Experts: FDA’s Promotion Rules Need to be Updated to Survive Court Challenges

The FDA’s regulations for drug promotions desperately need to be updated as they are unlikely to survive future court challenges, industry experts say.

A spate of setbacks in off-label promotions are symptomatic of a larger problem: the government cannot withstand most First Amendment challenges by relying on decades-old regulations crafted before commercial speech was recognized as protected speech, they say.

“This has really caught the FDA flatfooted,” explained Michael Listgarten, senior associate general counsel for Genentech. “FDA has not done so well in the courts, in part because its policies and rules are very dated.”