shipped.
She took immediate personnel actions as a result of these
conclusions.
The hope of this committee is that we will hear admissions
from the FDA that reflect decisive leadership--an admission of
what went wrong internally to delay inspections, warnings, and
actions. What I fear we will hear this morning is continued
litany of excuses, bureaucratic talk, and blame on outside
organizations.
For the families of those who died, and those who are still
sick, we will not stop in our effort to get answers and fix
this problem.
I now recognize my distinguished colleague from Colorado,
Ranking Member DeGette, for her opening statement.
Mr. Murphy. I now recognize my distinguished colleague from
Colorado, Ranking Member Diana DeGette, who I think also wants
us to recognize some of the consent here, too.
Ms. DeGette. Thank you very much, Mr. Chairman. I know I
join you and the rest of the members of this subcommittee in
expressing our deepest condolences to those who are affected by
the tragic events yesterday in Boston, and we are all thinking
about all the victims. Our colleague, Mr. Markey, has been very
interested in this investigation, and understandably, he is not
here today, but he wanted to participate and he has a
statement, and he also has an October, 2012 report that you
folks have seen called ``Compounding Pharmacies, Compounding
Risk'', and I ask unanimous consent those both be entered into
the record.
Mr. Murphy. Without objection, they will be entered into
the record.
[The information appears in the document binder.]
OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF COLORADO
Ms. DeGette. Thank you very much.
Mr. Chairman, I want to thank you for having today's
hearing. Obviously, this fungal meningitis outbreak is a
serious, serious situation, and our committee needs to
understand the facts about how and why it occurred, and what we
can do to prevent it in the future.
I think that this investigation has the potential to become
part of the great bipartisan oversight history of this
committee. I know that good investigations don't always result
in legislative change, but in this case, I think we can use
this investigation to help us identify the legislative changes,
if any, that we need to help us avoid tragedies like this again
in the future.
As hospitals, clinics, and other medical providers
outsource more of their compounding, a number of compounding
pharmacies have sprung up, and frankly, they have been
operating underneath the regulatory radar screen. A spotty
pattern of state regulations and enforcement, combined with
conflicting federal law, have made that even worse.
So Mr. Chairman, I want to talk about some of the facts we
have uncovered as we have spent the last 5 months investigating
the New England Compounding Center, the FDA, and the deadly
fungal meningitis outbreak caused by contaminated compounded
drugs.
First of all, as we all can stipulate, the owners and
operators of NECC ran a shoddy, fly-by-night operation, and
jeopardized the lives of thousands of people. Second, for
several years prior to the outbreak, the FDA received warnings
about the company from its own inspectors, from State Boards of
Pharmacy, and from whistleblowers. The FDA received warnings
about, and seriously considered investigating, Ameridose,
NECC's sister company, just a few months before NECC began to
ship the deadly steroid products. One of the states that
discovered these deficiencies was my own home State of
Colorado, and in fact, my State Board of Pharmacy issued a
Cease and Desist Order to stop the company's practices.
Now, I am confident that we can all agree on these two
facts from both sides of the aisle, but I also hope that we can
agree on a third fact that will help explain why the FDA Was
unable to effectively regulate this company. Then I hope that
we can act together to fix the problem.
Mr. Chairman, in October of 2012, this committee requested
thousands of pages of documents from the FDA about their
interactions with NECC, and their approach to regulating
compounded drugs. The Democratic staff has reviewed these
documents, and yesterday released a supplemental memo with key
findings. I would also ask unanimous consent that this memo be
made a part of this hearing record.
This pattern of documents from 2002 through last year
demonstrates that under two Administrations and over 10 years,
the FDA has not been aggressive enough in attempting to
regulate compounding pharmacies. The question is why? It is a
serious and legitimate question to ask what the agency should
have been doing and could have been doing over these many
years, and I know from your opening statement you intend to do
just that.
I also, though, look forward to hearing what specific
solutions Commission Hamburg and the FDA believe would help
them protect the American people from another outbreak, because
these documents show us that for a year, the FDA has been
grappling with a law that is broken and we need to help fix
that law and keep the American public safe. We also need to
look at how court decisions impacted the FDA's ability to
regulate.
Mr. Chairman, you say that the FDA is hiding behind
judicial robes, but in fact, court decisions are the law of the
land. And what we have here in the wake of the serious
meningitis outbreak is a patchwork of laws. We have two
judicial circuits that are coming up with different decisions
about the authority of the FDA, which is causing some of these
compounding pharmacies, not all of them, but some of them to
resist any regulatory efforts by the FDA.
As the FDA has been attempting to better regulate this
situation since these issues came out, there have even been
instances of compounding pharmacies refusing to provide the FDA
access to records or facilities, and as we learned during our
food safety investigations and some of our other investigations
in this committee, if you have an allegation of little black
particles in some of the vials of the pharmaceuticals, the FDA
and its cooperating agencies need the ability to work fast. And
if you have a company that says you can't come in here and
makes the FDA go to court, that is not a speedy or a desirable
resolution.
And so I am looking forward to hearing from Commissioner
Hamburg about, number one, what the agency has done to improve
the situation and to improve enforcement, and number two, what
the agency thinks that we need to do legislatively to fix this
law so that this will never happen again.
Thank you very much, Mr. Chairman. I yield back.
Mr. Murphy. Gentlelady yields back. I will now recognize
the chairman of the full committee, Mr. Upton, for 5 minutes.
OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Upton. Well thank you, Mr. Chairman. I thank you for
convening this very important hearing on the deadly outbreak of
fungal meningitis so that the committee can get answers to the
question that we could not get last year: what did the FDA know
about NECC and Ameridose, and what did the FDA do about it?
When Commissioner Hamburg appeared before us last November,
32 innocent Americans had died. Today, the death toll stands at
53 and continues to grow. Hundreds are still sick and
suffering. An unthinkable, public health disaster continues to
get only worse. My home State of Michigan has been hit the
hardest by fungal meningitis. According to the CDC, 15 of the
53 people who died after receiving NECC's contaminated products
are from Michigan, including three from my district. Two
hundred and fifty-nine of the 730 people who are sick and
suffering from infections are from my state.
Just a few weeks ago, our Attorney General Bill Schuette, a
former colleague, announced that he planned to convene a grand
jury to investigate possible criminal charges, and I talked
with him again just minutes ago.
Criminal cases will rightfully examine the company's
liability for this tragedy, but it is our job at this committee
to also take a hard look at the agency under our jurisdiction,
the FDA, and ask: did its processes work? Did the agency do its
job and protect the public's health? And before we get to the
matter of additional authorities and new legislation, we have
to ensure that the agency is going to be ready to implement
them properly. It is not enough or right just to do something
for the sake of doing it. We have to do something that is truly
effective to prevent this from happening again.
It took months for the FDA to fully cooperate and provide
the necessary documents, but now we finally have them.
Commissioner Hamburg, as we look at these, many of us are
troubled by what we have learned. FDA received complaint after
complaint about these companies. FDA's documents paint a
picture of two companies who appeared to be acting more like
manufacturers than compounders. Doctors and other providers
made complaints about the sterility of their products. FDA
district staff pushed to go back out and re-inspect these
companies or take other enforcement action, but in most cases,
it simply didn't happen. It is this breakdown that concerns me
the most. Job one for the FDA is making sure the medicines we
take are safe, but the mission appears to be lost, as delays
prevented the FDA from taking decisive action and the agency
took years to finalize its guidance and regulatory documents.
We know now that 53 Americans did not need to die. It sickens
me that this could have been prevented.
And as we met this last week, I share your hope that this
is a constructive hearing. We all want that. We need to get all
the facts on the table, and I hope you can help us, so we can
move forward. We owe it to those families, and I know that we
can do better and work together.
And I yield now to Mr. Barton.
[The prepared statement of Mr. Upton follows:]
Prepared statement of Hon. Fred Upton
I thank Chairman Murphy for convening this important
hearing on the deadly outbreak of fungal meningitis, so that
this committee can get answers to the question we could not at
the last hearing: what did FDA know about NECC and Ameridose?
And what did FDA do about it?
When Commissioner Hamburg appeared before us last November,
32 innocent Americans had perished. Today, the death toll
stands at 53 and continues to grow. Hundreds are still sick and
suffering. An unthinkable, public health disaster keeps on
getting worse. My home state of Michigan has been hit the
hardest by the fungal meningitis outbreak. According to the
CDC, 15 of the 53 people who died after receiving NECC's
contaminated products are from Michigan, including 3 from my
district. Two-hundred fifty-nine of the 730 people who are sick
and suffering from infections are from my state. Just a few
weeks ago, Michigan Attorney General Bill Schuette announced
that he planned to convene a grand jury to investigate possible
criminal charges.
Criminal cases will rightfully examine the company's
liability for this tragedy. But it is our job at this committee
to also take a hard look at the agency under our jurisdiction,
the FDA, and ask: did its processes work? Did the agency do its
job and protect the public health? Before we get to the matter
of additional authorities and new legislation, we have to
ensure that the agency is going to be ready to implement them
properly. It is not enough or right just to do something for
the sake of doing something. We have to do something that is
truly effective.
It took months for the FDA to fully cooperate and provide
the necessary documents, but now we finally have them.
Commissioner Hamburg, I am troubled by what I have learned. FDA
received complaint after complaint about these companies. FDA's
documents paint a picture of two companies who appeared to be
acting more like manufacturers than compounders. Doctors and
other providers made complaints about the sterility of their
products. FDA district staff pushed to go back out and re-
inspect these companies or take other enforcement action, but
in most cases, it didn't happen. It is this breakdown that
concerns me the most. ``Job one'' for the FDA is making sure
the medicines we take are safe, but this mission seemed to be
lost, as delays prevented the FDA from taking decisive action
and the agency took years to finalize its guidance and
regulatory documents. We now know that 53 Americans did not
need to die. It sickens me that this could have been prevented.
Commissioner Hamburg, we met last week. I share your hope
that this is a constructive hearing. We need to get all the
facts on the table, and I hope you will help us, so we can move
forward. We owe it to the families who lost loved ones and we
owe it to those 730 Americans who are still suffering and may
never return to leading healthy lives. I yield my remaining
time to....
Mr. Barton. Thank you, Mr. Chairman, and I want to echo
what you just said.
We have asked several questions at the previous hearing on
this. The first one was how did this happen, and the second
one, could this outbreak have been prevented? At the time, we
didn't get answers. Finally after the committee has received
the documents, we do have at least partial answers to those two
questions.
To the first question, how did it happen, there are two
main reasons. Obviously, the company involved acted negligently
and didn't follow proper sterilization and sanitation
practices, but number two, the FDA, the agency responsible for
protecting the public health and safety, did not act properly,
did not do what it should have done, and did not act when it
could have acted. In fact, it failed to take the necessary
action against this company to prevent future outbreaks, even
though they had evidence of serious problems dating back to
2002.
The answer to the second question, could the outbreak have
been prevented, I believe the answer to be yes. I believe it
could have been prevented. Today, we are going to have our FDA
commissioner before us to explain the FDA's failure, and
hopefully the steps that she is intending and hopefully has
taken to prevent any future actions.
And with that, I yield the balance of the time to Dr.
Burgess.
Mr. Burgess. I thank the gentleman for yielding.
From a provider's perspective, I recognize the value of
compounding pharmacies and compounding pharmacists, and that
they contribute to the armamentarium of things that we can
offer to our patients, but there is a vast difference between
compounding preparation of progesterone to treat a condition,
or compounding a pediatric elixir for Tamiflu, and being
involved with a wholesale manufacturer of medicines that are
shipped all over the country, with no specific prescription
thereto attached. I do have to admit, reading through this
litany that has occurred, honestly, before you arrived at the
agency, but also since your arrival at the agency, and it is
troubling. I think the least we can do today is try to uncover
those things that were impediments to getting a rapid
resolution of this, and honestly, we cannot allow it to happen
again.
And I will yield back.
Mr. Murphy. Gentleman yields back. I now recognize the
ranking member of the committee, Mr. Waxman for 5 minutes.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you, Mr. Chairman.
I think that the comments of Chairman Upton and Mr. Barton
and Mr. Burgess are right on point. This has to be a
constructive investigation. We have to know what happened and
how to prevent it in the future.
This meningitis outbreak from compounded drugs has claimed
the lives of over 50 people, sickened over 700, brought
unspeakable grief upon hundreds of families, and it is one of
our Nation's worst public health disasters in recent memory. So
we need to get to the bottom of this.
Our most critical task is to answer this question: how can
we prevent another NECC tragedy from occurring again? This one
has happened. It is terrible.
Last fall, Joyce Lovelace, who lost her husband,
courageously testified before this committee and we should heed
her words. She said ``Don't just investigate, instead,
legislate and regulate. Put aside partisan politics, partisan
philosophies, industry lobbying, and wishes of campaign
contributions, and unanimously send to the White House a bill
that will prevent a recurrence of these events. If you will do
that, perhaps my family can take some solace in the fact that
any Lovelace's public service continues even after death.''
Well, I hope we can remember this advice during today's
hearing, and stay focused on our most important mission: how
can we prevent a recurrence of these events? The committee
received in preparation for this hearing over 27,000 documents
from the FDA. Mr. Chairman, I agree with your comments that the
record shows that FDA missed important opportunities to address
problems at NECC. FDA was warned about potential problems at
NECC and Ameridose, and was simply unable to act or act fast
enough. But the documents also show more than that. They show
why this happened, and if we want to fix this problem, that is
exactly what we need to understand.
Mr. Chairman, here is what the documents show. For over a
decade, FDA struggled to effectively regulate compounding
pharmacies. Basic flaws in the compounding law and a series of
conflicting court decisions have created uncertainty and
confusion. As a result, FDA was unable to develop a coherent
policy. Under this Administration, beginning in 2009, FDA began
to take new steps to develop an enforceable national policy for
drug compounders, but it was never finalized. But this was
difficult, because the court cases created different rules for
different parts of the country, which is inherently
problematic. FDA had to struggle with how to pick up the pieces
of a statute in tatters.
Mr. Chairman, we should ensure that FDA is able to protect
all of us in a uniform way from unsafe compounded drugs. It is
Congress' job to fix the law when it is inadequate or when
courts invalidate it, and that is why we must do more than
blame the FDA for this tragedy. We must heed the words of Joyce
Lovelace, and act to give the FDA the clear authority they need
to keep the American public safe and prevent another drug
compounding disaster.
I am pleased that Dr. Hamburg is here to further answer our
questions. At the last hearing, a lot of the documents that our
committee had requested on a bipartisan basis had not been
received, and we now have those documents. And what we have is
a muddied record of inaction where we would have liked to see
action, clarity in the law to give you instructions, Dr.
Hamburg, but that law wasn't clear and the courts made it even
more confusing.
Our job is not to dwell on the confusion. Our job is to
clarify what we want FDA to do, what we expect from FDA. We
need to clarify it not just by criticism in an oversight
hearing, but by acting together legislatively to spell out what
the law must be in order for FDA to do everything it can to
prevent another tragedy like this from occurring again.
Thank you, Mr. Chairman.
Ms. DeGette. Mr. Chairman, I would like to renew my
unanimous request to put the Democratic memo in the record.
Mr. Murphy. Without objection, so be it. Thank you.
[The information appears at the conclusion of the hearing.]
Mr. Murphy. I would now like to introduce the Honorable
Margaret A. Hamburg. She has been the commissioner of the U.S.
Food and Drug Administration since May 18, 2009. She is an
experienced medical doctor, scientist, and public health
executive. Thank you for being here.
I also ask--let me go here. You are aware that the
committee is holding an investigative hearing, and when doing
so, has the practice of taking testimony under oath. Do you
have any objections to testifying under oath?
Dr. Hamburg. No, I do not.
Mr. Murphy. The chair then advises you that under the rules
of the House and rules of the committee, you are also entitled
to be advised by counsel. Do you desire to be advised by
counsel during your testimony today?
Dr. Hamburg. I have with me Mr. Taylor, who is my senior
counselor, and I would like him to be available to answer
questions to give you the specific information that you might
need.
Mr. Murphy. Certainly. You have the right to have counsel
there, too.
In that case, would you both please rise and raise your--
one moment. Yes?
Ms. DeGette. Mr. Chairman, I don't believe that Dr. Hamburg
is saying he is her lawyer, I think he is----
Dr. Hamburg. Oh, I am sorry.
Ms. DeGette [continuing]. A lawyer at FDA here to answer
questions. My suggestion would be to swear them both in.
Mr. Murphy. We will swear them both in then, yes.
All right, if you both rise and raise your right hand, I
will swear you in.
[Witnesses sworn.]
Mr. Murphy. Let the record show that both have answered
affirmatively, so you are now under oath and subject to the
penalties set forth in Title 18, Section 1001 of the United
States Code.
You may now give a 5-minute summary of your written
statement, Dr. Hamburg.
TESTIMONY OF THE HONORABLE MARGARET A. HAMBURG, M.D.,
COMMISSIONER, U.S. FOOD AND DRUG ADMINISTRATION (FDA)
Dr. Hamburg. Thank you very much, Mr. Chairman and members
of the subcommittee. I am Dr. Margaret Hamburg, the
Commissioner of the FDA. I appreciate the opportunity to
testify today. I am joined, as I said, by Mr. John Taylor, my
senior counselor, and former head of both our Drug Enforcement
Office and of the agency's Field Inspection Force.
We are at a critical juncture for public health. The deadly
outbreak of fungal meningitis associated with a compounded
medication last fall was a horrible tragedy. I speak for
everyone at the FDA when I say that our hearts go out to the
victims and their loved ones.
While our investigation of this deadly outbreak has been a
top priority, my responsibility is also to make sure that this
does not happen again.
