In draft guidance, the FDA defines appropriate off-label comms as being 'consistent' with the label
FDA commissioner Robert Califf participated in a two-day hearing on off-label communications in November.
The FDA on Tuesday released draft guidance addressing questions about how the drug industry can share truthful and non-misleading information about a product outside of its approved label — but still consistent with that label — commonly referred to as off-label communications.
The agency cited a number of examples of ways pharma companies can share information and still meet the FDA's definition of being “consistent” with a product's FDA-approved labeling. This includes how a product performs in specific patient subgroups within its approved-patient population; data about long-term safety and efficacy of products that treat a chronic condition; updates from head-to-head trials for drugs with the same approved indication; and providing additional context about a drug's mechanism of action.
The FDA said that sharing information that meets that standard “should be accurately characterized,” including the “limitations of the strength of evidence and the conclusions that can be drawn from it.” In a section on what companies should consider when developing off-label communications, the agency wrote that any study results or other data that support a firm's communication should be “accurately represented,” and that communication should contextualize relevant information about a product “including by disclosing unfavorable or inconsistent findings.”
A PhRMA spokesperson said the lobbying organization is still going through the draft guidance.
See also: Off-label promotion: By the numbers
The pharma industry has long wanted clarity from the FDA about off-label communications. The FDA in November held a two-day hearing, during which drugmakers and other organizations made the case for sharing off-label information with healthcare systems and payers.
The FDA has faced several lawsuits in recent years about the rights of pharmaceutical companies to share truthful and non-misleading information about its products outside of the FDA-approved label. In 2015, a judge ruled in favor of Amarin, saying the drugmaker may engage in truthful and non-misleading speech to promote off-label uses of its fish oil pill Vascepa. Then in December of that year, the FDA settled a lawsuit filed by Pacira Pharmaceuticals over the marketing of its post-surgery pain drug Exparel.
If a drugmaker shares information outside of a product's label, it is considered misbranded and subject to enforcement actions if deemed false or misleading.
The FDA opened the comment period on the draft guidance for 90 days.