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Date: Friday, November 21, 1997 7:27:51 PM
From: AOL News
Subj: Clinton Signs FDA Overhaul Bill
.c The Associated Press
By LAWRENCE L. KNUTSON
WASHINGTON (AP) - President Clinton signed a law Friday giving
the Food and Drug Administration new powers to speed the approval
of drugs to combat a host of killer diseases including cancer and
AIDS.
Some critics have argued that the law will expose patients to
risky medicine for the benefit of the makers of experimental drugs
and new devices.
But Clinton said, ``The FDA has always set the gold standard for
protecting the public safety,''
``Today, it wins the gold medal for leading the way into the
future,'' he said at the bill-signing ceremony in the Old Executive
Office Building next to the White House.
A hard-fought compromise, the FDA Modernization Act of 1997 took
three years to hammer out. Many of its provisions have been put
into effect administratively through Vice President Al Gore's
``reinventing government'' programs.
``We know that for many patients, experimental treatments
represent their best -- perhaps their only -- chance for
recovery,'' Clinton said. ``That's why this bill writes into law
current FDA policies that allow doctors and patients to use new
drugs before they are formally approved.''
``Already thousands of AIDS, cancer, and Alzheimer's patients
have found new hope -- even new life -- with these experimental
therapies,'' he said.
Gore added: ``This fall alone, the FDA has approved new drugs
and treatments for everything from HIV to breast cancer,
cardiovascular disease to cystic fibrosis, Parkinson's to
epilepsy.''
Clinton said he first became interested in the issue during his
1992 campaign when he heard complaints that the FDA drug approval
system was ``too slow and somewhat arbitrary and not giving the
American people the drug approvals and the medical-device approvals
in a timely fashion.''
Clinton allies applauded the new law.
``The challenge now is to implement this far-reaching
legislation rapidly and effectively, so that the full benefits of
these changes will be available to patients and industry as soon as
possible,'' said Sen. Edward M. Kennedy, D-Mass.
But Dr. Sydney M. Wolfe, director of Public Citizen's Health
Research Group, called the new law ``the worst attack on the Food
and Drug Administration's ability to protect consumers and patients
in 91 years.''
``Americans will be exposed to defective drugs and medical
devices that Europeans with their weaker laws have been exposed to
for a long time,'' Wolfe said.
He contended that political contributions greased the bill's
progress through Congress and added: `This bill is good for
corporate profits and bad for public health - period.''
AP-NY-11-21-97 1423EST
Copyright 1997 The Associated Press. The information
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