E-DRUG: FDA staff approving medicines under pressure
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[Crossposted from Kaiser network with thanks; WB]
About One-Fifth of FDA Scientists Felt Pressured To Approve Medications,
Despite Safety Concerns, Survey Shows
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About 18% of FDA scientists in 2002 said that they felt "pressured to
approve or recommend approval for a (new drug application) despite
reservations about the safety, efficacy or quality of the drug,"
according to the results of a survey scheduled for release to the public
on Thursday, the Washington Post reports. The HHS Office of Inspector
General conducted the survey, which included interviews with almost 400
FDA scientists, as part of an investigation into the agency prescription
drug review process. In March 2003, HHS OIG released a report on the
investigation, and Bush administration officials focused on the
conclusion that FDA scientists and pharmaceutical companies "have
confidence in the decisions FDA makes." The report also highlighted the
effectiveness of FDA in the reduction of review times for prescription
drugs. Although parts of the survey appeared in the report, the
"dissenting voices of some FDA scientists were not generally
represented," the Post reports. The Union of Concerned Scientists and
Public Employees for Environmental Responsibility obtained the survey
results through the Freedom of Information Act and will make them
public.
Survey Results
The survey found that 36% of FDA scientists said they were "somewhat
confident" or "not confident at all" in agency decisions about the
safety of prescription drugs, and 22% said they were somewhat confident
or not confident at all in FDA decisions about the effectiveness of
medications. However, "as described in the report, drug manufacturers
reported significantly greater confidence in both categories," the Post
reports. In addition, 21% of FDA scientists said the work environment at
the agency's Center for Drug Evaluation and Research allowed limited or
no scientific dissent, the survey found. According to the survey, 6% of
FDA scientists said they were "completely confident" in the ability of
FDA to monitor the safety of prescription drugs after they reached the
market, compared with 28% who said they were "mostly confident," 47% who
said they were somewhat confident and 19% who said they were not
confident at all. The survey also found that more than half of FDA
scientists said they did not have adequate time to conduct reviews on
prescription drugs with "priority" status, which allows six months for
research.
Support for Graham Testimony
According to the Post, the "results of the survey ... appear to support
some portions of the controversial Senate testimony last month by FDA
safety officer David Graham" (Kaufman, Washington Post, 12/16). At the
Senate Finance Committee hearing, which addressed the recent market
withdrawal of the COX-2 inhibitor Vioxx over safety concerns, Graham
testified that FDA "as currently configured, is incapable of protecting
America against another Vioxx" because of ties between agency reviewers
and the pharmaceutical industry. In addition, according to Graham, five
prescription drugs currently on the market present significant safety
risks to consumers (Kaiser Daily Health Policy Report, 11/22). Graham,
who participated in the survey but never viewed the results, said on
Wednesday, "I think this provides evidence that among the reviewing
scientists at FDA, their experiences mirror the testimony I gave before
Congress. It also shows the unfortunate experience of many mirrors what
happened to me when I tried bringing safety issues to my managers and
the American public" (Washington Post, 12/16).
Spring Gombe
Policy Analyst
HAI Europe
Jacob van Lennepkade 334T
1053 NJ Amsterdam
The Netherlands
Phone +31 20 6833684
Fax +31 20 6855002
e-mail: spring@haiweb.org <mailto:spring@haiweb.org>
My working hours are 0900 to 1800, Tuesday to Friday