FDA issues draft guidances on drug, device labeling

FDA
The draft guidance concerning the promotion of off-label use of drugs and devices comes after a pair of companies notched off-label marketing victories last March.

The FDA released a pair of draft guidances detailing its recommendations on how drug and device makers should communicate information about their products on their labeling and to payers.

In its first guidance (PDF), the agency set out guidelines for companies wishing to promote their products for off-label use. Even if this off-label information, unevaluated by the FDA, is consistent with the FDA-required labeling, it is still not considered evidence of a new intended use, the agency said. Including info that looks like it has been assessed and endorsed by the FDA would misbrand the product, the agency said, and firms could come under fire if information is false or misleading.

The guidance comes after a pair of companies notched wins for off-label marketing last March. The FDA agreed to settle with Amarin, which filed a free speech lawsuit against the agency, claiming it had the right to promote its cardio drug Vascepa for uses not approved by the FDA as long as they were truthful. And a Texas jury found Vascular Solutions not guilty of misbranding its Vari-Lase device when it promoted its use for a type of varicose veins it was not approved to treat.

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Meanwhile, the second guidance dealt with the communication of healthcare economic information between companies and payers, including communications about drugs and devices that are not yet approved.

The FDA acknowledged in the guidance that payers may require information to make drug coverage decisions that is different from the data the agency uses to make approval decisions. The healthcare economic information a company gives a payer must relate to an FDA-approved indication, be based on reliable scientific evidence, and, if needed, include a “conspicuous and prominent statement” specifying any differences between the FDA-approved labeling and the economic information.

Communications to payers about investigational products should include “clear statements” indicating their investigational status and that their safety and efficacy have yet to be proven, according to the guidance.

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. The comment period is open for 90 days.

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