Health providers are bracing for massive disruptions as they await a federal judge’s decision on whether to halt national access to an abortion pill approved decades ago by the Food and Drug Administration.
Trump-appointed Judge Matthew Kacsmaryk is expected to rule soon on the Alliance Defending Freedom’s request for a preliminary injunction stopping the sale and distribution of mifepristone, a drug used as part of a regimen to end a pregnancy within the first 10 weeks. Such a ban, advocates say, would push health groups to guide patients and doctors to alternative ways to access reproductive services.
Pharmacists and reproductive rights groups are anxiously awaiting a decision, the outcome of which has sweeping implications for abortion medications and FDA’s authority over regulating drugs.
The impacts would be “devastating,” said Kirsten Moore, executive director of the Expanding Medication Abortion Access, or EMAA, Project. “It would be removing the most common form of abortion care currently used by patients in this country.”
Medical associations have defended the safety of mifepristone, a drug that studies show is safer than and sends fewer people to the emergency room than Tylenol and Viagra. Many attorneys say ADF’s argument is without merit, though note Kacsmaryk’s track record suggests he’s likely to give a sympathetic ear.
“This would be the first time a court has ever taken a drug off the market over the objection of the FDA and a drug sponsor. It’s just totally unprecedented,” said Greer Donley, a law professor at the University of Pittsburgh.
Justice Department attorneys representing the FDA didn’t respond to requests for comment.
ADF senior counsel Julie Marie Blake told Bloomberg Law that “the FDA should just do its job to protect women and girls.”
ADF and the FDA are expected to file additional legal briefs by Friday.
An injunction on mifepristone will effectively leave health-care providers with two options for abortion care: a misoprostol-only regimen, or surgical abortion, said Elisa Wells, co-founder and co-director of Plan C, an organization that provides information about how to access abortion pills online.
“This would be an injunction that really changes the status quo,” said Wendy Parmet, director of Northeastern University’s Center for Health Policy and Law. “It’s a pretty momentous thing to take the medication off the market that had been on the market for 20 years.”
Misoprostol still has the potential to be available for patients for off-label use, in part because it’s approved by the FDA to treat gastric ulcers.Misoprostol is used on its own for medication abortions in several countries where mifepristone is unavailable, and the World Health Organization has studied and defended its safety, although it’s generally more effective when used following mifepristone.
“There are approved regimens of managing medication abortion using only misoprostol” that are known to be “equally safe,” Jamila Perritt, president and CEO of Physicians for Reproductive Health, said in a webinar Thursday.
FDA action for so-called off-label use isn’t needed per se, attorneys say. They note, however, that guidance for more medical providers could lead to more widespread prescribing and ease access in more restrictive states.
The American College of Obstetricians and Gynecologists “is preparing clinical information updates for our members in the event that mifepristone becomes unavailable that lays out dwindling options that remain to obtain essential reproductive healthcare,” said Molly Meegan, the group’s chief legal officer and general counsel.
Jessica Nouhavandi, co-founder and president of California-based mail-order pharmacy Honeybee Health, said her company is “fully stocked up and ready to go” if providers switch to a misoprostol-only regimen. Honeybee last month officially became the first pharmacy certified to dispense mifepristone under the FDA’s updated safety program for the drug.
Demand Won’t Stop
The use of medication abortion has risen since mifepristone’s approval in 2000. As of 2020, the mifepristone plus misoprostol regimen made up roughly 53% of all abortions, according to data from reproductive health research firm the Guttmacher Institute.
Health professionals say restricting mifepristone won’t remove demand for it. Instead, they say more patients will turn to suppliers outside of FDA-regulated channels, including online sellers offering to ship the pills from abroad.
“As a certified pharmacy, there’s only a certain amount of states that we can legally ship to, but there are tons of people in other states accessing mifepristone from outside of the country that we can’t control,” Nouhavandi said.
In the wake of the US Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, many women in states with abortion bans or other restrictions have turned to online pharmacies in India—the world’s largest provider of generic drugs—to access mifepristone and misoprostol.
The FDA recommends against ordering the abortion pill online or personally transporting it from a foreign country. The agency says on its website that doing so “would be bypassing important safeguards specifically designed to protect their health.”
The agency, however, could “relax” some of the relevant website language should it want to promote pill access in light of an injunction, Donley said, and “perhaps make clear the personal use exemption applies if people buy mifepristone internationally for their own personal use.”
The “worst case scenario” for patients and clinicians would occur if Kacsmaryk decides to “order the immediate removal of mifepristone from the marketplace and apply his decision nationwide,” said ACOG’s Meegan.
Under this situation, the FDA could appeal to the US Court of Appeals for the Fifth Circuit and request a stay on the judge’s ruling. This would allow mifepristone to stay on the market, at least temporarily, Meegan said.
ADF has also asked the judge to suspend the use of misoprostol in medication abortion. Parmet said Kacsmaryk could broadly invoke the Comstock Act, which prohibits the mailing of items designed to produce an abortion.
But an assistant US attorney general in the Justice Department’s Office of Legal Counsel said in a Dec. 23 memo that federal law doesn’t prohibit the US Postal Service from mailing and delivering mifepristone or misoprostol, in part because the drugs could be used for other purposes, like miscarriage management.
The Fifth Circuit appeals court is widely considered to be one of the most conservative in the country. Twelve of the court’s 16 active judges are Republicans, according to the Federal Judiciary Center, six of which were appointed by former President Donald Trump.
Also from the Fifth Circuit: Supreme Court Justice Samuel Alito, who authored the Dobbs decision that removed a federal right to abortion.
Attorneys say the case could make its way to the Supreme Court, though a Dobbs-like outcome isn’t a guarantee.
“The merits here are so poor and the implications for broader food and drug law are potentially big enough that you may be able to convince the Fifth Circuit and hopefully the Supreme Court that this is a bridge too far,” Donley said.
The case is Alliance for Hippocratic Medicine v. FDA, N.D. Tex., No. 2:22-cv-00223.
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