Judge’s Ruling to Invalidate Abortion Pill Ruling Could Impact Other FDA-Approved Drugs
On Friday, a federal judge in Texas ruled to invalidate the FDA’s 23-year-old approval of the abortion pill mifepristone in an unprecedented move, says Nicole Huberfeld, Edward R. Utley Professor of Health Law, Bioethics & Human Rights at the BU School of Public Health and a professor at the School of Law. The abortion drug mifepristone is still lawful and available for now, says BU LAW professor, but she calls the ruling “part of the broad strategy to make it nearly impossible to have an abortion in the United States.”
The Unprecedented Challenge to Science
No federal court has ever “second-guessed the science” behind the US Food and Drug Administration’s approval of a medication, says Boston University health law professor Nicole Huberfeld—until now. On Friday, a federal judge in Texas ruled to invalidate the FDA’s 23-year-old approval of the abortion pill mifepristone in a decision that shocked many legal experts. Huberfeld says it was an unprecedented move that calls into question more than just the future of medical abortions. “This is a clear separation-of-powers problem,” she says. “The court—and really, this judge—doesn’t have the expertise to second-guess the FDA in this way.”
Status of Medical Abortion Protocols
The ruling concerns mifepristone, the first of a two-drug protocol for a medical abortion. And while Judge Matthew J. Kacsmaryk’s decision came down on April 7, both drugs typically used during the procedure (the other is misoprostol) are still available throughout the United States. Some states, including Massachusetts, have taken preemptive steps to stock up on the two drugs required for medical abortions. For instance, Governor Maura Healey said Monday that the state put in an order for close to two years’ worth of mifepristone last week.
The following table summarizes the primary medications involved in the case:
| Drug Name | Role and Availability |
| mifepristone | The first of a two-drug protocol; still lawful and available for now. |
| misoprostol | The other drug typically used during the procedure; still available throughout the US. |
Legal Appeals and Contradictory Rulings
Kacsmaryk stayed, or delayed, his order for seven days to give the federal government time to appeal the ruling. That didn’t take long as the Department of Justice immediately filed an intent to appeal, calling the decision “extraordinary and unprecedented.” Just an hour after Judge Kacsmaryk ruled on this case, another federal judge in Washington state issued what seems like a contradictory ruling in a separate case. The decision in Texas is a challenge to the FDA’s original approval of mifepristone 20 years ago, by physicians who would never prescribe it in the first place, whereas the Washington litigation was filed by Democratic attorneys general who wanted to make sure that mifepristone would continue to be available.
Wider Impact on the Pharmaceutical Industry
While for now the target is abortion care, this ruling (if it stands) could reverberate far beyond one drug. Already, more than 400 executives from the pharmaceutical industry have signed on to a statement condemning Kacsmaryk’s ruling, writing that it “creates uncertainty for the entire biopharma industry.”
Regarding the broader implications for medicine, President Joe Biden said that the “court in this case has substituted its judgment for FDA, the expert agency that approves drugs.” Huberfeld adds to this sentiment, stating:
- “They’re right to be alarmed.”
- “You could see the same thing play out in debates over vaccines or other medications.”
- “So, I do think that this is potentially problematic in a number of dimensions.”
If this ruling were to stand, then there will be virtually no prescription, approved by the FDA, that would be safe from these kinds of political, ideological attacks.