FDA official: Safety system broken down

WASHINGTON, Jun 09, 2005 (United Press International via COMTEX) -- A top U.S. Food and Drug Administration official says much still remains to be done by the government to uncover the dangers in drugs already on the market.

The warning was issued to a medical advisory board in Washington by Dr. Janet Woodcock, FDA's deputy commissioner of operations, the New York Times reported Thursday.

Woodcock, who has been asked to suggest safety improvements because of recent well-publicized drug industry troubles, said the government's safety system needs to be fixed, the report said.

"The keystone of the current system is the prescriber and that person is the one who decides if the benefits of a drug outweigh the risks for that patient," Woodcock said. "This system has obviously broken down to some extent, as far as the fully informed provider and the fully informed patient."

She said one way for the FDA to resolve problems with drugs on the market is to take advantage of electronic health records from managed-care organizations.

She also said physician and hospital errors are major contributors to the current problem.