Legal experts have expressed concern that the federal judge’s decision to overturn the FDA’s clearance of the abortion pill mifepristone might have far-reaching implications for the government’s ability to regulate pharmaceutical products in the United States.
A judge in Texas may have made history with his or her decision to consider taking an FDA-approved medicine off the market against the agency’s wishes.
If the preliminary injunction that was imposed on Friday holds up in court, it might pave the way for further cases challenging the approval or regulatory decisions of other pharmaceuticals. Experts say that the pharmaceutical industry’s faith in the F.D.A.’s procedures for producing new pharmaceuticals would be severely tested if the Texas judgement were maintained.
The Food, Drug, and Cosmetic Act of 1938 grants the F.D.A. exclusive jurisdiction over the evaluation of new medications for safety and efficacy. To prove to the FDA that their medicine is safe and effective, pharmaceutical firms must perform several expensive and time-consuming clinical trials on both animals and humans.
Since its inception over a century ago, the federal agency’s scientific knowledge and supervision have been well respected by the judicial system. However, the opioid epidemic, Covid vaccinations, and gender-related therapies are only some of the many examples of how the usage and approval of certain pharmaceuticals have been the subject of political rifts and state-level disagreements.
The question of FDA jurisdiction has been brought to the forefront as never before by the Texas verdict and a contrary finding by another federal court in a different case in Washington State on the same day. The subject is now very guaranteed to reach the Supreme Court.
There has been no public statement from the pharmaceutical industry’s strong lobbying arm about the Texas verdict or any indication that it would submit briefs in favour of the F.D.A. Priscilla VanderVeer, vice president of public relations for PhRMA, agreed with others that the F.D.A. is the gold standard when it comes to medication approvals, saying as much in a statement.
Mifepristone is the first of two pills used to induce an abortion. The second medicine at issue in the Texas complaint is misoprostol, which is FDA-approved for various ailments but is used off-label for abortion. Pfizer, which produces a tiny fraction of the misoprostol marketed in the United States, has said that it does not endorse the off-label use of any of its drugs and has refused to comment on whether or not it would file a brief in court in favour of the F.D.A.
However, “the agency serves a critical role in the U.S. public health system,” she said, “bringing new medicines to patients and conducting ongoing safety reviews that support the continued use of them.”
The lawsuits argue that federal law, in this case Congress’s authorization of the F.D.A. to regulate drugs like mifepristone, takes precedence over conflicting state law. This is because the commerce clause forbids states to impede interstate commerce.
After a medicine has been authorized, the F.D.A. will sometimes reevaluate the findings. This is particularly true for mifepristone, which has been reevaluated many times and is one of just 60 medications subject to stricter regulations.
On rare instances, the FDA has urged pharmaceutical companies to take drugs off shelves due to rising concerns about their potential effects on patient health and safety. The government has already requested that weight-loss medicine Belviq be withdrawn from the market by Eisai in 2020 due to research showing an elevated risk of cancer.
When it was shown that Merck’s best-selling pain medicine Vioxx increased patients’ risk of heart attacks and strokes, the company voluntarily pulled the drug off the market in 2004.
Professor Charo warned that the implications of overturning an FDA medicine clearance might extend to other government agencies with technical knowledge, such as those responsible for regulating the environment, energy, and digital communications.