Regulatory Focus™ > News Articles > FDA Begins Process of Overhauling Off-Label Communications Regulations

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Posted 31 August 2016 | By Zachary Brennan 

FDA Begins Process of Overhauling Off-Label Communications Regulations


The US Food and Drug Administration (FDA) on Wednesday announced a new two-day public meeting to address a comprehensive review of its regulations and policies governing firms’ off-label communications on unapproved uses of approved drugs and medical devices.

The hearing comes as FDA has come under fire recently for its limiting of what drug and device industries consider to be “free speech.” In March, FDA settled a lawsuit with drugmaker Amarin after the US District Court for the Southern District of New York ruled that the statements Amarin made to doctors for Vascepa as a treatment of persistently high triglycerides are “truthful and non-misleading.”

John Fleder, an attorney with Hyman, Phelps & McNamara who focuses on FDA litigation, explained to Focus the difficulty of determining if a statement made by a company is misleading: “People have to remember that [decisions from] CaroniaVascular and Amarin all said there is no protection to companies for statements and claims that are either untruthful or misleading, and while it may be easy to know in a particular situation whether a claim is untruthful, it is usually a much more complicated issue whether a claim is misleading or not.”

FDA says in its meeting announcement that this issue of misleading information is a particular area of interest as it works to develop standards that should apply to unapproved use communications that minimize the potential of these communications to be misleading or otherwise cause harm.

November Meeting

At the public hearing 9-10 November, FDA says it is also interested to learn about the extent to which additional communications about unapproved uses “can provide access to information that is relevant, scientifically sound, responsibly presented, and provides as full an understanding as possible about the limitations of the available evidence, as well as comment on the extent to which health care professionals currently face impediments to accessing such information, whether from firms or from other sources.”

The agency, which has been hesitant to address its off-label communications approach, also said it is interested in comment and information addressing “whether and in what ways firms’ communications of unapproved use information are

distinct and perhaps provide unique benefits compared to other sources.

“Not all communications of information about unapproved uses help support public health,” FDA adds. “For example, communications that emphasize a medical product’s claimed benefits, while minimizing the limitations of the supporting evidence, or minimizing the product’s known or potential adverse effects, may inappropriately influence prescribing or use decisions in a manner that is not in a patient’s best interest.”

PhRMA Interview

Industry group PhRMA is trying to work with FDA on ways to amend its regulations around off-label promotion.

Jeff Francer, VP and senior counsel at PhRMA, explained to Focus in a phone interview that it’s helpful to think about the different types of information that companies have when helping insurers make coverage decisions and helping physicians make treatment decisions (eg. peer-reviewed journal articles and electronic health record information).

“The interesting thing is that when a company puts out promotional labeling, they send it at the time of first use so the requirement isn’t for FDA to review it before it goes out,” Francer added, noting there are always exceptions, but by and large, companies use data to inform their communications before FDA evaluates it.

“Almost all information on medicines that’s out there, except for labeling, is not vetted” by FDA, he noted.

But Francer also explained that it’s “not PhRMA’s position that FDA shouldn’t regulate appropriate communications between companies and physicians,” though the standards in the current regulations “make it tough to communicate any information off of the labeling in a proactive way,” he added.

“If there is labeling that’s not truthful or misleading, FDA can bring a misbranding charge, [which can include] criminal penalties and jail and stiff financial fines for companies. I don’t think the issue is FDA doesn’t have the tools to do its job but the standards of misbranding haven’t been consistent with what the courts have said in terms of truthful and non-misleading,” Francer added.

FDA, however, noted in Wednesday’s hearing notice that as medical providers increasingly work in integrated systems, the use of system measurements of quality and measurements of the appropriate use of medical products has increased, and insurance carriers, health care systems and similar entities “may restrict coverage for medical products based on assessments of value and employ performance measures to monitor appropriate use and outcomes.”

The agency says it is interested in understanding more about whether and how these changes may be able to provide “an impetus for the development of additional high-quality data to address the balance of benefits and risks of each.”

Meeting Notice


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