I am appalled that this subject needs to be addressed.
The US Food and Drug Administration (FDA) isn’t perfect, but it is still the global gold standard for evaluating medicines for safety and effectiveness. The FDA, though not quite recovered from the self-inflicted damage caused by the Aduhelm® approval mess, is staffed by scientists who have done an admirable job of navigating the question of which drugs should be prescribed in the US. Who wants the judicial system deciding which medicines are safe and effective? No one. That’s right. Not a single thinking person would believe that the science-centric approach for evaluating pharmaceuticals, complex and otherwise, should be the purview of judges at any level of the system.
Texas District Court Judge Matthew Kacsmaryk’s ruling that mifepristone should be withdrawn from the market attempted to thinly mask the real basis for the action: his antiabortion leanings. His line of reasoning in overturning FDA’s decision in approving the drug 23 years ago on the basis of safety and effectiveness is absurd, possibly laughable.
As further evidence of the judiciary’s inability to (1) review this on a scientific basis and (2) comprehend the potentially vast implications of such an action, a federal appeals court preliminarily ruled that, without fully evaluating the safety evidence, the FDA “cannot deny that serious complications from mifepristone.” It pointed to the agreement that patients must sign before receiving it that use of the drug has risks. The New York Times reported that “the court also said that the FDA was incorrect in saying that mifepristone was comparable in safety to ibuprofen. ‘FDA’s own documents show that mifepristone bears no resemblance to ibuprofen,’ the court said.” What? Any healthcare professional will tell you that ibuprofen, when taken chronically and under certain conditions, can cause gastrointestinal bleeding, leading to serious health consequences. Does that mean it should be taken off the market, as well? The court is willing to conflate the experience of mifepristone, which is most often taken in combination with misoprostol, with that of ibuprofen, an analgesic.
Pending a full review by the Appeals Court (two judges appointed by the Trump administration and one by the Bush administration), this issue will likely be escalated to the Supreme Court. If the Appeals Court decides to uphold the Texas judge’s action, it will deal the FDA, the drug industry, and separation of powers a crippling blow.
If the Appeals Court decides to not trample the FDA’s authority, despite the Supreme Court’s recent Dobbs ruling, it should decline to entertain the appeal. The Supreme Court is already facing a crisis of credibility and confidence, and undermining the FDA, whose authority was formally established by an Act of Congress in 1962. Essentially, Congress has passed legislation saying that the FDA is the only entity qualified to make such decisions.
The Court would not question the overall constitutionality of the FD&C Act. Chief Justice John Roberts has long favored narrow rulings to avoid upsetting major legislation. There can be no narrow ruling if the decision to order the withdrawal of a drug is based on something other than scientific rigor. We all have preconceptions of how some of the justices would vote given the opportunity. Are they considering the wider implications? They had better.
The drug industry has reacted with apprehension, justifiably. What other FDA decision could be challenged in court if mifepristone is taken off the market? The only ones who benefit in that case are the lawyers.