(http://www.chron.com/content/chronicle/business/97/09/12/fda.20.html)

Compromise clears way for bill on FDA reform

WASHINGTON (AP) A Senate bill that would change the way the Food and
Drug Administration approves drugs cleared a major hurdle Thursday with
an agreement on how to regulate the cosmetics industry.

The cosmetics issue, raised by Sen. Edward Kennedy, DMass., was the
last major dispute on a bill that has been in the works for three years.
It could now pass as early as next week, sending it to the House for
consideration.

Kennedy said that some issues on medical device regulation remain, but
"I am hopeful that we will have a positive outcome."

The legislation is aimed at speeding up the testing and approval of new
drugs and would make it easier for seriously ill people to get
experimental drugs. It would allow the FDA, which monitors the
production and sale of some $1 trillion worth of food and medical
products each year, to contract with outside panels to review new
products.

Kennedy objected to a provision that would have allowed the federal
government to preempt state regulation of nonprescription drugs and
cosmetics. It barred states from imposing different or additional
requirements.

The purpose was to achieve uniformity in labeling and warnings, but
Kennedy argued that the FDA has had only a minimal role in cosmetics
oversight and might end up preventing states from offering stronger
protections.

Under the compromise, states would continue to regulate cosmetics except
in those cases where the FDA has already taken action in a certain area.

Sen. Jim Jeffords, RVt., a sponsor of the bill, said the compromise
resolved the most difficult remaining issue. "The time to move forward
on this measure is now," he said. "It provides moderate, incremental but
important improvements to the FDA."

A vote to cut off debate and move the bill toward passage is scheduled
for Tuesday.

The bill has undergone many changes in the past several years, partly
under pressure from consumer groups that have warned that efforts to
streamline drug approvals would lead to lesssafe products.