A lot could have gone wrong. As I detail in the piece, the experience with Plan B emergency contraception was a lesson in just how politicized the OTC approval process could be. https://t.co/OjobU0uE6h
The FDA’s approval for over-the-counter sales of emergency contraception marked a departure from its standard approval process and obstructed access to a safe and effective drug. That departure could set a dangerous precedent for future decisions: https://
The FDA’s approval for over-the-counter sales of emergency contraception marked a departure from its standard approval process and obstructed access to a safe and effective drug. That departure could set a dangerous precedent for future decisions: https://
Notably, inappropriate non-scientific speculation (which Marks’ reasoning exemplifies) by FDA and HHS was also a major driver of Plan B emergency contraception approval/access obstacles, where FDA’s decisions were eventually found arbitrary & capriciou