March 22, 2007
On March
22, 2007, the House Energy and Commerce Subcommittee on
Oversight & Investigations held its second hearing on
"The Adequacy of FDA to Assure the Safety of the Drug
Supply." The hearing lasted roughly five hours and was
well attended. Andrew von Eschenbach, Commissioner of
the Food and Drug Administration (FDA), testified on the
first panel. Witnesses on the second panel were:
- Bruce
M. Psaty - professor, Medicine, Epidemiology and
Health Services, Cardiovascular Health Research
Unit, School of Public Health and Community
Medicine, University of Washington
- Curt
D. Furberg - professor, Public Health Services,
Division of Public Health Services, School of
Medicine, Wake Forest University
- Marcia
G. Crosse - director, Public Health and Military
Health Care Issues, Government Accountability Office
(GAO); and
-
Raymond L. Woosley - president and CEO, The Critical
Path Institute.
Witness testimony and an archived webcast of the hearing
are available on the Committee website (http://energycommerce.house.gov/cmte_mtgs/110-oi-hrg.032207.FDA-drugsupply_part2.shtml).
O&I
Subcommittee Chairman Stupak (D-MI) asserted in his
opening statement that the FDA has had a long history of
not adequately protecting the public from dangerous
prescription drugs and has placed approval and marketing
drugs above public safety. Chairman Stupak noted that
the subcommittee has investigated three separate
instances where senior FDA officials overruled
"competent, conscientious" medical researchers and chose
to listen to the drug industry: antidepressant SSRIs,
anti-inflammatory medication Vioxx and Bextra, and the
antibiotic Ketek. Committee members made frequent
references to these three investigations. Chairman
Stupak reported that the Committee's work had resulted
in strengthened warnings and more information to protect
the consumer. In addition, Chairman Stupak noted that
after inquiries from the Committee, the FDA Office of
Oncology Drug Products advocated for a black box warming
for EPO drugs and convened an advisory committee on
these safety of these drugs He added that Amgen, J&J,
and Roche have worldwide sales of $10 billion on these
drugs, and three off-label studies have been stopped in
recent months because of serious adverse events.
Hearing
Issues:
Post-Marketing Safety:
-
Congressman Waxman (D-CA) asserted that FDA lacked
both resources and enforcement authority necessary
to ensure the safety of drugs post-approval, and
that 71% of post-market studies are pending or
delayed. If companies fail to conduct and complete
post-market safety studies, the only enforcement
tool the FDA has is to remove a drug from the
market, characterized by Congressman Waxman as a
"pretty harsh sanction." Commissioner von
Eschenbach responded that FDA did have the authority
to publicize drug companies' lack of compliance with
post-marketing studies.
-
Congresswoman DeGette (D-CO) stated that FDA should
be able to compel label changes if new data
indicates safety issues and should not be in the
position of negotiating a black box warning with the
manufacturer. Chairman Dingell (D-MI) also focused
on length of time it took for the FDA to negotiate
label changes for Vioxx.
-
Commissioner von Eschenbach testified that the FDA
needed to address issues of drug safety throughout a
product's life cycle, in order to improve
post-marketing surveillance. He also noted that
there are a range of new technological tools that
would vastly improve the ability to identify drug
safety issues, including the ability to "data mine"
for safety information. He specifically referenced
data from the FDA, CMS, and United Health as
offering useful safety information. The FDA intends
to engage drug manufacturers about the need for and
content of post-market drug safety studies earlier
in the approval process, in order to develop studies
that are more useful. The Commissioner also noted
that the PDUFA reauthorization proposal funds a
number of skilled FTEs who will be able to assist in
the post market surveillance review process.
-
Regarding the number of pending post-market studies
(Chairman Stupak estimated over 1200), Dr. Woosley
testified that 800 of these have been in the pending
for a long time. Many of these are too old, poorly
designed, or do not deserve to be conducted. He
recommended that FDA review all pending studies to
determine which ought to proceed and assign a start
date for each study. Dr. Furberg agreed and
suggested that study completion dates should also be
assigned.
