On November 18, 2022, the Alliance Defending Freedom (“ADF”), a conservative legal group, filed a motion with the federal district court in the Northern District of Texas against the U.S. Food and Drug Administration (“FDA”) to withdraw approval of Mifepristone, an FDA-approved drug used to end pregnancies in the first trimester.[1]  While this case addresses access to a single product and was prompted by abortion opponents’ efforts to eliminate access to medication abortion, a loss for FDA in this case could have far broader implications.

In its legal filings, ADF claimed that the FDA used accelerated approval regulations to improperly characterize pregnancy as an illness, and that those regulations were only meant to apply to drugs that “are intended to treat serious or life-threatening illnesses” and provide a substantial benefit over existing treatments. The lawsuit has sparked concern by both industry and the FDA. In a court filing dated January 13th, attorneys for both the Department of Health and Human Services (“DHHS”) and FDA cautioned that an order granting ADF’s motion to halt distribution of FDA-approved mifepristone would improperly undo a “longstanding scientific determination based on speculative allegations of harm.” The parties also voiced concerns that granting ADF’s motion would “upend the status quo and the reliance interests of patients and doctors who depend on mifepristone, as well as businesses involved with mifepristone distribution.”

The manufacturer for Mifeprex, the brand-name version of Mifepristone, Danco Laboratories, also filed a motion on January 13th to intervene in ADF’s lawsuit. The manufacturer argued that a decision in favor of ADF would deprive the company of “the federal agency approval that has guaranteed public access to Mifeprex for more than two decades.”

Since its approval in 2000, Mifepristone has been subject to a risk evaluation and mitigation strategy (“REMS”), a drug safety program that allows the FDA to ensure the benefits of a drug outweigh its risks. The American College of Obstetrics and Gynecology has long defended the safety of Mifepristone for use in terminating early pregnancies, and as of 2021, the abortion pill use has accounted for 54% of all U.S. abortions, according to the Guttmacher Institute.[2] Additionally, a 2008 Government Accountability Office (“GAO”) report[3] on FDA’s approval and oversight of Mifeprex found that the agency properly used its Subpart H authority for accelerated approval to impose dispensing restrictions on the medication to defend its safety, and supported FDA’s argument that “the termination of unwanted pregnancy is a serious condition, and that the drug provided a meaningful therapeutic benefit over existing therapies by allowing patient to avoid the procedure required with surgical termination of pregnancy.”

Should the Court decide in favor of ADF, overturning the FDA’s accelerated approval of Mifeprex, the effects may go far beyond limiting access to medication abortion. FDA’s accelerated approval program was developed in 1992 with the intention of allowing for the expedited approval of drugs that treat serious conditions that “fill an unmet medical need”. Twenty years later, Congress codified the pathway in the FDA Safety and Innovation Act (“FDASIA”)[4]. The accelerated approval program provides for approval of a drug based on a surrogate endpoint that is “reasonably likely” to predict a drug’s intended clinical benefit. Applicants must conduct post-marketing studies to confirm the anticipated clinical benefit of the drug. If the confirmatory trial confirms the clinical benefit of the drug, FDA will grant the drug traditional approval. If the studies do not confirm its clinical benefit or identify additional risks associated with the drug, then the drug’s approval may be withdrawn.[5]

Compared to traditional approval, the accelerated approval pathway has brought therapies to market several years sooner. In a review of accelerated approval drugs approved between 1992 and 2016, the Institute for Clinical and Economic Review found that 125 (49.4%) of all drugs receiving accelerated approvals have gone on to receive full approval, with a median time to full approval of 3.2 years[6] and many others have confirmatory studies ongoing. Over half of these approvals have been for oncology indications.[7] If the Court decides in favor of ADF, that decision would represent an unprecedented substitution of the Court’s judgment for FDA’s.  In its opposition to ADF’s motion for a preliminary injunction, the government pointed out that it could not identify any other instance in which a Court had rejected FDA’s safety and efficacy determination to order a product’s withdrawal. By creating a precedent for overturning FDA’s approval decision, a decision for the plaintiffs could put the approval of other FDA-approved products at risk.

While policy-related and political objectives have had a substantial impact on judicial decisions relating to abortion access in the wake of Dobbs v. Jackson Women’s Health Organization, this case may have implications that extend beyond the restriction of abortion care to challenge the authority and power of regulatory agencies more broadly. Allowing interested parties to challenge the regulatory authority of the FDA over the drug approval process would set a dangerous precedent with potentially widespread repercussions for the entire industry.  In what may be the beginning of a wave of similar cases, a manufacturer of the generic version of Mifepristone, GenBioPro, took the offensive, filing its own lawsuit this week in federal court in West Virginia to challenge newly-passed state laws banning abortions at any stage of pregnancy, thereby restricting the use of its drug, which was approved under FDA’s regulatory authority.[8] In addition to manufacturers, medical professionals are pushing back as well. This week in North Carolina, an obstetrician-gynecologist sued state officials challenging the state’s limitations on dispensing and prescribing Mifepristone, including an in-person dispensing requirement and a mandatory 72 hour waiting period, arguing that the requirements go beyond measures approved by FDA for safe use of the drug and run afoul of the federal authority of the FDA. The state laws at issue require that Mifepristone be taken in the presence of a physician, who must first provide state-mandated counseling to the patient before waiting 72 hours before administering the medication.[9] For additional resources on these topics, please see Epstein Becker Green’s From Roe to Dobbs additional resources.

[1] Alliance for Hippocratic Medicine et al v. U.S. Food and Drug Administration et al, CV #2:22-CV-00223-Z, N.D. Tex. (Nov. 18, 2022).

[2] Jones et al, Medication Abortion Now Accounts for More than Half of All US Abortions, Guttmacher Institute (December 1, 2022), https://www.guttmacher.org/article/2022/02/medication-abortion-now-accounts-more-half-all-us-abortions.

[3] Report to Congressional Requesters, Approval and Oversight of the Drug Mifeprex, U.S. Government Accountability Office (August 2008), https://www.gao.gov/assets/gao-08-751.pdf.

[4] 21 CFR Subpart H.

[5] 21 CFR 314.530.

[6] Kaltenboeck et al, Strengthening the Accelerated Approval Pathway: An Analysis of Potential Policy Reforms and their Impact on Uncertainty, Access, Innovation, and Costs,  Institute for Clinical and Economic Review (April 26, 2021), https://icer.org/wp-content/uploads/2021/04/Strengthening-the-Accelerated-Approval-Pathway-_-ICER-White-Paper-_-April-2021.pdf.

[7] Id.

[8] GenBioPro, Inc. v. Sorsaia et al, No. 3:23-cv-00058, S.D. W.Va. (Jan. 25, 2023).

[9] Bryant v. Stein et al, No. 1:23-cv-00077, M.D.N.C, (Jan. 25, 2023).

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