U.S. Senator Says FDA Too Cozy With Drugmakers It Regulates

By Julie Rovner

WASHINGTON (Reuters Health) Mar 10 - The U.S. cooking.net">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 {*filter*}agers
and
the withdrawal of the popular painkiller Vioxx, said Sen. Charles
Grassley,
R-Iowa, "the agency charged with protecting the public from unsafe
prescription {*filter*} 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 whistleblower 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 {*filter*}, 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 {*filter*}
to be
under the thumb of the office that puts the {*filter*} 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."

------------------------ Yahoo! Groups Sponsor --------------------~-->

What would our lives be like without music, dance, and theater?
Donate or volunteer in the arts today at Network for Good!
Click Here!
--------------------------------------------------------------------~->

Disclaimer: The goal of this ILADS Discussion Group is to provide
informational exchange among/between member physicians and other
member health care professionals regarding their interests in
tick-borne disease.
Information presented is intended only for educational exchange
based on personal medical experience and opinions. If you are a Lyme
patient, as well, please ask your own doctor to explain in what manner
this information may or may not apply to you. It is not intended as
medical advice for anyone.
The Co-moderators

For more information: http://www.***.com/

Yahoo! Groups Links

<*> To visit your group on the web, go to:
    http://www.***.com/

<*> To unsubscribe from this group, send an email to:

<*> Your use of Yahoo! Groups is subject to:
    http://www.***.com/