LEGISLATION:

It would set up a fast track to approve drugs for people with life
threatening diseases.

WASHINGTON_The Senate overwhelmingly approved legislation Wednesday that
would help speed new drugs and medical devices into the marketplace.

The bill to overhaul the Food and Drug Administration review process passed
982. But as the legislation moved to the House, disputes lingered on some
issues, and some consumer groups continued to warn that safety was being
sacrificed for speed.

The legislation, Senate Labor and Human Resources Chairman Jim Jeffors,
RVt., said, marks the first substantial reform in the FDA in 30 years.
"What we have is going to increase the efficiency and effectiveness of the
FDA tremendously," he said.

Sen. Judd Gregg, RN.H., said the bill would "overcome what you might call
the culture of overcautiousness, the culture of the FDA."

The bill would set up a fast track to approve drugs for people with
lifethreatening diseases. I t would make it easier for seriously ill
people to obtain experimental treatment, allow the use of private,
thirdparty experts to speed up reviews of new medical devices and renew a
program in which fees collected from prescription drugmakers are used to
help streamline the application process.

The Senate has been working on the bill for nearly three years, and it was
stalled on the Senate floor for several months as lawmakers struggled to
work out compromises with the administration on problematic provisions.

In the end, Jeffords said, they were able to resolve 19 of 20 outstanding
issues. Those included retaining state authority to set regulations for
nonprescription cosmetics and safeguards on the offlabel use of drugs.

The administration, in a statement, said the bill "represents a significant
step toward accomplishing our mutual goal of assuring the agency's optimum
performance while protection the health of the American public."

But it also expressed concern about the FDA's right to review lowerrisk
medical devices. The bill would bar the FDA from seeking reviews of uses
other than those specified by the manufacturers.

Sen. Edward Kennedy, DMass., said that prohibition would allow makers to
promote unapproved uses of new devices. An amendment offered by Kennedy and
Sen. Jack Reed, DR.I.,that would have strengthened FDA authority was
defeated Tuesday, 6535. Kennedy and Reed were the only senators to vote
against the bill.

"This bill has come a long way, but it's not yet acceptable," Kennedy said.
He said he would urge President Clinton to veto the measure if the
medicaldevice language isn't changed when the House and Senate agree on a
final version. The House Commerce Committee is to vote on the House version
today.

Maura Kealey of the consumer group Public Citizen warned that revamping the
FDA is a mistake at a time when revelations of the health problems from the
unapproved uses of diet drugs point to the need for strong federal
surveillance.

"This is the worst thing to happen to public safety in a long time. It's
the first major weakening of the FDA in 91 years," she said.

She expressed concern over a provision that would allow companies to
circulate reputable journal articles to promote uses of drugs that do not
have FDA approval. Under a compromise, companies must apply for FDA
approval of these offlabel uses within three years.

But Carl Feldbaum, president of the Biotechnology Industry Organization,
said the bill would benefit the industry,l the FDA and patients. "It is
bipartisan, moderate, much needed and I think over time we broke through
the mindset that any change at the FDA was bad," he said.