The abortion pill heads to the Supreme Court, with Big Pharma standing behind the FDA
A controversial case… The US Supreme Court heard arguments yesterday on its first abortion-related case since it overturned Roe v. Wade in 2022. At the center of the dispute is the abortion drug mifepristone made by Danco Laboratories. An anti-abortion group, the Alliance for Hippocratic Medicine, asked SCOTUS to limit access to mifepristone (which the FDA expanded in the past decade). The group argues that the FDA’s loosening of restrictions on the drug has led to adverse health effects (the FDA disagrees).
A ruling against the FDA could restore a seven-week limit on prescribing mifepristone and require that the pill be prescribed and taken in person at a doctor’s office. Mifepristone has become more widely available, including via telemedicine.
Abortion through medication now makes up nearly two-thirds of abortions in the US. There were 150K+ more medication abortions last year than in 2020, and 5M+ American women have used mifepristone.
Since SCOTUS overturned Roe, nearly a third of states have banned all or most abortions, but abortions haven’t declined.
To stock or not… Last year the FDA said specially certified pharmacies including CVS and Walgreens could sell mifepristone, but the chains only started stocking the pill this month (in states where it’s legal). A ruling against the FDA could lead to the drug being pulled from big chains. Experts say challenges to Perrigo’s Opill — the first daily birth-control pill cleared for over-the-counter purchase in the US — could be next. Opill went on sale last week.
The FDA’s gold standard is at stake… The pharmaceutical industry seems to be united in support of the FDA. The concern: a ruling that second-guesses the drug regulator’s guidance on mifepristone could open up scrutiny of the whole medicine cabinet. The lawyer repping mifepristone maker Danco Labs argued the opposition’s POV “would upend… virtually every drug approval” the FDA’s made.