Drug, Device Industries Get One-Year Delay on Off-Label Rule

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By Dana A. Elfin

The FDA is hitting the pause button on a recent rule affecting what drug and device manufacturers can say about the off-label uses of their products.

The rule (RIN:0910-AH19), published by the Food and Drug Administration in January, is important because it regulates how manufacturers can discuss the unapproved uses of their products with health-care providers. Currently, companies can face criminal prosecution and civil liability if they tout their products to doctors and the public for off-label uses the FDA hasn’t specifically approved..

The FDA is pushing back the rule’s effective date from March 21, 2017, to March 19, 2018. The FDA says the extra time will allow it to respond to an industry petition objecting to how it put out the rule on intended uses of regulated products. Pharmaceutical and device industry groups claim the agency didn’t follow proper rulemaking procedures, and asked the agency to stay the rule indefinitely.

The delay is in a notice that will be published March 20 in the Federal Register. The agency had pushed the effective date back once already this year to give the Trump administration time to review new regulations.

Industry Seeks More Flexibility

The drug and device Industries have long criticized the FDA’s off-label communications policy as unduly restrictive, and claim it violates their free speech rights.

Industry has been pushing the FDA to change the policy to allow companies more flexibility to share information about unapproved uses of their products with health care providers without fear of prosecution or liability.

In February, three industry groups, the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Innovation Organization (BIO) and the Medical Information Working Group (MIWG), submitted a citizen petition to the agency challenging the final intended use rule.

MIWG is an informal working group of major manufacturers of prescription drugs, biologics, and medical devices working to clarify and improve federal regulation and enforcement related to manufacturers’ dissemination of information about their products.

Rulemaking Wasn’t Proper

The groups said the rule violated the Administrative Procedure Act (APA) because the FDA revised the definition of “intended use” to include a new “totality of the evidence” standard that wasn’t in the proposed rule.

“There is no support in existing law for the totality standard, and it would represent a substantial change with significant constitutional and public health ramifications,” the petition said.

Under a totality of evidence standard, “everything may be considered to establish a product’s intended use,” the groups said. The petition said the standard would allow the FDA to rely 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.

Stakeholders weren’t given fair notice of the revision and opportunity to comment on the change, the groups said.

Petitioners Welcome Delay

PhRMA and the MIWG welcomed the delay, saying it would allow the agency time to consider the ramifications of the final rule.

“As PhRMA’s joint petition stated, the final rule contained significant changes from the proposal which raised serious concerns, including the potential to chill valuable scientific speech. Allowing stakeholders to comment on these significant changes, and the final rule more broadly, will help the Agency fully consider the legal and policy implications of the final rule,”PhRMA’s executive vice president and general counsel, James Stansel, told Bloomberg BNA March 17.

"[T]he agency recognized that the issues we raised in the petition provide good cause to delay the effective date,” Kellie B. Combs, a life sciences attorney with Ropes & Gray LLP in Washington, who is co-counsel to MIWG, told Bloomberg BNA March 17.

Device Group Praises Move

The Advanced Medical Technology Association (AdvaMed), which represents medical device manufacturers, told Bloomberg BNA it was also pleased with the delay.

“Along with many other stakeholders, we believe the final rule should be disregarded as provisions added late in the process to the final rule are expansive, unwarranted, and raise interpretational issues,” Khatereh Calleja, AdvaMed’s senior vice president for technology & regulatory affairs, said.

“Specifically, the totality standard set out in the final rule is inconsistent with the long recognized definition of intended use and creates substantial uncertainty for manufacturers,” Calleja said.

Current Version May Not Survive

The final rule is unlikely to survive in its current form, John Kamp, consulting counsel to Wiley Rein LLP and executive director of the Coalition for Healthcare Communication, told Bloomberg BNA March 17.

“The off-label issue is just too important to the public health and too sensitive to First Amendment challenges for this final rule to stand,” Kamp said. “I suspect when new leadership arrives at FDA, the final rule will be reviewed and revised.” President Donald Trump recently nominated Scott Gottlieb to be the FDA’s new leader, but the job requires Senate confirmation.

The Coalition for Healthcare Communication, whose members include media, health-care and other organizations, promotes the free exchange of scientific and medical information.

FDA’s Legal, Policy ‘Mistakes.’

“The FDA likely made two mistakes on this final rule, one that is focused on legal issues and one that is focused on policy issues,” Kamp said.

“On the legal side, the FDA did not give the public sufficient notice that it was moving to a ‘totality of the evidence’ standard. While it can change its rules, FDA simply must give interested parties notice and opportunity to comment before creating a new rule,” Kamp said.

“On the policy side, the industry petitioners likely are correct that the new standard is sufficiently broad and vague for plaintiff’s lawyers to have a heyday bringing questionable lawsuits against industry.”

Change Not Significant?

Michael Carome, director of Public Citizen’s Health Research Group, downplayed the industry’s concerns about the changes to the final rule.

“We don’t see it as a significant change in the interpretation of intended use,” he told Bloomberg BNA March 17. The FDA didn’t violate the APA in making the change in the final rule, he said.

And, he said, the delay means the language industry wanted revised will remain in place for the time being.

To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

For More Information

The Federal Register notice set for March 20 publication is at http://src.bna.com/m4P.

Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.

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