FDA Drug Regulation Challenged by Anti-Abortion Campaign

The recent Supreme Court decision revoking the legal right to abortion services in the US (Dobbs vs. Jackson Women’s Health Organization) has bolstered efforts in some states to also limit patient access to certain FDA-approved medicines and treatments. A main target is mifepristone (Mifeprex), approved by the agency more than 20 years ago as safe and effective to block progesterone production. When taken in combination with a second drug, misoprostol (Cytotec), in the first 10 weeks of pregnancy, this medical treatment halts a pregnancy.

More than half of abortions in the US are brought about by these medicines, now also available as generics. As more states ban abortion services of all types, a major battle is anticipated over the legality of states blocking access to these drugs. In response, attorney general Merrick Garland recently asserted that “states may not ban mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”¹ Garland stated that the Justice Department is ready to work with lawful authorities to “protect and preserve access to reproductive care.”

FDA approval of mifepristone (also known as RU-486) has been controversial from the start. Manufacturer Danco Laboratories, a small, privately held firm, markets only this one product, which gained FDA approval in 2000 despite strong opposition from right-to-life groups at the time. The agency issued several labeling updates over the years and authorized a generic version from GenBioPro in 2019.² FDA also required Danco to implement a Risk Evaluation and Mitigation Strategy (REMS) that limited prescribing to certain qualified physicians and required in-office administration of the pill.³

However, FDA relaxed the mifepristone REMS requirements in 2021 to permit its prescribing via telemedicine and mail-order delivery of the drug during the pandemic. That added flexibility will be a target when at some point the declared COVID-19 public health emergency ends and abortion foes look to bring back FDA’s earlier prescribing and dispensing limits in all states.

Meanwhile, with more than 25 states banning abortions completely or moving to adopt such policies, efforts already have intensified to limit access to mifepristone more broadly. Biden administration officials have contested such moves, and manufacturers such as GenBioPro has challenged a Mississippi law that blocks telehealth access to mifepristone.⁴ Reproductive health advocacy groups also are establishing systems to assist women in states that ban all abortions to obtain access to these treatments. The campaign against medication abortions will only intensify, though, as more states enact laws specifically blocking physicians from prescribing the medicine, as proposed recently in Texas.

Curbs for Plan B and cancer treatment

A similar confrontation is emerging over access to the “morning after” emergency contraception pill, Plan B One Step, and several additional brands. Those drugs, which are not considered abortifacients, are approved to prevent pregnancy when taken within three days of unprotected sex and are available in pharmacies without a prescription. There was a notable spike in demand for these pills following the Supreme Court decision, as many patients looked to stock up on what they feared would become a banned product. While morning-after pills work by blocking ovulation for several days, abortion opponents claim that the pills also prevent egg implantation and thus should be restricted as causing early abortions.

Also facing the healthcare community are related challenges to widely used contraceptives by staunch right-to-life advocates. Justice Clarence Thomas spotlighted the issue in releasing an opinion in the Dobbs case urging the Supreme Court to “reconsider” past rulings on right to contraception and other practices seen to undermine family relationships. Such proposals may have the added impact of heading off efforts to gain FDA approval of non-prescription status for birth control pills and to strengthen requirements for health insurers to cover contraceptives without added cost-sharing.

An equally taxing issue for medical professionals is the possibility that certain approved drugs for cancer or other serious conditions may harm the fetus or cause a miscarriage when needed to treat a pregnant woman, raising the potential for prosecution under strict abortion bans. The American Association for Cancer Research (AACR) recently raised concerns that state legislative actions could limit access to cancer care for patients diagnosed during pregnancy, even to protect the life of the mother. AACR fears that critical care could be denied to patients in certain states where it might also jeopardize development of the fetus.⁵

The legal battle over the right of states to ban access to FDA approved drugs is slated to escalate, with more than 20 states planning or already enforcing limits on mifepristone prescribing and use. To avoid taking action that could be challenged in the courts, some states with strong anti-abortion laws may move to curb the use of a drug to induce an abortion, but not impose an outright ban on products approved by FDA.

References

1. https://www.justice.gov/opa/pr/attorney-general-merrick-b-garland-statement-supreme-court-ruling-dobbs-v-jackson-women-s
2. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/mifeprex-mifepristone-information
3. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifeprex
4. https://www.liveaction.org/news/wp-content/uploads/2022/03/Letter-gov.uscourts.mssd_.109735.18.0.pdf
5. https://www.aacr.org/about-the-aacr/newsroom/news-releases/aacr-statement-on-the-recent-u-s-supreme-court-decision-in-the-dobbs-v-jackson-womens-health-organization-case/