Rx, Device Groups Tell FDA to Scrap Latest Off-Label Rule

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By Dana A. Elfin

Drug and device industry groups want the FDA to abandon its most recent proposed rule on what manufacturers can say about the unapproved uses of their medical products.

In comments submitted to the FDA docket on the July 18 deadline, AdvaMed, PhRMA and the Medical Information Working Group criticized the FDA’s latest iteration of its off-label communication policy, calling it harmful to free speech and patient access. The groups want the FDA to drop its Jan. 9 rule indefinitely and return to its earlier 2015 proposal.

The “intended use” rule is important because it regulates how manufacturers can discuss 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 or the public for off-label uses the FDA hasn’t specifically approved. Industry has criticized the policy as unduly restrictive and claims it infringes manufacturers’ free speech rights. The comments AdvaMed, PhRMA and MIWG submitted July 18 document those concerns.

AdvaMed is a trade group representing large medical device manufacturers, and PhRMA is the lobbying arm of the brand-name drug industry. 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.

Stay Petition

The FDA’s most recent version of the intended use rule had been scheduled to take effect earlier this year but the FDA pushed back the rule’s effective date to March 19, 2018, to respond to an industry petition asking the FDA to stay the implementation of the rule.

PhRMA and MIWG and the Biotechnology Innovation Organization (BIO) submitted the petition.

Industry Concerns

PhRMA’s letter expressed its “grave concerns” about the final rule’s new provision expanding the definition of “manufacturer knowledge” for purposes of determining whether a manufacturer was violating the intended use rule.

“PhRMA believes that FDA may establish that a manufacturer has a particular ‘intended use’ for an article only when the manufacturer has made a promotional claim about that use to a third party,” its letter said. Under the September 2015 proposed rule, a manufacturer’s mere knowledge that its drug is being prescribed for an unapproved use would not establish such a use as a manufacturer’s intended use, PhRMA said.

The FDA’s final rule is overbroad, because it allows a particular “intended use” to be established even without any external manufacturer claim about that use. “Such an approach is simply not supported by the case law,” PhRMA said.

PhRMA’s letter also said the final rule raises free speech concerns.

"[I]f allowed to stand, the Final Rule would, in some circumstances, inappropriately restrict important speech about unapproved uses of FDA-approved medical products that could be beneficial to both healthcare professionals and the patients they serve,” PhRMA said.

The final rule should be scrapped, AdvaMed concurred in its letter. “To avoid the problems that would be created by the amended ‘intended uses’ definition included in the Final Rule, FDA should abandon the Final Rule and instead return to its original and unambiguous proposal.”

Consumer Group Critical

Public Citizen, a consumer group, said the industry groups’ concerns about the rule are unwarranted. Public Citizen has opposed loosening restrictions on off-label communications, saying relaxation of the restrictions could cause safety issues.

“The final rule that was issued was appropriate and really doesn’t change the FDA’s approach to making a determination about whether a company is marketing a product for a particular use,” Michael Carome, the director of Public Citizen’s Health Research Group, told Bloomberg BNA in a July 25 phone call.

The groups’ free speech concerns are also unfounded, he said.

Sharing Information

The manufacturers’ free speech concerns shouldn’t be downplayed, Bradley Merrill Thompson, a health-care attorney at Epstein Becker & Green PC in Washington, told Bloomberg BNA July 25. Thompson is a Bloomberg BNA advisory board member.

“The question is really whether medical device or pharmaceutical companies should be permitted to share the best information with these physicians to help inform their decision-making, decision-making they are already engaged in,” he said in an email. “It’s by the sharing of such information that our overall knowledge base advances.”

Insurance Group Weighs In

America’s Health Insurance Plans, a Washington-based insurance industry trade association, agreed off-label communication was important.

“AHIP emphasizes the importance of communication between medical product manufacturers, providers, and health plans,” Cathryn Donaldson, AHIP’s director of communications and public affairs told Bloomberg BNA in a July 25 email.

But Donaldson said any off-label communication “must work in tandem with the FDA’s current requirements for meeting high standards of evidence for safety and efficacy to help ensure that robust evidence exists to support approval of drugs, biologics, and devices for specific uses and indications.”

AHIP didn’t submit comments on the FDA proposed rule, she said.

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 PhRMA letter is at http://src.bna.com/q3Z.The AdvaMed letter is at http://src.bna.com/q30.The MIWG letter is at http://src.bna.com/q31.

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