June 22, 2006

Senators plan bill to revamp FDA drug safety

By Susan Heavey

WASHINGTON (Reuters) - Two top U.S. senators plan to
propose bipartisan legislation next month to revamp the Food
and Drug Administration's handling of drug safety issues, a
senior Republican aide said on Wednesday.

The move comes as the FDA, which has been without a
permanent leader for most of the Bush administration, grapples
with renewed safety concerns following the withdrawal of a
popular painkiller and warnings over possible suicide risk with

However, the aide to Senate Health, Education, Labor and
Pension Committee Chairman Mike Enzi of Wyoming also said the
Senate was "highly unlikely" to confirm acting FDA chief Andrew
von Eschenbach this year, although the committee may hold a
hearing later this year.

The bill being worked on by Enzi and Sen. Edward Kennedy of
Massachusetts, the health panel's top Democrat, aims to
integrate the FDA's drug safety review with the overall
approval process, the aide told an investment conference.

"What the bill will require is better planning before
approval of how drugmakers and the FDA are going to identify
and manage risks after approval," the aide said.

A government expert who has seen an outline of the proposal
said it would require drug companies to include a
risk-management plan with their drug approval submission.

The proposal would also penalize companies that do not
follow the risk plan and would require them to disclose results
from major clinical trials, according to a New York Times

In April, the Government Accountability Office found
lingering safety issues at the agency, citing an unclear
process of monitoring products once they are on the market.

Another FDA drug safety report is expected next month from
the independent Institutes of Medicine.

The lawmakers are still seeking input from industry
leaders, patient groups and the FDA, but want to introduce the
bill before Congress adjourns for its summer recess in August,
the aide said at the event sponsored by Bank of America Corp..

Enzi and Kennedy appear to be taking a different approach
than Senate Finance Committee Chairman Charles Grassley, an
Iowa Republican, who has proposed a bill to make the FDA's
Office of Drug Safety independent of the drug-approval office.

FDA spokeswoman Susan Bro said the agency has been taking
steps to improve safety and welcomed additional ideas. She
declined to comment on von Eschenbach's nomination.

Von Eschenbach has been acting chief since September but
his nomination has been halted by political friction over
"morning after" emergency contraception.