FDA AIMS TO REDUCE CONFUSION ON DRUG RISK COMMUNICATION
The FDA plans to issue guidance clarifying when the agency would use its proposed Drug Watch website to present drug safety information because of concerns about confusion caused by the number of different information outlets. This announcement comes on the heels of an agency decision to clarify the information presented on Drug Watch.
The agency will clarify when Drug Watch -- as opposed to other tools, such MedWatch, Drug Safety Oversight Board comments or agency press releases -- will be used to communicate drug risks, agency officials said during a recent conference call hosted by the Drug Information Association.
The FDA has learned that the variety of tools for communicating risk may be confusing the public, according to Susan Cummins, executive director of the agency's Drug Safety Oversight Board, who addressed conferees during the Center for Drug Evaluation and Research Town Meeting.
This latest effort follows the agency's pledge to clarify warnings posted on the site. The agency said it would hire risk communication experts to help it effectively convey whether information posted to the site represents a confirmed or a potential risk.
The FDA also will to use the guidance to clarify how the Drug Watch site is meant to work, including what evidence of risk must be shown in order for a drug to be posted; and to explain when and under what circumstances the agency will remove drugs from the list.
Furthermore, the agency will seek to "strike the right balance" between being overly cautious and not cautious enough and when to post a drug warning, Cummins said.
The FDA in February 2005 proposed the Drug Watch website as a tool to communicate the most up-to-date information on emerging safety issues to the public even before the agency has fully determined the significance of such safety alerts or decided whether regulatory action is appropriate.
The proposed site has been controversial. PhRMA and other groups have insisted that the Federal Food, Drug, and Cosmetic Act along with the FDA's implementing regulations have established labeling as the primary means of communicating drug product information, including safety-related content, to the public.