The House Energy & Commerce panel last week proposed an amendment to the Food, Drug & Cosmetic Act to give companies more freedom in marketing their products outside of their labeling. Chairman Rep. Fred Upton (R-Mich.) and health subcommittee chairman Rep. Joseph Pitts (R-Pa.), in a letter to Health & Human Services secretary Sylvia Burwell, said the proscription of off-label communication makes it harder for physicians to stay abreast of best practices.
“Ensuring that doctors and others involved in influencing treatment decisions are informed about scientifically accurate new ‘off-label’ information in a timely yet responsible manner is often critical to optimizing patients care,” they wrote. “Strictly preventing manufacturers from proactively providing this information, except in narrow and poorly defined circumstances, is no longer sound public policy – nor is it constitutionally permissible.”
The problem is exacerbated by an interagency feud, Upton and Pitts wrote, citing a stalled HHS approval of the FDA’s updated guidance on off-label marketing.
“It has come to the committee’s attention that such inaction may be the result of disagreements between FDA and HHS leadership. Specifically, despite being on FDA’s guidance agenda since 2014, it is our understanding that HHS has not allowed FDA to issue its completed draft guidance addressing the scope of permissible ‘scientific exchange,'” they wrote.
The representatives included a draft amendment to the FD&C Act that would tighten the definition of “labeling” to materials required to accompany products by the act, exempting other materials including ads, scientific papers or presentations and investor relations materials.
The amendment would also limit the definition of intended use to its maker’s “objective intent,” reining in the FDA’s power to regulate products it deems misbranded. That would also cut the legs out from under civil False Claims Act based on misbranding.
It would also let companies disseminate materials for “scientific exchange,” as long as it’s backed by “evidence generated in accordance with the scientific method” and clearly indicates whether the use is off-label and not proven safe and effective.
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