GAO: FDA’s Mifeprex approval ‘consistent’

The Government Accountability Office said the FDA’s approval process for Mifeprex, the RU-486 abortion pill, was “consistent with the processes for the other Subpart H restricted drugs,” and its post-market oversight also has been consistent with other such drugs that have special distribution and administration controls. 

The GAO report was issued in response to a congressional inquiry from Sen. Mike Enzi (R-WY) based on lingering suspicions that the drug’s approval was politically coerced by the Clinton administration. The GAO said critics have questioned aspects of the Mifeprex approval process, including the reliance on historically controlled clinical trials that compare a drug’s effects on a condition rather than to another drug or placebo.

Critics said that Mifeprex does not fit within the scope of Subpart H, which applies to drugs that treat serious or life-threatening illnesses. And concerns have been raised about the agency’s post-marketing oversight, including its response to deaths in women who took the drug. The GAO reports the FDA reviewed the NDA through three review cycles.