The courts, abortion pills, and what you need to know
Harvard Public Health magazine
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The Supreme Court yesterday issued its second administrative stay of an order by a U.S. District Court judge in Texas, Matthew Kacsmaryk, to suspend FDA approval of mifepristone. The court will continue to consider the case through Friday evening.
While we await the Supreme Court’s next move—we’ll untangle the complex legal battle of the past week, what it means for abortion access, and what’s likely to happen next.
What happens now?
For now, mifepristone retains its FDA approval and remains widely available across the country, including through online ordering and mail-forwarding to states with abortion bans in effect. But the fight isn’t over. The Supreme Court has only temporarily maintained the status quo while it considers lower court rulings and competing requests in the case. Future access remains uncertain.
There’s too many rulings! Remind me how we got here?
It started April 7 with a contradictory pair of federal court rulings, one invalidating the FDA’s 23-year-old approval of mifepristone, the other ordering the federal government to keep the drug available in the 17 states that filed lawsuits before that court.
On April 13, a federal appeals court granted an emergency stay on the order invalidating the FDA’s approval of mifepristone. But this ruling imposed some temporary restrictions, like preventing mifepristone from being delivered to patients by mail.
The uncertainty of events led some states with Democratic legislatures to purchase the drug in bulk. Meanwhile, pharmaceutical companies—including Pfizer and Biogen—lambasted the decision against the FDA for not just undermining the agency’s authority but making politics, not science, the foundation of drug approvals. And prominent voices in public health rallied on behalf of the agency, including Joshua Sharfstein, a former FDA deputy commissioner, who dismissed?the accusation that the FDA acted improperly in its approval of the drug as “just not credible.”
The Supreme Court weighed in April 14, restoring full availability of mifepristone until midnight yesterday. Justice Samuel Alito then announced yesterday afternoon that the court would extend its stay on lower court rulings until Friday.
Does a protracted court battle make it harder to get abortion pills?
Yes and no. Both mifepristone and misoprostol, the two most common medications used for abortion, will most likely remain broadly available while litigation is ongoing. However, some experts and observers argue that legal confusion and existing abortion restrictions have already created a chilling effect on access to mifepristone and misoprostol, which in 2020 were used in more than half of all abortions in the U.S.
One report estimates that 32,260 fewer abortions were provided in the U.S. in the first six months after SCOTUS overturned Roe v. Wade, and not only in states where abortion is banned. In Ohio, where a judge has blocked the state’s proposed abortion ban indefinitely, abortion rates have also dropped. Mifepristone is also used to treat miscarriages, and anecdotal reports suggest doctors are reluctant to prescribe abortion medications to treat miscarriages in states with abortion bans.
Abortion bans have even made some providers and pharmacists reluctant to prescribe abortion medication—the main three are mifepristone, misoprostol, and methotrexate—for other conditions they are used to treat like uterine fibroids and autoimmune diseases.
So, will all medication abortions become illegal in the future?
It’s unlikely, at least in the near-term. The FDA has tools to fight court rulings that interfere with its drug approval process, and the courts have no practical way to compel the FDA to comply with their orders. While Congressional Republicans would likely flay the FDA if it chooses not to enforce rulings, mifepristone should remain broadly available in states where abortion remains legal.
Even if the Supreme Court were to uphold Judge Kacsmaryk’s order in the future, and the FDA chose to comply with it, there are other approved drugs that can safely and effectively end pregnancies that are not yet under scrutiny, notably misoprostol. That being said, misoprostol-only abortions tend to have more severe side effects and can take up to a day longer to take full effect than the two-drug regimen.
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What about online ordering and mail delivery for abortion pills?
The online marketplace for abortion pills will continue to operate. Online ordering of abortion pills grew significantly after Dobbs, with patients in states with abortion bans relying on mail-forwarding to receive pills. As long as mifepristone retains its FDA approval and can be prescribed in states without abortion restrictions, it should remain available through online ordering and mail-forwarding.
If U.S.-based providers and pharmacists become more reluctant to turn a blind eye to mail-forwarding, as the result of continuing litigation, then women residing in states with abortion bans will have to rely on international providers, which are not subject to U.S. restrictions.
How long before other abortion medications come under threat?
Watch this space. Medical abortions make up more than half of all abortions in the U.S., and abortion rights supporters say the legal challenges will keep coming. One legal expert already says misoprostol could be the next target.
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Christine & Jo