Abortion pill maker sues FDA to preserve access

A ruling by the 5th Circuit Court of Appeals now pending before the Supreme Court would unwind policies the FDA has approved since 2016 to make the abortion pill more accessible — including telemedicine prescription, mail delivery and retail pharmacy dispensing — and shrink the window of time patients are approved by FDA to take the drug from 10 to seven weeks of gestation — before many know they are pregnant.

The 5th Circuit’s decision, which endorses much of a challenge brought by the anti-abortion medical group Alliance for Hippocratic Medicine, would also suspend the FDA’s 2019 approval of the generic version of mifepristone made by GenBioPro.

“If the AHM Fifth Circuit Order goes into effect, the result will be chaos,” GenBioPro warned in its suit. “No court in history has ever ‘stayed’ or ‘suspended’ a longstanding FDA approval, and FDA has no template for responding to — or implementing — those decisions.”

The FDA declined to comment on the litigation.

Making similar arguments to the company’s, some Democratic lawmakers and activists have recently demanded that the Biden administration ignore a potential court order suspending approval of the pill or direct the FDA to use enforcement discretion to keep the pill on the market.

GenBioPro claims that, before suing, it repeatedly approached the FDA to ask what the process would be for suspending approval and what rights the company has under that scenario and received no response.

“Notwithstanding the exigent circumstances and the numerous tools available to FDA, FDA has repeatedly refused to assure GenBioPro or the public that it will afford GenBioPro adequate procedures before suspending GenBioPro’s … approval,” the company wrote.