By Julie Rovner
Texas District Court Judge Matthew Kacsmaryk’s decision April 7 to rescind the approval of the abortion pill mifepristone dealt a blow to more than just people seeking a medication abortion.
It appears to be the first time a court has directly usurped the FDA’s authority to provide the final word on which medicines are safe and effective and, thus, allowed to be sold in the United States. And it could well throw the pharmaceutical industry into turmoil.
If the decision is allowed to stand, it could affect far more than abortion drugs. “It will radically alter the process for approving drugs and will kill innovation and hinder bringing new drugs to market,” Jennifer Dalven, director of the ACLU’s Reproductive Freedom Project, told reporters in a briefing April 10. It might also invite what she called “fringe groups” to challenge any other drug they object to for political reasons.
So you’d think challenging the decision would be a top priority for the prescription drug industry’s national 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 the court,” or amicus, briefs in the Texas case.
And since the ruling, PhRMA has declined to weigh in beyond the relatively bland statement it made weeks ago. “The FDA is the gold standard for determining whether a medicine is safe and effective for people to use,” said Priscilla VanderVeer, PhRMA’s vice president for public affairs. “While PhRMA and our members are not a party to this litigation, our focus is on ensuring a policy environment that supports the agency’s ability to regulate and provides access to FDA-approved medicines.”
Even more puzzling, though, is that PhRMA has only to look at another major health industry player, the physicians’ major lobbying group, the American Medical Association, for an object lesson in how sitting on the sidelines of a polarizing political issue can cost an industry or profession a chunk of its autonomy.
By contrast, many individual drug companies, as well as the biotech industry’s trade group, were quick to decry the ruling. The Biotechnology Innovation Organization said the ruling sets “a dangerous precedent for undermining the FDA and creating regulatory uncertainty that will impede the development of important new treatments and therapies.”
PhRMA’s relative silence is puzzling, said Carole Joffe, a professor at the University of California-San Francisco and an expert on the sociology of reproductive health issues. “PhRMA now has to contemplate the politicization of potentially everything. For Big Pharma, one could argue that a Pandora’s box has been opened.”
Even more puzzling, though, is that PhRMA has only to look at another major health industry player, the physicians’ major lobbying group, the American Medical Association, for an object lesson in how sitting on the sidelines of a polarizing political issue can cost an industry or profession a chunk of its autonomy.
When it comes to abortion, lawmakers at the state and federal level, not to mention judges, have been essentially practicing medicine without a license for over a half-century, since the decision in Roe v. Wade itself. In that case, seven Supreme Court justices signed on to a framework for pregnancy (dividing it into “trimesters”) that did not exist before, at least not medically.
The AMA played a major role in making abortion illegal in the 19th century, when it sought to supplant midwives and others whom doctors saw as threats to their economic and professional power. But in the 20th century, the organization was slow to recognize that doctors’ professional judgments were being supplanted by those of others — lawmakers and judges. The AMA did not even file an amicus brief in the Roe case itself, and for much of the next four decades tried mightily to stay out of the abortion fray, even as warnings grew that medical professionals were losing the right to practice according to the best medical evidence.
After the Supreme Court upheld the first ban on a specific abortion procedure in 2007 — a ban the AMA had initially endorsed, then opposed — it was clear that physicians were losing their primacy over the practice of medicine.
Yet the stigma attached to abortion remained. Even after the AMA formally supported abortion rights, the group “did as little as possible,” said Joffe. Over several decades, most doctors tried to distance themselves from both the abortion issue and their colleagues who performed the procedure, Joffe said.
It wasn’t until 2019 that the AMA stepped out of the shadows on the subject of lawmakers interfering in the doctor-patient relationship. That’s when the group filed suit to block two North Dakota abortion laws, which the organization said “compel physicians and other members of the care team 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 take up the Mississippi case that would eventually overturn Roe, the AMA realized what was at stake. The state law being challenged — a ban on all abortions after 15 weeks — “threatens the health of pregnant patients by arbitrarily barring their access to a safe and essential component of health care,” the AMA said in an amicus brief it filed with two dozen other medical groups.
And after the decision reversing Roe in 2022, the AMA’s new president, Dr. Jack Resneck Jr., was quick to lament what had been lost. “Medicine is hard, and it’s hard enough without members of Congress or governors or state legislators or others trying to sit in your exam room with you and second-guess all the decisions that you’re making,” he told KHN’s “What the Health?” podcast in July.
So the AMA has apparently learned its lesson the hard way. Now the question is whether the drug industry will learn that same lesson — and when. (PB/KHN)