Chilling SCOTUS colloquy on FDA authority is a wake-up call

It’s time to get off the sidelines and explain to the court and the public how a weakened FDA threatens U.S. leadership in life sciences

In C-suites across our industry, most of us understand that the stability of our regulatory ecosystem is vitally important to ensuring the success of a biopharmaceutical enterprise.

As the U.S. Supreme Court prepares to hear oral arguments March 26 in the mifepristone medication abortion case, biopharma leaders have taken different tacks in response to the risk this case and concurrent Supreme Court jurisprudence represent to biomedical innovation writ large.

In one camp are executives who’ve remained silent — wary of stepping on to the third rail of abortion politics, perhaps hoping for a narrowly tailored decision. In the other camp are 341 innovators, trade groups, investors and executives who’ve been issuing urgent public statements and filing pointed amicus briefs.

Our coalition has repeatedly warned that it would be profoundly destabilizing if federal judges with no scientific training abrogate the FDA’s long-established authority to determine how, when and if a medication may be safely administered in our country.

Those who’ve opted to stay mum and hope for the best should read BioCentury’s explosive reporting last month surrounding a challenge to the Chevron doctrine — a 40-year-old precedent of judicial deference to federal agencies when statutory language is ambiguous. BioCentury reports that the “Supreme Court seems poised to issue a ruling that will curtail the power of federal agencies, including FDA, to interpret laws.”

During oral arguments last month, Justices Ketanji Brown Jackson and Elena Kagan each invoked the FDA’s authority. Under the Food, Drug and Cosmetic Act, new drugs can be approved only if an “adequate and well-controlled investigation” shows that the drug will have its intended effect. In a concerning colloquy, Justice Jackson asked the attorney representing parties seeking to overturn the Chevron doctrine who should “decide what it means for a study to be adequate or well-controlled?”

The lawyer responded that the meaning of “adequate or well-controlled” is a statutory interpretation for courts to decide, not the FDA. Disconcertingly, this firm represents many biopharma companies that value and appreciate the FDA’s scientific expertise and authority.

How deeply the FDA is implicated in the court’s imminent retraction of administrative regulatory authority remains an open question, but perhaps not for long. Final rulings in the Chevron doctrine and mifepristone cases are just months away. Respectively, these cases may diminish the FDA’s ability to interpret statute and undermine its scientific expertise, with troubling implications for biopharmaceutical development.

The risk to the FDA gold standard — and, with it, U.S. global dominance in the life sciences — is no longer speculative. Deference to FDA scientific decisions soon may become a casualty of a populist war on the administrative state. Regardless of personal politics, all of us must start giving stricter scrutiny to the court’s docket this term.

Silent hand-wringing isn’t a viable strategy. There are several steps industry leaders can and should take right now.

• Get off the sidelines. We need more CEOs to issue public statements in business forums and explain the threat a weakened FDA poses to U.S. leadership in the life sciences.

• Talk about the implications of this court. The 2024 docket could be the beginning, not the end, of investment-chilling threats to our regulatory ecosystem. Companies reluctant to participate in amicus briefs on FDA jurisdictional issues should reconsider their posture. The voice of industry is needed right now to explain to judges and justices why we need a strong, independent FDA to accelerate innovation.

• Act in our self-interest. Introducing additional regulatory uncertainty into our ecosystem erodes the “FDA gold standard” and chills life science investment. Our companies and trade associations must immediately begin educating leaders on Capitol Hill that the Chevron doctrine’s expected demise will require Congress to enshrine specific, unambiguous statutory language codifying the FDA’s scientific decision-making authority into law.

For decades, medical innovation has flourished in our country because of opportunity, need, competition and predictable policy incentives. We recently witnessed, however, that foundational expectations that underpin our sector can evaporate in an instant, as we saw with the passage of the Inflation Reduction Act.

 In a sector defined by scientific risk, regulatory predictability is precious. We are running out of time to articulate our concerns about the impact these Supreme Court cases could have on our business. We must mobilize and express our concerns of how a weakened FDA hurts patients and could stymie innovation for a generation or more.

For those who have not yet engaged on FDA jurisdictional threats, the time for mutely sitting on the sidelines has passed. If not, we may wake up one day to find we missed the warning signs.

Meg Alexander is chief strategy officer at Ovid Therapeutics Inc. (NASDAQ:OVID).

Signed commentaries do not necessarily reflect the views of BioCentury.