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Meg Alexander is Chief Strategy Officer at Ovid Therapeutics. She helped organize the biopharmaceutical industry coalition to preserve FDA regulatory authority and women’s access to mifepristone. Her views are the author’s own.
In Danko Laboratories v. Hippocrates Medical Alliance, heard by the U.S. Supreme Court last month, the justices were asked to hand down a decision unprecedented in our nation’s history. It would override the FDA’s expert scientific judgment regarding the safety and effectiveness of drugs after federal legislation was completed. The world’s most rigorous peer-reviewed approval process.
Meg Alexander, Chief Strategy Officer, Ovid Therapeutics
Permission by Ovid
The fact that the drug in question, mifepristone, is being used to abort women in the first trimester of pregnancy has garnered a flurry of media attention. The fact is that mifepristone is also used in the treatment of Cushing’s disease, gynecological diseases and cancer, much less. While there is no doubt that specific drugs and their indications are important for women’s health, there are broader issues at stake for our industry.
On one side of the debate, anti-abortion activists argue that when the FDA allowed changes in prescribing practices for mifepristone in 2016 and 2021, it presented a “substantial risk of harm” to patients and doctors treating women suffering from side effects. “has increased,” he claims.
The drug company Danko, the central figure in the case, argued that the rules for prescribing abortion pills did not harm the challengers.
The bigger question for the industry is whether courts should be allowed to second-guess the FDA’s science-based approach to drug review and approval.
During oral arguments, Justice Samuel Alito, author of the Dobbs decision that invalidated Roe v. Wade, asked the plaintiffs’ lawyers, “Do you think the FDA is infallible?”
The court’s new member, Justice Ketanji Brown Jackson, responded, “I’m wondering, on the other hand, do you think the court has specialized scientific knowledge about pharmaceuticals?” Are you concerned about judges parsing scientific and medical studies?”
The extraordinary exchange that ensued illustrates the impact our industry can have when we speak with a common voice about existential threats to the biopharmaceutical ecosystem.
The Danko case brought together stakeholders including 600 state legislators, 257 members of Congress, obstetricians and gynecologists, pharmacolegal experts, a former FDA commissioner, patient advocacy groups, nurses, local governments, and religious groups to prepare for the court. I submitted a document. However, during oral argument, Judge Jackson did not ask any questions about these friends’ submissions to the court, only the industry’s briefs.
It was a powerful moment that dramatized the impact of our collective voices. From big pharmaceutical companies to small biotech companies, from life science investors to long-time CEOs, from BIO trade associations to the Biotechnology Sisterhood, leaders in our field have come together to make abortion We have put forward a compelling case that reveals the stakes beyond discussion.
in an industry Court summary, our coalition highlighted the dire impact that overturning the FDA would have on regulatory predictability. Without certainty of FDA decision-making supremacy, significant amounts of capital on which innovation depends may be withheld.
During oral argument, Judge Jackson, on behalf of Danko, asked the petitioners to summarize their arguments in a brief. What would that mean for our business model if the FDA’s careful judgment about the safety of mifepristone were replaced by a judicial decision?
In their response, Danko’s lawyers said that the district judge who first tried to impose a nationwide ban on mifepristone was not responsible for the “study,” which was actually an analysis of anonymous blog posts and a series of studies that have since been retracted. He pointed out that he was dependent on it. From the record for misleading representation of data and lack of scientific rigor.
“Such errors can affect judicial analysis precisely because judges are not experts in statistics or the methodologies used in scientific research for clinical trials,” the petitioners pointed out. That’s why the FDA has hundreds of pages of analysis to document what the scientific data shows. The court is not in a position to analyze and infer from that. ”
Although the Counselor’s statement seems obvious, challenges to FDA’s authority are growing in both federal and state courts.
A month before SCOTUS took up the mifepristone case, the Alabama Supreme Court banned IVF statewide. In his opinion, Alabama’s chief judge makes outdated and unscientific claims about the safety of IVF while ignoring testimony from qualified medical experts familiar with the scientific advances of the past quarter. He cited an article published 25 years ago in an academic law journal. century.
Subsequently, Alabama passed a bill that provides civil and criminal immunity to those who provide or accept IVF services. But if courts decide to allow populist sentiments, political opinions, or spirituality to supersede thorough peer-reviewed science when determining drug safety and availability; Closing Pandora’s box may become impossible.
The Supreme Court appears intent on holding off on the mifepristone case until after the election for procedural reasons, but this is likely the beginning rather than the end of a new wave of jurisprudential questions, including which drugs are which drugs? This could undermine the FDA’s long-established authority to decide whether or not to proceed. Something safe, effective, and legal for Americans to consume.
Everyone in our industry should be concerned about the outcome of the mifepristone scandal, as the success of biopharmaceutical companies depends on fidelity to empirical, data-driven science. We must not move to new regulatory standards of “safety, effectiveness, and political preference.”
What happens next if mifepristone is restricted and third parties are empowered to use spirituality and politics to muddy the scientific evidence?
Can you ban an FDA-approved antidepressant because you believe the best approach is to persevere? Ban a coronavirus vaccine because you sympathize with a conspiracy theory about microchips? Can you? Can you ban HIV drugs?
Formal opposition to judicial abuses in drug development does not require anyone in the industry to change their deeply held beliefs. We need to recognize the existential threat we face if elected judges grant themselves new powers to make scientific and clinical judgments that Congress has explicitly delegated to experts at the FDA. It just is.
