Battle Over US FDA’s ‘Intended Use’ Rule Continues
Executive Summary
PhRMA and Pfizer attorneys criticize the rule’s broad evidence standard, lack of safe harbors, and disregard of the First Amendment. Opposition to the rule is expected to continue to play out in lawsuits.
The long saga over the US Food and Drug Administration’s “intended use” rule may not be over. Industry attorneys sharply criticized the rule at an industry conference and suggested that legal challenges may be waged in the courts.
“I don’t know that for manufacturers who have approved products and have information about unapproved uses that it really settles things. And I think you’re bound to see this continue to play out through individual lawsuits and such,” Kelly Goldberg, VP, law and senior counsel for biopharmaceutical regulation at the Pharmaceutical Research and Manufacturers of America, said.
Goldberg, speaking on a panel at the Food and Drug Law Institute’s 13-15 October virtual conference on advertising and promotion for medical products, said that despite the long journey to a final rule, it feels like we haven’t come very far. She noted that while the “totality of evidence” standard is gone, the final rule ultimately adopts such a standard, stating that FDA will consider all relevant sources of evidence in determining intended use.
FDA's final rule on intended use, issued in August, amends regulations describing what the agency will consider in assessing whether a manufacturer intends to market a product for a new “intended use,” colloquially referred to as an “off-label” use. The agency rejected industry requests that it focus solely on promotional claims in considering if a product is being marketed for its intended use. (Also see "Off-Label Use Final Rule: US FDA Declines To Focus Solely On Promotional Claims" - Pink Sheet, 30 Jul, 2021.)
Goldberg noted that PhRMA has long advocated that FDA establish that a manufacturer has a particular intended use for a product only when the manufacturer has made a promotional claim about that use to a third party. The association also argued that there should be a safe harbor for nonpromotional scientific exchange communications. However, the agency rejected that request.
In the final rule, FDA said a safe harbor to exclude scientific exchange from determinations of intended use might give companies an incentive to promote new intended uses for marketed products based on incomplete or otherwise flawed data.
FDA’s First Amendment Position Is ‘Backwards And Upside Down’
Jeffrey Chasnow, senior VP and associate general counsel at Pfizer Inc., said the real problem with the rule is what FDA didn’t do, specifically that it failed to address responsibilities with regard to the First Amendment.
In the rule, the agency stated that it disagreed with arguments that the rule is vulnerable under the First Amendment. “The intended use regulations describe evidence that may be relevant to established intended use; they do not themselves directly regulate speech,” the agency said.
Chasnow said this is a remarkable position. “What FDA appears to be saying is that its mission and its jurisdiction are primary and that any other considerations, including constitutional ones, take a back seat. And it’s laughable, honestly,” he stated. “I think it’s wrong and I think it’s backwards and upside down because this is not how constitutional doctrine works.”
He said the agency’s insistence, a decade after the US Supreme Court’s ruling in Sorrell v. IMS Health Inc., that “it’s mission entitles it to an easement through or perhaps a bridge over First Amendment protection is really a bridge too far.” The court ruled in Sorrell that a Vermont statute violated the First Amendment by restricting the speech of pharmaceutical companies. (Also see "Rx Data Mining Opponents Will Need New Pitch After Supreme Court Strikes Down Vermont Law" - Pink Sheet, 23 Jun, 2011.)
Another aspect of the final rule that had raised concerns was the agency’s inclusion of the design or composition of a product as evidence relevant to determining a product’s intended use. Allison Fulton, a partner at Sheppard Mullin Richter & Hampton, said she thought that some of her medical device clients would be up in arms over this provision. But she said that when she surveyed them they said this language would not necessarily have an immediate impact on the way they are operating.
Agency Feels Rule Should ‘Put To Rest’ Disputes Over Evidence
In a keynote address opening the FDLI conference, Lauren Roth, FDA’s associate commissioner for policy, said the final rule “should put to rest any dispute about FDA’s interpretation of our authorities regarding evidence that might be relevant to establishing intended use.”
Roth said she had heard chatter that the intended use rule reflects an expansion of a manufacturer’s potential liability from misbranding and new drug and device violations. “I think that reflects a misreading of FDA’s intent,” she stated.
“What the final rule says is not novel. Instead, it captures FDA’s steadfast view that to perform our public health mission, and to ensure that bad actors are not able to circumvent FDA regulation by masking their true intent, the agency may look to any relevant source of evidence, including a variety of direct and circumstantial evidence in determining a product’s intended use,” Roth said.
Panel moderator James Czaban, a partner at Loeb & Loeb, noted Roth’s comments and asked if the final rule ends disputes over the meaning of intended use. Goldberg said she could understand why that would be FDA’s perspective as it is looking at this from its public health authority dealing with a universe of different products. But she said it does not resolve issues for manufacturers.