FDA to create independent safety board

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FDA to create independent safety board

By Richwine

WASHINGTON (Reuters) - The U.S. Food and Drug

Administration (news - web sites) said on Tuesday it

was creating an independent drug safety board after

the agency's monitoring of drugs already in the

marketplace was criticized amid the withdrawal of

arthritis drug Vioxx.

The announcement comes on the eve of a three-day FDA

(news - web sites) meeting called to discuss the

safety of painkillers like Merck & Co. Inc.'s

(NYSE:MRK - news) Vioxx that have been linked to an

increased risk of heart disease and stroke.

Health and Human Services (news - web sites) Secretary

Leavitt announced the new safety board in a

meeting with FDA staff and was later due to give a

news conference.

Criticism of how the FDA monitors the after-market

safety of drugs has grown in the past year, starting

with concerns about suicides in youth who took

antidepressants and followed by Merck's September

withdrawal of Vioxx.

Questions have also been raised about the safety of

Pfizer Inc.'s (NYSE:PFE - news) Celebrex and Bextra,

painkillers similar to Vioxx, and about whether they

should remain on the market.

The FDA already has an Office of Drug Safety but

consumer groups and some lawmakers have said it lacks

sufficient independence and resources.

At a congressional hearing in November, a veteran FDA

drug safety scientist testified that the FDA was

virtually defenseless against another Vioxx.

The new board will include representatives from the

FDA and medical oversight experts from other agencies

like the Veterans Administration, an administration

official said, and will consult with patient and

consumer groups.