Cross posted from The Pop Tort by Amanda.
Several months ago the New York Times opined, "The F.D.A. in Crisis: It Needs More Money and Talent,"
That had come shortly after Congress was told that the FDA wasn't
able to guarantee the safety of the drugs manufactured abroad (um,
almost all of them) because overseas manufacturing facilities have less
rigorous safety standards.
Gregory Curfman, the Executive Editor of the New England Journal of
Medicine during his recent congressional testimony in front of the
House Committee on Oversight and Government Reform said:
We have learned over the years that
approval of a new drug by the FDA by no means guarantees its safety. It
is not uncommon for drugs to be approved by the FDA without long-term
studies of their safety. Indeed, FDA approval of a drug is just one
milestone along a path to the assessment of long-term safety. It is
essential that a drug's safety continue to be carefully monitored
during the post-marketing period, because we know that serious safety
issues may come to light only after a drug has entered the market.
Just yesterday, MSNBC reported that the FDA has been
experiencing a "brain drain" as many of the most experienced scientists
are being wooed into the private sector – leaving the federal agency
inexperienced and understaffed. Included in the article were anecdotal reports of scientists leaving in part because of concerns over safety issues:
FDA's outside advisers say frustration with FDA culture is a major reason its turnover rate is twice that of other agencies.
Staffers
who disagree with management are reportedly discouraged from speaking
up, according to an Institutes of Medicine report on FDA's drug safety
system.
Staffers say strict deadlines for the review of drugs also contribute to stress.
"People
are under enormous pressure to meet those review dates and they get
burned out," said David Ross, a former FDA drug reviewer who now
teaches at George Washington University's medical school.
Ross left FDA in 2006 after a dispute with agency management over the safety of an antibiotic.
Then of course there was Dr. David Graham, who had spent his entire career at the FDA's Office of Drug Safety and garnered national attention when he was highly critical of the federal agency in the way it handled
Vioxx. In 2004, Dr. Graham testified in front of Congress saying:
In my opinion, the FDA has let the
American people down, and sadly, betrayed a public trust…. It is
important that this Committee and the American people understand that
what has happened with Vioxx is really a symptom of something far more
dangerous to the safety of the American people. Simply put, FDA and
its Center for Drug Evaluation and Research [CDER] are broken… the
scientific standards CDER applies to drug safety guarantee that unsafe
and deadly drugs will remain on the US market.
What perhaps makes matters worse is the chilling drive by
drug companies to allow them complete immunity when their drugs or
medical devices harm or kill people. In fact, the U.S. Supreme Court
has already ruled that if the FDA has approved a medical device, then
the manufacturer can't be sued. Luckily, Congress has decided to get into the act.
House Energy and Commerce Health
Subcommittee Chairman Frank Pallone, (D-NJ), and House Oversight and
Government Reform Chairman Henry Waxman (D-CA) will introduce
legislation before the Independence Day recess that would explicitly
state that FDA regulation does not trump medical device patients'
ability to seek damages under state law.
