FDA Embroiled in Reproductive Rights Debate

State laws imposing strict curbs on surgical abortions have put FDA in the center of the debate on access to medicated abortion and morning-after pills and even to widely used contraceptives. A possible change in leadership on Capitol Hill has aggravated fears of political push-back on FDA regulation and approval of such treatments, as well as policies that could block prescriptions to medicines that treat a range of conditions that could affect maternal health and broader disease treatment.

A prime target of reformers is to limit patient access to the abortion pill, mifepristone, which is approved by FDA for use in the first 10 weeks of pregnancy, together with a second readily available pill misoprostol. Although the Justice Department has said it will take action against states that ban use of the medicine, the federal government may have limited authority to oppose such local actions. In addition, some analysts anticipate that abortion opponents will bring multiple legal challenges to FDA’s authority to approve medicated abortion pills, an issue likely to end up before the Supreme Court.

Meanwhile, FDA has raised alarms over the rise in rogue online pharmacies offering often bogus or dangerous “abortion pills.” Such operations have multiplied since the Supreme Court decision in June limiting abortion rights, which has sent demand for abortion medications soaring. Adding fuel to the fire is the move by some legitimate vendors and healthcare providers to give these pills to people before they become pregnant. Online telemedicine provider Choix Health and some physicians offer “advance provision” of mifepristone so that patients can be prepared to perform an abortion when needed. FDA, however, has objected to the practice, maintaining that a medical professional should be consulted to determine pregnancy status.

At the same time, FDA is under pressure from leading physicians and abortion advocates to remove all restrictions on how mifepristone is prescribed and used to make it more accessible to patients. FDA initially required that patients see a certified doctor to obtain the abortion pill as part of a Risk Evaluation and Mitigation Strategy (REMS) adopted for the treatment. During the pandemic, FDA temporarily permitted doctors to conduct examinations and prescribe mifepristone via telemedicine, a policy that is still in force but open to restoration of the earlier restriction. However, agency officials are wary that a move by FDA to make permanent its telemedicine consult policy is sure to draw protests from abortion opponents and could jeopardize further access to the pills, which have become more vital at a time of spreading curbs on abortions in any form.

Birth control controversies

Even though all patients are supposed to have no-cost access to birth control pills under the Affordable Care Act (ACA), some health plans and formularies have set co-pays and cost-sharing requirements for many products that threatens to limit availability of needed treatments. A report on Barriers to Birth Control issued in October 2022 by the House Committee on Oversight and Reform cites widespread restrictions on multiple contraceptive products, based on data from leading health insurers and pharmacy benefit managers.

One response from women’s health advocates is for birth control pills to become available without prescription, and several manufacturers have expressed interest in developing such products. However, an anticipated approval has been delayed, as FDA recently postponed an advisory committee meeting scheduled for November to review a requested Rx-to-OTC switch for the progestin-only birth control pill Opill made by Perrigo subsidiary HRA Pharma. The HRA pill has been available by prescription since its approval in 1973, providing ample safety and efficacy data. FDA said it wanted to review additional information and left open when it would reschedule the committee discussion of what would be the first non-prescription daily birth control pill. Such a switch is sure to ignite disputes between advocates seeking easier and less costly access to birth control, and opponents claiming that a physician must review the health status of any woman seeking to use the pill.

About the author

Jill Wechsler is Washington editor for BioPharm International.