FDA Triages its new powers

Sponsors of 16 drugs that FDA has determined meet criteria for converting voluntary risk management plans into legally enforceable risk evaluation and mitigation strategy (REMS) plans met the Sept. 21 deadline for submitting a proposed REMS, FDA officials told BioCentury last week.

There is no timetable for reviewing the REMS proposals and FDA will not make them public until it has approved them. But based on how the agency has exercised its new post-market authorities in the first year under the Food and Drug Administration Amendments Act of 2007, it seems unlikely to pile on new restrictions...