New FDA commish extends time for comments on off-label communication rules

Under the agency’s new commissioner, Dr. Scott Gottlieb, the FDA has reportedly extended the time for comments in its review of off-label communication rules.

In the past, Gottlieb has advocated for off-label uses of medical products, arguing that doctors are adequately trained to make decisions in the best interest of their patients.

The FDA maintains authority to regulate a product based on its intended use and in January, the agency issued a rule allowing it to consider the “totality of evidence” in determining a company’s intended use for its drug or device.

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