Anti-abortion groups sue FDA in Texas, demand agency revoke abortion pill approval – Endpoints News


Abortion opponents sued the FDA in federal court on Friday seeking to overturn the approval of mifepristone, a drug approved more than two decades ago and used in medical abortions.

Alliance Defending Freedom, a conservative legal defense group that has been involved in previous anti-abortion lawsuits, filed the lawsuit in federal court for the Northern District of Texas on Friday on behalf of four anti-abortion medical groups — the group of the Alliance for Hippocratic Medicine, along with three of its member groups: the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, and the Christian Medical & Dental Associations. The plaintiffs also included four doctors who had treated patients with the drug: Shaun Jester, Regina Frost-Clark, Tyler Johnson and George Delgado.

Defendants headed in the lawsuit 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 lawsuit claims that the FDA lacked the authority to approve the drug, did not study the drug adequately, and that the drug is unsafe. Mifepristone is a frequently used drug, with the majority of abortions in the United States being performed using this drug. The FDA and other health experts have clearly stated that it is safe.

The lawsuit also added, “The FDA failed American women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States. And it continued to fail them by repeatedly removing even the most basic precautionary requirements associated with their use.

Lawyers point to six certain ‘agency actions’ the federal regulator has taken to deregulate chemical abortion drugs over three decades – and the suit is asking the court to declare those actions illegal and strike those actions down. shares. So far these include:

  • Mifepristone’s initial approval dates back to 2000. The lawsuit claims the only way the FDA can get it is to declare the pregnancy a “disease” in order to use the expedited drug approval pathway.
  • A petition denial in 2016. The FDA denied a petition by two plaintiffs in 2016 to withdraw its approval of chemical abortifacient drugs. Lawyers 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 non-enforcement in 2021 by FDA management to cease enforcing in-person distribution of mifepristone and temporarily allow chemical mail-order abortions during the Covid-19 pandemic, and
  • a response to the 2021 petition. The FDA denied a motion by two plaintiffs to ask the FDA to restore and strengthen a pre-2016 drug regimen for chemical abortifacient drugs.

It should be noted that only two of the plaintiffs are located in Texas – the umbrella group and Shaun Jester. The others are located or are headquartered in states such as Florida, Tennessee, California, Indiana and Michigan.

Law professor Greer Donley said Terminal news that from his point of view, the trial is quite frivolous.

By Donley:

The allegations are essentially that the FDA abused its power by using Subpart H authority to approve mifepristone, and that was evidence that the agency acted leniently. But the reality is that the agency used subpart H so that they could regulate the product much more strictly than any other product that they approve, so that they could impose what we call post-approval restrictions on distribution of mifepristone. And so that was the only way for the FDA to do that before the REMS statute came into effect in 2007…

I think 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 to be able to try to be very conservative and really limiting the distribution of this very safe drug.

The FDA told Endpoints that the agency does not comment on possible, pending or ongoing litigation.


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