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# Courts Could Cut FDA Labeling Enforcement: Avorn
- URL: https://www.fdaweb.com/courts-could-cut-fda-labeling-enforcement-avorn/
- Published: 2023-10-18T12:00:00.000Z
- Updated: 2026-09-14T14:13:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155596

Harvard Medical School professor **Jerry Avorn** thinks recent court decisions involving “compelled speech” could end up limiting FDA’s ability to ensure that drug makers accurately describe their products’ side effects. Writing in a *New England Journal of Medicine* Perspective [column](https://www.nejm.org/doi/full/10.1056/NEJMp2307908?ref=fdaweb.com), Avorn cites the Supreme Court decision in *303 Creative LLC v Elenis*, in which the court upheld the right of a wedding Web site designer to refuse to provide services for a same-sex marriage. The court said in a 6-3 decision that the plaintiff’s First Amendment rights would be violated by a requirement that she provide the services, since it would be “compelled speech.”

The *303* decision, Avorn writes, “is the latest of several decisions that trace a potentially ominous trend eroding the regulation of corporate statements.”

He notes that while the First Amendment is traditionally seen as protecting the freedom of individuals’ speech from government interference, in recent years it also has been used by conservative litigators and relied on by judges to justify forbidding compelled speech. “In this view,” Avorn writes, “just as the government cannot prevent a person from saying something, it cannot oblige a person to say something.” The situation is further clouded, he says, by court rulings that corporate entities should have the same constitutional rights as individuals.

Avorn then tells how the *303* ruling could have sobering implications for FDA’s time-honored ability to regulate statements from drug companies about the potential risks posed by their products.

“*303 Creative* could undercut the capacity of FDA (and therefore of the nation) to require that drug makers fully disclose important risks to doctors and patients before a drug is prescribed,” Avorn says. “The threat of litigation by patients would probably ensure that some obvious adverse effects, such as potential anaphylaxis, would not be hidden. But 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.”

He says one example of this dilemma is Eisai/Biogen’s Leqembi (lecanemab-irmb), which was granted full FDA approval in July to treat Alzheimer’s disease. Avorn says the companies chose not to list some adverse effects and contraindications in the labeling.

And he suggests that in its apparent eagerness to pave the way for wide use of the drug three years after approving Biogen’s Aduhelm (aducanumab-avwa) that demonstrated little evidence of clinical benefit, FDA “did not require Leqembi’s manufacturer to state these risks more strongly. But if FDA were to insist on clearer warnings, or if emerging data prompts it to do so in the future, will the latest Supreme Court decisions limiting compelled speech now hamper the agency’s ability to require such statements, for fear of violating the manufacturer’s First Amendment rights?”

When it comes to understanding the risks of the medications we use, Avorn concludes, all prescribers and patients could become vulnerable groups. “It’s not too early to wonder whether the power that Congress has vested in 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,’” he says.