For 26 years, the U.S. Food and Drug Administration has delayed safety reviews for the dangerous chemical abortion drug mifepristone and defied every attempt to subject the drug to normal medical scrutiny. Still, the FDA claims, as it recently told the 5th Circuit during oral arguments in Louisiana v. FDA, pro-life states such as Louisiana lack standing to sue the agency over its chemical abortion regulations. The FDA wants further to delay scrutiny of its politicized chemical abortion regime.
Louisiana is challenging the FDA’s 2021 mifepristone Risk Evaluation and Mitigation Strategy change, which scaled back the drug’s safety protocols to allow abortionists to deliver mifepristone via the mail. Under these REMS, abortionists are facilitating illegal abortions by mailing these drugs into pro-life states, including Louisiana.
Initially, the FDA’s mifepristone REMS required women to visit the doctor three times, limited prescriptions to women who were less than seven weeks pregnant, required abortionists to report all adverse events, and required the drug to be dispensed in person.
In 2016, the Obama FDA amended the REMS to require only one visit to the doctor, allowed prescriptions for women up to 10 weeks pregnant, and only required abortionists to report fatal adverse events. In 2021, the FDA removed the in-person dispensing requirements entirely.
Because of the FDA’s weakened protections, Rosalie Markezich, a Louisiana woman who wanted to keep and raise her baby, was forced by her boyfriend to take mifepristone, killing the baby. Her boyfriend received the drugs by mail from a California abortionist.
Had the FDA maintained its in-person dispensing requirements, Rosalie’s child would likely be alive. Yet, during oral arguments, the FDA denied any responsibility for Rosalie’s injury or for impairing Louisiana’s ability to enforce its laws. According to the FDA, the shield laws that protect the abortionists from prosecution cause the harm, not the FDA’s decision to allow the mailing of mifepristone.
Danco, a mifepristone manufacturer, joined the Louisiana case and told the 5th Circuit that Louisiana cannot seek relief in court because it has not exhausted all avenues for relief directly from the FDA. According to Danco, Louisiana must first file a petition with the FDA and be unsuccessful. Further, the mifepristone manufacturer argued that such a petition would not necessarily have been futile or doomed to fail. Both of these claims stretch credulity.
First, when two pro-life associations of medical professionals filed a citizen petition in 2002 challenging mifepristone’s approval, the FDA did not respond for 14 years.
When the medical associations filed a lawsuit, Alliance for Hippocratic Medicine v. FDA, the district court recognized that “even though the law requires an agency response within ‘180 days or receipt of the petition’ … FDA waited 4,971 days to adjudicate Plaintiff’s first petition and 994 days to adjudicate the second.”
Second, Danco’s claim that another petition would not be futile is contrary to the evidence. Why should the court believe that the FDA would grant relief for harm that it denies any involvement in causing? Why should the court believe that the FDA will comply with or even respond to a citizen petition when the FDA took 14 years to reject a previous petition and has ignored a congressional request for information for decades? The FDA has only now begun producing the documents that Congress requested because of a Freedom of Information Act lawsuit brought by Advancing American Freedom and Judicial Watch.
For a year and a half, the Department of Health and Human Services and the FDA have promised a review of mifepristone. In the meantime, with no indication of progress on that review, the FDA approved a new generic chemical abortion drug for prescription in the United States. The FDA’s record gives no reason to believe that a new petition would spur the agency to conduct the sort of review it has been stonewalling for years.
As the cliche goes, the definition of insanity is doing the same thing over and over again and expecting different results. The pro-life movement has been through the “hang tight, help is on the way” drill long enough. It’s been on the way for a year and a half.
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In the meantime, many unborn Americans have been killed, and abortionists and pro-abortion states have significantly undermined the constitutional authority of states to protect life recognized by the Supreme Court in Dobbs v. Jackson Women’s Health.
The 5th Circuit ought to put an end to the charade and rule for pro-life states that would protect the unborn since the FDA refuses to do so itself.
J. Marc Wheat is general counsel at Advancing American Freedom. Davison Drumm is a research assistant at Advancing American Freedom.