In looking at the history and our role with compounding
pharmacies, it is clear to me that we should have more
aggressively applied existing authorities, in spite of an
ambiguous statute, a changing legal landscape, and continuous
challenges by industry to our authorities. We are being more
aggressive now. We are working with states to inspect
pharmacies that we believe may present the highest risk, in
addition to responding to specific complaints we may receive.
Over the past few months, we have conducted over 55 such
inspections.
What we have seen is troubling: serious issues, including
quality concerns that have led to product recalls, and
practices that create risk of contamination, and these
inspections have underscored our need for stronger, clearer
authority to adequately protect public health. Even in light of
the recent tragic events, astonishingly, some of the firms are
challenging us, delaying our inspectors or denying them full
access to records. In two recent instances, we have had to
secure administrative warrants from the court and have U.S.
marshals accompany our inspectors so they could complete their
work. In other cases, we had to threaten the use of warrants to
achieve cooperation.
Lack of clarity in our statutory authorities is not the
only concern. The healthcare system and this industry have
evolved tremendously. A new breed of pharmacy compounding--
``outsourcers,'' has outgrown the legal framework. These
outsourcers produce high volumes of high risk drugs, often for
hospitals that rely on them to meet critical product needs for
their patients.
The tools we have under current law for regulating these
firms are simply not the right fit. Applying them in full force
could lead to significant dislocations in the healthcare
system, and likely shortages. We need legislation to preserve
the benefits of traditional compounding, while at the same time
giving us the right tools to regulate the highest risk
practices and products. For these higher risk compounding
pharmacies, we need legislation that: requires compliance with
federal quality standards; requires federal registration so we
know who they are, where they are, and what drugs they are
making; and requires reporting to FDA of serious adverse
events--so that we can act before potential problems grow out
of hand.
For all pharmacy compounding, certain basic protections
should be in place, including: clear authority to inspect
records to determine the scope and nature of a pharmacy's
operations, and to more quickly determine the cause of an
outbreak; a prohibition on compounding of the most complex and
highest risk products; and clear labeling of compounded drugs
to allow prescribers and consumers to make more informed
choices.
We look forward to working with Congress to explore funding
mechanisms to support this oversight.
If you look at FDA's attempts to regulate pharmacy
compounding over the last 20 years, as detailed in the tens of
thousands of pages of documents we have provided to the
committee, you see that the agency has been struggling with how
to effectively oversee this industry. You see numerous
approaches that were derailed by a constantly changing legal
landscape, challenges to our authority, and conflicting court
decisions. I wish that during my tenure I had brought the need
for legislation to you sooner. To be frank, given the history
of this issue and the efforts of this industry, there were many
at the agency concerned that seeking new authority would result
in a weakening, rather than a strengthening of the law. But I
am here now to ask for your help. We have had an urgent call to
action. We are all on notice, and we owe it to the public and
the victims to provide better protection in the future.
I am happy to answer any questions you may have.
[The prepared statement of Dr. Hamburg follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Murphy. I thank you for your testimony, Commissioner
Hamburg, and I appreciate you want to move forward, but we also
would like to find out if there are things within the FDA that
has been going on for the last 10 years that need to be
addressed first.
So I am assuming you accept that the buck stops with you
with regard to how things are going with the FDA, am I correct?
Dr. Hamburg. Yes.
Mr. Murphy. OK. Now the FDA documents show that the FDA put
enforcement actions against NECC and Ameridose on hold in 2011
through 2012, and suspended all inspections of compounders
because the FDA wanted to issue new guidance first. For
example, On October 24 of 2011, e-mail from a compliance
officer in the FDA's district office to the district compliance
branch director shows that in light of the FDA process of
drafting guidance on compounding, the FDA inspectors did not
immediately follow up on an informant's allegations about
Ameridose. Salespeople were in the clean area, filling product,
and that Ameridose continued to repack without an FDA license.
The e-mail stated that Tamara Ely, the compounding team leader
from CDER, said ``no compounding facility is slated to be
inspected in 2012,'' and a September, 2011, e-mail from a
compliance officer at CDER to others in the FDA headquarters
stated ``the plan is to re-inspect Ameridose 6 months after
issuance of 503A guidance.'' Likewise, an October, 2011,
memorandum from the Office of Unapproved Drugs and Labeling
Compliance stated ``currently we have suspended inspections of
compounding facilities, but will reinstate proactive
inspections based on a risk model 3 to 6 months after the
finalization of the guides to the industry.''
Did you personally approve of the FDA decision to delay or
suspend enforcement actions or inspections of compounding
facilities, or did somebody else?
Dr. Hamburg. I was not directly involved in those
decisions, but they did reflect the concern that we needed to
really have a clear regulatory regime that was outlined so that
we could bring the strongest and best possible cases.
Mr. Murphy. So were they then implemented under your
knowledge? If you were not the decision-maker, were they
implemented under your knowledge that they were occurring?
Dr. Hamburg. I was not aware of those decisions.
Mr. Murphy. Were you personally advised at any time about
suspending enforcement actions against compounders back in
2011?
Dr. Hamburg. It is important to understand that there were
ongoing responses with the compounding industry when problems
were brought to our attention about specific products, but that
in terms of a proactive inspectional strategy, we did not have
the framework in place and we were trying to put that in place
with the development of the CPG.
Mr. Murphy. I appreciate that, but we are trying to find
out when were you informed about the policy to suspend any
enforcement actions and inspections of compounders?
Dr. Hamburg. I regret that I was not more fully aware, but
I----
Mr. Murphy. When did you find out? Do you recall when you
finally found out that there were no inspections? Do you recall
when that was?
Dr. Hamburg. I want to make clear that there were
inspections of compounding facilities in reaction to specific
issues that were----
Mr. Murphy. Well, with NECC and----
Dr. Hamburg [continuing]. Brought before us with
adulterated or other problems with products, but that there was
not--there was this effort going on within the agency to try to
develop----
Mr. Murphy. I understand that. I am just trying to help
focus here, because I read you quotes from e-mails of at least
three different people that the inspections of NECC and
Ameridose were suspended. It is an important decision. Had the
FDA taken enforcement actions, conducted its own inspections,
or caused the Massachusetts Board of Pharmacy to inspect, we
may have been able to prevent this huge public health disaster.
So when the FDA made the decision to suspend compounding
enforcement in 2011, did the FDA weigh the potential public
health consequences of that decision?
Dr. Hamburg. It was not a decision to suspend all
enforcement of compounding pharmacies----
Mr. Murphy. I know, just with----
Dr. Hamburg [continuing]. But I regret that we didn't do
more, and I regret that I was not more directly engaged----
Mr. Murphy. I appreciate that.
Dr. Hamburg [continuing]. But I am now and----
Mr. Murphy. I know.
Dr. Hamburg [continuing]. And I really hope----
Mr. Murphy. I am still trying to find out when did you find
out that inspections of NECC were suspended?
Dr. Hamburg. I do not recall specifically but I was not
aware at that time.
Mr. Murphy. Was it in preparation for the hearing in the
fall or this hearing that you finally found out that the
inspections hadn't been taking place?
Dr. Hamburg. I as Commissioner obviously am not aware of
all of the inspections we are doing. We are responsible for
regulating products that come from over 300,000 different
facilities----
Mr. Murphy. I am just asking about NECC and I am not
getting an answer, but that is important because something--it
appears what has happened with NECC, that the information was
not going to the top where the buck is supposed to stop, and
while you are telling us that you didn't have authority to
inspect, last week a flurry of publicity came out that you went
to 31 different places. CBS News did an interview with you, and
only one of those was someone questioned about a court order.
So we still are going to need to get some answers to that, but
I see my time is up so I am now going to recognize the Ranking
Member, Ms. DeGette.
Ms. DeGette. Thank you very much, Mr. Chairman.
Commissioner Hamburg, did you ever find out why they
inspected--why they suspended these inspections while they are
writing new guidance? Why couldn't they walk and chew gum at
the same time?
Dr. Hamburg. There was, I think, real concern given the
history with this issue, and the repeated challenges to our
authorities that we needed to really understand, as court
decisions were coming down, what were going to be the legal--
what was the legal framework under which we would be----
Ms. DeGette. So they were afraid that they might not have
the authority to do the inspections? Is that what you are
saying?
Dr. Hamburg. We have the authority to do the inspections--
--
Ms. DeGette. So why couldn't they do both at once?
Dr. Hamburg [continuing]. But inspections are just a piece
of what needs to be done to take enforcement actions, and
Ms. DeGette. Right, so you don't know why they didn't do
both, because you didn't know at the time? Is that what you are
saying? Why didn't they both do the inspections and write the
new guidelines?
Dr. Hamburg. I wish that there had been a more aggressive
approach in terms of inspections.
Ms. DeGette. But you don't know why?
Dr. Hamburg. There was an effort to follow up on specific
concerns. That doesn't always require an inspection. But the
desire was to--the CPG was being worked on in order to really
provide clear guidance about the standards under which we would
be looking at enforcement in these facilities, and I wish it
had been completed more quickly and I----
Ms. DeGette. OK. So you testified now that this is at your
level, the last number of months since November have been
aggressively trying to go in and inspect, and that various
companies have tried--have refused entry and you had to get
court orders and so on. Very briefly, can you tell me how long
it took you--it took the FDA from the time that you announced
you wanted to go in and inspect to get these orders to get the
marshals in? Was there a delay because of the resistance of the
compounding pharmacies?
Dr. Hamburg. Yes, there have been a variety of delays in
terms of----
Ms. DeGette. But how long were those delays?
Dr. Hamburg. Days to weeks.
Ms. DeGette. Days to weeks, OK. Now, are you saying--this
is a really pretty simple question. Are you saying that the FDA
should have the authority to regulate all drug compounders?
Dr. Hamburg. We believe that we need to focus on those
compounders that are making the highest risk products, the
sterile products, in advance or without a prescription and
shipping to other states. We believe that there are not
sufficient standards in place in the law and enforceable----
Ms. DeGette. So it is really a targeted group of
compounders that are engaged in interstate commerce that the
FDA believes that need stronger authority, is that correct?
Dr. Hamburg. We believe we need to focus on the highest
risk facilities, and that includes those making sterile
products and shipping----
Ms. DeGette. And what percentage of all the drug
compounders is that?
Dr. Hamburg. Well, we don't really know because we don't
know----
Ms. DeGette. Because you don't have the authority----
Dr. Hamburg [continuing]. Those compounders because they
are not required to register with us, and we don't have full
access to their records for assessment.
Ms. DeGette. Right. Now let's talk about this court case
thing, because some people on this committee seem to think this
is more important than others.
Now in 2001, the Ninth Circuit Court found that part of the
1997 Food and Drug Administration Modernization Act was
unconstitutional, correct?
Dr. Hamburg. Correct.
Ms. DeGette. And so--and then in 2002, the Supreme Court
affirmed that decision about the constitutionality. Is that
right?
Dr. Hamburg. Correct.
Ms. DeGette. And then in 2008, there was a different
circuit court that reached a different conclusion, finding that
the key parts of the 1997 drug compounding law could remain in
effect. Is that correct?
Dr. Hamburg. That is correct.
Ms. DeGette. And is that that map that your staff put up
over there? That looks to me like the map that shows, so in
other words, in the red, that is one of the court decisions. In
the blue, that is the other court decision, right?
Dr. Hamburg. Correct.
Ms. DeGette. And then in the gray, that is the rest of the
country that is covered by different courts that have not ruled
on this, right?
Dr. Hamburg. Correct.
Ms. DeGette. And so the result of this has been that the--
is that the industry has pushed back against the FDA's attempts
to regulate, right?
Dr. Hamburg. Correct.
Ms. DeGette. Now, I think you do understand and I think you
recognize we are not saying here that this absolves the FDA
from responsibility to try, and you believe the FDA does have
the responsibility to try to enforce to make sure that these
compounding pharmacies are doing the right thing, right?
Dr. Hamburg. Absolutely.
Ms. DeGette. But nonetheless, there is not a clarity in the
law, and that is hampering the FDA to know clearly what it
should do and to do it in a quick fashion. Is that right?
Dr. Hamburg. That is absolutely correct.
Ms. DeGette. OK, thank you very much, Mr. Chairman.
Mr. Murphy. I now recognize Mr. Barton for 5 minutes.
Mr. Barton. Thank you, Mr. Chairman.
Madam Commissioner, I was puzzled as I listened to you
evade the answer to the chairman's questions about when you
learned. You never gave him a straight answer, so I am going to
ask a question and let's see if we can get a straight answer.
Does the sun rise in the east, Madam Commissioner?
Dr. Hamburg. You have me so confused, I don't know.
Mr. Barton. Well, I would hope that we could have gotten a
straight answer from that.
Dr. Hamburg. No, yes.
Mr. Barton. My seven-year-old would know the answer to that
in the first grade, so if we have now established that you can
give us some straight answers, I will give you once more chance
to answer the chairman's question, when did you learn about all
this? When did you become aware? Just a date, a time.
Dr. Hamburg. You know, many of the issues that are involved
here I did become aware of in the course of the investigation
and reviewing the many documents that----
Mr. Barton. Why are you afraid to just tell us?
Dr. Hamburg. Because I am not--I really don't remember.
Compounding pharmacies were an issue that----
Mr. Barton. OK, well that is an answer.
Dr. Hamburg [continuing]. I was not, deeply----
Mr. Barton. If you don't remember, you really don't
remember.
Dr. Hamburg. And I regret it.
Mr. Barton. So we will assume that you really, really don't
remember.
So I am going to ask you another question. You have been
the commissioner, I think for a little over 4 years, since you
got confirmed by the Senate, so when you found out about this
problem, how did you feel then and how do you feel now?
Dr. Hamburg. When the meningitis outbreak began, like all
of you, I was deeply concerned and committed the resources of
our agency to engaging in the public health investigation and
response, and I have been deeply involved in the subsequent
activities, and I do believe we need to be more aggressive, and
I intend to be more aggressive.
Mr. Barton. I am asking for the--all the people of America
that depend on the FDA, the gold standard of regulatory
authority in the world. You are the point person. Obviously
there are thousands of people at the FDA and you can't be
personally responsible for each and every one of their actions,
but in our form of government, you are the person that the
President of the United States, confirmed by the Senate, is the
leader. Are you upset with what this company did? Are you
outraged? Are you confused? Are you puzzled? I mean, how do you
feel?
Dr. Hamburg. I am deeply troubled and I am committed to
working with all of you, with industry, and with the states in
order to ensure that we have the regulatory framework that we
need in order to be able to best protect the health of the
American people and ensure the safety of their health.
Mr. Barton. All right.
Dr. Hamburg. We do not presently have that in place, and I
am worried that if we don't work together to address it, there
may be future problems of this magnitude.
Mr. Barton. OK, deeply troubled and worried. OK, that is--I
find that acceptable.
Now, at our first hearing there was a lot of ping-pong
balling back and forth whether it was a state problem, a state
regulatory problem, or a federal regulatory problem, and I
believe you testified that you needed more authority, and there
was some ambiguity in the law, things like this. Since that
time, you have shut the company down. I think there is a
criminal case against the company. So obviously, the FDA had
enough authority to do what it has done. Do you, today, think
that the authority is adequate on the books for your agency, or
do you continue to believe that you need more authority?
Dr. Hamburg. My understanding is that it was the state
authority that was able to--NECC was licensed by the State of
Massachusetts and it was the state authority that enabled----
Mr. Barton. But my question is knowing what you know now,
do you still want this committee to give the FDA additional
authority, or are you satisfied that your agency, the FDA, has
sufficient authority to do its job?
Dr. Hamburg. We definitely need additional authorities. At
the present time, compounding pharmacies under existing law,
despite the ambiguities and the split court decision,
compounding pharmacies are not required to register with us, so
we don't know who they are and what they are making. They are
not required--these large compounding pharmacies that are
making sterile products are not required in law to----
Mr. Barton. OK, so you think you need additional----
Dr. Hamburg [continuing]. Apply uniform standards----
Mr. Barton. My time is expired and I have one more question
that I want to ask. Do you feel that this company is typical of
the average compounding pharmacy?
Dr. Hamburg. You know, I cannot--there is an ongoing
criminal investigation, as you know. I can't comment on the
specifics, but there are good players and bad players out
there, compounding drugs. Compounding plays a critical role in
our healthcare system, but we need to make sure that there are
the standards in place and that FDA has the authorities to
enforce those standards that will assure the quality and safety
of these products, particularly these highest risk sterile
products.
Mr. Barton. I thank the commissioner and thank the
chairman.
Mr. Murphy. Thank you. Mr. Waxman is now recognized for 5
minutes.
Mr. Waxman. Thank you, Mr. Chairman.
Dr. Hamburg, if a manufacturer wants to produce a drug,
they have to go to FDA and get approval and show the drug is
safe and effective, and you keep track of those manufacturers,
or even inspect some of their facilities, isn't that right?
Dr. Hamburg. That is correct.
Mr. Waxman. So a compounding pharmacy can put together
drugs, but they don't have to come to the FDA to ask approval
or even register with you to let you know that they are doing
that, isn't that correct?
Dr. Hamburg. That is the case.
Mr. Waxman. They go to their states and have to let the
states know, or does that depend on state law?
Dr. Hamburg. State laws are very variable, as well as the
resources for enforcement.
Mr. Waxman. Well, some people have said that because
recently you have gone out and done inspections, between
February and April of this year, of 30 compounding pharmacies
that make sterile injectable drugs, and that there are
inspections on occasion, that you have all the authority you
need. Dr. Hamburg and Mr. Taylor, can you say that you have the
authority to be able to comprehensively oversee and inspect
this industry that can act without your approval and maybe even
in occasions you don't even know who they are?
