The pharmaceutical industry wants the FDA to change a final rule, published in the Jan. 9 Federal Register (82 Fed. Reg. 2,193), that affects the off-label promotion of drugs and devices.
The final rule, (RIN:0910-AH19), among other things, revised the definition of “intended use” to include a new “totality of evidence” standard. The intended uses of a product determine whether the product is regulated as a drug or device by the FDA, and they are described in the product’s labeling. Doctors can prescribe products for off-label uses, but manufacturers can’t promote their products for off-label uses. If they do, they can face enforcement action by the agency.
The Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO) and the Medical Information Working Group (MIWG) said in a Feb. 8 citizen petition to the agency that under a totality of evidence standard, “everything may be considered to establish a product’s intended use. This standard would allow FDA to rely even on non-promotional scientific exchange as evidence of intended use” and could include clinical practice guidelines and a company’s response to unsolicited requests for information about off-label uses.
The industry groups said the new standard wasn’t in the proposed rule and because stakeholders weren’t given fair notice of the revision and opportunity to comment, the FDA violated the Administrative Procedure Act (APA). They want the FDA to indefinitely stay the final rule, reconsider it and use a final definition of “intended use” that is consistent with the proposed rule issued in 2015.
Deborah M. Shelton, a partner in the FDA Practice Group of McCarter & English in Washington, told me “the petitioners have a very strong argument that this is actually a change in position from the proposed rule. To do that in the final rule without providing an opportunity for comment, is arguably violative of the APA.”
But Michael Carome, director of Public Citizen’s Health Research Group, told me that he doesn’t think the FDA violated the APA in making the change in the final rule.
“We don’t think there’s anything unique there that’s inconsistent with the existing regulation or what was proposed in 2015,” Carome said.
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