By Lisa Jarvis / Bloomberg Opinion
A Texas federal judge’s ruling to remove the 23-year-old drug mifepristone from the market not only threatens abortion access in the U.S.; it’s also an appalling sideswipe at the Food and Drug Administration’s authority and expertise.
And if allowed to stand, it will have a stifling effect on pharmaceutical innovation. Discovering and developing a drug is expensive; depending on who you ask, the average cost of bringing a new medicine or vaccine from idea to market is anywhere from a few hundred million dollars to more than $2 billion.
Companies make that investment under the assumption that their products can be sold anywhere in the U.S. for a certain number of years; that they will come out on the other side of the FDA’s rigorous review process with a product that doctors consider safe and effective enough to prescribe, patients trust enough to take, and insurance companies regard as worth paying for. They know that if an issue arises with their product, the FDA has a well-defined (albeit far from perfect) process for removing it from the market. The agency’s stamp has become the gold standard for regulatory authorities around the world.
The Texas ruling removes the certainty from FDA’s imprimatur. Companies contemplating where to put their R&D dollars might now reasonably ask if some areas of medicine are worth the trouble.
Legal scholars say Judge Matthew Kacsmaryk could have rendered a decision that would have limited the impact to just mifepristone. That would have been a terrible blow to abortion access, but it would have left alone the question of FDA’s authority, and limited the potential impact on other medications. Instead, he rendered a 67-page opinion that cherry picks evidence regarding the safety of the drug — ignoring dozens of studies and over two decades of its safe use around the world — in order to overturn the approval, says I. Glen Cohen, faculty director at Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics.
Think about that: a single judge without medical training decided his read on select data on a drug was more sound than the FDA’s vast expertise. That should make the drug industry — not to mention their patients — very nervous.
The breadth of the ruling and the judge’s clear willingness to second-guess the FDA’s own expertise could breed similar lawsuits in jurisdictions with similarly sympathetic judges. “It really could become a roadmap for people seeking to challenge the approval of a wide range of other drugs, vaccines and health care products,” says Rachel Sachs, a professor at Washington University in St. Louis who specializes in FDA and health law.
As I’ve written in the past, it’s not hard to imagine a short list of products that could be targeted next. Emergency contraceptives, birth control, HPV vaccines and medicines to prevent HIV would all make that list given other ongoing efforts to limit access to them. Given the politicization of the covid vaccines, it’s not a stretch to think they’d be at risk, too. In years past, a federal court blocked one governor’s attempt to prevent the sale of a new opioid; could that decision be reversed by asking a different judge to consider it?
“Anything that can get caught up in that sort of cultural war is something that could easily be relitigated now by a judge who decides that he or she has an ax to grind,” says Ameet Sarpatwari, director of the Program on Regulation, Therapeutics and Law at Brigham and Women’s Hospital.
From there, the list could unfurl to include any number of products, whether that’s routine vaccines that have been deemed controversial despite decades of safe use or, really, any pill or shot that someone decides is problematic. “Where does it stop? The answer is, we don’t really know,” Sarpatwari says.
Pharmaceutical companies, a powerful lobbying force, are slowly starting to come off the sidelines. An open letter signed by hundreds of biotech executives and life sciences investors asked for the decision to be reversed, pointing to the ruling’s broader effects:
As an industry we count on the FDA’s autonomy and authority to bring new medicines to patients under a reliable regulatory process for drug evaluation and approval. Adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterizes our industry.
By Monday, Pfizer Inc. chief executive officer Albert Bourla had become the first big pharma chief to sign the letter, and eventually a handful of other executives from larger companies added their names.
But notably absent from the broader conversation about the mifepristone ruling? PhRMA, the industry’s powerful lobbying group. So far, the organization has only made a milquetoast, two-sentence statement to reporters noting that the FDA is the gold standard regulatory body. The biotechnology lobbying group BIO issued a press release condemning the decision as setting “dangerous precedent.”
Members should be pushing them to go further. For example, the groups could make clear their stance on the decision by filing an amicus brief in support of the government’s position. The Biden administration has already filed an appeal, but so far neither organization has publicly discussed plans to do so.
The outcome matters for abortion access. But it also could have far-reaching consequences for pharmaceutical innovation in the U.S.
Lisa Jarvis is a Bloomberg Opinion columnist covering biotech, health care and the pharmaceutical industry. Previously, she was executive editor of Chemical & Engineering News.
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