FDA Critic Seeks Revamp of Drug Safety Review
Senator Calls for Independent Drug Safety Office
March 10, 2005 - A key congressional critic of the FDA says he will soon
begin an effort to overhaul the way the agency monitors the safety of the
nation's prescription drug supply.
His bill is likely to be the first attempt by lawmakers to reform the FDA in
the wake of lingering questions over its handling of safety issues, including
risk in adolescents taking antidepressants and heart problems with
Sen. Charles E. Grassley (R-Iowa), who leads the Finance Committee, says he
will introduce a bill designed to set up within the FDA an independent drug
safety office with expanded new powers to police -- and possibly remove --
drugs already on the U.S. market.
The FDA's existing Office of Drug Safety is under the authority of its
Office of New Drugs, which is responsible for declaring new drug products safe
and clearing them for sale to consumers.
Critics have said that the arrangement intimidates FDA scientists who raise
safety questions about already available drugs because they are forced to take
their concerns to superiors who have already declared the drugs safe and
New Drug Safety Office, New Power
A current draft of the new bill instead creates an independent drug safety
office with the power to force manufacturers to tighten drug warning labels and
to order new drug safety trials for products already on the U.S. market.
The bill is also likely to give the new office the power to suspend
advertising of suspect drugs and to pull drugs from the market that it
determines are unsafe for patients to use, a Senate aide tells WebMD.
"The existing Office of New Drugs is hampered by real and perceived
conflicts of interest. An independent drug safety office would more effectively
regulate drugs once they're on the market," Grassley said in a speech
before the Consumer Federation of America.
"If you want accountability, it doesn't make sense to have the office
that reviews the safety of drugs to be under the thumb of the office that puts
the drugs on the market in the first place," he said.
The FDA lacks the authority to force drug companies to conduct additional
safety trials on drugs already on the market or to order changes to warning
The Office of Drug Safety came under public scrutiny last year when several
of its scientists said the FDA had tried to prevent them from telling the
public about safety concerns with several available drugs.
Andrew Mosholder, MD, publicly complained last winter that agency superiors
barred him from presenting findings of a study that showed that widely used
antidepressant drugs can raise the risk of suicidal thoughts and behaviors in
children and adolescents. Later, in November 2004, scientist David Graham,
MD, complained to Grassley and other lawmakers that his superiors
ostracized and intimidated him when he raised questions about the safety of
Both scientists were eventually allowed to present their findings in front
of FDA scientific advisory committees.
Vioxx was pulled from the market by its manufacturer, Merck & Co., in
September of last year.
"We now know that the FDA has gotten too complacent. The agency charged
with protecting the public from unsafe prescription drugs was too cozy with the
with the drug companies," Grassley says.
Other lawmakers have pledged to launch their own FDA reform efforts but have
so far not unveiled any detailed plans.