Abortion pills may face new limits
Pharmaceutical industry says second-guessing FDA could disrupt approvals, research
Less than two years after the Supreme Court overturned Roe v. Wade, the issue of reproductive rights is returning to the high court Tuesday as the justices consider whether to limit access to a medication used in more than 60% of U.S. abortions.
The Biden administration and the manufacturer of mifepristone are seeking to reverse a lower-court ruling that would make it more difficult to obtain the medication, first approved nearly 25 years ago and shown in multiple studies to be overwhelmingly safe.
The conservative U.S. Court of Appeals for the 5th Circuit said the Food and Drug Administration failed to follow proper procedures and thoroughly explain its reasoning when it began loosening regulations. The changes made in 2016 and again in 2021 allowed mifepristone to be taken up to 10 weeks into pregnancy, instead of seven weeks, prescribed by a medical professional other than a doctor, and mailed directly to patients without an in-person medical consultation.
The pharmaceutical industry has warned second-guessing the FDA’s determinations in this case will more broadly disrupt the nation’s drugapproval process and stymie private investment in research. A decision should come by this summer.
The case could make it harder to get medication abortions even in states where abortion is legal.
Allowing medication abortions to proceed without an ultrasound or in-person medical visit has increased access, particularly for women in rural areas and others who struggle to go to a clinic in person by allowing them to complete the process from home.
The Supreme Court could also further impede abortion access for those living in one of the more than a dozen states with strict abortion bans in place.
A few telemedicine clinics have started allowing U.S.-based doctors to prescribe and mail pills into restricted states, relying on new “shield laws” passed in several blue states to protect them from prosecution. The largest of those clinics, Aid Access, now mails approximately 6,000 doses of medication abortion into antiabortion states every month, according to founder Rebecca Gomperts.
A narrowed time window for accessing abortion pills would have major implications nationwide. In 2021, 56% of all abortions occurred beyond seven weeks of pregnancy.
Just 20% occurred after 10 weeks, the FDA’s current mifepristone limit.
For the FDA and the pharmaceutical industry, the legal battle over mifepristone casts a shadow over all drugs, medical devices and diagnostics the agency approves.
If the 5th Circuit’s decision is upheld, industry and former government officials say, it would undercut the FDA’s stature as the global gold standard of regulating medicine — as well as the ability of drugmakers to raise money from investors.
That, in turn, could deprive patients of innovative therapies.
Pharmaceutical companies denied approval for a drug could use the courts to reverse the agency’s scientific judgments — or challenge the approval of a competitor’s drug, former FDA commissioners said in a brief to the high court.