FDA Drug Regulation Challenged by Anti-Abortion Campaign

The recent Supreme Court ruling that repeals the legal right to abortion services in the U.S. (Dobbs vs. Jackson Women’s Health Organization) has strengthened efforts in some states to also restrict patient access to certain FDA-approved medications and treatments. A major target is mifepristone (Mifeprex), which was approved by the FDA more than 20 years ago as a safe and effective way to block progesterone production. When taken in combination with a second drug, misoprostol (Cytotec), in the first 10 weeks of pregnancy, this medical treatment stops a pregnancy.

More than half of abortions in the US are caused by these drugs, which are now also available as generic drugs. As more states ban abortion services of all kinds, a major battle is expected over the legality of states blocking access to these FDA-approved drugs. In response, Attorney General Merrick Garland recently claimed that states could not ban the drug on the grounds of disagreement with the FDA’s expert opinion. Garland also indicated that the Department of Justice is ready to work with law enforcement agencies 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, private firm, markets only this one product, which received FDA approval in 2000 despite strong opposition from right-to-life groups at the time. The agency has released several label updates over the years and approved a generic version of GenBioPro in 2019. The FDA has also required Danco to implement a risk assessment and mitigation strategy (REMS) that restricts prescribing to certain qualified physicians and that requires the pill in the office.

However, the FDA relaxed the mifepristone REMS requirements in 2021 to allow its prescribing through telemedicine and mail order of the drug during the pandemic. That additional flexibility will be a target when the declared COVID state of emergency ends at some point and abortion enemies want to bring back FDA’s earlier prescribing and dispensing limits in all states.

Meanwhile, with more than 25 states completely banning or moving abortions to adopt such policies, efforts have already intensified to restrict access to mifepristone more widely. Biden administration officials have disputed such moves, and manufacturers like GenBioPro have challenged a Mississippi law blocking telehealth access to mifepristone. Reproductive health advocacy groups are also establishing systems to help women in states that ban all abortions from accessing these treatments. However, the campaign against drug abortions will only increase as more states introduce laws that specifically prevent doctors from prescribing the drug, as recently proposed in Texas.

Curbstones for Plan B and Cancer Treatment

A similar confrontation ensues over access to the “morning-after” emergency contraception pill, Plan B One Step and several additional brands. Those drugs, which are not considered abortion drugs, are approved to prevent pregnancy when taken within three days of unprotected sex and are available without a prescription in pharmacies. There has been a significant increase in demand for these pills after the Supreme Court ruling, as many patients sought to obtain supplies of what they feared would become a banned product. While morning-after pills work by blocking ovulation for a few days, abortion opponents claim that the pills also prevent egg implantation and should therefore be restricted because it causes early abortions.

Even more worrying for the healthcare community are related challenges to widely used contraceptives by loyal right-to-live advocates. Judge Clarence Thomas highlighted the issue by releasing an opinion in the Dobbs case and urging the Supreme Court to “reconsider” previous rulings on the right to contraception and other practices that undermine family relationships. Such proposals could have the additional impact that efforts to obtain FDA approval of non-prescription birth control pills strengthen the requirements for health insurers to cover contraceptives without incurring additional costs.

An equally worrying 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 it is necessary to treat a pregnant woman, which raises the potential for prosecution under strict increase abortion ban. The American Association for Cancer Research (AACR) recently expressed concern that state legislative action could restrict access to cancer care for patients diagnosed during pregnancy, even to protect the life of the mother. AACR fears that critical care may be denied to patients in certain states where it may also jeopardize the development of the fetus.

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

About the author

Jill Wechsler is Washington editor for Pharmaceutical Technology.