The FDA has been the subject of much criticism for their apparent failure to quickly respond to and appreciate the adverse side effect(s) of agency-approved drugs. For example, Merck & Co.’s Vioxx painkiller, which was approved by the FDA, was later pulled from the shelves due to an established link between the drug’s use and heart attacks and strokes.
On May 1, 2012 the Institute of Medicine (“Institute”) released an independent report that, in sum and substance, recommended that the FDA conduct a regular safety review of all drugs currently on the market. The Institute further advised that a comprehensive, publicly available document or release should be generated reflecting the FDA’s findings. Although the Institute recognized that “[i]’ts impossible to know all of the risks and benefits of a drug before approval,” such a formal release would allow practitioners and patients alike to better understand potential safety issues throughout the proceeding lifecycle of a particular drug. Such an analysis is particularly integral to a determination of a drug’s side effects, for many side effects are “lagging” in nature and only become readily apparent in an appreciable percentage of users months or years after initial use.
The FDA’s response to the Institute’s recommendations was routinely noncommittal, stating that while it supports “the general concept of enabling the public to be able to clearly monitor relevant safety issues for all drugs . . . it would be very challenging to implement this recommendation without our current resources without seriously compromising other critical regulatory activities.”
So, as of now, the FDA’s current practice stands: the FDA is only required to check for new safety issues after the drug has been continuously sold for a period of 18 months, or after it has been used by 10,000 patients—whichever is longer.