While this guidance specifically applies to approved drugs, the agency is seeking comments on whether the recommendations apply to approved or cleared medical devices, or if it should implement other recommendations for devices.
We also look forward to stakeholder input on another, distinct topic - communications about unapproved uses of approved or cleared medical products.
The FDA on Tuesday released draft guidance addressing questions about how the drug industry can share truthful and non-misleading information about a product outside of its approved label - but still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The second draft guidance, Medical Product Communications That Are Consistent With the FDA-Required Labeling, contains frequently-asked questions and answers on how FDA evaluates firms' medical product communications, including promotional materials that present information that is not contained in the FDA-required labeling for the product, but that may be consistent with the FDA-required labeling for the product. 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.
FDA considers it "essential that information provided by firms about their investigational products be truthful and non-misleading" because firms use such information to help make coverage and/or reimbursement decisions prior to FDA approval or clearance of investigational products.
FDA says firms have asked the agency to allow them to include in promotional materials data and information about the approved/cleared uses of their drug and device products that are not contained in these products' FDA-required labeling, which was reviewed and approved by FDA during said products' marketing application or submission (and for devices, also during the classification process). FDA requires firms to ensure that FDA-required labeling is not false or misleading.
The FDA opened the comment period on the draft guidance for 90 days.
We recognize that there is a high level of interest regarding FDA's views on communications about medical products. 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.