Doctors Seek Clarity From FDA as States Stockpile Abortion Pills

Medical groups say they’re awaiting clearer guidance from the FDA and courts on the legality of prescribing state supplies of the abortion pill mifepristone, which could have its approval suspended this week.

Massachusetts and Washington have announced plans to stockpile supplies of mifepristone, and New York and California are securing supplies of another drug called misoprostol. The two drugs are used together to terminate early pregnancies.

Attorneys and the drug’s brand-name manufacturer—Danco Laboratories—say that even if the US Court of Appeals for the Fifth Circuit denies the Biden administration’s request for an emergency stay on a Texas federal judge’s mifepristone suspension, this wouldn’t prohibit health providers from prescribing supplies of the drug already available to them.

But some health providers say they don’t believe this protection is guaranteed as of now, and that the uncertainty over nationwide abortion law following last week’s contradictory federal rulings on mifepristone from federal courts in Texas and Washington will only further limit reproductive health access.

Sign up for The Brief, a daily afternoon newsletter showcasing Bloomberg Law’s top stories.

“At this time we still do not know if clinicians will be able to prescribe or dispense mifepristone that is already in pharmacies or other existing supplies,” said Christopher Zahn, the American College of Obstetricians and Gynecologists’ chief of clinical practice and health equity and quality.

“Part of the harm of this ruling, even if the federal government’s appeal is ultimately granted, is the lasting confusion and delays in care it will create for our patients,” Zahn said.

The Biden administration has asked the appeals court to issue an emergency order by Thursday at noon that would block the April 7 ruling from US District Judge Matthew Kacsmaryk in Amarillo. Kacsmaryk’s ruling, which is currently set to go into effect Friday, would temporarily reverse the Food and Drug Administration’s decades-old approval of mifepristone.

The Department of Justice and the lead counsel representing Danco in this case have indicated they would elevate the order to the Supreme Court if the request for an emergency stay is denied.

The FDA also faces a conflicting ruling from Judge Thomas O. Rice of the US District Court for the Eastern District of Washington, who said the FDA can’t change anything about the way it regulates the drug. The Justice Department on April 10 asked Rice for clarification on how the federal government could best comply with this order, given the Texas ruling.

Practice of Medicine

The order from Kacsmaryk, who was appointed by President Donald Trump, would effectively put a hold on the ability of Danco and GenBioPro—the manufacturer of generic mifepristone—to move the drug through interstate commerce, attorneys say.

But the “practice of medicine is regulated at the state level,” said Denise Esposito, former deputy chief counsel for drugs and biological products in the FDA Office of the Chief Counsel.

“It is not a violation of the Federal Food, Drug and Cosmetic Act for a health-care provider to prescribe or administer a drug that is already on the shelves after an approval is suspended,” added Esposito, now co-chair of Covington & Burling LLP’s global Food, Drug, and Device Practice Group.

Susan Lee, a partner in the life sciences group at Goodwin Procter LLP who advises biologic and drug makers on FDA regulations, agreed with this analysis, adding, there’s “a basis for the physicians to continue to dispense and administer the drugs,” even if the existing supply is finite.

This protection could potentially enable prescribers to issue supplies gathered by states like Massachusetts and Washington state. But this security may not be available to pharmacies, Lee said.

“What’s a more difficult question is whether, if pharmacies have a bunch on their shelves, can they continue to just distribute that out after Judge Kacsmaryk’s order goes into effect? And I think the answer to that may be no,” Lee said.

But even for pharmacies, the “FDA, except in the limited circumstance of pharmacy compounding, typically leaves the regulation of those activities to the various states,” said Delia Deschaine, an attorney at Epstein Becker & Green specializing in FDA regulations.

Danco spokesperson Abby Long said the company is “definitely not” concerned about meeting the increase in demand for mifepristone. And while GenBioPro has also seen an uptick in orders, it’s not worried about its ability to supply the drug, a company spokesperson said.

“What we’ve heard is that providers, if they have stock in their clinics or office or wherever they are, then that stock is available for them to use,” Long said.

Clinical Guidance

Some states have offered mifepristone guidance to providers in the wake of the dueling abortion pill rulings, while others are emphasizing a misoprostol-only regimen under the scenario that mifepristone becomes unavailable.

Upon announcing April 10 that Massachusetts would receive and stockpile 15,000 doses of mifepristone, Gov. Maura Healey (D) also issued an executive order declaring that Massachusetts’ 2022 Shield Law—which protects providers and patients from abortion restrictions from other states and extradition requests—also extends to medication abortion.

In response to that order, the Massachusetts Department of Public Health released guidance to licensed physicians, nurses, pharmacists, and other health professionals stating that “it remains lawful” to “continue using, prescribing, dispensing, or administering” mifepristone in the state, “provided that any such use, prescribing, dispensing, or administration is done in accordance with the acceptable standards of care and utilizing sound medical judgment.”

In Washington, “medication abortion remains legal and available,” and the state’s pharmacy commission “has final say over mifepristone distribution within Washington,” said Washington State Department of Health spokesperson Raechel Sims.

In the situation that mifepristone is unavailable, “then a one-drug regimen using misoprostol only is the recommended medication abortion alternative.”

While mifepristone plus misoprostol is the safest and most effective medication abortion option, misoprostol is also highly safe and effective, and is used on its own in other countries where mifepristone isn’t available, according to ACOG.

“Without clear guidance from the FDA on whether the existing mifepristone can be prescribed and dispensed, we recommend the misoprostol-only regimen,” ACOG’s Zahn said.

Some states have already opted to prepare for a misoprostol-only regimen situation. Both California and New York announced stockpiles for that drug, which is officially approved by the FDA to prevent and treat gastric ulcers.

‘Geographic Divide’

The stockpiling of abortion pills has the potential to be a significant tool in preserving access to reproductive care, but Lee also pointed out that these efforts are currently concentrated around the coastal US.

“What about the middle of the country? What about the Mid-Atlantic? It’s really just going to kind of further exacerbate the geographic divide that already exists” with “access to medication abortion,” Lee said.

But in the meantime, it’s essential for providers and patients to remember that as of now, “medication abortion is still available in states where it is legal,” Zahn said.

“Patients do not need to cancel their appointments. Even if mifepristone is not available at the end of this week, the misoprostol-only regimen is still a safe and effective method of medication abortion and miscarriage management,” he added.

—With assistance from Jeannie Baumann