Dr. Hamburg. No, we, as you note, don't have the authority
to even know who is out there and what they are making. We
don't have those uniform national standards for safe practices,
good manufacturing practices to inspect against and hold them
to. They do not have to report adverse events that they might
hear about to us so we can respond rapidly. This is not a
system that is adequate to protect in the light of this
changing healthcare system and its needs, and this evolving
industry.
Mr. Waxman. The inspections that you have done are based on
what information?
Dr. Hamburg. We determined who to inspect based on either
past awareness of concerns, public information about concerns,
concerns states had brought to our attention, but we were
inspecting companies that made sterile products because we view
them as the highest risk, and we have certainly found
considerable concerns about ongoing sterility practices, and we
have also found that even in light of recent events, that
companies are questioning our authorities to do full
inspections, and the appropriateness of the inspections.
Mr. Waxman. When FDA wanted to look at this NECC, the
company that made the drug that has done so much harm, in
December of 2006--before you were there--FDA sent them a
warning letter highlighting a series of violations of federal
law, and this company responded in part that it didn't need FDA
approval before dispensing compounded medications, and further,
did not operate in a manner that would subject us to FDA
regulation. In other words, they were resisting FDA doing its
job. They were emboldened. Didn't that make your job even
tougher?
Dr. Hamburg. Well, it certainly has made it tougher. It has
made it much less effective and efficient, and I think it
speaks to the reason why I am here now, really asking for the
chance to work with you to put in place the systems of legal
and regulatory requirements that will enable better
cooperation----
Mr. Waxman. I appreciate that.
Dr. Hamburg [continuing]. And coordinating.
Mr. Waxman. Now if you find that pharmacy compounder and
they are doing high risk work and you have some suspicions that
there are problems and you want to do an inspection, can you
get their records?
Dr. Hamburg. We cannot always get their records.
Mr. Waxman. Well, you don't have the authority to get
record inspections, isn't that right? The reason I say that is
that at the Senate hearing in November, the compounding
industry witness said FDA doesn't need new records inspection
authority because it can access pharmacy records by getting a
warrant.
Mr. Taylor, what does it mean, you have to go get a warrant
if you want to see their records?
Mr. Taylor. Yes, so it is--once a refusal has occurred,
what you actually have to do is put together essentially an
affidavit that you would take to court explaining why you are
seeking this warrant. Then an FDA employee would testify to the
truth of the warrant, and you actually have to bring it to a
federal court judge. So it is----
Mr. Waxman. Well let me just stop you and say if we want
you to do your job, we have got to give you the tools. We would
rather make the law clear, and one ought to be you can do
inspections and you can get these records and not have to go
through the whole rigmarole where they want to fight you and
have to go and get a warrant. Some cooperate, but some,
especially those we are most suspicious of, can force you to go
to court and get a warrant. Isn't that right?
Mr. Taylor. That is correct.
Mr. Waxman. Well, I hope we take that into consideration,
Mr. Chairman, in addressing this question of the law that needs
to be adopted by the Congress.
Mr. Murphy. Thank you. Gentleman yields back, and I now
recognize Dr. Burgess for 5 minutes.
Mr. Burgess. I thank the chairman for the recognition. Dr.
Hamburg, as always, welcome back to our humble committee room
here in the Energy and Commerce Committee.
You know, I just have to say, reading through the
information that was provided by your office that the staff has
assembled, I mean, your staff must be some of the most
frustrated people in the world, because it seems like they were
always coming right up to the point where someone could pull
the plug on NECC, on the New England Compounding Center, and
then for whatever reason, they backed off. I don't know whether
they were thrown off the scent or dissuaded by your lawyers,
but you are a doctor. You run a public health agency. Lawyer
stuff is for lawyers. We are supposed to take care of people.
We are supposed to prevent this stuff from happening, and the
system was blinking red for 10 years. So I appreciate that
there is a newfound enthusiasm and vigilance after the end of
September of 2012. Everything seems to be a pre- and post-
meningitis mindset at the FDA and I am grateful for the work
that the agency is doing now, but I just fail to understand why
you could not do that same work prior to the death of 50
people. It just--it almost defies gravity.
In your own written testimony, you--on the third page,
beginning of the top of the page, you actually reference
``Since the NECC outbreak'', and then you go into magnesium
sulfate preparation that was contaminated, apparently with no
injuries. Then you talk about eye infections associated with
repackaged Avastin. But that is not really new information,
because the FDA had received warnings and complaints relating
to the sterility of NECC's Avastin products for a long time,
2007. The FDA was repeatedly put on notice that NECC may again
be experiencing problems relating to the sterility and/or
safety of its products. An adverse drug reaction report which
was supplied by you to our committee, so obviously it was
received by the FDA, talked about just one of those eye
infections that occurred after repackaged, repurposed Avastin--
apparently the company took a bulk amount of compound that was
duly licensed for treatment of colon cancer, broke it up into
smaller amounts, and dispensed it to ophthalmologists for use
in treating macular degeneration. The problem is, and as has
been referenced by your folks, every time you pierce that vial,
the risk for contamination occurs. So you make up multiple
preparations that can now be used for intraocular injection,
but the last syringes that are prepared that day may have extra
stuff in them. You cannot have a preservative to prevent the
growth of bacteria or fungus in an Avastin preparation for
ophthalmic use, because it is going into the eye and you can't
have a preservative injected into the eye.
So I guess what troubles me is you are talking about it
here, the serious eye infections with repackaged Avastin, but
that wasn't exactly news to you, was it?
Dr. Hamburg. I think what you are speaking to underscores
the fact that we really do now need to recognize that the
existing legal authorities and enforcement strategy is not
adequate to address the problems that we have. We need to be
able to----
Mr. Burgess. I am sorry, I do need to interrupt----
Dr. Hamburg [continuing]. Repackaging to sanitary
standards.
Mr. Burgess [continuing]. In the interest of time, because
you now are in those companies. I mean, in your own testimony
you talk about compounding pharmacies producing what should be
sterile products shipping across state lines, and in advance of
or without a prescription--I am not a lawyer. I don't really
understand what makes a manufacturer a manufacturer, but I feel
like that old Supreme Court justice. I don't know the
definition of manufacturer, but I know one when I see it, and
that is a manufacturer, and you have absolute authority to
regulate manufacture of pharmaceuticals, do you not?
Dr. Hamburg. Yes, we do.
Mr. Burgess. Yes is the answer. Thank you for the direct
answer to that question. And you are doing it now in the post-
NECC environment and we are grateful for that enforcement
activity. I just got to believe your folks at the various
divisions within the agency, I mean, they had to be pulling
their hair. In fact, we have the testimony of one of--the
fellow that is now the head of the whole New England district
office, Mutahar Shamsi, I mean, he said why do we even inspect
if we are not going to follow through on these things? They are
doing all the work. They are getting right up to the point
where, again, someone should pull the plug on the bad guys and
they tell the cop to stand down. Don't do it. Your agency must
be internally in turmoil because of this.
Dr. Hamburg. We would very much like to have some of the
same kinds of authorities that we have with conventional
manufacturers with these highest risk compounders.
Mr. Burgess. Wait a minute.
Dr. Hamburg. We do not presently have them, and that is why
we are seeking legislation.
Mr. Burgess. You have the authority to regulate
manufacturing. I mean, that is--no one is disputing that. That
is not in question. You have that authority. In fact, if you
don't believe you have that authority, maybe somebody else
ought to run the agency, but you have that authority.
Dr. Hamburg. Of course we do, but what I am saying to you
is we do not have the same authorities to regulate compounding
pharmacies.
Mr. Burgess. If they are manufacturing--if they are
engaging in manufacturing, I submit that you do.
Thank you, Mr. Chairman. Maybe we can have time for a
second round.
Mr. Murphy. Thank you. Chair recognizes the gentleman from
Michigan, Mr. Dingell.
Mr. Dingell. Thank you, Mr. Chairman.
I am quite outraged. Here I sit. We are picking nits and
straining at nats instead of addressing what this committee
should be doing. We should be figuring out what are the
problems, and then to proceed to address them. We have had 733
cases, 53 deaths, 15 deaths in Michigan, the highest number of
cases, and the deaths, and we are dealing here with an agency
that doesn't have the authority to do the things that it needs
to do.
Section 503 exempts compounded drugs from three critical
requirements at FDA. First of all, they don't have to comply
with good manufacturing practices. If you look at what happened
up in New England, you will find they weren't even within rock-
throwing distance of good manufacturing practices. And so they
have no authority to address these things as new drugs. They
really have questionable, if any, authority to address these
people as manufacturers, and there is no requirement that these
things have directions for proper use. In addition to this,
these people who have vigorously opposed any kind of control
have not only got themselves statutory exemption, but they
don't even have to report adverse consequences of the use of
their pharmaceuticals.
And here we sit, picking nits about what did Food and Drug
know, and when did they know it? This committee should be
saying what authority do you need, and then saying by golly, we
are going to get it for you.
Now, let me ask you a few questions, Administrator. You
said that you don't have sufficient authority to regulate these
people. Is that right?
Dr. Hamburg. Correct.
Mr. Dingell. Yes. Now, since the fungal meningitis
outbreak, FDA has inspected compounding pharmacies that are
known to have produced sterile drugs in the past. Is this
correct?
Dr. Hamburg. That is correct.
Mr. Dingell. Can you explain briefly what the Food and Drug
Administration found during these inspections?
Dr. Hamburg. We have found serious lapses in sterility--
procedures, insufficient ventilation----
Mr. Dingell. I want you to submit that for the record, if
you please.
Now, was Food and Drug granted full access to all of the
identified compounding pharmacies for inspection? Yes or no?
Dr. Hamburg. No.
Mr. Dingell. Would you submit to us what it was that they
did to deny you that access?
Now, was Food and Drug granted full access to records by
all of the identified compounding pharmacies during inspection?
Dr. Hamburg. No.
Mr. Dingell. Did you encounter resistance from any of the
identifying compounding pharmacies when Food and Drug arrived
for inspection?
Dr. Hamburg. Questioning of our authority, yes.
Mr. Dingell. All right. Now, would you please submit for
the record what actually happened to you in these cases where
they refused you access to the records?
Now, Madam Administrator, even in light of the fungal
meningitis outbreak, with 53 deaths and over 700 confirmed
cases, some of these compounding pharmacies refused to grant
you access to their facility or records for inspection. Yes or
no?
Dr. Hamburg. Yes.
Mr. Dingell. Do you need inspection authority to
effectively regulate compounding pharmacies? Yes or no?
Dr. Hamburg. Yes, absolutely.
Mr. Dingell. Do you believe that the states are able or
have carried out their responsibilities fully on these matters?
Dr. Hamburg. It is very variable, but no, not in their
entirety.
Mr. Dingell. OK. Do you believe that FDA has clear
authority to access all records when inspecting a compounding
pharmacy? Yes or no?
Dr. Hamburg. I am sorry. Could you repeat that?
Mr. Dingell. Do you believe that FDA has clear authority to
access all records when inspecting a compounding pharmacy? Yes
or no?
Dr. Hamburg. No.
Mr. Dingell. Has FDA faced litigation regarding its ability
to inspect records in pharmacies?
Dr. Hamburg. Yes, we have.
Mr. Dingell. Do you need this authority to effectively
regulate compounding pharmacies?
Dr. Hamburg. Yes.
Mr. Dingell. Would these authorities help FDA to enter a
compounding pharmacy without delay to conduct proactive
inspections?
Dr. Hamburg. Yes.
Mr. Dingell. Would these authorities assist FDA in
preventing future outbreaks?
Dr. Hamburg. Yes.
Mr. Dingell. Thank you, Commissioner.
Now, I want to make some observations here. This committee
has an important responsibility. Our responsibility is to find
out if the laws are being properly enforced and if there is
additional law that is needed to make the situation better. We
are having people who have been killed. We can anticipate if we
don't do something more, there are going to be more. The
Democratic members on this committee have sent to the
leadership of this committee a request to bring in the trade
association of these people to discuss what it is they are
doing, and why and when and how. They have refused to assist
and cooperate with Food and Drug. They have gone further and
they have instructed their members as how to obfuscate, delay,
and to refuse to comply.
We have a nasty situation on our hands. Let's get down to
addressing the problem that is before us. Let's haul the right
people in. Let's get the right kind of legislation drafted.
Let's get the proper testimony, and let's move forward.
Thank you, Mr. Chairman.
Mr. Murphy. Thank the gentleman.
By the way, Chairman Dingell has asked for a number of
documents for the record, and at the last hearing in November,
a number of members also asked for documents. We haven't
received those yet, so I would like to expect those documents
by the 19th of April, to have answers to those questions.
Dr. Hamburg. By the 19th of April?
Mr. Murphy. The questions for the record from the last
hearing. the questions for the record from the last hearing,
which was in November.
The chair now recognizes for 5 minutes the gentleman from
Louisiana, Mr. Scalise, for 5 minutes.
Mr. Scalise. Thank you, Mr. Chairman. I appreciate you
having this hearing and following up on something that we have
been delving into for a few months now.
I know I had asked, as others did, back at that last
hearing--and I will reiterate, I would like to get whatever law
it is that you all are hiding behind that says you do not have
the legal authority to investigate these pharmacies like
Ameridose and NECC. I don't know why haven't gotten it in the
months since our hearing, but can you get us whatever it is
that legally you are hiding behind that you say prevented you
from doing the proper investigation, things that you are saying
you need to change the law now. Well, if you need to change the
law now, then clearly you are hiding behind some section of law
that you think doesn't allow you to do it today. Can you get us
that information?
Dr. Hamburg. I can certainly get you relevant law. I would
just like to underscore that it is not just the FDA that is
concerned about the ambiguity in the law. This has been a
serious issue for a long time, going back to when it was first
enacted, the statute--503A of the Food, Drug and Cosmetic Act,
when David Kessler sat before a committee and said that he was
concerned that the law was going to create loopholes that would
enable compounding pharmacies to be able to----
Mr. Scalise. But did you just say earlier in your testimony
that you have gone and investigated over 50 of these pharmacies
since the outbreak?
Dr. Hamburg. Because we have been able to go in and
investigate----
Mr. Scalise. Well if you have been able to investigate----
Dr. Hamburg [continuing]. Does not mean that we have the
full authority that----
Mr. Scalise. So you are investigating without legal
authority now? Is that what you think you are doing?
Dr. Hamburg. No, we have the authority to go in, as
Congressman Dingell just indicated. We don't have the full
authorities we need in order to do the full inspections, and we
don't know who they are.
Mr. Scalise. Well let me just ask you this. We are running
low on time, I apologize, but if we can first put up, there is
a chart that documents complaints that have been filed for
months and months prior to the deaths that you all were
receiving. FDA was getting complaints about this facility--not
in general, but about this facility. Now, I don't know what you
all were doing about it back then, but if you were claiming you
didn't have the legal authority to do it and yet you are
getting these complaints, did you at least pick up the phone
and call the State of Massachusetts and ask them to use their
legal authority to investigate?
Ms. DeGette. Mr. Chairman, I have to ask, does the witness
have a list of those complaints, because I certainly can't read
it from here.
Mr. Scalise. Do you know about those complaints? I will ask
the commissioner. Those complaints, we got them because we got
them from the FDA. Do you know that they are out there?
Dr. Hamburg. I am aware that there were complaints, and----
Mr. Scalise. So did you all pick up the phone and call the
State of Massachusetts?
Dr. Hamburg. To the best of my understanding, we have made
an effort to follow up in the general----
Mr. Scalise. During the time prior to the 53 deaths, you
are getting flooded with complaints from people saying this
place is unsafe. It is highly questionable what they are doing.
Did you, at some point--when you said in your own decision
making process that you didn't think you had the legal
authority to go in and check them out, did you at least pick up
the phone and say----
Dr. Hamburg. No. I want to be clear.
Mr. Scalise. You are here to protect public health. Call
Massachusetts.
Dr. Hamburg. I did not say we don't have authority. We have
authority that is not adequate to fully regulate----
Mr. Scalise. Then why didn't you pick up the phone and call
somebody who did? If in your opinion you were concerned about
your question on authority, why didn't you call Massachusetts,
or did you call Massachusetts prior to the deaths occurring?
Dr. Hamburg. We----
Mr. Scalise. That is a yes or no question.
Dr. Hamburg. We have worked with Massachusetts and we
worked with others----
Mr. Scalise. But did you call the State of Massachusetts
and forward the complaints and say look, there is a real
serious question about this company in your state. We are not
sure if we can go in. You all ought to go in because you have
the legal authority. Did you make that call? Did you pass that
information on?
Dr. Hamburg. I have said that----
Mr. Scalise. Yes or no.
Dr. Hamburg [continuing]. I do not believe----
Mr. Scalise. We are running out of time here.
Dr. Hamburg [continuing]. That our response to the
compounding industry and specific issues that you are raising--
--
Mr. Scalise. So did you forward any of these complaints?
Dr. Hamburg [continuing]. Was adequately----
Mr. Scalise. And this is a yes or no question. Did you
forward any of these complaints to the State of Massachusetts
prior to the deaths? Any of them?
Dr. Hamburg. In many instances we are working----
Mr. Scalise. Yes or no?
Dr. Hamburg [continuing]. With the states to do
inspections.
Mr. Scalise. Did you forward the complaints? Yes or no?
Dr. Hamburg. I can't speak to--I don't know what complaints
you are referring to, but----
Mr. Scalise. You don't know?
Dr. Hamburg [continuing]. In many instances yes, we were--
--
Mr. Scalise. Yes, you did?
Dr. Hamburg. I don't know what complaints you are referring
to.
