Texas District Court Judge Matthew Kacsmaryk’s decision Friday to withdraw approval of the abortion pill mifepristone wasn’t just a blow to people who wanted medicated abortions.

It appears to be the first time that a court has directly usurped the authority of the Food and Drug Administration to give the final say on which drugs are safe, effective and thus allowed to be sold in the United States. And it could well shake up the pharmaceutical industry.

If the decision is upheld, it could have far more consequences than abortion drugs.

It will revolutionize the drug approval process and will stifle innovation and hamper the commercialization of new drugs, Jennifer Dalven, director of the American Civil Liberties Unions’ Reproductive Freedom Project, told reporters this week.

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It could also invite what she called fringe groups to challenge any other drug they object to for political reasons.

Abortion pill ruling: Texas judge withdraws FDA approval, but another judge contradicts it

So you’d think challenging the decision would be a top priority for the national drug industry advocacy group, the Pharmaceutical Research and Manufacturers of America, or PhRMA. Yet the drug lobby did not join the long list of medical, legal, and academic groups that filed friend-of-court or amicus briefs in the Texas case.

And since the ruling, PhRMA has refused to weigh any further than the relatively bland statement it made weeks ago.

The FDA is the gold standard for determining whether a drug is safe and effective for people to use, said Priscilla VanderVeer, PhRMA’s vice president of public affairs. While PhRMA and our members are not parties to this lawsuit, our focus is on ensuring a policy environment that supports the agency’s ability to regulate and provide access to FDA-approved drugs.

In contrast, many individual pharmaceutical companies, as well as the biotech industry trade group, were quick to reject the ruling. The Biotechnology Innovation Organization said the ruling sets a dangerous precedent for undermining the FDA and creating regulatory uncertainty that will hinder the development of important new treatments and therapies.

PhRMA’s relative silence is puzzling, said Carole Joffe, a professor at UC San Francisco and an expert on the sociology of reproductive health problems. PhRMA must now think about the politicization of potentially everything. For Big Pharma you could say that a Pandora’s box has been opened.

Even more puzzling, however, is that PhRMA has only to look at another major player in the health industry, the largest physician lobby group, the American Medical Assn. for a graphic lesson on how sitting on the sidelines of a polarizing political issue can cost an industry or profession some of its autonomy.

Column: It’s not about babies. Abortion restrictions are about power

When it comes to abortion, state and federal legislators, not to mention judges, have essentially been practicing medicine without a license for over half a century, since the decision in Roe v. Waad itself. In that case, seven Supreme Court justices signed a framework for pregnancy (divided into trimesters) that didn’t exist before, at least not medically.

The AMA was instrumental in making abortion illegal in the 19th century when it sought to displace midwives and others who saw physicians as a threat to their economic and professional power. But in the 20th century, the organization was slow to recognize that the professional judgments of physicians were being supplanted by those of other legislators and judges. The AMA didn’t even file an amicus brief in the Roe case itself, and for much of the next four decades it tried vigorously to stay out of the abortion fight, even as warnings grew that medical professionals were losing the right to use best practices. to practice. medical evidence.

After the Supreme Court upheld the first ban on a specific abortion procedure in 2007, a ban that the AMA had initially endorsed but opposed, it was clear that doctors were losing their primacy over the medical practice.

Still, the stigma attached to abortion remained. Even after the AMA formally supported abortion rights, the group did as little as possible, Joffe said. For decades, most doctors tried to distance themselves from both the abortion issue and their colleagues performing the procedure, Joffe said.

Her illegal abortion paved the way for Roe. 56 years later, she shares her story

It wasn’t until 2019 that the AMA stepped out of the shadows when it comes to legislators meddling in the doctor-patient relationship. That’s when the group filed a lawsuit to block two North Dakota abortion laws that the organization says force doctors and other healthcare team members to provide patients with false, misleading, non-medical information about reproductive health. (A federal judge subsequently blocked the law.)

By the time the Supreme Court was ready in 2021 to hear the Mississippi case that would ultimately overturn Roe, the AMA realized what was at stake. The state law challenging a ban on all abortions after 15 weeks threatens the health of pregnant patients by arbitrarily blocking their access to a safe and essential part of health care, the AMA said in an amicus brief it filed with two dozen other medical groups.

And following the decision to rollback Roe in 2022, the AMA’s new president, Dr. Jack Resneck Jr. quickly complained about what had been lost.

Medicine is hard, and it’s hard enough without members of Congress or governors or state legislatures or others trying to sit with you in your exam room and question all the decisions you make, he told KHN’s What the Health? Podcast in July.

So the AMA apparently learned its lesson the hard way. The question now is whether the drug industry will learn the same lesson and when.

HealthBent, a regular feature of KFF Health News, provides insight into and analysis of policy and politics from KFF Health News chief Washington correspondent Julie Rovner, who has covered health care for more than 30 years.