-
Chairman Stupak advocated granting FDA authority to
subpoena safety data from manufacturers. Dr.
Furberg agreed that this authority is essential if
there is to be any progress on safety data.
-
Members of the second panel testified that when a
drug is taken off the market, it demonstrates that
the system works -- in recent instances, the system
has just taken too long to work. Dr. Woosley called
for a National Transportation Safety Board-type
approach, where the whole process is examined to
determine what went wrong when a drug is taken off
the market.
Whistleblowers/Tolerance of Dissent:
- A
majority of Committee Democrats focused on the FDA's
treatment of whistleblowers and tolerance of
scientific disagreement in the SSRI, Vioxx, and
Ketek issues, and a number of them indicated
specific concerns about a statement Dr. Ross
attributed to the Commissioner that anyone who is
not a "team player" will be "traded." (Dr. Ross
attended the hearing and later spoke to reporters.)
Commissioner von Eschenbach responded that he
emphatically supported the legal rights of every
employee and deeply regrets the misinterpretation of
his comments by Dr. Ross. Chairman von Eschenbach
testified that he is trying to create an atmosphere
where scientific dissent is encouraged, but that he
did not regard it as particularly helpful when
employees chose not to be a part of that process and
express their views independently.
-
Chairman Dingell quoted extensively from the March
9, 2007 letter from Senator Grassley (R-IA) to the
Commissioner, and noted that "this Committee has a
special interest in whistleblowers and their safety
and comfort."
Prescription Drug User Fee Act (PDUFA) Reauthorization:
- Many
Committee Democrats advocated for drug safety to be
strengthened in the PDUFA reauthorization.
-
Chairman Stupak questioned witnesses on the second
panel about the effect of PDUFA on drug safety. Dr.
Furberg testified that in the first two versions of
PDUFA, no funding could be spent on safety.
Although funding for safety has improved in
subsequent reauthorizations, the ratio of funding
for approvals to safety in the latest PDUFA draft
reauthorization is 13:1.
FDA
Resources/Leadership:
-
Chairman Dingell commented that the FDA's response
to the Committee's questions has been slow and
informed the Commissioner that "our questions will
be answered properly and swiftly."
-
Congressman Waxman cited GAO and Institute of
Medicine (IOM) reports recommending Congress
adequately fund post-market surveillance, noting
that he had introduced a bill recently to address
congressional support for the agency.
-
Responding to a question about leadership at the FDA
from Congressman Whitfield (R-KY), members of the
second panel testified that agency leadership has
been a consistent problem -- not just at the
Commissioner level but throughout the agency. Panel
members noted that the FDA lacked simple
infrastructure and, until recently, did not even
have a database of all previous post-market study
commitments.
-
Ranking Minority Member Barton (R-TX) praised the
Commissioner for responding to the call to service
to head the FDA during this crisis in leadership,
recognizing that Dr. von Eschenbach had been very
successful at the M.D. Anderson Clinic in Texas.
Drug
Advertisements:
-
Congressman Waxman questioned the Commissioner about
the FDA's authority to issue injunctions and fines.
With more than 3,200 new ads each month, he
questioned whether FDA had the resources to
adequately monitor content. Commissioner von
Eschenbach responded that the agency has requested
(both in the budget and in the PDUFA reauthorization
proposal) more resources.
Off-Label Use:
-
Chairman Stupak asked Dr. Crosse whether FDA should
be given the authority to restrict off-label use of
drugs. Acknowledging that she was not qualified to
answer, she responded that the FDA did have the
authority to regulate the promotion of drugs in an
off-label way.
Pediatric Exclusivity:
- During
questioning of the second panel, Chairman Stupak
asserted that we often don't know study results
until 14 months after the exclusivity period is
granted, and that he would again fight to condition
the extension of the patent on completion of a
study.
Mark H.
Smith
Senior Government Relations Advisor
King & Spalding LLP
1700 Pennsylvania Avenue, N.W.
Washington, D.C. 20006
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