Mr. Scalise. Did you send the complaints? Yes or no? And I
am only trying to pressure--I mean, you were happy to answer
Mr. Dingell's questions yes or no. I have got 40 seconds left.
Did you forward any of these complaints that you got to the
State of Massachusetts? Yes or no?
Dr. Hamburg. We discussed complaints----
Mr. Scalise. Yes or no?
Dr. Hamburg [continuing]. With the states. We did
inspections with the states----
Mr. Scalise. Can you answer this in a yes or no fashion?
Are you evading?
Dr. Hamburg. I can't speak----
Mr. Scalise. Let me ask you this. I went to your Web site.
I went to your Web site. This is right now, live. Your Web site
Commissioner's Page says that it is your mission to find
``novel ways to prevent illness and promote public health, and
be transparent in explaining our decision-making, says Dr.
Hamburg.'' That is you. You are not--number one, you did not
find novel ways to protect public health, and you are not right
now being transparent in explaining your decision-making
process. So you are failing in your mission.
So I will at least ask you this. Maybe you can answer----
Dr. Hamburg. I am not----
Mr. Scalise. Has anybody at FDA been held accountable for
the 53 deaths that occurred? Anybody?
Dr. Hamburg. We are working hard, both in responding----
Mr. Scalise. Has anyone been held accountable? Yes or no?
Or do you not know?
Dr. Hamburg. You know, my statement to you is that we could
have been more vigorous, but that----
Mr. Scalise. Has anyone been held accountable?
Mr. Murphy. Gentleman's time is expired.
Mr. Scalise. Have you held anyone accountable? The buck
stops with you. You said that today in your testimony. Have
you----
Mr. Murphy. Gentleman's----
Mr. Scalise [continuing]. Held anyone accountable for 53
deaths?
Dr. Hamburg. This is a problem that is one that needs to be
addressed by----
Mr. Scalise. I will take that as a no.
Dr. Hamburg [continuing]. The FDA, states----
Mr. Scalise. I will take that as a no and I will yield back
the balance of my time.
Mr. Murphy. Gentleman's time is expired. Now recognize the
gentlelady from Illinois, Ms. Schakowsky, for 5 minutes.
Ms. Schakowsky. Thank you, Mr. Chairman, and thank you, Mr.
Tonko, for allowing me to go out of turn.
Commissioner Hamburg, by the time the Obama Administration
entered office in January of 2009, FDA guidance and law
regarding compounding pharmacies had been governed by confusion
and uncertainty for nearly 7 years. In May, 2009, top FDA
officials met with the acting commissioner, your predecessor,
to resolve the issue of unregulated compounding pharmacies. I
want to ask you about a document that the FDA produced--gave to
the committee. You can find it at Tab 45. It is a written
summary of a meeting that occurred on May 12, 2009. This
summary of the meeting noted that ``Unregulated compounding
raises significant public health concerns. FDA has seen
numerous examples of serious patient injury and death caused by
improper compounding.'' At this meeting, the recommended path
forward was to seek legislation amending Section 503A to
enhance FDA's oversight of compounded drug, much, I guess, like
you are saying now to do that.
But this document also lists a disadvantage of that
legislative approach, and the summary stated ``The legislative
process will be time and resource intensive, and the
compounding community will actively oppose the changes that we
seek. They have a very effective grass roots organization that
will make it difficult for us to achieve our legislative ends.
We cannot know if the result of our efforts will be better law
than Section 503A in its current form.''
So Dr. Hamburg, this was not a meeting that you attended,
and I am not going to ask you about it specifically, but I
would like to ask you a question about the influence of the
compounding industry generally, and its leading trade group,
the International Academy of Compounding Pharmacies, or IACP.
Can you describe the general views of the compounding industry
with regard to the FDA authority that you are talking about
requesting today?
Dr. Hamburg. Well, I think it is clear that the
organization and the industry more broadly has, over many
years, questioned our authorities to fully regulate the
compounding pharmacies. They have challenged us in court, as
has been documented, and in addition to questioning FDA
authorities, as was demonstrated in the document that was put
together by Congressman Waxman and others, they also were
making concerted efforts to weaken regulatory authorities at
the state level and I think that this was even while
recognizing that this could lead to some serious concerns, and
certainly it has made our ability to regulate this industry
much more challenging. It has required much more complexity in
terms of the actions we can take and the resources required to
take those actions, and it has certainly also thwarted earlier
efforts at legislation. In 2007, Senators Kennedy, Burr, and
Roberts proposed some legislation that would have strengthened
the FDA role and clarified some of these issues, and industry
was up on the Hill lobbying intensively, and that legislation
was never introduced. And I don't believe there was anything on
the House side either.
Ms. Schakowsky. So would you say that the IACP has made it
more difficult for FDA to effectively regulate drug
compounders?
Dr. Hamburg. I would.
Ms. Schakowsky. And would you agree that the compounders
have traditionally been adamantly opposed to any expansion of
FDA authority over drug compounders?
Dr. Hamburg. Absolutely, and I think the industry is
questioning the inspections that we are doing now.
Ms. Schakowsky. So Dr. Hamburg, earlier this week the
subcommittee released a letter asking that a representative of
compounding pharmacies be invited here today, but the Majority
rejected our request. I would like to ask that the letter and
underlying documents, all of which show that the compounding
industry has fought relentlessly to avoid FDA oversight, be
added to the hearing record.
Mr. Murphy. Without objection.
[The information appears at the conclusion of the hearing.]
Ms. Schakowsky. Thank you.
I think this proceeding would have benefitted from hearing
their testimony. Our drug supply needs to have FDA oversight
and drug compounders shouldn't get to create--to evade
regulation by the agency. We as a committee need to join
together and finally give the FDA, give you the authority that
you need, that the agency needs to effectively oversee drug
compounders.
And I yield back.
Mr. Murphy. The gentlelady yields back. I now recognize Mr.
Olson for 5 minutes.
Mr. Olson. I thank the chair, and welcome, Dr. Hamburg.
As you know, ma'am, one of my duties as an elected
representative of the people of Texas 22 is to provide
oversight and investigate the Executive Branch to ensure that
they comply with the Constitution and the laws. Put simply, my
job is to find the truth. The truth is that 55 Americans died
because their spinal injection was contaminated, and at least
700 Americans were made seriously ill by that drug. These
families deserve to know the truth, and I intend to get that
for them.
During your testimony in November, you made a number of
statements about how the compounding industry has evolved in
recent years. You also highlighted that the Massachusetts State
Pharmacy Board was in the best position to oversee NECC. But
that decision was made in 2003, is that correct?
Dr. Hamburg. As I think you probably know, compounding
pharmacies historically have been regulated by states, and it
is the states that license pharmacies.
Mr. Olson. Yes, ma'am. These are complaints--please refer
to Tabs 2 and 3 in your binder there. I will give you some time
to do that. These complaints about the NECC from pharmacists in
Wisconsin and Iowa that the Massachusetts Pharmacy Board
forwarded to FDA in April and May of 2004.
In an e-mail to Massachusetts Board related to the second
complaint in Tab 3, the lead attorney for the board asked,
could you clarify what we may not have known about your
operation previously that this e-mail tells us, as in what the
FDA might not know in a prior assessment that the NECC was not
a ``manufacturer.''
Commissioner Hamburg, a different picture of the NECC began
to emerge soon after the FDA decided the state should take the
lead, isn't that right? Much different picture, ma'am, much
different.
Dr. Hamburg. As I think was discussed at the last hearing,
it was agreed during this early period that, in fact, the State
of Massachusetts had the lead in responding because it was a
licensed pharmacy in Massachusetts. However, I think it is
important to underscore that the line between compounder and
manufacturer is not a bright one, and that that is part of what
we are seeking is to get more explicitness in law with respect
to what is a manufacturer and what is a compounder.
Mr. Olson. Yes, ma'am, but these documents show that by
2004, soon after the FDA's decision that the state would take
the lead in overseeing NECC, FDA had already begun to receive
information showing that the company was shipping products
across the country without patient-specific prescriptions.
Based on documents provided, pharmacists and hospitals
continued to forward NECC's solicitation to you, to the FDA.
Let me give you one example. It is Tab 4 there in your
binder. In January of 2006, the FDA received a complaint about
NECC soliciting a multiple use sterile injectable product. Are
you familiar with this complaint, ma'am? Yes or no?
Dr. Hamburg. Yes.
Mr. Olson. Yes. This complaint stated that NECC does, and
this is a quote, ``not need or desire to have the patient's
name.'' This would suggest that the company is no longer acting
like a compounder, right? It is not filling patient-specific
prescriptions.
Recently, a 60 Minutes report in which you were
interviewed, an NECC anonymous informant claimed the company
was forging patient prescriptions. Are you familiar with that
charge, ma'am? Yes or no?
Dr. Hamburg. You know, with respect to some of these
specific documents, et cetera, because of the ongoing criminal
investigation--I discussed this with the chairman before--I
cannot characterize this situation for you. We all want that
criminal investigation to go forward, and I do not want to----
Mr. Olson. Ma'am, with all due respect----
Dr. Hamburg [continuing]. Do or say something that would
compromise that.
Mr. Olson [continuing]. You are not the subject of an open
investigation. This committee has not sought any documents from
the FDA or U.S. Attorney's Office that are being used in an
open criminal case. By definition, we are not asking any
questions about the open case or evidence that is part of that
case. This Congress does not necessarily have your respect for
``open criminal case'' and that excuse. Thirty years ago in the
Reagan Administration, this committee and other committees in
the House held EPA Administrator Anne Gorsuch in contempt for
not producing documents, even though Administrator Gorsuch was
advised by Department of Justice and the White House that she
could not produce to Congress these documents because of
executive privilege. Please give us these documents.
Again, I don't think open case applies. It hasn't
historically. It shouldn't apply here.
Dr. Hamburg. You clearly have a huge number of documents,
but I cannot speak to the specifics of some of these documents
because of the ongoing criminal investigation. I don't know the
specifics of what is--I am not part of the ongoing criminal
investigation in terms of the collection of information and its
analysis, but I have been told that I need to be careful not to
compromise that investigation.
Mr. Olson. That is----
Mr. Murphy. Gentleman's time is expired.
Mr. Olson [continuing]. A subject of investigation and we
have not sought any documents from FDA or----
Ms. DeGette. Mr. Chairman?
Mr. Murphy. Gentleman's time is expired.
Mr. Olson. I yield back.
Ms. DeGette. I would respectfully ask that members--I would
ask unanimous consent to ask Commissioner Hamburg, were you
advised by counsel not to answer questions about the ongoing
criminal investigation at NECC?
Dr. Hamburg. I was.
Ms. DeGette. So Mr. Chairman, I would ask members not to
ask those--if she has been advised by counsel not to do that, I
don't want to hurt a criminal investigation of a company that
has killed 55 people and sickened hundreds more, and I am going
to assume no one else does.
Mr. Murphy. I am assuming you would be able to show us a
letter from the Attorney General or someone's office saying you
cannot speak to certain subjects here so we know exactly where
you can and cannot. Can you show us some documentation?
Dr. Hamburg. Well, I don't have such a letter but I was
advised that I should be very careful about not compromising
the criminal investigation, and I think we all share that
concern. None of us want to imperil the important criminal
investigation that is ongoing.
Mr. Murphy. I appreciate that. We will make sure we ask
questions relevant to what you did and didn't do, and what the
FDA is responsible for in this. Thank you.
Chair now recognizes the gentleman from New York, Mr.
Tonko, for 5 minutes.
Mr. Tonko. Thank you very much, chair.
First, thank you for appearing before the committee, Dr.
Hamburg, and thank you for your service as commissioner at FDA.
It has been well-documented that the FDA has been stepping
up its inspections of compounding pharmacies in the wake of
tragedies, and while that is a first good step, can you tell us
which additional efforts you need? What follow-up intervention
would and should be available as the next tools in the kit to
do your job and do it effectively?
Dr. Hamburg. Well thank you for that question. We do feel
that we want to be more aggressive, and to do that, there are
some critical gaps in our authorities.
First of all, we need these companies that are making the
highest risk products, the sterile products, in advance of or
without a prescription and shipping them interstate, they need
to be held to a national uniform standard for safety practice
in good manufacturing that they will adhere to, that we can
inspect against, and that we can take enforcement actions
against that will hold. They need to be required to register
with us so that we can even know who is out there and what they
are making. And we certainly want them also to report adverse
events to us if they hear about them in relation to a product
so that we can get in quickly and try to mitigate that problem
as fast as possible.
Mr. Tonko. Thank you. The partnership, the
interrelationship with the state authorities, are there
requirements for them to inform the FDA as to findings? Does
the ball rest in your court to approach them? Are they
required--is there a registry of sorts that requires them to
update you routinely as that structure--is it standardized?
Dr. Hamburg. A very important question. As you know, states
historically have regulated compounding pharmacies, as they do
the practice of pharmacy in general, and states have very
different laws with different requirements. But as far as I
know, there are not any specific requirements on reporting to
the FDA. We often work in concert with states and that is
important, and we sometimes piggy-back on their authorities
when we are going into facilities and, for example, trying to
get access to records which we might be denied. Going forward,
we feel very strongly that we need to strengthen the working
relationships with the state and systematize some of the
mechanisms for communication, because that will make a
difference.
In these recent inspections that we have just done, we did
do them in almost all the cases in coordination with the
states.
Mr. Tonko. It seems to me that there was a lot of talk as
to what intervention there was or what interaction there might
have been between FDA and the states. It seems to me there is
an added safety net offered if there is a structured,
standardized requirement of states to inform good and bad news
being shared with you about their oversight and to give an
authority that they now have. I think that would improve the
system.
And also, you asked about the explicitness of some of the
details that guide your day-to-day operations in these matters.
Are there other things you would bring to this committee's
attention that would be useful and provide for, perhaps, more
public safety here and consumer protection?
Dr. Hamburg. Well, I think what is just abundantly clear
and is demonstrated in the documents that we have given to you
is that we have been compromised in our ability to provide the
full and aggressive enforcement that I think is necessary to
protect the health of the American people, that we have an
ambiguous statute. We have a statute that is complicated by
differing court opinions that reflect the ambiguity that even
federal courts can't agree about what the law is and how it
should be applied. And that just is not a system that serves
anyone, and that is overlaid on the fact that all of the states
have different laws and practices. So we do not have the kind
of strong regulatory system that really can assure safety and
get patients the products that they need.
In addition, the statute doesn't fit the current healthcare
environment, patient needs, hospital needs. It is simply the
wrong fit and we have an opportunity--I think we have an
obligation now to work with all of you to try to make sure that
we have the kind of regulatory program in place, the kinds of
laws that we can really build on and enforce against.
Mr. Tonko. I appreciate that effort, and I would hope that
we gather this information and go forward and do the work that
is essential to respond to--in the aftermath of these tragedies
to the needs of the general public.
So thank you again for your information here today.
Dr. Hamburg. Thank you.
Mr. Murphy. Right now recognize the----
Mr. Tonko. I yield back.
Mr. Murphy. Gentleman yields back. We now recognize for 5
minutes the gentleman from Virginia, Mr. Griffith, for 5
minutes.
Mr. Griffith. Dr. Hamburg, while the circuits may disagree
on some aspects of the law, isn't it correct that in order to
be a compounding pharmacy, you are supposed to be making
something for a specific patient with a specific prescription?
Isn't that true?
Dr. Hamburg. Well in fact----
Mr. Griffith. Yes or no?
Dr. Hamburg [continuing]. Many states allow anticipatory
compounding and----
Mr. Griffith. I am talking about the code that--the Federal
Code, and isn't it true that for federal purposes, it is
supposed to be a specific prescription and a specific patient?
Yes?
Dr. Hamburg. That is.
Mr. Griffith. All right. Now let's move on to the sister
of--the sister company of NECC, Ameridose, because they also
had problems and you all received--FDA received information
about those problems at Ameridose in 2009, 2010, 2011 from
internal company sources, isn't that correct? Yes or no?
Dr. Hamburg. That is correct.
Mr. Griffith. And the concerns that were raised related to
the safety of the products and practices at Ameridose, but also
the company's management, isn't that also correct?
Dr. Hamburg. Yes.
Mr. Griffith. And isn't it correct that you all were
alerted by the folks in Ohio that there was actually a question
that they didn't have these prescriptions for individual
patients, but in fact, were manufacturers and Ohio was asking
you all to look into this in trying to decide whether they were
going to issue a Cease and Desist letter? Isn't that also
correct?
Dr. Hamburg. Again, I apologize but we are getting into the
area of an ongoing investigation and----
Mr. Griffith. I am asking you if it is a fact whether you
gave information to this committee, and I want it out there in
the public so everybody in the United States knows, you all
received information--I am not asking you whether it was true
or not, but you received information from the State of Ohio
that they felt like what they were looking at with Ameridose
was a manufacturer and not a prescriber. Isn't that correct?
Excuse me, not a compounder, because they didn't have specific
prescriptions. You received that information, yes or no?
Dr. Hamburg. You know, I actually cannot speak to that
specific document.
Mr. Griffith. So you were unaware that this information had
come to the attention of the FDA that Ohio was very concerned
about this?
All right, I am going to move on. Are you aware that there
were notes that were involved in these complaints and concerns
about whether or not there was going to be an investigation,
and that one of those notes--and I would point you to Tab 26,
go to the second part where it starts listing out things, and
it says--I believe I have got this right here. On page 4, note
4, specifically part of the inspection was to read ``Are
written prescriptions/physician orders for identified
individual patients received before dispensing compounded
injectable products each time they are dispensed?'' That is
part of one of your own memos, is it not?
And Mr. Taylor, if you want to jump in here, it might be
your memo, but it is an FDA memo. Yes or no?
