FDA guidelines for payer, off-label communications: OK as long as 'truthful'
The FDA has outlined how drugmakers should communicate with intermediaries, like payers, formulary committees, and pharmacy benefit managers, as well as how to communicate information not covered by FDA labeling guidelines.
The two final guidance documents were released on Tuesday. Both were distributed as draft guidance in 2017, allowing the public to comment on the proposals.
One legal expert noted that the guidelines have received a positive reception.
“Most in the industry were pleased with direction of the final guidance documents because they show the FDA understands the value that this information can have for payers,” said Kellie Combs, partner at law firm Ropes & Gray. “Certainly the payer communication guidance eliminates some barriers and it also allows manufacturers to communicate with payers earlier in the process, prior to FDA approval.”
Both guidance documents encourage more communication between drugmakers and payers about new products and uses. The guidelines, which are nonbinding, show that the FDA is not looking to punish drug or device makers for sharing information not included in the required labeling with payers as long as it is truthful and non-misleading.
According to the guidance on payer communications, pharma companies can share unapproved product and use information with middlemen, as long as they clearly state the product or use is not approved, the product's status in the approval process, and details of studies used to test the product.
For example, if a drug approved to treat mild asthma, but also in studies or in the process of being approved to treat severe asthma, drugmakers can talk about those studies with payers.
The second guidance for communicating information not included in FDA labeling had a similar conclusion. Drugmakers can communicate about approved and unapproved uses of their products that are not contained in their products' FDA-required labeling in a “truthful and non-misleading way,” according to the guidance documents.
Although this opens up what companies can say about off-label uses, some experts said it does not go far enough in allowing off-label uses.
“It's guidance which increases clarity, and that's a good thing,” said John Kamp, executive director at the Coalition for Healthcare Communication. “But it's very, very narrow guidance and doesn't touch the topic of off label use — that's a disappointment.”
Two First Amendment lawsuits in 2015 essentially set a precedent that off-label communications were protected. Amarin and Pacira brought lawsuits against the FDA saying it violated the company's First Amendment rights by limiting what information they could communicate about a product. In the ruling for Amarin, a federal judge said that the company could share unapproved off-label information about the drug as long as it was truthful and not misleading.
“Those cases are certainly part of the story,” Combs said. “Industry groups and others have been pushing FDA to provide more clarity about many communications, particularly about information that does not appear in the product labeling. Those efforts extend way back years before the First Amendment cases. I do think that [the cases] have resulted in some movement in the FDA.”