Fact Check: Was the FDA 'required' to approve the new generic abortion pill?

At the end of September, the FDA approved another generic manufacturer's abortion pill — and in the outrage that followed, Health and Human Services Secretary Robert F. Kennedy, Jr. (RFK) claimed the FDA was required by law to approve it. He stated on X, “@US_FDA only approved a second generic mifepristone tablet because federal law requires approval when an application proves the generic is identical to the brand-name drug.”

But is this claim accurate?

Key Takeaways:

• When the FDA approved another company's generic abortion pill, HHS Secretary Robert F. Kennedy Jr. claimed the FDA was required by law to do so.

• The FDA has failed to follow certain time-limit guidelines for drug approval, and they did so in this case as well, with the abortion drug under review for four years instead of the required 180-day limit.

• There are avenues for the denial of a drug application, including for reasons of safety and efficacy.

The Details:

180-Day Response Debunked 

The U.S. Code states the FDA must respond to generic drug applications within 180 days. Cases such as Mylan Pharmaceuticals Inc. v. Thompson and In Re Barr Laboratories reveal how this deadline is not strictly enforced and the courts very rarely order the FDA to “reorder their priorities.” 

The FDA’s 180-day timeline for this generic abortion pill filled by Evita Solutions expired on March 30, 2022, under the Biden Administration. Evita Solutions filed their application on October 1, 2021. This new abbreviated drug application has been under review for four years – well past its due date.

The United States Government Accountability Office reports show the average time for the FDA abbreviated drug approval process in 2015 was 14 months (426 days) – over the 180-day statute. The FDA often adheres to their own timeline in the drug approval process that is not in line with the 180- day statute.

In the case of the Evita Solutions generic abortion pill application, the 180- day statute was disregarded by the FDA.  

Automatic Approval Claims Debunked 

RFK claims that he must approve the generic abortion pill because “federal law requires approval when an application proves the generic is identical to the brand-name drug.” However,  U.S. Code 21 U.S.C. § 355(j)(4)(H)–(K) (2021) offers avenues for the Secretary to deny the application including safety and efficacy reasons. 

RFK admitted to having safety concerns surrounding the abortion pill on X: “Last month, I joined @DrMakaryFDA in writing to state attorneys general, pledging to review all the evidence — including real-world outcomes — on the safety of this drug. Recent studies already point to serious risks when mifepristone is used without proper medical oversight” (emphasis added). 

Further, the U.S. Code states that RFK may deny the generic drug application if “the application contains an untrue statement of material fact.” The Evita Solutions FDA documents declare that “no causal relationship between [m]ifepristone Tablets, 200 mg and misoprostol use and an increased risk of infection or death has been established.” This statement fails to account for the vast number of innocent victims (nearly 650,000 in 2023 alone), whose deaths were a direct result of the drug. 

Why It Matters:

RFK has the legal authority to remove both Mifeprex and the generic mifepristone tablet for two reasons: (1) safety or efficacy, and (2) any false statements of material fact. The abortion pill is not safe for women or the lives of their babies.

Research reveals that anywhere from 11-12% percent of women experience serious adverse events after taking the abortion pill, and all forms of mifepristone, including generics, are meant to end the life of the baby in the womb. 

The Bottom Line:

Approving the generic abortion pill was not mandatory. It was a choice.