House Introduces Bill to Loosen Communication Restrictions for Off-Label Use

Representative Morgan Griffith (R-Virginia) recently introduced a new bill aimed at reducing the restrictions on off-label communications between pharmaceuticals companies, payers, and providers—allowing drugmakers to discuss unapproved uses for medications. 

The bill, entitled the Medical Product Communications Act (HR 1703), is meant to combat a recently proposed FDA rule that would prevent pharmaceutical companies from discussing anything other than a drug’s “intended use” with physicians and payers. 

“Congress should clarify the statute so this type of scientific exchange between medical product manufacturers and health care decision-makers can occur,” Rep Griffith said in a press release. “Doctors should have the most up-to-date information when caring for their patients and, when done responsibly and in an appropriate context, manufacturers should be able to provide it.”

Drugmakers have argued that the proposed FDA rule is an infringement on their first amendment rights, and Rep Griffith agreed.

“Furthermore, in my opinion, FDA prohibiting companies from communicating truthful and non-misleading information is not Constitutional, based on First Amendment commercial speech protections,” he said in the press release.

HR 1703 would loosen restrictions on communications for intended use by limiting which communications the FDA could use to enforce a determination of intended use. The bill specifically mentions “scientific exchanges” would be exempt from intended use determinations, which would allow drugmakers to discuss their products outside the scope of their FDA-approved indications. 

STAT reported that the pharmaceutical industry was a primary contributor to Rep Griffith campaign committee during the 2015 to 2016 election cycle. 

Meanwhile, the FDA recently delayed the effective date for the intended use rule until March 19, 2018. —David Costill