Lawsuit Challenges States’ Ability to Bar Access to Mifepristone

Questions remain for mail order pharmacies since the Dobbs v. Jackson Women’s Health Organization Supreme Court case was decided in June 2022, which eliminated the constitutional right to abortion.

States have responded to the Dobbs decision in different ways. Some states, like California, New York, and more recently, Illinois, have provided additional protections via statutory changes for providers that assist in medical abortions. For example, Illinois amended the Pharmacy Practice Act to expand protections to pharmacists and technicians, prohibiting discipline solely for providing, recommending, aiding, assisting, or otherwise participating in a health care service if it is not unlawful in the state, regardless of whether the patient was a resident of Illinois.¹ The amendment similarly provides protections against sister state discipline for any violations of another state’s laws if the health care service is not unlawful under Illinois law.¹

Post-Dobbs, other states have enacted more restrictive laws. For example, in September 2022, West Virginia enacted the Unborn Child Protection Act, which prohibits abortions at any stage, with very limited exceptions.² The state already had other laws further restricting the ability for a woman to have an abortion, including a law from the 1800s that makes it a felony resulting in imprisonment for any person other than a licensed medical professional to cause an abortion.³ The term “licensed medical professional” is specifically defined in the law and does not include pharmacists.⁴

As a result of the enactment of the Unborn Child Protection Act, GenBioPro, the manufacturer of the generic form ofthe abortion-inducing drug mifepristone, filed suit in January in federal court challenging the constitutionality of the West Virginia laws.⁵ In its lawsuit, GenBioPro argues that West Virginia state law has severely restricted its ability to provide access to mifepristone and its generic form to West Virginia residents, despite FDA approval of mifepristone and the establishment of a certification process for pharmacies to dispense the medication through a modification to the FDA risk evaluation and mitigation strategy (REMS) program in January 2023. At the heart of the debate between GenBioPro and West Virginia is the preemption of such state laws by federal law, and that when the states ban or drastically restrict FDA-approved mifepristone, those states are imposing policies that interfere and conflict with the FDA’s authority to regulate mifepristone through its REMS program.

At the same time, Attorneys General in 12 states filed suit in federal court in Washington, DC, in February 2023, stating that mifepristone should not even be subject to such a restrictive REMS program.⁶ An additional 6 states joined suit in an amended complaint filed on March 9, 2023. The Attorneys General argue that mifepristone, a medication that has been used approximately 5.6 million times with very low rates of complications and very high rates of efficacy, should not be included in the very limited class of dangerous drugs subject to REMS (e.g., fentanyl and other opioids). This is a relegation by FDA that has been imposed on only 60 of the more than 20,000 FDA-approved prescription drug products (significantly less than 1% of all drugs) marketed in the U.S.

For pharmacies that deliver medications across state lines, challenges remain. Without a constitutional right to abortion, these mail order pharmacy providers need to consider both the federal requirements and various state laws in how they approach the dispensing of mifepristone across state lines. With a flurry of litigation, these pharmacy providers also need to pay close attention to the outcome of these and other pending lawsuits related to the post-Dobbs fallout in weighing the risks of moving forward with the certification process required by the FDA REMS program with compliance with more restrictive state laws, and patient reproductive health.

About the Authors

Jaya White, JD, is Chicago office chair of the Health Law Group at Quarles & Brady LLP, where she represents pharmacies and other clients in the health care industry in regulatory and transactional matters.

Katie Lavigne, JD, is an associate in the firm's Minneapolis office and advises clients on an array of pharmacy regulatory issues.

References

1. Illinois Public Act 102-1117. Accessed March 15, 2023. https://www.ilga.gov/legislation/publicacts/102/102-1117.htm.

2. W. Va. Code Ann. § 16-2R-1 et seq. Accessed March 15, 2023.

3. W. Va. Code Ann. §61-2-8. Accessed March 15, 2023.

4. W. Va. Code Ann. §16-2R-2, citing the West Virginia Medical and Osteopathic Practice Acts, W. Va. Code Ann. §31-3-1 and §30-14-1. Accessed March 15, 2023.

5. GenBioPro, Inc. v. Sorsaia et al. Docket No. 3:23-cv-00058 (S.D. W. Va. January 25, 2023). Accessed March 15, 2023.

6. State of Washington et al v. United States Food and Drug Administration et al. Docket No. 1:23-cv-03026 (E.D. Wash. February 23, 2023). Accessed March 15, 2023.