Doctors’ Lesson for Drug Industry: Abortion Wars Are Dangerous to Ignore

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.”

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.”