The FDA asks for input on off-label comms
The FDA said it plans to hold a public hearing in November to solicit feedback from drugmakers and other stakeholders about regulations regarding the dissemination of truthful and non-misleading information to healthcare providers about approved prescription drugs.
In a notification published Wednesday, the FDA said the hearing is scheduled to be held November 9 and 10 in Silver Springs, Maryland, on the FDA's campus. An agenda will be made available by November 2.
The agency had announced in 2014 that it planned to review its regulatory framework for these kinds of communications. A series of lawsuits that favored the industry's push to engage in “truthful” off-label communications have also taken place since then.
In the meeting announcement, the FDA noted that “relevant, truthful, and non-misleading scientific or medical information regarding unapproved uses of approved medical products may help healthcare professionals make better individual patient decisions.”
The FDA is asking for input regarding how manufacturers should communicate these unapproved uses and if these communications should be accompanied by a disclosure or delineation so the audience knows what information is for an approved use versus a unapproved use. The agency is also seeking information about how these communications should be monitored.
The hearing comes on the heels of two recent court cases the agency lost over off-label communications. A federal judge from the U.S. District Court for the Southern District of New York in August last year ruled in favor of Amarin, which had argued that the First Amendment protects manufacturers from FDA accusations of off-label marketing if the communications are truthful and not misleading. Amarin had been seeking approval to communicate non-approved uses for its fish-oil pill, Vascepa.
Then, in December, the FDA settled a similar case with Pacira Pharmaceuticals. The company had sued the agency after it issued a warning letter saying it could not market its pain treatment Exparel beyond the two surgeries cited in the company's clinical data. Pacira had argued that the original approval had allowed the company to market its product for a broader range of patients, not just those undergoing the two cited surgeries. As part of the settlement, the FDA formally withdrew its warning letter and granted the product a new labeling supplement.