Dr. Hamburg. The issue about prescriptions is one that has
been an area of ambiguity in terms of whether 503A applies or
not, et cetera, and it has been part of this changing landscape
in terms of----
Mr. Griffith. There was an inspection request and as a part
of that inspection request, attached to that was background
information and what you ought to do, and one of those was to
look into that information. But you all never did that with
Ameridose, did you? Before the NECC problem, their sister
company was discovered through the deaths of American citizens
and 1,415 people in my region of the State of Virginia and a
little bit over into West Virginia were impacted by these drug
companies or these manufacturers posing as compounders. You
never asked for that information--the FDA never did that, did
they?
Dr. Hamburg. As I said, there is an ongoing investigation
by the FDA with respect to Ameridose, and we are----
Mr. Griffith. All right. You never held an inspection, yes?
Dr. Hamburg. We have inspected Ameridose on a number of
occasions, but I cannot speak to the specifics.
Mr. Griffith. All right. And there were numerous requests
to inspect both Ameridose and NECC, and as these inspection
requests came in, you all sometimes--you answered earlier that
to get a warrant might take you days or weeks, but isn't it
true that on several occasions when NECC wrote you back and
said we don't think you have authority, you took 2 years before
you even sent them a letter back? Isn't that not also true?
Dr. Hamburg. As I said, I wish that we had been more
prompt----
Mr. Griffith. And I appreciate that, and I do appreciate
the answers today much better. My time is running out, ma'am,
so I am going to move on. I do appreciate it. I understand that
you are now going to be more aggressive, but in order to fix
this, we have to figure out where the problems are. And when
you have 2-year delays when somebody just sends you a letter
and says hey, we don't think you have authority, that is not
acceptable. I believe that we have got to figure out what the
problems were, not just at NECC, but across the board. I
believe there are a lot of companies out there posing, perhaps,
as compounders who are really manufacturers and I think if you
insisted on the requirement that there be a prescription for a
specific patient or that the compounding made for a specific
patient like it was for my son on one occasion, then we
wouldn't have had this problem in the first place and I think
you all failed the American people.
Mr. Murphy. Gentleman yields back. Now recognize the
gentleman from Texas, Mr. Green, for 5 minutes.
Mr. Green. Thank you, Mr. Chairman. Again, thank you, Dr.
Hamburg, for coming back. I remember the hearing that we had
earlier, and I have to admit, having been on the committee for
a long time, I didn't think the FDA was something we could be
proud of then because of what my colleagues on the other side
have talked about.
Since the fungal meningitis outbreak was traced back to the
so-called compounding pharmacy in Massachusetts, all we have
seen is finger pointing from the FDA, the industry,
Republicans, Democrats, even states have played this role, and
it is time for the finger pointing to end and we begin to
legislate.
I have always supported community-based compounding
pharmacies, because historically that is how pharmacies
started. But I was shocked at what was going on in
Massachusetts was considered the same type of facility as my
neighborhood compounder who is filling the prescription from a
physician, or even a larger pharmacy that supplies hospitals or
large practices, or even a heavy client load. And to know the
FDA is requesting additional authority from Congress to
regulate certain compounding pharmacies.
I also know that that was your testimony previously, but in
the meantime, you have been able to open up investigations. So
you can see why from our side of this, it looks like maybe FDA
did have some authority and just didn't use it. But I also know
that in a legal situation, you probably need some background or
some support based on changing the law. But I don't want you
not doing what you are doing right now, and I know you have
opened some investigations. So somewhere along the way, one of
your attorneys said we can do this now. And I guess they didn't
tell you that 2 years ago or whenever. Is that correct?
Dr. Hamburg. I want to be clear that I never said we didn't
have authorities. I said our authorities were limited and we
are determined to be as aggressive as possible using our
current authorities. But they are not adequate to provide the
American people with the safety protections that they need, and
our current round of inspections are, I think, underscoring
that fact that we cannot have an inspectional system in a
regulatory regime where the very players that are at the center
of the questions don't even have to register with us, don't
even have to let us know what----
Mr. Green. And I agree, but what the FDA is requesting the
authority, is it over all compounders, including the ones who
are regulated by the states, particularly like a local
compounding pharmacist who just does prescriptions? Does the
FDA want to get into that, or do you want to look at the
manufacturing that only goes across state lines?
Dr. Hamburg. Traditional compounding, the corner pharmacy
type you are describing, I think has a very important role in
our healthcare system, and we all recognize that. We are
concerned about this evolving new hybrid of compounding
pharmacy that is making sterile, high risk products in advance
of or without a prescription and selling across state lines. We
do believe we need new authorities in order to adequately
regulate them. Again, they provide an important service to our
healthcare system. Hospitals depend on the products that they
make, and if done right, they can make these products safe.
Mr. Green. That is one of my concerns, and I am going to
run out of time, and you know our time limits.
As we write legislation, we should keep in mind that your
intent is to try to keep the compounding pharmacies that are
locally in the domain of state regulators, but for example, in
Texas we have a great medical center in Houston, and I am
assuming they have a contract with some type of compounding
company that--whether it is across state lines or not, that
they may work with, but that compounding company is using
prescriptions from this medical center or this hospital system
or this practice of doctors. You don't intend to go as far as
for someone that has a prescription from either a group of
doctors to a compounding pharmacist?
Dr. Hamburg. We appreciate the tradition and the importance
of traditional compounding. We do think that there are some
requirements that should apply to all compounders, big or
small, traditional, non-traditional. For example, there are
certain products that probably should not be compounded by
pharmacies, no matter what. They should be made by
manufacturers within the new drug approval process to assure
safety and efficacy, products that are complex and involve
hard-to-deliver kinds of mechanisms, et cetera. We also believe
that FDA-approved commercially available drugs should not be--
--
Mr. Green. OK. I hate to cut you off, but I want to ask--
get a chance to ask you a question. These additional
inspections that you are doing now, or the additional
authority, does FDA have the capacity to expand on that,
considering the funding flow that you already have? Are you
going to be able to find the money to do that, even if Congress
continues with sequestration, which it looks like we are, but
also with the current appropriations process?
Dr. Hamburg. It is an enormous concern in terms of the
expansion of responsibilities. Already, we are responsible for
overseeing some 5,600 conventional manufacturers. It is
estimated there are about 28,000 compounding pharmacies
overall, probably 7,500 or so specialty pharmacies, and about
3,000 that are doing sterile compounding.
Mr. Green. Mr. Chairman, I am out of time and I understand.
I have one more question I would like to submit, if we could
submit a question particularly dealing with the Texas--an
entity in Texas with--but I would like to submit that too if I
have permission to do that.
Mr. Murphy. Yes, and we probably are going to be doing a
second round, too. If you are still here, you can ask that
directly.
Mr. Green. OK. If we do a second round, I will be back.
Dr. Hamburg. OK.
Mr. Murphy. Now recognize the gentleman from Ohio, Mr.
Johnson, for 5 minutes.
Mr. Johnson. Thank you, Mr. Chairman.
Ms. Hamburg, you said in a response to our colleague, Mr.
Tonko, a little while ago that you want compounding pharmacies
to report adverse events so we can mitigate them as fast as
possible. Would you please explain briefly, what is an adverse
event report?
Dr. Hamburg. An adverse event report is when someone
submits to the FDA a concern about a product. It doesn't mean
that actually there is a legitimate or ultimately verified
concern, but it is that there seems to have been some negative
reaction associated with a product.
Mr. Johnson. OK. Well the FDA made a decision in 2011 to
suspend inspections of compounding pharmacies until the agency
could issue guidance on compounding and manufacturing, right?
That is what you have testified to thus far?
Dr. Hamburg. Yes.
Mr. Johnson. That is a yes, correct?
Dr. Hamburg. Yes. You know, it is a bit more complicated
than that----
Mr. Johnson. No, it was a very simple question. The FDA
made a decision in 2011 to suspend inspections of compounding
pharmacies until the agency could issue guidance on compounding
and manufacturing.
Dr. Hamburg. We were doing for-cause inspections when we
learned about a problem----
Mr. Johnson. Well, I want to talk about certain adverse
event reports that came into the agency about Ameridose after
this decision to suspend inspections were made. The agency
produced these reports to us, but didn't produce any documents
showing how the agency responded to them, so let me run through
them.
They are located--the complaints are located in your binder
starting at Tab 40. We know that the FDA didn't conduct any
inspections of Ameridose from 2011 until the outbreak. Is that
accurate? Is that correct?
Dr. Hamburg. After 2011, I do not believe we did any
inspections.
Mr. Johnson. OK. I want to determine what the FDA did with
these reports, including sharing the information with the state
or investigating them. On November 17, 2011, FDA received an
adverse event report associated with three pregnant women in
labor having to have c-sections, since the epidural injections
of an Ameridose-made Fentanyl product were not working. Did the
FDA take any action on that adverse event report?
Dr. Hamburg. My understanding is that we were in there
inspecting. We did----
Mr. Johnson. No, I am not asking if you were in there
inspecting. I asked did the FDA take any action on that adverse
event report? You testified earlier that you want to mitigate
them as fast as possible, so these have a sense of urgency to
them in your own opinion. Did the FDA take any action on that
report that came in on November 17?
Dr. Hamburg. I can't speak to every complaint----
Mr. Johnson. Would you get that back to the record?
Dr. Hamburg. I will get back to you on that.
Mr. Johnson. OK. On January 24, 2012, FDA received an
adverse event report associated with Ameridose-made Fentanyl
injections. This time, the complaint related to confusing
labeling resulting in two near-misses where nurses had stated
that they almost gave their patients 100 milligrams instead of
50 milligrams. What action did the FDA take in that case?
Dr. Hamburg. I would like to get back to you on that.
Mr. Johnson. OK, submit that one for the record as well,
please. Can I have your commitment on that to submit that one
to the record?
Dr. Hamburg. Yes.
Mr. Johnson. OK. The next day, on January 25, 2012, FDA
received an adverse event report involving an Ameridose-made
Heparin-IV bags that a hospital administered to patients, only
for the hospital staff to determine after several tests that
the bags contained no Heparin. What did the FDA respond to that
adverse event report?
Dr. Hamburg. Again, it would be very helpful to me, because
of the ongoing FDA investigation----
Mr. Johnson. They are in your tab, ma'am.
Dr. Hamburg. I am uncertain what would be harmful for me to
say----
Mr. Johnson. No, what did the FDA do in response to that
adverse event report, if anything?
Dr. Hamburg. You know----
Mr. Johnson. Get that back for the record, also.
Dr. Hamburg [continuing]. Adverse event report----
Mr. Johnson. Looks like we are striking out here. My time
is limited, ma'am, because I have several others here. On March
12, 2012, the FDA received another adverse event report
involving potency issues with Ameridose-made Fentanyl products,
at Tab 43. Any response by the FDA?
Dr. Hamburg. I would like to get back to you----
Mr. Johnson. OK, I would appreciate that.
Dr. Hamburg [continuing]. Because I can't respond to----
Mr. Johnson. Less than 2 weeks later, on March 23, 2012,
the FDA received yet another report involving another hospital
close call associated with confusing Ameridose labeling. That
is at Tab 44. I am out of time, so I will ask you to get me
responses back--the committee responses back on all of those,
please.
Mr. Murphy. Gentleman yields back. Chair now recognizes Mr.
Long of Missouri for 5 minutes.
Mr. Long. Thank you, Mr. Chairman, and thank you, Dr.
Hamburg, for being here today. I know this hasn't been real
easy, and Mr. Taylor, for your assistance.
The President stepped to the microphone yesterday and said
that at a time like this with the Boston attack yesterday, that
we are not Democrats and we are not Republicans, we are
Americans. And I think when a situation like this NECC
situation with the FDA comes up, well, that is how we need to
approach things, as Americans, and trying to get to the bottom
of this and see what you can do to be helpful to us and what we
can to do be helpful to you. Back in--do you remember the first
time--when was the first time you were apprised of the fact
that warning signals or warning flags had been raised about the
activities of the New England Compounding Center?
Dr. Hamburg. You know, as I think I said before, as
Commissioner, I am not aware of every enforcement action that
is being taken, every complaint that comes in, and so,
unfortunately I was not aware of many of the facts that are now
before us until----
Mr. Long. Well, I am just asking the first time that you--
--
Dr. Hamburg [continuing]. This tragedy occurred.
Mr. Long. The first time you were apprised of this, I mean,
was it on a newscast, or how were you made aware of the serious
problem?
Dr. Hamburg. You know, I became aware of NECC when the
first reports of the meningitis outbreak began to emerge, and
you know----
Mr. Long. Which was approximately----
Dr. Hamburg. Which was in the fall of 2012, and we began to
work very quickly with our colleagues at the state level, and
with the CDC to try to understand the nature of the
contamination and what could be done to address it, and to make
sure that appropriate actions were taken.
Mr. Long. Prior to that time, had you all ever inspected
the facilities of NECC? Had the FDA ever been in there and done
any inspections?
Dr. Hamburg. Yes, there had been inspections.
Mr. Long. What type of inspection? I mean, what were they
inspecting for? I mean, is this something where you would
monitor for such things as mold, or do you do microscopic
tests, or what kind of inspections would you conduct?
Dr. Hamburg. Well, I think we were not doing routine
inspections because NECC was being regulated by the State of
Massachusetts as a licensed pharmacy. But over the course of
history, we were in there for various reasons in response to
specific complaints of product contamination or adulteration or
misbranding.
Mr. Long. Did you know they were bad actors then? I mean,
would you have considered them a bad actor from your prior
experience?
Dr. Hamburg. This is the area that I cannot address because
of the ongoing criminal investigation.
Mr. Long. But you have no letter or anything from Justice
or anyone telling you not to speak here openly today about--to
answer a question, I guess?
Dr. Hamburg. You know, I think none of us would want to
compromise the importance of that criminal investigation and
what----
Mr. Long. We don't want to compromise the American public,
either, and----
Dr. Hamburg. No, and that----
Mr. Long. We have had 53 deaths and we have 700 and some
that are ill now with it, might lead to their demise. There is
another--I think Morgan Griffith said there are 1,400 and some
just in his district alone, so--but back on April--in fact, it
has been 2 years and 1 day ago, Colorado issued a Cease and
Desist order to the New England Compounding Company, or
whatever the last ``C'' is on there, for shipping drugs to
states without requiring individual prescriptions for each
drug. Back then, 2 years ago, prior to 2012 and this outbreak,
what--isn't there somewhere you all called off the dogs for a
year? What point was that?
Dr. Hamburg. Well, I think you are referring to a Cease and
Desist order that had happened----
Mr. Long. From Colorado.
Dr. Hamburg [continuing]. Based on Colorado State pharmacy
law.
Mr. Long. Right, but that didn't raise any red flags to you
all that----
Dr. Hamburg. You know, as we have discussed, states have
very different laws with respect to what they will allow in
their states, and what also they will license pharmacists and
pharmacies to do, and we did do that as a matter of state law
fundamentally.
Mr. Long. You said earlier in your testimony that we needed
legislation, and legislation takes a little while in this town.
And while we are waiting for this legislation, what are you
doing in the interim to prevent this from happening again, or
continuing to happen? There may be other compounding facilities
out there as we speak with mold in their facility, along with
other things. What are you doing now?
Dr. Hamburg. Well, I am deeply concerned that we could have
another tragedy, and that is why I really am hoping we will be
able to work with you on new legislation. But in the meantime,
we are going to apply our current authorities as adequately as
we can, recognizing that they are limited, that they don't
allow us to know everyone who is out there and what they are
making. They don't allow us to have a clear uniform set of
standards that are enforceable in law for these highest risk
compounders to adhere to, and that we are being challenged
every day about our authorities in terms of the industry
believing that we are overstepping, that we don't have
authorities, and we know we need changes in the law in order to
really be able to proactively provide the kind of regulatory
framework that will prevent problems from happening in the
first place, rather than responding----
Mr. Long. Short of having new legislation, are you
satisfied that your agency is doing everything possible----
Mr. Murphy. Gentleman's time is expired.
Mr. Long [continuing]. Now to protect the American public
in the interim? Because like I said, it takes forever and a day
to get new legislation done in this town.
Mr. Murphy. Gentleman's time----
Dr. Hamburg. Yes.
Mr. Long. Particularly when one side of the aisle refers to
the other side of the aisle, and then that side of the aisle
refers to their friends on the other side of the aisle. Like I
said, I want to go back to my opening statement that I think we
need to all work as Americans for a solution here and forget
this malarkey about each side of the aisle. I think this is one
time that we need to pull together, because there has been a
lot of people that--families that have been crushed by this
and----
Mr. Murphy. Gentleman's time is expired.
Mr. Long [continuing]. We need to prevent this in the
future. I yield back what time I don't have.
Mr. Murphy. Thank you. Gentleman's time has expired. Now
recognize the gentlewoman from North Carolina, Ms. Ellmers, for
5 minutes.
Mrs. Ellmers. Thank you, Mr. Chairman, and thank you, Dr.
Hamburg, for coming today. I do have many questions, but most
importantly, I would like to say that I am incredibly confused
by your testimony, and because I am confused, I would like to
try to break this down into very simple terms. I would like for
you to answer as if you were answering to one of the 53
families who are now without their loved one as a result of
these actions that have taken place.
You continuously contradict yourself on what the FDA knew,
what the FDA did not know, what the FDA passed on to the state,
what the FDA did not pass on to the state, and then when you
find yourself in a corner, you say that you cannot respond
because of the ongoing criminal investigations. So let's try to
get to the bottom of it in very simple terms, because there
again, one minute you were going in for inspections, and then
the next minute you were not going in for inspections. One
minute you understand that there were complaints filed, and the
next moment you did not know that there were complaints filed.
