MEASURE SIGNIFICANTLY CHANGING FDA IS OKD

CONGRESS:

Among the provisions is one speeding the approval of lifesaving drugs.

WashingtonCulminating years of work,Congress on Sunday approved
legislation that will bring basic changes to the Food and Drug
Administration and accelerate the approval of lifesaving drugs.

The bill, headed to President Clinton for his expected signature, gives
Congress one major achievement as it brings a quarrelsome and highly
partisan session to a close.

The House passed the measure by voice vote just hours after Senate
approval, which also came on a voice vote.

The bill expands patient access to new drugs for lifethreatening
illnesses, provides for accelerated approval of some drugs and medical
devices, and allows the Health and Human Services secretary to accredit
independent thirdparty groups to speed up reviews of lowrisk devices.

It also reauthorizes a fiveyear program under which fees paid by drug
companies have gone to hire 600 new reviewers, who have helped cut the
backlog in new medicine approvals. Incentives are included for developing
and testing medicines for children.

The bipartisan agreement came after extensive negotiations on a number of
issues:

The final bill gives the FDA the right to request data for medicaldevice
uses not listed on the devices' labels.

As in the original bill, drug companies will be able to circulate reputable
journal articles about offlabel use of drugs, but the FDA will also be
able to review and approve those articles.

Thirdparty review for medical devices was limited to apply mainly to
lowerrisk devices.

The final legislation preserves state authority to regulate cosmetics.