Abortion pill: judicial activism poses threat to US pharma industry

Incensed by product adulteration, American housewives fought hard for the creation of the Food and Drug Administration almost 120 years ago. Now a legal battle over an abortion drug used by millions of women threatens the agency’s authority. This time, their lobbying efforts have the support of pharmaceutical groups alarmed by a new regulatory uncertainty.

More than 400 senior pharma and biotech executives have attacked a preliminary injunction against mifepristone. Texas federal judge Matthew Kacsmaryk last week curbed access to the abortion medication across the US.

Kacsmaryk concluded that the FDA violated its statutory duty to address safety concerns in a court action backed by anti-abortion groups. However, there is no shortage of data supporting the safety of mifepristone, which was approved 23 years ago. The Department of Justice has lodged an appeal.

Bosses representing the likes of Pfizer, Biogen and Merck claim the ruling puts “an entire industry focused on medical innovation at risk”. That is hyperbolic. But they are right to worry the ruling would set a precedent.

Few of the signatories are involved in reproductive healthcare. Pfizer’s misoprostol is used in conjunction with mifepristone in abortions. But this is an off-label use for a drug approved for other medical conditions.

Mifepristone was developed by a French subsidiary of Germany’s Hoechst. The rights are now held by boycott-immune, one-product companies. New York-based Danco Laboratories sells mifepristone under the brand name Mifeprex in the US. Las Vegas-based GenBioPro makes a generic version.

The legal threat to FDA decisions has emerged when pricing reforms are crimping pharma returns. Developing a drug takes years and costs an average of $2.3bn. Though some blockbusters earn spectacular returns, many therapies disappoint.

If the Texas ban becomes permanent, challenges to the authority of the FDA could proliferate. More might come from anti-abortion groups energised by last year’s reversal of abortion rights enshrined in the Roe vs Wade court case. But a broad range of special interest groups could exploit the new precedent.

This would increase the capital costs of pharma groups. They would not be able to develop as many drugs, particularly in fields exposed to moral controversy. The Texas injunction is bad for US medical science and for investment. It is to be hoped that the DoJ succeeds in its appeal.