FDA Caught in Abortion Battles

As the nation awaits further decisions from the Supreme court on the legality of restricted abortion policies adopted by certain states, FDA has become embroiled in the debate over access to “chemical” or “medication” abortions through the prescribing and distribution of the abortifacient mifepristone. The two-dose treatment to bring on a miscarriage of an early pregnancy was approved by FDA in 2000 with the requirement that patients receive the pill directly from a physician, with administration of the initial dose in the doctors’ office. That physician-dispensing requirement has been contested by reproductive rights groups and state officials since 2017. In 2020, the in-person prescribing and dispensing requirement was lifted as part of efforts to reduce the need for patients to go to healthcare facilities during the pandemic.

Under pressure to determine whether to continue the use of telemedicine and remote office visits for prescribing mifepristone, FDA disclosed on Dec. 16, 2021 that it would retain its more flexible prescribing policy, reflecting the broader adoption of telemedicine by public health programs. In this controversial decision, officials at the Center for Drug Evaluation and Research (CDER) said they would modify the Risk Evaluation and Mitigation Strategy (REMS) for mifepristone to remove the requirement for physicians to physically hand the drug to a patient [see]. However, the agency retained the requirement that patients sign a special form to be prescribed the drug and that clinicians pre-register and receive training under the REMS program. The rationale is that prescribing physicians should be able to date pregnancies accurately and provide any necessary surgical intervention or other treatment if needed.

At his Senate confirmation hearing this week, Robert Califf sidestepped a query on how he would prevent policies that permit abortifacient pills to be casually dispensed to patients, responding that he would rely on FDA staffers to “make good decisions.” Anti-abortion activists already are predicting that Califf will collaborate with Democrats and abortion advocates to speed the drugs to patients through the mail. Conversely, abortion rights groups plan campaigns to better inform patients of the availability of the drugs, their safety, and proper use. In fact, medical abortions have risen in popularity, accounting in 2019 for 44% of pregnancy terminations by women who sought abortions in clinics before 10 weeks of pregnancy, according to data from the Centers for Disease Control and Prevention.

Meanwhile, states are acting on this issue. In October 2021, Texas added to its controversial six-week limit on surgical abortions another law that limits medication abortions to the first seven weeks of pregnancy, even though mifepristone is considered effective for up to 10 weeks after conception. The Texas law also blocks sending the pills through the mail or prescribing the treatment through telemedicine.

About the author

Jill Wechsler is Washington editor for Pharmaceutical Technology.