The U.S. Food and Drug Administration shouldn’t be blocked from requiring that a drug used to induce abortions must be dispensed in person at a hospital, clinic, or doctor’s office, the agency told a federal court in Maryland.
The in-person dispensing requirement addresses serious health risks associated with mifepristone, one of a two-drug regimen used in medication abortions, the agency said in a brief Wednesday. FDA urged the U.S. District Court for the District of Maryland to deny a motion for a preliminary injunction that would require it to allow women to receive the drug through the mail.
The American College of Obstetricians and Gynecologists and other women’s health-care providers sued FDA in late May, arguing the restriction is unnecessary and increases health risks for patients during the Covid-19 pandemic.
The provider groups lacked standing to bring the lawsuit because their claims are speculative, FDA said. There is no proof patients might contract Covid-19 by leaving their homes to pick up mifepristone at a health-care facility, it said.
Additionally, providers who prescribe mifepristone may not assert their patients’ alleged due process and equal protection rights to access the drug by mail because they lack the type of “close relationship” with their patients that would confer standing on them, FDA said.
The providers’ due process claim isn’t likely to succeed on the merits, because patients have no due process right to use mifepristone to induce an abortion, FDA added. The providers also likely won’t be able to show the requirement “poses a substantial obstacle to a large fraction of women seeking an abortion,” since the drug can be used only in the earliest stage of pregnancy and isn’t appropriate for many women, it said.
The equal protection claim likely will fail as well, because the requirement is reasonably related to protecting patients’ health and safety, FDA said.
ACOG, in a brief also filed Wednesday, opposed 10 states’ request to be allowed to join FDA in defending the suit. The states want to defend laws imposing their own restrictions on the use of mifepristone, ACOG said. Those laws aren’t at issue in this case, it said.
The U.S. Department of Justice represents FDA. Arnold & Porter Kaye Scholer LLP and the American Civil Liberties Union Foundation represent ACOG and the providers.
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The case is Am. Coll. of Obstetricians & Gynecologists v. U.S. Food & Drug Admin., D. Md., No. 20-cv-1320, brief filed 6/10/20.