Controversy Surrounds FDA Approval of Mifepristone and Access to Abortion Pill

A federal judge in Texas ruled that the FDA improperly approved the abortion pill mifepristone in 2000, but outside the courts, there are concerns that the litigation could undermine the agency's authority. The FDA went through three rounds of reviews over four years, each time issuing an "approvable" letter, meaning the safety and efficacy data was solid. The approval relied on two pivotal French studies and one U.S. study with similar safety and efficacy findings. The FDA did not use accelerated approval in its process, however, and mifepristone's approval and oversight were in line with other drugs approved with similar safety requirements.