Big Pharma is challenging a final rule that affects the off-label promotion of drugs and devices.
The Food and Drug Administration in the final rule revised the definition of “intended use” to include a new “totality of the evidence” standard that wasn’t in the proposed rule.
Because stakeholders weren’t given fair notice of the revision and opportunity to comment, the FDA violated the Administrative Procedure Act (APA), three industry groups—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.
Deborah M. Shelton, a partner in the FDA Practice Group of McCarter & English in Washington, told Bloomberg BNA Feb. 13 the FDA “is saying [in the final rule] it’s not the knowledge in and of itself that would inform the ‘intended use,’ but that could be part of the equation and could go into the totality of evidence.”
“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,” Shelton said.
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