With the Texas ruling against the product mifepristone on April 7, the biotech industry came together to both denounce the ruling and help the wider public, as well as national policy makers, understand the deep impacts that such a ruling would have on public health and the economic core of American industry.
This week, Bio.News takes a step back to look at what happened and talk about the many impacts of the ruling with John Murphy, Chief Policy Officer of the Biotechnology Innovation Organization (BIO).
The validity of scientific regulators
One of the major impacts of the ruling is on the role of the Food and Drug Administration (FDA), which has been a respected scientific regulatory body in the U.S. for decades. The recent attacks on the institution, including the mifepristone ruling, could have further-reaching and longer-lasting effects than many have realized—and are already negatively affecting patients nationwide.
From the “assault on the FDA’s long-standing accelerated approval program” to the decision on coverage of a breakthrough Alzheimer’s drug to mifepristone, the FDA “is being systematically undermined in its efforts to advance and protect public health,” argues John Murphy and Dr. Cartier Esham, BIO’s Chief Scientific Officer, in STAT News.
“As a result, both Americans and the biopharmaceutical companies that provide them with needed care and solutions are losing out,” they said. And indeed, the mifepristone ruling is yet another chip at the armor of the FDA.
“There are hundreds of medical studies to determine the risks associated with mifepristone,” Murphy explains to Bio.News, “and they’ve found that the risks are not any more profound than many other drugs that are currently on the market.”
“There are Attorneys Generals across the country that are saying that this drug is so safe that you shouldn’t even have a pharmacist certification before dispensing it, and FDA equivocates have said that as well,” says Murphy.
This element of the ruling shines a light on the Achilles heel of the recent anti-FDA move: the Texas ruling lack of scientific language. “The judge does a lot of two-step in his opinion to try and claim that he’s not substituting his judgment for FDA’s medical judgment,” explains Murphy, “but implicit in all of his ruling is that he focuses on unreported side effects and harms to the plaintiffs and uses those to justify his standing.”
Yet, these harms to the plaintiff are an interesting aspect of the ruling that opened the door for the Justice Department to appeal in a specific way.
The Justice Department appealed the Texas ruling the following Monday, April 10, arguing that the challengers had no right to file the lawsuit since they were not personally harmed by the abortion pill. The Justice Department noted the ruling “upended decades of reliance by blocking FDA’s approval of mifepristone and depriving patients of access to this safe and effective treatment, based on the court’s own misguided assessment of the drug’s safety,” reported by the Washington Post.
Essentially, it is impossible that the side effects are so bad and so profound that there is reason to challenge this drug in court while other scientific bodies and institutions have said this product is overwhelmingly safe.
Additionally, Judge Kacsmaryk seems to prioritize one type of safety over another. “Judge Kacsmaryk’s ruling does a very specific job of outlining the risks he believes exist in keeping the product on the market, but ignores any potential risks that could happen by taking a product off the market—and there are consequences to that,” says Murphy. “This is why many judges grant interim relief to keep the status quo while litigation continues.”
The place for judicial review of FDA
“FDA has a long history of understanding and tracking adverse events and articulating iterative labeling requirements based on what they’re seeing in real-world evidence and what they’re seeing in subsequent studies,” says Murphy. “You have to look at FDA as the expert when it comes to working with companies and working with the physician community to evaluate on an ongoing basis the effectiveness of a product and balance it with its risks, because all drugs in some way or fashion have risks.”
What many in the industry are arguing, and trying to explain, is that there is no inherent issue with a judicial review on the FDA. However, there is an issue with a ruling that is driving outside of its lane.
“Big determination of medical questions are ones that the medical community should be making,” says Murphy, “and what judges should be doing is making sure that FDA followed the statutory process in getting to its ultimate professional medical decisions. It should be making sure that its regulations speak with clarity, and there isn’t ambiguity in how it is making decisions.”
“In other words, there is a process and a place for judicial review of FDA decision-making,” he continues. “Questions about whether FDA violated the Administrative Procedures Act in adequately taking notice and comment or adequately responding to comment is a valid and appropriate place to have legal oversight and judicial review. The question then becomes, in those cases, what should the remedy be?”
Judicial review is much better focused towards regulatory and procedural missteps, not scientific judgements, and should not undercut the validity of scientific ruling and regulation. Mifepristone should never have been the issue; FDA’s response to the mifepristone plaintiff’s petition should have been.
The slippery slope of the recent ruling muddies the waters when it comes to who oversees what, and the effects of such a murky situation on the industry are profound.
Protecting American innovation—and patients
The U.S. biotech industry directly employs some 2.5 million people, and a little more than 10 million indirectly, with $2-3 trillion in economic impact. This multitrillion-dollar contribution to American innovation relies on strong and stable regulatory and distribution systems. As BIO has explained time and time again, funding biotech innovation is a risk that only occasionally pays off if a drug makes it to market. Investors need to feel confident it will be able to stay on the market.
“Mifepristone has been on the market for 23 years, and it is a chilling notion for the industry that you could have a judge say we’re going to have a fact-finding mission for this established drug, and while we do that, we’re going to deny all access to the product,” said Murphy. “I think that’s a problem.”
BIO’s Executive Committee joined an amicus brief with more than 400 biotech CEOs urging suspension of the Texas ruling. “Here at BIO, we stand with a strong FDA, and we stand with patients,” said BIO’s CEO Rachel King.
The amicus brief reiterated “the fact that Congress empowered the FDA with the ability to approve or deny the safety of drugs, and claims the courts lack the medical expertise to make decisions affecting access to safe medical treatments for millions of Americans,” as we reported.
Arguments in the brief include:
- The court, which lacks scientific or medical expertise, undermines the FDA’s ability to act on behalf of patients.
- The ruling is an assault on the importance of comparative safety data and would inhibit FDA’s broad acceptance of new data.
- The decision would create new regulatory barriers regarding approved labeling. BIO supports a balance between agency regulatory flexibility and judicial checks, but the ruling’s unprecedented obstacles “could upend crucial investment, research, and development in the biomedical field.”
The coming weeks
On April 7, Justice Samuel Alito ordered a stay on the lower court rulings until Wednesday, April 19, which has been extended until Friday, April 21. He issued no statement with the order. In the meantime, the groups that originally brought the lawsuit have to respond to the appeal brought by the Justice Department on or before Tuesday, April 18, 2023, by 12 p.m.
It is likely that another order will be issued at some point next week and that the litigation is far from over. Until then, the biotech industry is keeping an eagle eye on the case and is working to do everything in its power to protect innovation and patients alike—hopefully, the U.S. judicial system will follow suit.