Following complaints from industry, the FDA has delayed until March 2018 implementation of a final rule that would broaden the definition of intended uses for medical devices and drugs using a “totality of the evidence” framework.
Industry representatives say the final rule’s totality of the evidence standard greatly expands the current regulatory definition of intended use.
Khatereh Calleja, AdvaMed’s senior vice president for technology and regulatory affairs, told IDDM the final rule’s totality of the evidence standard “is inconsistent with the long-recognized definition of intended use and creates substantial uncertainty for manufacturers.”
Hyman, Phelps, and McNamara attorney Jeffery Shapiro said the final rule appears to be “a blank check” for the FDA “to find whatever intent it wishes to find, using an unconstrained calculus as to what the ‘totality of the evidence’ shows.”
The Medical Information Working Group, Pharmaceutical Research and Manufacturers of America, and the Biotechnology Innovation Organization filed a petition last month arguing for more time for public comment because the final rule expands the scope of intended use and raises First Amendment Concerns. “There is no support in existing law for the [totality of the evidence] standard, and it would represent a substantial change with significant constitutional and public health ramifications,” the petition says.
Under the current intended-use regulation, if a manufacturer knows or should know that a medical product will be used for off-label purposes, the manufacturer should provide labeling for the additional uses.
A Jan. 9 final rule, which was scheduled to go into effect March 21, amends the intended-use provision to state that if the totality of evidence shows a manufacturer “objectively intends” that a device or drug is to be used for off-label purposes, the company must provide new labeling.
According to the FDA, the changes merely clarify that the manufacturer’s knowledge of an off-label use is just one factor the agency considers when determining intended use. Other factors can include evidence such as the product’s labeling, promotional claims, and advertising.
No comments have yet been posted in the docket for the final rule.