I don't understand how we can get to the bottom of this
situation. Furthermore, I would like to say that I don't
understand how more legislation, regulation, and authority is
going to help this situation, when the FDA did not apply what
they already had. That is very confusing to me because the
authority that was there, the authority that you had to share
information with a state obviously did not take place. Were
there complaints that the FDA received shared with the state?
Yes or no?
Dr. Hamburg. In some cases, but what you asked me to speak
to the families----
Mrs. Ellmers. There are a number of incidents of complaints
there starting in 2002 all the way to 2012. Which of those
complaints were shared with the state? Now mind you, I
understand in your testimony you said here that you worked very
quickly with your colleagues at the state level. How did you
work with the state level when this went on for 10 years?
Dr. Hamburg. You know, I think the critical point that I
want to make to you and would make to the families and their
victims is that I wish that the FDA had been more aggressive--
--
Mrs. Ellmers. That is the third time you have used the term
``I wish.'' I bet that those families wish you had acted as
well.
Now let me go on to my questioning, because again, I am so
confused as to what authority you have, what authority you
don't have, how you have worked with the states, because they
are the licensure of these pharmacies and compounding
pharmacies/manufacturers. You know, we keep getting into this
gray area and that seems to be your reasoning for inaction.
I have some documentation in front of me, some from the
previous hearing that took place, of which I was not here. I am
a new member to the Energy and Commerce Committee. Basically
you said at the last hearing in your written statement, you
pointed to the fact that the state had inspected NECC in 2011
and found that the facility to be ``satisfactory.''
Commissioner Hamburg, when did FDA first become aware of the
inspection by Massachusetts Board of Pharmacy that had taken
place? Did you know about this?
Dr. Hamburg. I was not aware of it personally until
preparing for the hearing, but----
Mrs. Ellmers. So it was----
Dr. Hamburg [continuing]. Let me say that it is not
surprising that you are confused, because even federal judges
have been confused about----
Mrs. Ellmers. We are not going to talk about federal judges
today. We are going to talk about the FDA. We are going to talk
about your role and your responsibility. Was it in
preparation--that inspection, was it in preparation for the
November hearing?
Dr. Hamburg. Was it preparation, yes.
Mrs. Ellmers. OK. Did you know that the state's inspection
you cited was announced and conducted solely in connection with
the renovation of NECC, and that inspection had taken place not
as a follow-up to previous violations, or the complaints, but
because they were actually under renovation?
Dr. Hamburg. My understanding that--this is really a
question for the state--that as part of their licensure as a
compounding pharmacy in Massachusetts, they needed to have the
state come in to do an inspection when they were----
Mrs. Ellmers. And they said that they were satisfactory?
Dr. Hamburg [continuing]. And that was where they were--and
I think that was the facility where subsequently these products
were being made.
Mrs. Ellmers. And it was called satisfactory?
Dr. Hamburg. It was a state inspection, but that is my
understanding.
Mrs. Ellmers. OK. All right, I am looking forward to the
second round of questioning. Thank you.
Mr. Murphy. Thank you. Now recognize Mr. Harper for 5
minutes.
Mr. Harper. Thank you, Mr. Chairman.
As you are likely aware, CMS recently modified its billing
methodology for compounding pharmacies providing drugs used in
implanted pain pumps. This change jeopardizes access to
necessary pain medications for some of Medicare's most
vulnerable beneficiaries. Even more, this change prohibiting
compounding pharmacies from billing Medicare directly
eliminates an important accreditation requirement designed to
protect patient safety. Pharmacies billing Medicare directly
for these drugs must comply with Medicare, supplier standards,
and federal regulations such as U.S. Pharmacopeia 797. These
standards provide an additional layer of quality promotion and
patient safety for compounding pharmacies and dispensing
sterile products for use in implanted pain pumps.
On the other hand, pharmacies which sell their compounded
products to physicians, clinics, or hospitals are not required
to be accredited, since they do not bill Medicare directly. In
light of the recent tragedy relating to a pharmacy which
appears to have been acting outside of its licensure, I believe
it is critical that CMS and FDA encourage models of care that
promote patient safety.
Saying this, do you find it concerning that CMS in the wake
of a tragic outbreak is encouraging pharmacies to sell drugs
directly to physicians, as opposed to billing Medicare directly
and complying with quality accreditation standards?
Dr. Hamburg. You know, I am really not an expert on the CMS
policy in this regard, and so I think--I mean, many aspects of
your question are probably best directed toward CMS, but with
respect to the FDA role, I would like to be able to look at the
question you have asked and get back to you.
Mr. Harper. Would you be willing to look into that
situation and if you are indeed concerned about that, would you
be willing to express your concern to CMS about that?
Dr. Hamburg. Yes.
Mr. Harper. OK. In September, 2008, the head of the FDA New
England office, Mr. Shamsi, e-mailed a senior FDA compliance
officer, Ms. Autor, and asked to do a new inspection of NECC
due to concerns about sterile injectables. Now, sterile
injectables are difficult drugs to make, am I correct?
Dr. Hamburg. That is correct.
Mr. Harper. Some have questioned whether compounding
pharmacies should even make these drugs, am I correct?
Dr. Hamburg. Some have, yes.
Mr. Harper. At the time the request for a new inspection
was made, the 2006 warning letter was still pending because FDA
hadn't replied to NECC's response to the warning letter. I
would ask if you would refer in your notebook to Tab 19, if you
could look at that? Tab 19. In this e-mail from October 1,
2008, Mr. Shamsi, the current head of the FDA district office,
e-mailed Ms. Autor, a senior compliance officer, and asked
whether ``our lack of response would hinder any further action
against NECC?'' Mr. Shamsi believed the FDA lawyer in the chief
counsel's office would be reluctant to approve an injunction if
they had replied to NECC's response to the warning letter. It
seems like FDA's staff were considering--it seems like if they
were--the FDA staff were considering serious enforcement
actions like enjoining the company, but a breakdown in process
was preventing the agency from taking decisive action. Is that
a correct statement?
Dr. Hamburg. As I said before, we should have been more
prompt, but it is the case that during that period, there was a
series of court decisions that were altering the landscape with
respect to the application of relevant legislation with respect
to FDA authorities, and that was, unfortunately, slowing our
response.
I hope that we will not be in that situation again going
forward, that is why I am here really saying that we do need
strengthening and clarification of our regulatory authorities.
We do need new laws that will enable us to be able to provide
the clear, consistent, and uniform regulatory oversight and
action with these compounding pharmacies that are making, as
you point out, the higher risk sterile products.
Mr. Harper. So in that situation, no matter the risk, FDA
was not willing to do anything?
Dr. Hamburg. You know, again I am a little bit uncertain
about how much detail to speak to because of the ongoing
criminal investigation.
Mr. Harper. OK. The ongoing criminal investigation, which
you have nothing in writing advising you of constraints for
that, correct? You have said that there is nothing in writing.
Do you have anybody here from the U.S. Attorney's Office that
is here with you today to advise you on which questions to
answer or not answer?
Dr. Hamburg. No, I don't.
Mr. Harper. Has there been any communication from the U.S.
Department of Justice to this committee advising you what you
should or shouldn't respond to?
Dr. Hamburg. There has not been formal communication to
this committee, no.
Mr. Harper. I yield back.
Mr. Murphy. Thank you. The gentleman's time is expired.
We will go through a quick second round of questions here,
so let me begin here.
Commissioner Hamburg, obviously one of our key concerns
here is that the FDA's process failed. For a year, inspections
were suspended. I am not sure we still have a clear answer yet
of when you became aware of that. And we also recognize this
has gone on for 10 years. There is nothing political about
this. This took place under different commissioners, different
Administrations.
What I believe a number of us are concerned about is that
while you were here asking for some new laws and new authority,
I, for one, am not yet convinced that the FDA has taken steps
to clean up its own house here. Inspectors wanted to go back
and re-inspect. They were frustrated because of decisions by
the Chief Counsel's Office to delay it.
Now, it would seem to me that a common sense next step
would be for you to call together a post mortem after you
became aware of all these problems. Get the people together
responsible, and say who knew what and when and who made this
decision and why. So I want to ask, have you gone back and had
such meetings with your agencies, and have you done this post
mortem and asked your staff to review the process that took
place?
Dr. Hamburg. We have looked very carefully back at some of
the steps that were taken, decisions made, and as I said, I am
troubled that we did delay because of internal discussions and
conflict, and the changing legal landscape, and not being
certain exactly what law we would be applying in different
parts of the country, et cetera, so we have taken that deeper
dive. We also have reorganized within FDA to try to strengthen
our efforts in this area, and as you noted, have embarked on a
much more aggressive effort to use our current and existing
authorities.
Mr. Murphy. I understand that, and you told us you embarked
on a more aggressive effort. We have seen you doing more
inspections now. You have acknowledged that, and you have made
some recommendations to us about changes you want into law.
What I am asking is have you had an internal formal
investigation where you have addressed the issues that have
taken place? For example, has anyone at the FDA at your request
talked to the head of the Center for Drugs about the NECC or
Ameridose cases in terms of what happened?
Dr. Hamburg. We have internally had many ongoing
discussions about not just the specifics of this case, but also
the broader efforts with the compounding industry, and I think
we all agree that the FDA could have done a stronger job, and
that we are committed to doing so going forward, but to do the
best job for the American people, we do feel that our
regulations, the ambiguity of the statute, the----
Mr. Murphy. I understand that, but I am trying to find out
about the post mortem----
Dr. Hamburg [continuing]. Different state laws, all
compromise that.
Mr. Murphy. I am trying to find out what the policy change
within that--we will address the ambiguities and other things
later, but did you talk to the head of the New England District
Office since you became aware of the problems with NECC?
Dr. Hamburg. I have talked--well, the head of the district
office that you are probably referring to retired around that
time, but we have had discussions and clearly we want to learn
as much as we can about the inadequacies of past responses to
the compounding pharmacy issues----
Mr. Murphy. Well let me ask you this----
Dr. Hamburg [continuing]. So we can do a better job going
forward.
Mr. Murphy. Listen, we are trying to help you. We really
are. If you have done a post mortem, if you have done this
analysis that for 10 years handcuffed the agency from moving
forward because of internal decisions, there were multiple
times that the FDA knew about problems taking place in states,
but it appears that they didn't call Massachusetts or the
states to say we got this complaint. You are the agency in
charge. And I go back to when you say that you want them to
report adverse events so you can mitigate as fast as possible.
One of the ways to mitigate is to inform the states. You don't
have to take other action, other than to pass that on. I am not
sure yet I hear that there has been a change of policy. Has
there been a change of policy with regard to notifying states
of information you have received in complaints?
Dr. Hamburg. We are actively engaged in that. Now, one
thing we did was, in fact, to bring in all the 50 states soon
after this event to start to talk about how to strengthen
communication----
Mr. Murphy. So there is no specific policy at this point to
say when we get a complaint, that is to be passed on to the
state of jurisdiction. Until such time we can clarify that you
have authority, you know the states have authority. Do you have
a policy in place that those complaints would be passed on to
the states right away?
Dr. Hamburg. There has been a reorganization and we have
identified a new set of players to work on this, and we will
be----
Mr. Murphy. Who is that----
Dr. Hamburg [continuing]. Beginning stronger follow-up with
the states and we will be----
Mr. Murphy. Is that an automatic process now?
Dr. Hamburg. Pardon me?
Mr. Murphy. Is it going to go through--because see, part of
the problem here is it goes through--what we have heard from
you is it goes through lots of chains of lawyers and
discussions, and there is one year that no inspections were
taking place, everything was on hold. There was a long period
of time before a complaint was responded to, and what you are
telling me is there is going to be more discussions. That does
not satisfy this committee or the American public to know that
you are going to have more discussions. They want to know about
action. Do you have some automatic policies that you have
authorized now when you receive complaints from the states who
have jurisdiction, you have said, that they automatically get
that information?
Dr. Hamburg. We have set up a structure to ensure that
those kinds of communications occur. We also do try to respond
and investigate----
Mr. Murphy. Is it automatic?
Dr. Hamburg [continuing]. Complaints that we get and
adverse event reports that we get.
Mr. Murphy. Would you give us any documents that describe
that policy now, because I am not satisfied with saying you are
going to try, you are going to review, you are going to
discuss. I think this is what hamstrung the FDA up the last 10
years, and why in the words of one family who lost a loved one,
they said they don't trust the FDA. If there is one federal
agency among them all that we ought to have an inherent and
implicit trust in, it should be the FDA, and I don't think that
is there right now, so I would like you to share with us those
policy documents so we could know that.
Thank you--and in a timely manner.
Ms. DeGette for 5 minutes.
Ms. DeGette. Thank you very much, Mr. Chairman.
The real issue here, Commissioner Hamburg, is what
authority does the FDA have that they didn't exercise for
whatever reason in the last 10 years, and what new authority
does Congress want to give them? I never met a member of
Congress on either side of the aisle who said, I think the
agency should just go out and do whatever they want. We are
always concerned that the agency acts within the authority that
we give it. But if you already have the authority, we want you
to exercise that. If you need a clarification, we want you to
do that. I think that is pretty clear, correct?
Dr. Hamburg. Correct.
Ms. DeGette. OK. So I want to talk to you specifically
about the authority that you have, because Mr. Burgess, in his
questioning, he accurately said that the FDA has authority over
drug manufacturers, correct?
Dr. Hamburg. Correct.
Ms. DeGette. But under that authority, that is not the
authority that the FDA has over compounding pharmacies, is that
correct?
Dr. Hamburg. That is correct.
Ms. DeGette. And that is because the courts and others have
determined that compounding drugs is not the same as
manufacturing drugs, is that right?
Dr. Hamburg. There are certain explicit exemptions for
compounding pharmacies from the authorities we have over
conventional drug----
Ms. DeGette. Right, and that is in Section 503A of the 1997
Food and Drug Modernization Act, right?
Dr. Hamburg. That is right.
Ms. DeGette. So in 1997 when Congress enacted that law, we
specifically set forth--we thought we specifically set forth
what authority the FDA had over compounding pharmacies,
correct?
Dr. Hamburg. Correct.
Ms. DeGette. And what has happened since 1997, number one,
the nature of the industry has changed. It is not just a mom
and pop pharmacy down on the corner, right?
Dr. Hamburg. Correct.
Ms. DeGette. And the other thing that has happened is that
around the country, some of the compounding pharmacies have
been aggressively challenging the FDA's authority even under
Section 503A, right?
Dr. Hamburg. That is very true.
Ms. DeGette. And that is what we talked about before with
the confusing court cases, right? So now what happens is--and I
want to say, I share everybody else's deep concern that the
agency really fumbled around for about 10 years. OK, so now you
come in and you say this is appalling. These people shouldn't
be at risk, this poster over here with the black stuff
floating, that is unacceptable. It is unacceptable. You agree
with that, right?
Dr. Hamburg. I absolutely agree with that.
Ms. DeGette. So now you are trying to take the authority we
gave you under 503A and to inspect at-risk pharmacies, people
that you think might have a trouble, right?
Dr. Hamburg. Correct.
Ms. DeGette. And what you are saying to us is that these
pharmacies are pushing back and they are saying that Congress
did not give you the authority to conduct these investigations,
is that right?
Dr. Hamburg. Yes, and it is broader than that in terms of
we don't have the authorities to have a regulatory regime that
makes sense.
Ms. DeGette. OK. What is it specifically that you need,
Commissioner Hamburg?
Dr. Hamburg. We need these compounder of high risk products
to register with us. We need----
Ms. DeGette. And how do you know what the high risk
products are?
Dr. Hamburg. Well, in order--we also need the authority--
the high-risk products we define as--the highest risk, I think,
are the sterile products. We all agree on that.
Ms. DeGette. OK.
Dr. Hamburg. We need inspectional authority and full access
to records in order to determine if a compounding pharmacy, in
fact, is making products of concern, and how they are
distributing, et cetera. Clearly, there should be a uniform set
of standards for safety practices and quality manufacturing.
Ms. DeGette. OK. Do you know that you don't have those
inspectional abilities now?
Dr. Hamburg. Pharmacies are exempt in terms of full
inspection requirements and access to records under section
704.
Ms. DeGette. OK, so the answer is yes, you know you don't
have that authority, right? And what other authority do you
need?
Dr. Hamburg. We need--I mean, I sound a little bit like a
broken record, but we need the authority for high risk
manufacturers to register with----
Ms. DeGette. And then once they register, what will that
do?
Dr. Hamburg. Then we will know who they are and what they
are making, how they are distributing, if they are selling to
wholesalers, then they are behaving like a manufacturer, so----
Ms. DeGette. And then do you--once they register then, do
you think if you get a complaint about them you have the
authority to investigate them, or is that the second thing you
were just talking about?
Dr. Hamburg. We need the inspectional authority. We need
the ability to have these clear standards that they will adhere
to for safety and that we can inspect against and enforce
against, and the adverse event reporting is very critical as
well.
Ms. DeGette. And do you think that if we do some of this
very targeted legislative language, that will help with what
the chairman was talking to you about, about the tensions
between the regulators and the lawyers and the agency, which is
really of a concern to all of us?
Dr. Hamburg. I think it absolutely will. You know, I think
we allowed ourselves to be far too cautious because of fears of
litigation that might actually further undermine our ability to
apply authorities and take enforcement actions, and that should
not happen. Public health should not be impeded by those kinds
of legal regulatory ambiguities.
Ms. DeGette. Thank you very much. Thank you, Mr. Chairman.
Mr. Murphy. Thank you. Now recognize again Mr. Griffith for
5 minutes.
Mr. Griffith. And in fact, you have authority over
manufacturers, isn't that true? Yes or no?
Dr. Hamburg. Yes.
