Anti-abortion groups file suit against FDA in Texas, demands agency revoke approval for abortion pill
Abortion opponents sued FDA in federal court on Friday in a bid to have the agency reverse its approval of mifepristone, a drug approved more than two decades ago and used in medication-induced abortions.
Alliance Defending Freedom, a conservative legal advocacy group that has been involved in past anti-abortion lawsuits, filed the suit in the Northern District of Texas federal court Friday on behalf of four anti-abortion medical groups — the umbrella group Alliance for Hippocratic Medicine, alongside three of its member groups: American Association of Pro-Life Obstetricians and Gynecologists, American College of Pediatricians, and the Christian Medical & Dental Associations. Plaintiffs also included four doctors that had treated patients with the drug: Shaun Jester, Regina Frost-Clark, Tyler Johnson and George Delgado.
Defendants directed in the suit include FDA commissioner Robert Califf, deputy commissioner Janet Woodcock, CDER director Patrizia Cavazzoni and Xavier Becerra in his official capacity as head of HHS.
In the 113-page complaint, the suit claims that the FDA lacked the authority to approve the drug, did not adequately study the medication and that the drug is unsafe. Mifepristone is a frequently used drug, with the majority of abortions in the US conducted using the drug. The FDA and other health experts have made clear that it’s safe.
The suit also added, “the FDA failed America’s women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States. And it has continued to fail them by repeatedly removing even the most basic precautionary requirements associated with their use.”
Attorneys highlighted six certain “agency actions” that the federal regulator took to deregulate chemical abortion drugs over the course of three decades — and the suit is asking that the court holds those unlawful and vacate those actions. So far, those include:
- The initial approval of mifepristone was in 2000. The lawsuit claims that the only way the FDA could have gotten it approved is by declaring pregnancy an “illness” in order to use the accelerated drug approval pathway
- A petition denial in 2016. The FDA rejected a petition from two plaintiffs in 2016 to withdraw its approval of chemical abortion drugs. The attorneys argued that the petition explained how the agency violated federal law by approving said drugs
- A “major changes” amendment also in 2016, allowing patients to take the drug at seven weeks gestation instead of 10 weeks, for example
- a 2019 ANDA approval of generic mifepristone
- a 2021 non-enforcement by FDA leadership to stop enforcing in-person dispensing of mifepristone and temporarily allow mail-order chemical abortions during the Covid-19 pandemic, and
- a 2021 petition response. The FDA rejected a petition from two plaintiffs that had to ask the FDA to restore and strengthen a pre-2016 drug regimen for chemical abortion drugs.
It’s worth noting that only two of the plaintiffs are located in Texas — the umbrella group and Shaun Jester. The rest are located or headquartered in states such as Florida, Tennessee, California, Indiana and Michigan.
Law professor Greer Donley told Endpoints News that from her perspective, the lawsuit is fairly frivolous.
The claims essentially are that the FDA abused its power by using the subpart H authority to approve mifepristone, and that that was evidence that the agency had acted leniently. But the reality is that the agency used subpart H so that it could regulate the product much more strictly than any other product it approves, so that it could impose what we call like post-approval restrictions on the distribution of mifepristone. And so this was the only way the FDA could do that before the REMS Statute came about in 2007…
I think that the fact that the plaintiffs in this lawsuit are trying to use that subpart H authority as evidence of leniency is ironic, because, you know, the agency really used that authority so that it could try to be very conservative and really limit the distribution of this very safe medication.
FDA told Endpoints that the agency does not comment on possible, pending or ongoing litigation.