Emerging Drug-safety Issues Will be Posted on New FDA Site

Late last week the FDA announced guidelines for its proposed "Drug Watch" web site, which would be aimed at letting patients know about emerging drug-safety concerns in a more timely manner.  Plans for this new Drug Watch site is part of a new series of drug-safety initiatives launched by the FDA in the aftermath of the Vioxx debacle.

According to the FDA guidelines, discussions about emerging drug-safety issues would be posted on the new Drug Watch web site only after a preliminary review of the safety information for a subject drug was conducted by the soon-to-be-formed Drug Safety Oversight Board.  More specifically, the FDA said that the Drug Watch site "is intended to identify drugs for which the FDA is actively evaluating early safety signals." 

Details of the FDA’s proposed Drug Watch web site are supposed to be published in today’s Federal Register; there will be a 90-day comment period for the public to provide comments and feedback regarding this FDA proposal.  Due to the comment period as well as the time required for other administrative procedures, the FDA Drug Watch site is not expected to be available on-line until later this year.

(Posted by: Tom Lamb)