Life Science Compliance Update

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February 22, 2017

Citizens Petition Challenges FDA’s Off-Label Rule


On February 8, 2017, three organizations called on the United States Food and Drug Administration (FDA) to overhaul a newly finalized regulation giving the agency wide latitude to police off-label promotion, saying it contains abrupt and unconstitutional policy changes. The three organizations include: Pharmaceutical Research and Manufacturers of America, the Biotechnology Innovation Organization, and the Medical Information Working Group (a coalition of pharmaceutical manufacturers).

The three organizations collectively represent essentially all major drugmakers, and the petition challenges a January 9, 2017, final rule issued by the FDA. 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. The final rule caught the pharmaceutical and medical device industries off guard because the proposed rule simply deleted the knowledge-based labeling directive without hinting at a change to a totality-of-evidence standard.

The Citizens Petition

The three groups filed a citizens petition because they believe that the FDA violated the Administrative Procedure Act (APA) because stakeholders were not given fair notice of the revision and opportunity to comment. It also undercuts the FDA’s reasoning for implementing a totality-of-evidence standard, stating that such a standard is overly vague and not supported by relevant case law.

The petition states that, among the consequences resulting from the revised definitions, the open-ended, subjective totality of the evidence standard will result in: (1) increased False Claims Act (FCA) litigation because qui tam relators will be emboldened to use circumstantial evidence to allege that manufacturer communications caused the government to pay for off-label uses of medical products; and (2) a chilling of free speech about legitimate scientific data related to off-label uses of medical products.

According to Bloomberg, some attorneys agree with the three organizations that the FDA violated the APA when it made the change to the final rule.

Stay of Rule Requested

The industry groups said in the petition the FDA should 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.

The final rule, published in the Jan. 7 Federal Register, also describes when a product made or derived from tobacco intended for human consumption will be subject to regulation as a drug, device or a combination drug/device product under the Federal Food, Drug and Cosmetic Act. The rule’s effective date was Feb. 8, but the FDA postponed it until March 21 in a Feb. 7 Federal Register notice.

The FDA has 180 days to respond to a citizen petition, but the agency can respond by saying it is still considering the issue, Bradley Merrill Thompson, a Washington-based attorney with Epstein Becker & Green PC, told Bloomberg BNA. Therefore, the deadline is not really that effective.

Totality of the Evidence

In the proposed rule, the FDA deleted from the “intended use” definition a provision that said if a manufacturer has knowledge that a drug or device is used for off-label conditions, the manufacturer is required to provide adequate labeling for that use. But in the final rule, the FDA replaced that provision with languages saying it would consider “the totality of the evidence” when deciding whether a company needs to provide labeling for an off-label use.

The petition said 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.

Anne K. Walsh, an attorney with Hyman, Phelps & McNamara PC in Washington, told Bloomberg BNA the totality of evidence standard “it’s clear to me that FDA tried to avoid the notice and comment requirements of the APA,” Walsh said. Walsh said the petitioner’s APA argument “is certainly strong enough that they could have filed directly with the court and challenged it on an APA basis.”

Deborah M. Shelton, a partner in the FDA Practice Group of McCarter & English in Washington, told Bloomberg BNA 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. Shelton noted that she felt it makes sense for the FDA to stay the final rule.

Public Citizen’s Health Research Group Disagrees

Michael Carome, director of Public Citizen’s Health Research Group, told Bloomberg BNA Feb. 13 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.

The proposed rule struck the last sentence of the definition of “intended use,” which said “that if a manufacturer knows that a drug or device is being used for off-label uses such knowledge would require the manufacturer to update the labeling for that use,” Carome said.

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