Mr. Griffith. And with complaints from the State of Ohio
indicating that they were--the manufacturing process going on--
back to Ameridose, which is the sister of NECC, and the Cease
and Desist from Colorado, Mr. Taylor, wouldn't have been that
difficult to probably get--if they refused to let you in,
wouldn't it have been that hard to get a warrant under your
manufacturing authority, isn't that true, for both NECC and
Ameridose?.
Mr. Taylor. I am not sure that--I mean, it takes more
evidence than that, but let me just--to your point,
communication with the states is one of the things that we
recognize needs to be improved.
Mr. Griffith. OK, but the bottom line is, you and I both
know as practicing attorneys that it doesn't really take a very
high standard to get a warrant to go and get information,
particularly when the risk to the public is as great as it is
when you are doing things with sterile injections. Isn't it
true that it is a fairly low bar to get a warrant under these
types of circumstances? Yes or no?
Mr. Taylor. No. It requires----
Mr. Griffith. I respectfully disagree. I got to move on.
Mr. Taylor. All right.
Mr. Griffith. I only get 5 minutes, so I would love to have
that discussion with you sometime, but not today.
Mr. Taylor. That is fair.
Mr. Griffith. I am concerned that you all were receiving--
Dr. Hamburg, you all were receiving a lot of things--if you
look at Tab 31 in the binder that is there on your table, and
then you flip over to page 3, a summary would be that in July
and August of 2008, FDA came to Ameridose for inspection. The
company performed--this is an informant's statement that was
sent to you all that is in documents you provided us. In July
and August of 2008, FDA came to Ameridose for an inspection.
The company performed illegal and unethical actions. They
directed the testing facilities to change reports based on the
drug resorts. They forged documents. Now that was--the person
was referring to July and August of 2008. This was received by
you all, according to the information you sent us, in August of
2009. And after that complaint came in, FDA New England
District Office Mr.--I don't want to--he may be a doctor but I
can't tell here--Shamsi, after reviewing the complaint, sent an
e-mail saying ``we are waiting for assignment from the Center
for Drugs to go out and we will follow up on this. Ameridose
has been on our radar for quite some time.''
Commissioner, nothing was done at that time to further
investigate Ameridose, isn't that correct?
Dr. Hamburg. You know, there was follow-up to many of the
concerns that were raised.
Mr. Griffith. OK. Can you provide that to us, because in
the information we already have, there doesn't appear to be any
follow up on that. Can you provide that to us, because
apparently it was neglected--somebody neglected to give that to
us before this hearing.
Dr. Hamburg. I want to be clear----
Mr. Griffith. Yes, ma'am.
Dr. Hamburg [continuing]. That I do not feel that we
responded adequately but that----
Mr. Griffith. I am asking you to respond adequately to this
committee and the documents that we have in the binder here
don't show that you responded at all after that complaint came
in in 2009, even though your New England District Office was
asking for clearance to respond. ``We are waiting for an
assignment from the Center for Drugs to go out and we will
follow up on this. Ameridose has been on our radar for quite
some time.'' And you didn't follow through, unless you have got
documents we don't have that you failed to give to us.
Dr. Hamburg. What I am saying is that we get a lot of
complaints and----
Mr. Griffith. So more authority really wouldn't do you any
good?
Dr. Hamburg. I can't speak to the specifics there, but
there is just no doubt that, I don't think that we responded
with the vigor that we should have. I do think that we were----
Mr. Griffith. So now you are saying that you didn't follow
up on that?
Dr. Hamburg. No, I am saying that I can't speak to the
specifics of----
Mr. Griffith. All right.
Dr. Hamburg [continuing]. All of the 30,000 pages of
documents.
Mr. Griffith. All right. You also received information, and
that would be Tab 32, an internal source at Ameridose raised in
July and August of 2010, and the source was identified as a
pharmacist in the notes that you have given to us, and
according to a memorandum of conversation between the
pharmacist and a compliance officer, the pharmacist said that
``Ameridose personnel from their sales force were assisting in
labeling''--and this is sales force--``assisting in labeling
operations in the clean room, and that one of the three clean
rooms had a result for positive mold growth.'' Now, the sales
force is not supposed to be involved in that, according to
other documents. That is correct, isn't it? They are not
supposed to be cleaning up and labeling things, they are
supposed to be selling.
Dr. Hamburg. Right.
Mr. Griffith. And yet, there is a note here that there was
a positive result for mold growth. That individual was told
that the FDA takes this seriously. There is an e-mail in that
Tab 32, that ``this is taken seriously. Mold growth can affect
sterility of drugs.'' Now remember, this is the sister to NECC.
It is usually taken seriously by the FDA, but the FDA didn't
follow up, so it wasn't taken seriously in this case, was it,
ma'am?
Dr. Hamburg. I cannot speak to the specifics of that
instance, but those kinds of concerns are concerns that would
worry me then, and certainly worry me now. There are,
unfortunately, too many ongoing problems with compounding
pharmacies, and I really do feel strongly that if we are going
to be----
Mr. Griffith. But Ameridose was----
Mr. Murphy. Gentleman's time is expired.
Mr. Griffith [continuing]. Also a manufacturer, was it not?
Mr. Murphy. Gentleman's time is expired.
Mr. Griffith. I apologize, Mr. Chairman. I yield back.
Mr. Murphy. Gentleman from Michigan, Mr. Dingell, is
recognized for 5 minutes.
Mr. Dingell. Thank you, Mr. Chairman.
Dr. Hamburg, we have here before us a most interesting
circumstance. You have got a recalcitrant industry, trade
association that is circularizing folks as to how they can
frustrate Food and Drug, and its examination of their
businesses and their protection of consumers. They are
instructed as to limitations on Food and Drug's authorities.
They are also--we also find that they are diligently at work to
get the powers of Food and Drug curtailed. And to see to it
that legislation as was done here specifically exempts them
from three critical provisions: premarket approval of new
drugs, requirement that drugs be made in compliance with good
manufacturing practices standards, and the requirement that the
drug bear adequate directions for use, i.e., your labeling
requirements.
Have those situations caused you difficulty at Food and
Drug as you go about your business trying to regulate these
good-hearted folk?
Dr. Hamburg. We do not have the same kinds of problems with
conventional manufacturers----
Mr. Dingell. I understand that, but----
Dr. Hamburg [continuing]. As we have with compounding
pharmacies.
Mr. Dingell. But you have huge problems with the
compounders, do you not?
Dr. Hamburg. We do.
Mr. Dingell. Unsafe clean rooms, pharmaceuticals that are
compounded with all kinds of things, including filth and other
things in them, dust spots and things of that sort, am I right?
Dr. Hamburg. That is correct.
Mr. Dingell. OK. So you don't have authority to require
them to register so you know who is in the business, right?
Dr. Hamburg. Correct.
Mr. Dingell. States have a somewhat varied record on these
matters. Michigan has five people who are looking into this, is
that right? And Michigan's folk cannot go across the borders of
the State of Michigan to look see what those good-hearted folks
in Massachusetts are doing to kill off Michigan's citizens by
unsafe pharmaceuticals, is that right?
Dr. Hamburg. You know, I am not familiar with the specifics
of state laws, but it creates a real--we have heard from the
states that they don't feel that they can provide adequate
regulatory oversight of what is happening in pharmacies in
other states----
Mr. Dingell. Now, you have no authority to get in books and
records and to inspect compounders, is that right?
Dr. Hamburg. We are limited in our access to records.
Mr. Dingell. All right. And you have no authority to
inspect a business according to what they circularize their
memberships from the trade association, is that right?
Dr. Hamburg. That is right.
Mr. Dingell. Now, you had no authority to require
information on adverse events, right?
Dr. Hamburg. Correct.
Mr. Dingell. So on that wonderful event that occurred up in
Massachusetts where they shipped all this bad stuff around to
Michigan and other places, they had no requirement and no
responsibility to circularize--rather, to inform you of the
events that occurred, is that right?
Dr. Hamburg. That is right.
Mr. Dingell. And you had no authority to extract it from
them, is that right?
Dr. Hamburg. No authority to inspect--to fully inspect?
Mr. Dingell. You had no authority to compel them to present
that information, is that right?
Dr. Hamburg. That is correct.
Mr. Dingell. OK. And you have no requirements for good--you
have no ability to impose good manufacturing practices on them?
Dr. Hamburg. Pharmacies that are exempt under existing
legislation, we don't have that authority.
Mr. Dingell. And good manufacturing practices are
absolutely critical to seeing to it that the pharmaceuticals
are safe, is that not so?
Dr. Hamburg. Good manufacturing practices are essential.
Mr. Dingell. All right. And you--do you have the resources,
the monies that you need to properly police the behavior of
these organizations?
Dr. Hamburg. We do not have the resources that would be
necessary to put in place the kind of strong regulatory
oversight we need.
Mr. Dingell. At what point does it cease to be compounding
and become manufacturing?
Dr. Hamburg. Well----
Mr. Dingell. There are good-hearted folks up in
Massachusetts who were churning out stuff by the thousands, and
you couldn't find out who they were, you couldn't find out what
they were doing, you couldn't impose good manufacturing
practices on them, but at what point could you have--could they
have been charged with being manufacturers? They are shipping
all over the country.
Dr. Hamburg. Yes, it is an issue where people think it is
black and white. Either you are a compounding pharmacy or a
manufacturer, but that has been at the root of many of these
problems in terms of the conflicting court decisions, and it is
not written in the statute.
Mr. Dingell. Do you have----
Dr. Hamburg. The statute is ambiguous.
Mr. Dingell. Do you have the personnel to inspect these
people?
Dr. Hamburg. We don't have the personnel to inspect all
the----
Mr. Dingell. OK. Now Doctor, do you have the authority to
ban bad actors?
Dr. Hamburg. Not directly.
Mr. Dingell. These----
Dr. Hamburg. The compounding pharmacies are licensed by the
states.
Mr. Dingell. You have got these people in Massachusetts
that are creating thousands of prescriptions that are being
distributed all over the country, clearly to me, that are bad
actors. You have virtually no authority of them. What can you
do about them?
Dr. Hamburg. Well, I think that if we want a system that is
really preventive and protects against problems and ensures
safety, we do need new legislation. I think that----
Mr. Dingell. What authority----
Mr. Murphy. Gentleman's time is expired.
Mr. Dingell. What authority do you have to supervise to see
to it that stuff moving across the state lines that is supposed
to be supervised by the states, which can't do it, is, in fact,
not something that is going to create safety problems for
people? Now would you just submit the answer to that for the
record?
Dr. Hamburg. OK.
Mr. Dingell. Mr. Chairman, you have graciously given me a
minute more than I am entitled to.
Mr. Murphy. I thank the gentleman. Now I recognize the
gentleman from Texas, Mr. Olson, for 5 minutes.
Mr. Olson. I thank the chair and I yield to him as much
time as he may consume.
Mr. Murphy. Thank you. I appreciate that.
Ms. Hamburg, you have said repeatedly in one version or
another you feel you don't have the authority to have strong
oversight. My concern remains that where you do have authority,
you haven't had that kind of oversight that you can exercise,
except for the recent flurry of well-publicized inspections.
Let me run through some specifics here to again illustrate
my concerns of the agency for 10 years, and hopefully your
comments of what you have done to rectify that, within the
authority you have now.
The FDA inspected NECC in 2004, primarily in response to
complaints related to the company soliciting a product being
used in cataract surgery. You may recall that, if you reviewed
that. The violations letter the FDA observed during that
inspection were finally addressed over 2 years later in a
warning letter issued in December of 2006. That warning letter
noted the concerns about NECC and mentioned the fact that NECC
was reportedly informing patient's physician's offices that
patient-specific prescriptions were not required. Do you recall
that from history? OK. It wasn't under your administration, but
I just wanted to make sure you knew that.
NECC responded immediately in January 2007, noting that it
had been over 2 years since the FDA had been at their facility
and rejecting a number of FDA's charges. Is that correct?
Dr. Hamburg. Yes.
Mr. Murphy. Now, at Tab 16 in your binder, if you look at
it there, Steven Silverman, who was then the director of the
Division of New Drugs and Labeling Compliance at FDA's Center
for Drugs thought that ``NECC's response was unacceptable.'' Do
you agree that staff appeared frustrated with the fact that it
took chief counsel's office 2 years to issue the warning
letter?
Dr. Hamburg. Yes.
Mr. Murphy. And this frustration appears to have been
shared by Deborah Autor, the head of the compliance at FDA's
Center for Drugs at the time. In an e-mail to Mr. Silverman,
which is located at Tab 17, Ms. Autor stated that they have
``completely lost sight of the point that the warning letters
are intended to quickly get word to violators that they need to
come into compliance. Instead, the lawyers are concerned about
perfecting documents that quickly become irrelevant.'' Now, do
you agree with this observation that concerns about perfecting
documents have resulted in delay when issuing warning letters?
Dr. Hamburg. I am concerned when there are those kinds of
delays.
Mr. Murphy. The key is does that mindset still exist today?
Dr. Hamburg. I think that the mindset is very different. I
think we are determined to use the authorities that we have to
the greatest degree that we possibly can, even in the face of
challenges to our authority, and in the face of potential
inability to actually be successful in some of our enforcement
actions. We are doing inspections now. We are finding things
that are of serious concern. We intend to pursue those
concerns, and already there have been recalls and other actions
taken. But we intend to use the authority we have to the
greatest degree possible. But I am deeply concerned that we
don't have the authorities we need to have the kind of system
in place that will provide better protection and that will
reduce the kinds of problems that we are seeing that could put
people at risk in the future.
Mr. Murphy. Did the FDA have the authority to suspend
inspections in 2011 and 2012 for NECC?
Dr. Hamburg. I think what happened there was what happened
in other instances as well where unfortunately because of a
lack of clarity about what should the regulatory and
enforcement framework be that we slowed down. We weren't as
aggressive as we could have been, and I regret that.
Mr. Murphy. What other instances----
Dr. Hamburg. But I don't think that we have a system now in
terms of the authorities that are available to us that is
sufficient for these highest risk manufacturers making the
sterile products.
Mr. Murphy. So have you identified who made this decision
that the inspections wouldn't take place against NECC in 2011,
2012 in your post mortem? Have you determined who that was?
Dr. Hamburg. There was an ongoing debate that was
reflecting the fact that decisions--a series of legal decisions
had come down. There was an issue about whether to go to the
Supreme Court to try to resolve the circuit court split, and
then we were sort of left with the map and trying to determine
what was the best way to develop the enforcement----
Mr. Murphy. So given that, have you gone back in to see if
there are any stalls or other problems like that with other
companies under--who are compounding pharmacies? I know you
just did a bunch of inspections. Have you gone back to see if
those conditions exist for any other pharmacies?
Dr. Hamburg. I am sorry, in terms of----
Mr. Murphy. Well, did any other----
Dr. Hamburg. During that period, we were not aggressively
pursuing compounding pharmacies in a proactive way. We were
responding when complaints came to us. We were, in fact,
engaged in some litigation around compounding pharmacies, and
sadly, one that we thought was one that would be very
successful and we lost, all of that was contributing to the
sense that the uncertainty and ambiguity in the law and the
patchwork of applications of this law was making it harder for
us to do our job.
Mr. Murphy. I appreciate that, and I know that the concern
still from the American public is these discussions are taking
place, lawyers, et cetera, but still, it wasn't addressing your
primary mission as taking care of some of the public's health
first. But we will continue to talk about that.
Mr. Waxman is recognized for 5 minutes.
Mr. Waxman. I thank you, Mr. Chairman. I haven't been here
throughout the whole hearing, but I find it hard to understand
why anyone would argue with you that you had enough authority
under the law, when it is clear that two different circuit
courts have said different things about a law, and limited the
amount of actions you can take. For example, under existing
law, under the underlying law itself, you can't have sample
collections, you can't--just go through some of the things you
cannot do.
Dr. Hamburg. Under 503A?
Mr. Waxman. Yes.
Dr. Hamburg. Well, there is, of course, the broader issue--
--
Mr. Waxman. Let me--look. This is not where I wanted to go
with my questions, but there are so many things you cannot do,
including some things my staff pointed out to me, and I wrote
it down and I can't read my writing. But----
Dr. Hamburg. Well, I am happy to discuss----
Mr. Waxman [continuing]. It is hard for any reasonable
person to not conclude you need a stronger, clearer law to give
you authority.
People want to go over the history, and so I want to ask
you about the history of the Obama Administration. I mean, this
started much before, but in 2009, the Obama Administration
entered office. For 7 years, the Bush Administration had been
stymied by a series of conflicting court decisions and
inherently weak laws. So leaders at FDA met in the spring of
2009, and according to the notes of the meeting, the
participants acknowledged the risks of compounding and sent
forth a new path for a national policy. Ultimately, they
decided to implement Section 503A nationwide, except in the
Ninth Circuit. And there they would implement a compliance
policy guidance based on Section 503A. Most of these decisions
were made before you were confirmed, isn't that correct?
Dr. Hamburg. That is correct.
Mr. Waxman. But can you elaborate on why, in your
understanding, the agency made those decisions?
Dr. Hamburg. Well, I think that we were faced with a
situation where we felt we did need to do more, and there was a
lot of eagerness as reflected in the documents to do more, and
we needed to determine the legal framework that we would be
applying. We needed to----
Mr. Waxman. You were looking for the most legally
defensible way to develop a coherent and rational policy.
Dr. Hamburg. Well, that is absolutely right, and I----
Mr. Waxman. And so as you looked at different alternatives,
you said well, we can't do this and we can't do that. Is that
right?
Dr. Hamburg. That is absolutely right.
