FDA Publishes Guidance on Drug Safety Information
The FDA has recently published a guidance document entitled "Drug Safety Information--FDA's Communication to the Public" that discusses the procedure by which the FDA disseminates drug safety information. The FDA noted that it has been taking a more comprehensive approach to reporting drug safety information to the public and may make safety announcements even before the FDA has decided to take regulatory action. The FDA acknowledged, however, that "[t]here will always be some tension between the goal of having people informed about potentially important information as early as possible and the goal of having that information thoroughly substantiated." To address this tension, the FDA will consider multiple factors when determining whether to make information available, including the following:
(1) Reliability of data;
(2) Magnitude of the risk;
(3) Seriousness of the event relative to the disease being treated;
(4) Plausibility of a causal relationship between the use of a drug and the adverse event;
(5) Extent of patient exposure;
(6) Potential to prevent or mitigate the risk in the patient population;
(7) Effect on clinical practice; and
(8) Disproportionate impact on particular populations.
The FDA qualified the guidance document by stating that the FDA reserves the right to modify its current approach and to amend the guidance document in the future.
