Delia A. Deschaine, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg Health Law & Business, in “Doctors Seek Clarity from FDA as States Stockpile Abortion Pills,” by Celine Castronuovo. (Read the full version – subscription required.)
Following is an excerpt:
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. …
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 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.
Related reading:
Bloomberg Law, “Abortion Pill Prescribers Are Uncertain with New Court Order,” by Celine Castronuovo. (Read the full version – subscription required.)
