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Congressman Turns up the Heat
on the FDA Over Accutane and Others
February 23, 2008
By Ginger Gillenwater
Washington, DC: Rep. Bart Stupak is turning
up the heat on the FDA over the type of protection they
are providing Americans when it comes to unsafe drugs.
One of those drugs that Stupak is especially concerned
about is the acne medication, Accutane.
Stupak's battle against Accutane runs
deep because in 2000, his 17-year old son, who was taking
the medication, committed suicide. After his son's suicide,
Stupak conducted his own investigation into whether
or not the drug could be associated with any psychiatric
side effects. He even made a personal appearance at
the headquarters of the FDA in Rockville, Maryland in
order to go through their records.
During a hearing, he held up the prescription
packaging that belonged to his son and alleged that
the FDA was not doing enough to assure the safety of
the food and drug supply, and that the public would
be protesting if they knew. He states that Accutane
is just one drug of many that are potentially harmful
due to the FDA's alleged neglect to properly protect
the American public.
An eight-term Democratic congressman,
Mr. Stupak is the Subcommittee on Oversight and Investigations
chairman, which is the House's very powerful Energy
and Commerce panel. This panel's jurisdiction includes
the FDA.
This places Mr. Stupak in the middle of
an effort by congress' Democrats to bring attention
to what they claim are issues with the Bush administration's
position on issues surrounding consumer safety. Mr.
Stupak is probing other drugs that the FDA has handled
such as the blood-thinning drug heparin, which has been
related to hundreds of bad reactions and is linked to
four deaths. It is alleged that A Chinese plant that
manufactures one of the main ingredients of Heparin
was not at all inspected by the FDA prior to it being
used in the drug.
Other drugs that the subcommittee is paying
special attention to are Vytorin, Lipitor, Ketek, and
various anemia drugs sold by Amgen Inc. The focus is
on how the FDA has handled these drugs, so Stupak has
a bigger agenda than simply probing the agency since
he claims it is broken in many ways.
Stupak claims that his focus on the FDA
has nothing to do with his son's death, but his wife
has stated that she believes their son's death has made
him even more aware of the issues at hand.
As for the Accutane, the FDA has put in
place an aggressive plan to regulate Accutane access,
which is also believed to be connected to birth defects
if taken by women who are pregnant.
The FDA has declined to make any comments
on the criticism drawn from Mr. Stupak, but in a recent
hearing before the subcommittee, the FDA's commissioner,
Dr. von Eschenback, stated that the FDA has created
a new food-safety plan and hired a chief information
officer to take care of technological issues. He has
also stated that it is his goal to place inspectors
for the FDA in countries such as India and china. The
budget set forth by the Bush administration included
an increase in funds for the FDA.
The FDA has declined to make any comments
on the criticism drawn from Mr. Stupak, but in a recent
hearing before the subcommittee, the FDA's commissioner,
Dr. von Eschenback, stated that the FDA has created
a new food-safety plan and hired a chief information
officer to take care of technological issues. He has
also stated that it is his goal to place inspectors
for the FDA in countries such as India and china. The
budget set forth by the Bush administration included
an increase in funds for the FDA.
Stupak has stated that the limits placed
upon the FDA and some of the practices within the drug
industry has put consumers in danger or has misled them.
Everyone is in agreement that if the FDA receives the
necessary funding, then the agency would be able to
do a far better job. However, it is believed that constant
scrutiny from Congress can result in the FDA being more
cautions when reviewing new treatments, and then, perhaps,
such tragedies as Stupak's son's death would not be
so easily attributed to a drug.
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