Perspective: High-profile court decisions may undercut FDA’s ability to keep drugmakers truthful

Recent court decisions upholding individual First Amendment rights could be used to hide inconvenient truths about a medicine’s full benefit and adverse event profile, under the claim that regulators cannot compel them to publicize that information, Jerry Avorn wrote in a perspective in the New England Journal of Medicine.

A recent series of court decisions upholding the right of free speech could potentially limit FDA’s ability to regulate drug labels and off-label promotion, wrote Avorn of the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital and Harvard Medical School, both in Boston.

“The First Amendment is traditionally seen as protecting the freedom of individuals’ speech from government interference,” Avorn wrote. “But in recent years, it has also been invoked by conservative litigators and relied on by judges to justify forbidding ‘compelled speech.’ In this view, just as the government cannot prevent a person from saying something, it cannot oblige a person to say something. Both uses of the newly weaponized First Amendment have become powerful tools in conservatives’ attempts to dismantle ‘the regulatory state.’”
The leap from supporting free speech to condemning compelled speech is not an obvious one, Avorn explained, pointing to the complex principles underlying the decision in the recent 303 Creative L.L.C. v. Elenis case. Here, the US Supreme Court upheld the right of a wedding website designer to refuse to provide services for a same-sex marriage.

The decision was based on the concept of “compelled speech,” meaning that the designer could not be forced to participate in an activity she found objectionable. This concept, which also underlies recent high-profile anti-abortion cases, is also showing up in the pharmaceutical regulatory landscape, Avorn wrote.

Earlier this year, Merck objected to allowing Medicare to negotiate drug prices, “arguing that requiring the company to state its acceptance of a future negotiated price would represent impermissible compelled speech.” In July 2023, a district court judge blocked the Biden administration from contacting social media platforms about misleading or untruthful COVID-19 claims, claiming such contact could have a chilling effect on freedom of speech.

The First Amendment also has been used to uphold the promotion of off-label drug uses by pharmaceutical companies, Avorn wrote, citing the 2012 case United States v. Caronia. This involved a representative for Orphan Pharmaceuticals found guilty of promoting off-label use of certain products. The conviction was overturned by the Court of Appeals for the Second Circuit in Manhattan on the grounds that it infringed on the defendant’s constitutionally protected free speech.

“That decision potentially called into question the FDA’s right to regulate all forms of companies’ promotional claims,” Avorn wrote. “The government could have appealed the decision to the Supreme Court but chose not to, concerned that an unfavorable ruling could gut the agency’s ability to impose any regulation on drug makers’ promotional claims.”

After the decision, the FDA “sharply reduced” the number of actions filed against drugmakers for improper marketing claims, Avorn wrote.

The current legal atmosphere could open the door for drugmakers to be less than forthcoming about risks in drug labeling, Avorn wrote. “Manufacturers could argue that other harms or potential risks lie in a gray area that gives companies considerable discretion in deciding how and even whether to describe them.”

For example, the product labeling for Eisai’s Leqembi (lecanemab) doesn’t contain complete information about the risks for patients who are homozygous for apolipoprotein E4 (ApoE4), including that these patients may not benefit from the drug and that they have an increased risk of potentially fatal bleeding when taking concomitant anticoagulants, compared with noncarriers.

“Lecanemab’s manufacturer chose not to list ApoE4 homozygosity or anticoagulant use as contraindications in its label (only allergy to the drug is listed),” Avorn wrote. “A separate section suggests that ApoE4 testing ‘should be performed prior to initiation of treatment’ but does not state that patients homozygous for ApoE4 shouldn’t take the drug. In fact, the label even indicates that the drug can still be given if such genotyping is not performed. As for anticoagulants, the label says only that ‘caution should be exercised’ concerning use of the drug in patients taking these medications.”

While FDA approved the Leqembi labeling, Avorn questioned whether the agency would have the power to require stronger warnings in the future in light of the direction of recent court decisions. “It’s not too early to wonder whether the power that Congress has vested in the FDA to ensure that drug makers accurately describe their products’ side effects might before long also be limited by the courts as a form of prohibited ‘compelled speech,’” Avorn wrote.

NEJM perspective

Perspective: High-profile court decisions may undercut FDA’s ability to keep drugmakers truthful

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