The US Supreme Court is expected to make a decision soon on whether the Food and Drug Administration’s approval of mifepristone more than 20 years ago should be revoked. It’s an important case with broad implications beyond access to abortion: Never before has a court challenged the authority of the FDA, a federal agency tasked with scientific and medical oversight, when it comes to making prescription drugs available to the public.
If mifepristone is taken off the market, it potentially opens the door to challenges on other types of drugs, too. But drug companies and their leadership don’t seem very worried. To date, their involvement in the issue has been relatively limited, a far cry from recent outspokenness of CEOs on social issues ranging from gay rights to gun control.
Danco, the maker of branded mifepristone known as Mifeprex, joined the Biden administration in seeking a Supreme Court intervention to restore the full FDA approval. And GenBioPro, which makes the generic version of the mifepristone, filed a lawsuit against the FDA asking for the drug to continue being available.
But the actions from the rest of the pharmaceutical industry haven’t gone much beyond an amicus brief filed by PhRMA, the industry’s main lobby, alongside individual pharmaceutical companies and executives—and even this only happened when the case reached the appeals court.
Why aren’t pharmaceutical companies more outspoken about keeping mifepristone available?
“I don’t think this is a threat to the pharmaceutical industry yet,” says Nielsen Hobbs, lead analyst at Citeline, a consultancy focused on the pharmaceutical industry. “If it was, I think you would have seen companies intervening at the district court level.”
A small and contained threat, political in nature?
Mifepristone isn’t the only drug to fall along the social fault lines motivating the suit. Gender affirming hormonal therapy and contraceptives sit in this space, too, though altogether represent just a tiny part of the $1.5 trillion global pharmaceutical industry.
The specifically political nature of these controversies makes it likely that the expected potential losses to pharmaceutical companies will be contained. “I think [drug makers] recognize this is a strategy that will be employed along this narrow topic,” says Hobbs.
Even if additional legal challenges were extended to vaccines, which indeed have been the subject of political controversy, any resulting restrictions likely would be limited to mandatory vaccinations, not general availability of the vaccines altogether.
In each of these areas, the social cost of new restrictions on the drugs would be far higher than the cost to the drug industry itself. But rulings in favor of restrictions may dissuade companies from developing new products in areas such as reproductive and preventive health, which would be a loss to both public health and potential (if small) future revenue streams of the drug industry.
What’s at stake in the court battle over mifepristone?
While the legal battle over mifepristone isn’t the kind of event that threatens the drug industry with extinction, it does present long-term consequences.
“The loss of trust in the FDA is becoming an issue and it cannot be good for the industry’s business model,” says Hobbs. “It remains a theoretical threat that can be brought on against any product.”
But there is no sustainable scenario in which the FDA’s approvals are systematically challenged, meaning that so long as pharmaceutical companies keep developing new products and finding customers for them, there isn’t too much at stake in the mifepristone fight—at least not for them.