Mr. Waxman. Can you help us understand what FDA's concerns
were about going forward with inspections and potential
enforcement actions before releasing a new compliance policy
guidance that would give a coherent national policy to address
conflicting court cases? You were asked earlier why the agency
couldn't walk and chew gum at the same time; that is, conduct
the inspections while developing the CPG. I assume the agency
had compelling concerns about the problems it would encounter
if it had conducted those inspections. Can you describe them
for us? I would like to address this question Mr. Taylor,
because he is the enforcement expert.
Mr. Taylor. I am sorry, I was----
Mr. Waxman. OK, put your mike on, first of all. And what I
want to know is why couldn't the agency go forward with the
inspections at the same time you are doing a CPG?
Mr. Taylor. Well, the--and I wasn't there, but the people
were worried that if they moved ahead with actions with the
circuit courts split and without clear guidance, that it would
lead to losses in court, some losses that would possibly
undercut the authority that the agency had further. So there
was a fear that it could actually make this unsettled legal
landscape even worse, and it appears from the documents that
that accounts for some of the conservative--which we regret,
which is why we are being more aggressive now.
Mr. Waxman. Right, why you are here and why you have to
answer questions. I know one thing, if you had acted, you know
what would have happened? The compounding industry would have
clear ordered their--they would have alerted all their members.
They would have aggressively pursued back in the public and on
the Hill, to push back on you. Maybe you would have gone to
court, maybe they would have sued you to go to court to
challenge what you were doing. FDA probably would have faced
pressure from members of this body to pull back. In hindsight,
it is easy to blame the FDA, but in the real world, prior to
that outbreak, it would have been very hard to do this.
One internal document said the agency intended to release
the guidance by December, 2011. The subsequent internal
document indicated the agency was trying to get the document
cleared by September, 2012. October came and went. Dozens of
people died in the meningitis outbreak, and still FDA showed no
guidance. So my question is what happened here? Why did it take
the agency this long to get the guidance out? Had you gotten
the guidance out, do you think you could have prevented the
meningitis outbreak? Can you describe what the guidance would
have accomplished, and can you describe what the guidance would
not have been able to do, and would have the guidance
eliminated the need for new legislative authority that you now
seek?
Dr. Hamburg. It took too long to get the guidance out, but
it is important to understand what the guidance actually
represents. It is just that. It is guidance to industry about
how we would be approaching regulation in this area. But the
guidance is only as strong as the underlying statute. It cannot
substitute for a strong, clear law. You cannot fill gaps in the
law with guidance, and so it was an imperfect second to what we
really need and what we are hoping to work with all of you to
do, which is to get the kind of strong, clear law that is
necessary to put in place a program that is comprehensive in
terms of the kinds of authorities we don't have now, that
focuses on the highest risk producers of the sterile products,
and that will enable us to really work with industry in a
preventive way, rather than being forced into a situation where
we are more reactive than we should be.
Mr. Waxman. Yes, I thank you.
Let's work on that law, Mr. Chairman.
Mr. Murphy. Thank you, Mr. Chairman.
Mr. Johnson, 5 minutes.
Mr. Johnson. Thank you, Mr. Chairman.
Commissioner Hamburg, despite your assertions at the last
hearing that FDA really doesn't know how many compounding
operations were out there because they didn't have access or
didn't have to register with the agency, FDA has recently
embarked on a sweeping risk-based inspection campaign,
targeting approximately 50 facilities, primarily of large scale
compounding operations. Is that right?
Dr. Hamburg. That is correct, but it is not because they
have----
Mr. Johnson. OK, good. Commissioner Hamburg, then in your
opinion, how many of these companies have been operating in the
shadows?
Dr. Hamburg. We targeted these inspections--about 31 of
those inspections were surveillance. Others--the rest of them--
were for cause when problems were brought to our attention, but
we targeted them based on information that had come to us about
concerns that they were making sterile products; but that is
not an adequate approach when it comes to really being able to
have a regulatory system that enables us on a routine basis to
go in and do inspections, and as I said, to work in a way with
the companies so that problems can be prevented.
Mr. Johnson. So how did you determine which facilities to
inspect?
Dr. Hamburg. It was a risk-based determination, using
information from different sources----
Mr. Johnson. So it is safe to say that----
Dr. Hamburg [continuing]. From what states were telling
us----
Mr. Johnson [continuing]. Many of these companies had long
been on the agency's radar, correct?
Dr. Hamburg. Some of them had been. Some of it was based on
what states had told us. Some was public information from the
media.
Mr. Johnson. Public information from the media?
Dr. Hamburg. But we would like----
Mr. Johnson. Had you received event reports--I think that
is what we call it--earlier? Had you received reports from----
Dr. Hamburg. I don't believe we had for all of the
facilities that we inspected. I would have to go back and ask--
--
Mr. Johnson. Well what I am trying to figure out is you
didn't choose to inspect NECC and you didn't choose to inspect
Ameridose, but you chose to inspect all of these others, and
you don't even know whether or not there were event reports
associated with them, so what I would like--if you would take
this for the record, to provide this committee with all the
complaints that the FDA has received associated with their
products and practices, because I think the committee could be
enlightened by what your standard or what your water level is
to determine who you are going to inspect and who you are not.
I would like to see that, and I think many of my colleagues
here on the committee would too. That would be edifying to us,
because there is a real--because I am sort of alarmed by what
you just said that many of them did not have event reports.
Dr. Hamburg. It is not required for these facilities to
provide us----
Mr. Johnson. I didn't say it was----
Dr. Hamburg [continuing]. Provide us with----
Mr. Johnson. I didn't say it was required. That is a
judgment call, apparently, on who you inspect and who you
don't, and you made the decision not to inspect NECC or
Ameridose, but you chose then since the outbreak to inspect
these other 50. I want to see what the criteria is. What causes
you enough alarm to want to go inspect, and if event reports,
let's say public health is in danger and that lives are in
danger, if that is not enough, I would like to be able to
understand that.
Dr. Hamburg. Well, I--what I am saying to you is that we
need to have a system that actually requires these compounding
pharmacies to register with us so that we will know----
Mr. Johnson. We are not talking about----
Dr. Hamburg [continuing]. Who they are----
Mr. Johnson [continuing]. The ones that didn't register. We
are talking about the 50 that you chose to inspect. What was
the criteria----
Dr. Hamburg. We chose to do that in lieu of having
information that we think should be part of a strong and
meaningful regulatory scheme going forward----
Mr. Johnson. But what was the criteria used, and how does
that balance against the criteria of the multiple event reports
that you received on Ameridose? So I--can you take that for the
record and----
Dr. Hamburg. We can certainly take that for the record and,
I think this goes to the heart of some of our concerns about
what we need to do to have the kind of safety net in terms of--
--
Mr. Johnson. The heart of my concern is the judgment. The
heart of my concern is the judgment used by the FDA to decide
who to inspect and who not to inspect, and based upon your
testimony here now, I have even further questions about that
because you just said that many of the new 50 that you are
inspecting did not have event reports associated with them. So
I am really confused how, with as much advanced notice and
concern that you had about Ameridose, that something didn't
trigger with your organization and you said the buck stops with
you, how that did not trigger something at the FDA that that
company needed to be inspected?
So to be clear, I need you to provide the committee, if you
would, please, all of the complaints that the FDA had that led
you to--with their products and practices that led to the
selection of those 50 that you chose to inspect.
And with that, I yield back, Mr. Chairman.
Mr. Murphy. Gentleman yields back. Now recognize the
gentlelady from North Carolina, Ms. Ellmers, for 5 minutes.
Mrs. Ellmers. Thank you, Mr. Chairman.
II would like to follow my colleague from Ohio. Of the 50
that were inspected, were they all registered with you, with
the FDA?
Dr. Hamburg. No, they were not. That is what I am saying is
we need----
Mrs. Ellmers. OK, you just went in and inspected and chose
to inspect those. So I don't understand how, then, you keep
reflecting back on the fact that you did not have the authority
to inspect the numerous complaints that we have received here
about Ameridose and NECC. How then----
Dr. Hamburg. I didn't say we didn't have the authority, and
I said I regretted that we didn't, in some of the instances, go
back in more quickly.
Mrs. Ellmers. But you didn't have the authority--and there
again, I am just jotting down notes here. So you felt you
didn't have the ability or authority to intervene with
Ameridose? OK. Let's get back to the common sense of this.
There have been numerous complaints which over a 10-year period
had been submitted. They were submitted to you, the FDA, things
that were taking place in these facilities. Somehow, there
should be that communication with the state. Of the complaints
that were submitted, which ones were reported to the state, and
when?
Dr. Hamburg. I indicated that we would try to go back and
look at that, but I----
Mrs. Ellmers. OK. Were any submitted to the state? Were any
complaints then passed on to the state?
Dr. Hamburg. In certain instances, we actually went in with
the state to do inspections.
Mrs. Ellmers. In certain instances you did go--OK. I do
want that for the record. I would like for you to submit the
complaints that were passed on to the state and the number of
inspections that took place with the state into these
facilities, especially the Ameridose and the NECC.
Now having said that, is there a law in place now that
prevents you from sharing information?
Dr. Hamburg. No.
Mrs. Ellmers. Legislation, law, regulation, guideline that
prevents you from sharing information----
Dr. Hamburg. With the states?
Mrs. Ellmers [continuing]. With the states?
Dr. Hamburg. No, and I think that that is an area where we
are trying to do a much stronger job.
Mrs. Ellmers. So there wasn't anything preventing you, but
you want to do a better job. How do you do a better job if
there wasn't anything preventing you?
Dr. Hamburg. I am just saying that as I look back over some
of the----
Mrs. Ellmers. This was an area of failure.
Dr. Hamburg [continuing]. Issues, that I think that we
could definitely benefit, all of us, by working more closely,
having more systematized mechanisms----
Mrs. Ellmers. Because you have noted over and over again
the state has the authority, the licensure ability, the
regulation for the state, and yet, there seems to be this
barrier there for sharing information that had been given to
you, privy to you.
Now, let's back up to some of the complaints here. I just
want to point out a couple, and this had to do with Ameridose.
In one of the instances here, it says the ``FDA received
another call from Ameridose, informant alleging that not only
was the Ameridose sales team assisting in labeling in the clean
room, but that one of the three clean rooms had a positive
result of mold growth.'' Let me further that. That was August,
2010. Another from August, 2010, ``Informant called again a few
days later, stating that the mold was found in the hood in
which operations took place.'' Dr. Hamburg, what is mold?
Dr. Hamburg. Mold is an organism that can cause diseases--
--
Mrs. Ellmers. And what kind of disease? What is mold
specifically?
Dr. Hamburg. Well, my microbiology days are long behind me,
but it is a micro-organism----
Mrs. Ellmers. It is a fungus.
Dr. Hamburg. Well, OK.
Mrs. Ellmers. It is a fungus. So you will acknowledge that
it is a fungus? August, 2011, an Ameridose informant notifies
FDA ``when packaging was dropped on the floor, employees are
told to pick it up and ship.'' He further stated that ``the
bubble wrap is stored directly on the floor and that this room
is dirty and never cleaned.'' I can go on and on. There is also
an incident after the event, after 53 Americans died as a
result of the failures of these facilities, that there were
dead birds found in that facility. Dr. Hamburg, what kinds of
diseases can result as of human contact with bird feces or
droppings?
Dr. Hamburg. Clearly, there are serious medical
conditions----
Mrs. Ellmers. Fungal diseases.
Dr. Hamburg [continuing]. And clearly, the kinds of
environmental exposures you are describing are not acceptable
to sterile practice.
Mrs. Ellmers. Absolutely not, completely and totally. And
that is where I get back to the common sense factor here. When
these things have been reported to you, how could it possibly
be that they were not relayed on to the states?
And with that, I use up the remainder of my time. Thank
you, Mr. Chairman.
Mr. Murphy. Thank you. Now recognize Dr. Burgess of Texas
for 5 minutes.
Mr. Burgess. Thank you, Mr. Chairman, and Director Hamburg,
thank you for being with us through this long session.
When Ms. Ellmers was just talking about picking up of the
product that had fallen on the floor and then was retrieved and
still shipped out, it made me remember in this very
subcommittee, probably 4 years ago, Mr. Parnell of the Peanut
Corporation of America undertook the same sort of practice in
his peanut factory, and the consequence was a significant
salmonella outbreak that sickened and I think killed some
patients. Mr. Parnell is now in jail. So I mean, this is--he
had been indicted. All right, I stand corrected. He should go
to jail. But I mean, those are peanuts to make peanut butter.
This is a sterile injectable to go into the subdural space or
the epidural space of a patient. And so it is equally, if not
much more, serious what Ms. Ellmers was just bringing up.
I do want to say for the record, early on in this process
and in September of 2012, I want to acknowledge the help that
the CDC provided our office when it was just almost impossible
to get any phone calls returned or any information. The doctors
at the CDC actually walked me through what they thought was
going on, and I have to say, they did an excellent job of
rounding up patients and getting people in for testing. I had--
it had been a long time since I had been in microbiology, too.
I don't think I even encountered--while I was in microbiology,
but they did a very good tutorial for me on just what that
organism was, how dangerous it was, even though it was one that
wasn't normally thought of as a pathogen.
I know we have been through a lot of this stuff over and
over and over again, and this stuff with Ameridose just--we
keep coming back to it and I recognize a lot of it happened
before you became administrator, and so I will stipulate that.
But in July of 2011, you were the administrator, and in an
exchange of e-mails that is in your binder there, Tab 37, there
was a lot of discussion about, once again, there are problems
that have come up at Ameridose. I think it is Paige Taylor, a
lawyer who sort of re-documented all of the problems that were
there, and she sent that in an e-mail to the FDA's chief
litigator. And the FDA's chief litigator, when she asked should
we not re-inspect, I mean, I think he said well, it is CDER's
call, but if the problems are serious safety issues, why would
we only issue a warning letter? Why not seize? So that is a
valid question. I mean, at this point, in July of 2011, the
evidence is finding that there is a problem. Ameridose has come
across the screen so many times. Your own chief litigator said
why are we doing another warning letter? Why don't we just go
in there and shut them down? So why not?
Dr. Hamburg. Well I think that there was, again, internal
discussion about how we should proceed, and I wish that we had
been more aggressive, but I am saying we are going to be more
aggressive now. And you mentioned the Peanut Corporation of
America example. That is an example where actually in working
with Congress, we were able to get the additional legislation,
the Food Safety Modernization Act, that gave us new tools to
work with companies to prevent problems and to really address
some of those kinds of concerns, and I think that is not----
Mr. Burgess. Well, let's not wax too eloquent, because we
still have salmonella outbreaks and we all recognize that, but
we all recognize that there were problems that needed to be
addressed.
Your chief litigator went on to say my concern is that if
we just issue a warning letter under one legal theory, and
either do nothing until we issue the guidance, which apparently
will take forever, or as noted below, would put another nail in
our consistent policy coffin. I mean, those words were kind of
prophetic, weren't they?
I will accept the fact that you acknowledge that the agency
was far too cautious and that you are accepting some
responsibility for that--being that risk averse. But I just got
to tell you, I disagree with Mr. Waxman on the issue of the
circuit court split. I mean, yes, there is a reason to protect
their traditional compounding pharmacists. I used them when I
was in medical practice. They fill a niche that needs to be
filled, but the FDA has known for years that New England
Compounding Corporation and Ameridose were not the mom and pop
compounding. They were not traditional compounders in any
conceivable definition. And I guess the concern as we wrap up
this hearing, it does seem that at the agency the priority was
on perfecting the policy or perfecting the policy guidelines,
and not on protecting the patient. And if we learned nothing
else from this today, it is that the mission of the Food and
Drug Administration should be, first and foremost, on patient
safety. The policy will always work itself out if we keep that
number one objective in mind.
Mr. Chairman, you have been very generous with the time. I
don't know if the commissioner wishes to respond, but I will be
happy to yield back my time.
Mr. Murphy. I thank the gentleman and on his behalf,
Commissioner, do you want to answer that question?
Dr. Hamburg. I just wanted to underscore what Dr. Burgess
said, that I agree that patients and public health have to be
our first priority, and I want to assure you that we are going
to be as aggressive as we can be with our current authorities,
and that if you give us additional authorities that we feel we
need to do the best job possible for the American people, we
will use them.
Mr. Burgess. I just have to say, it is going to take--that
takes a lot of time, and you know that. You know what the
political environment is here in Congress. Why not just use the
authority that you have? Don't ask us for another tool when you
have existing tools. My old daddy used to say, it is a poor
worker who blames his tools. Don't blame your tools. Do your
work.
Dr. Hamburg. I think we need new tools.
Mr. Murphy. Well, to that, I want to thank you for coming
today and sitting through two rounds of questions, and for the
members' devotions to this hearing today.
The committee rules provide that members have 10 days to
submit additional questions for the record to witnesses. Let me
say something very important about that. It was brought to our
attention earlier today, Mr. Dingell and other members had
asked questions last November. This is an opportunity to prove
that the culture delay within the FDA has changed, because even
with this committee, it has not. So I ask you to get the
answers to the committee questions from last November to us by
the 19th of April, and the members, since they have 10 days to
submit questions to you, that you get back to us within 30 days
of that date. It is important, because otherwise it leaves us
thinking that delays continue.
I also ask unanimous consent to put the following documents
into the record: the document binder at the witness table,
subject to appropriate redactions by staff; opening statements
of members; and the reports issued by Majority and Minority
staff for this hearing, including the report from Mr. Markey,
the Minority staff report of April 15, and the Majority staff
report of April 16.
[The information appears at the conclusion of the hearing.]
Mr. Murphy. Again, I thank all members for coming here, and
with that, this hearing is adjourned.
[Whereupon, at 1:00 p.m., the subcommittee was adjourned.]
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