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Updated: 2005-03-10 13:06:28 -0400 (Reuters Health)
By Julie Rovner
WASHINGTON (Reuters Health) - The U.S. Food and Drug Administration
has grown too close to the drug companies it regulates, raising
questions about whether its acting director should be given
a permanent job, a top Republican Senator said Thursday.
In disputes last year involving the use of antidepressants
by teenagers and the withdrawal of the popular painkiller
Vioxx, said Sen. Charles Grassley, "the agency charged with
protecting the public from unsafe prescription drugs was too
cozy with the drug companies."
The problems at FDA come at a time when "some drug companies
are placing greed ahead of drug safety," Grassley said. In
a speech to the Consumer Federation of America, he cited Justice
Department statistics that "there are currently under seal
in the neighborhood of 100 whistle-blower cases involving
allegations against over 200 drug companies."
In the Vioxx case in particular, Grassley said, "the FDA allowed
itself to be manipulated by Merck," the drug's maker.
Grassley said that while he is convinced that FDA Acting Commissioner
Lester Crawford's "heart is in the right place," he noted
that both controversies occurred "under his watch," and suggested
that he will not be prepared to support Crawford's nomination
to head the agency permanently "until he has answered some
tough questions."
Grassley also said that the FDA has not yet responded to several
committee requests for documents, and that if Crawford cannot
get his staff to answer Congress's questions, it raises the
question "is he the right man for the job?"
Grassley noted that he has already introduced legislation
to make data from prescription drug clinical trials more widely
available to the public and to doctors, and that he plans
to introduce another bill "in the coming days" to establish
an independent Office of Drug Safety within FDA that would
report directly to the commissioner.
The problem with the current office, he said, is that it reports
to the Office of New Drugs, whose officials are unlikely to
admit they might have made a mistake in approving a product.
"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," Grassley said.
When the FDA approves a drug, he said, "Consumers shouldn't
have to second-guess the safety of what's in their medicine
cabinets."
