DATE: Saturday, November 22, 1997           TAG: 9711220324

SECTION: FRONT                   PAGE: A5   EDITION: FINAL 

SOURCE: Associated Press 

DATELINE: WASHINGTON                        LENGTH:   51 lines

PRESIDENT SIGNS BILL GIVING FDA POWERS TO RUSH DRUGS TO MARKET

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.

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.'' KEYWORDS: FDA

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