FDA Releases Details for Proposed Drug Watch Web Site
FDA officials on Friday issued guidelines for its Drug Watch Web site -- expected to be launched later this year -- that will contain safety information on drugs currently under review, Dow Jones/Wall Street Journal reports. FDA said the Web site "is intended to identify drugs for which FDA is actively evaluating early safety signals." Drug manufacturers would be notified of a relevant posting just prior to its placement on the site. According to the agency, a drug or a class of drugs would be placed on the site only if the new Drug Safety Oversight Board determined there was sufficient information on a potential safety problem to warrant further investigation. The drug would be removed from the site's list after safety issues were resolved.
Details of the proposed site will be published Monday in the Federal Register. The Web site aims to "provide a forum in which [FDA] can communicate emerging safety information to the public while ... continu[ing] to evaluate that information," FDA said in its guidance. FDA has requested a 90-day public comment period on the site. FDA on Thursday posted on the Internet "drug-specific" safety information intended for consumers and health care professionals, the Dow Jones/Journal reports. Typically, FDA disseminates such information through its MedWatch program.
FDA on Friday also released details on the proposed Drug Safety Oversight Board. According to the agency, the board would have 15 voting members, with one member from each of the offices of the Center for Drug Evaluation and Research. One member also would be chosen from the center's medical device division and another from the biologics division. Another member would come from a "non-FDA health agency," and another from a "nonhealth government agency," Dow Jones/Journal reports.
The FDA commissioner would appoint board members. Three of the members would be from the FDA Office of New Drugs. Board members would be able to confer with outside consultants. The board would discuss emerging drug-safety issues and be responsible for information posted on the Drug Watch Web site. FDA would not publicize most of the board's deliberations; however, "any relevant information" would be posted on the Drug Watch Web site. The CDER director would make all final decisions on drug-safety issues. The board would likely meet once a month in its early stages, and subsequently "on an as-needed basis," according to Dow Jones/Journal. The proposals are part of a series of drug-safety initiatives the agency announced in February in response to increased criticism over the agency's drug safety regulation (Corbett Dooren, Dow Jones/Wall Street Journal, 5/9).