US Supreme Court will soon decide whether to revoke the Food and Drug Administration approval of mifepristone, which was granted more than 20 year ago. This is a case that has broad implications, beyond abortion access: It's the first time a court has challenged the FDA's authority to make prescription drugs available. The FDA is a federal agency responsible for scientific and medical oversight.
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If mifepristone was taken off the market it could open the door for other types of drugs to be challenged. The drug companies, and their leaders, don't appear to be very concerned. Their involvement has been limited to date. This is a far cry compared to recent CEOs who have spoken out on issues such as gay rights and gun control.
Danco, which makes the branded version of mifepristone, Mifeprex (also known as Mifeprex), joined the Biden Administration in seeking Supreme Court intervention for the FDA to be given full approval. GenBioPro, the manufacturer of the generic version, has filed a suit against the FDA to ask for the drug's continued availability.
The pharmaceutical industry has not taken any action beyond the amicus brief that was filed by PhRMA (the industry's principal lobby) along with individual pharmaceutical companies and executives. And even this happened only when the case reached an appeals court.
Why don't pharmaceutical companies speak out more about the availability of mifepristone?
Nielsen Hobbs is the lead analyst for Citeline, an industry-focused consultancy. If it were, I believe you would have seen the companies intervene at the district courts.
Mifepristone wasn't the only medication to fall under the social fault line that motivated the lawsuit. The same goes for gender affirming hormone therapy and contraceptives, which are also included in this category. However, they represent only a small part of the $1.5 billion global pharmaceutical industry.
It is likely that pharmaceutical companies' losses will be limited due to the specific political nature of this controversy. Hobbs says, "I believe [drug manufacturers] understand this is a specific strategy that will be used along this narrow subject."
If additional legal challenges are extended to vaccines that have indeed been the subject political controversy, then any restrictions resulting from this would likely be limited to mandatory vaccines and not the general availability of vaccines.
The social cost associated with new restrictions on drugs in each of these fields would be much higher than what the industry could pay. However, if the ruling is in favor of restrictions, it may discourage companies from developing products in certain areas like reproductive health and preventive medicine. This would have a negative impact on both public health as well as potential future revenue streams for the drug industry.
The legal battle over the mifepristone doesn't threaten the drug industry, but it has long-term effects.
Hobbs says that "the loss of confidence in the FDA has become an issue, and it can't be good for the business model of the industry." It is still a theoretical risk that could be applied to any product.
There is no scenario where FDA approvals can be systematically challenged. This means that as long as the pharmaceutical companies continue to develop new products and find customers for them, the fight over mifepristone is not too important for them.