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# Lawmakers Consider Easing Off-label Promotion: Report
- URL: https://www.fdaweb.com/lawmakers-consider-easing-off-label-promotion-report/
- Published: 2018-05-09T12:00:00.000Z
- Updated: 2026-09-15T00:04:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141394

Congress and state legislatures may be where new efforts are made to ease FDA restrictions on off-label promotion of drugs, according to an open-source PLOS Medicine [report](http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002564&ref=fdaweb.com) by Harvard Medical School’s **Michael Sinha** and **Arnold Kesselheim**. They cite the 2012 case *U.S. v. Caronia* in which a divided 2nd Circuit Court of Appeals extended protection for “commercial speech” under the First Amendment to off-label marketing statements made by a drug company sales representative. The court said that manufacturers could engage in off-label promotion if it was “truthful and non-misleading,” a standard that the authors say is “far less rigorous than FDA’s current standards for determining a drug’s efficacy and safety for a particular indication.”

Since *Caronia* applies only within the 2nd Circuit, the article says, FDA has continued to enforce its existing rules on manufacturer promotion, although it has added additional company safe harbors.

“In the meantime,” the authors say, “state and federal legislators have seized on the *Caronia* decision to propose statutory changes that would give wide latitude to manufacturers engaging in off-label promotion.” They review changes under the 21st Century Cures Act and in a law approved in Arizona, as well as measures introduced in the U.S. House of Representatives to extend the permitted range of off-label promotion.

“Buoyed by a narrow victory in one appeals court,” Sinha and Kesselheim conclude, “advocates have turned to state and federal legislatures to unravel current FDA rules relating to off-label promotion. But these rules are essential for the ability of FDA to fulfill its public health mission by defining what uses of drugs have benefits that outweigh their risks versus those that lack sufficient evidence to warrant such use. These distinctions are crucial for individual physicians, who do not have the time or expertise to perform the same critical data evaluation conducted by the scores of highly trained scientists at FDA, and for patients, who could be exposed to more non-evidence-based and potentially dangerous off-label uses of high-cost drugs.”