FDA ALREADY POSTING SAFETY INDICATIONS
While the FDA's much publicized Drug Watch website is still under consideration, the agency has already started posting information on emerging safety issues, a top FDA official told the Drug Information Association's (DIA) annual conference June 30.
There have been many questions about whether the Drug Watch is already active, Steven Galson, acting director of the FDA's Center for Drug Evaluation and Research (CDER), said in response to a question from a Pfizer representative during a wide-ranging DIA conference session on CDER activities.
"I want to be very clear," he said. "The guidance that we published is a proposed guidance. The Drug Watch is a proposal. There is not a Drug Watch website yet, and the policies in the Drug Watch are proposed," Galson said. "However, we have been posting emerging drug safety information."
The decision to post the information was made after consulting with the agency's attorneys, who concluded current regulations and statutes allow the FDA to post information about approved pharmaceutical products, Galson said.
The information appears on CDER's "Drug Specific Information" website, which went live in May and includes data on more than 200 approved drugs. "Some of [the drugs] have information that is very late breaking and some have information that is a couple of years old," Galson said. When the Drug Watch guidance is finalized, "presumably you will be able to just click on something called Drug Watch to see more clearly and succinctly the specific emerging drug information," he added.