?Two different federal court rulings on the U.S. Food and Drug Administration’s (FDA’s) longstanding approval of an abortion medication have forged an uncertain future for medication abortion access in the country—the latest fallout from the overturning of Roe v. Wade by the Supreme Court late last year.
U.S. District Judge Matthew Kacsmaryk in Texas rejected the FDA’s approval of mifepristone on April 7, but stopped his ruling from going into effect for a week. The same day, U.S. District Judge Thomas Rice in Washington state concluded the drug should remain available in 17 states and Washington, D.C., preserving the status quo, stating in the decision that a nationwide injunction would be inappropriate.
For now, there are no immediate changes to the legal status of the drug. If the Texas ruling ultimately goes into effect nationwide, it could have huge ramifications for abortion access, employer’s health care costs and insurance plans, including prescription drug formularies. The Biden administration appealed the Texas decision on April 10.
There are many reasons why some employers cover abortion in their health plans, such as to recruit and retain women, to ensure gender equity in their health benefits, or to support reproductive freedom.
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Opposing Rulings
The two court rulings thrust the drug called mifepristone into legal uncertainty. The FDA is in an unparalleled legal bind. The Biden administration has appealed the Texas ruling and ask for the drug’s approval to remain, pending the outcome of the case. The two conflicting rulings could mean fast-tracking the case to the U.S. Supreme Court.
Medication abortion accounts for more than half of all abortions in the country and is used to terminate several hundred thousand pregnancies every year.
(The Washington Post and Quartz)
Drug Safety
Kacsmaryk’s ruling said the FDA failed to appropriately assess the drug’s safety and made a series of legal errors in approving the pill for sale in the U.S. “It is indisputable that chemical abortion drugs are both drugs and are for producing abortion. Therefore, federal criminal law declares they are nonmailable,” the decision stated. It added that “plaintiffs are likely to suffer irreparable harm if the motion is not granted. At least two women died from chemical abortion drugs just last year.”
However, leading medical organizations, such as the American Medical Association and the American College of Obstetricians and Gynecologists, say robust evidence accumulated over years shows the drug is safe and effective.
The Texas case now heads to the New Orleans-based 5th U.S. Circuit Court of Appeals, one of the most conservative appellate courts in the country. Once that court acts on the Biden administration’s stay request, the litigation could land at the U.S. Supreme Court on an emergency basis shortly thereafter.
(The Wall Street Journal and The Washington Post)
Agency Authority
Mifepristone has been widely used in the U.S. since securing FDA approval 23 years ago. Courts have long deferred to the FDA on issues of drug safety and effectiveness. But the agency’s authority faces new challenges in a post-Roe legal environment, in which abortions are banned or unavailable in 14 states, while 16 states have laws specifically targeting abortion medications.
If allowed to stand, the Texas ruling would prohibit mailing mifepristone or selling it at retail stores. Mifepristone is one of two drugs used together for medication abortion in the United States, along with misoprostol.
Retail Pharmacy Sales
The White House is planning to restart discussions with abortion pill manufacturers and U.S. pharmacy chains on ways to push back against efforts to ban mifepristone.
In January, the FDA made a regulatory change that permitted retail pharmacies to sell abortion pills after receiving a prescription from a certified prescriber, but more than a dozen states have passed laws limiting such sales. In 2021, the FDA permanently removed restrictions on mail-order shipping of abortion medication and the ability to prescribe it through telehealth care.
(Reuters and SHRM Online)