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. Pharma fought back, filing a Citizen Petition which requested that the FDA reconsider its language. The FDA agreed to delay the date of the rule for a year and said it would take comments until May 19.
Yesterday, the FDA extended the comment period until July 18.
The FDA wrote that it “has received a request for a 30-day extension and another request for a 90-day extension of the comment period . . . . The requests conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to issues FDA raised in the Final Rule Extension.”
The 90-day extension request comes from the Medical Information Working Group, the Biotechnology Innovation Organization and the Pharmaceutical Research and Manufacturers of America.
Off-label use of drugs is legal and common, so expanding the evidence that the FDA can use to claim that a drugmaker misbranded its product could prove problematic to the industry, according to industry groups.
