4/17/23
In a preliminary injunction this month, a federal judge in Texas suspended the Food and Drug Administration’s (FDA) approval of mifepristone, one drug in a regimen used for medication abortion in the first ten weeks of pregnancy. As a direct response, a federal judge in Washington filed an opposing preliminary injunction less than an hour later, barring the FDA from changing the availability of mifepristone. This week, the Texas ruling passed the US Court of Appeals in the Fifth Circuit. While the Court of Appeals did not uphold the Texas injunction, they did limit mifepristone treatment access. Until the Department of Justice appeals the case to the Supreme Court, patients with pregnancies up to seven weeks rather than ten weeks can access treatment, which cannot be sent by mail. This judicial back-and-forth comes less than a year after the Dobbs ruling, where the Supreme Court overturned Roe v. Wade, such that access to abortion is no longer a federally protected right. Several states have already outlawed abortion, but if the Texas ruling is upheld, it could be difficult to access mifepristone even in states where abortion is legal. Medication abortion accounts for a majority of all US abortions, so restriction of mifepristone would significantly limit options for those seeking legal abortions.
While the FDA is not infallible, it is critical to acknowledge its history and approval process, especially regarding mifepristone. Since the Kefauver-Harris Amendment of 1962, the FDA has required new drug applicants to demonstrate patient safety and efficacy for approval. Approval requires preclinical animal testing and three phases of human testing to develop toxicity and dosage profiles for a drug. When a drug is approved, it has already been tested on thousands of patients. Part of the argument against mifepristone’s approval was due to its accelerated approval process in 2000, implying that the FDA did not perform an adequately thorough review. However, the FDA did not invoke accelerated approval. Instead, they used the policy to implement further postmarket restrictions on the drug. Mifepristone is subject to a Risk Evaluation and Mitigation Strategy (REMS), which requires a certified prescriber and supervision. Ultimately, the FDA remains adamant that no part of mifepristone’s approval was accelerated, and an extensive review of data shows the effectiveness of the treatment outweighs the risks.
Beyond patient access to abortion, the Texas ruling could change the regulatory power of the FDA. This case is the first time a court has overturned an approved drug despite direct opposition from the FDA. While the Court of Appeals did not wholly agree with this ruling, it still modified the use and access for mifepristone without any FDA recommendation. Depending on the Supreme Court’s ruling, this could set a new precedent where courts could unapprove other drugs without consultation. Medication abortion is not the only therapeutic held in contention: vaccines, opioids, and gender-affirming treatments have also become political talking points in recent years. Days after the Texas ruling, over 400 drug company executives signed a memo protesting the injunction, criticizing the decision for ignoring extensive safety and efficacy data. As the memo states, drug discovery is an inherently risky endeavor. Under 10% of drugs receive approval, excluding the number of candidate drugs eliminated during preclinical testing. The average cost to develop a single therapeutic is $2.3 billion. Additionally, the FDA already has an involved recall system if products have quality or labeling issues while on the market. With careers and lives at stake, introducing an unpredictable and biased factor into the FDA approval process would significantly disrupt the industry.
Overall, many of the people who are against mifepristone are against the idea of abortion through any means. While politicians and their constituents may hold moral objections towards abortion, their objections are not issues of science, data, or safety related to FDA approval. The incumbent president appoints federal judges, who are then expected to align with the views of the president’s party. Thus, granting courts from either party the independent power to reverse FDA decisions directly inserts partisan political influence into an area requiring objective analysis. Of course, the government is expected to protect citizens’ medical safety and well-being, but the FDA has fulfilled this role for over 60 years without judicial opposition.