FDA ANNOUNCES NEW DRUG SAFETY RISK COMMUNICATION PROGRAM

The FDA has released a final guidance detailing new and current programs that convey drug safety information to the public as part of a larger drug safety initiative, the agency announced.

The final guidance, "Drug Safety Information -- FDA's Communication to the Public," replaces a draft guidance published in May 2005 that proposed a "Drug Watch" program. The agency will instead establish a web page where drugs with active FDA safety alerts will be identified by a red asterisk.

The FDA abandoned the "Drug Watch" program because of potential confusion between that system and the agency's 10-year-old "MedWatch" program, Paul Seligman, CDER's associate director for Safety Policy and Communication, said. The MedWatch program sends out alerts to subscribers on an almost daily basis, Seligman said.

The asterisks in the new system can be changed or removed when the agency learns they are no longer necessary, Seligman said, but the agency will make "judgment calls" on when to release information to the public.

"There's no restriction on the frequency with which we would use this tool to report emerging safety information," Seligman added.

For now, the drug safety information will only be available online, he said. However, he admitted that "there are aspects of our website that are somewhat impenetrable." The agency is investigating ways to make the website easier to navigate, and Seligman said the red asterisk program would help clearly designate the drugs with new, emerging information.

The guidance can be viewed at www.fda.gov/cder/guidance/7477fnl.pdf ( http://www.fda.gov/cder/guidance/7477fnl.pdf ).