FDA Seeks Input on Drug, Device Off-Label Communications

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By Dana A. Elfin

Aug. 31 — Drug and device manufacturers will soon have a chance to tell the FDA directly about changes they’d like to see the agency make to its off-label communications policy.

The FDA regulates what device and drug manufacturers can tell health-care professionals about the off-label use of those products—uses the FDA hasn’t specifically approved them for.

The Food and Drug Administration will hold a two-day meeting on off-label communications Nov. 9-10, according to a notice to be published in the Federal Register Sept. 1. The meeting will take place right after the presidential election, but written comments aren't due until Jan. 9, 2017. Any FDA policy announcement on the issue probably won't be forthcoming until after the new administration reviews it.

Regardless of the timing of any policy changes, the meeting is a welcome first step for the drug and device industries, which have been pushing the FDA to clarify its policy in this area for a long time.

“We are pleased that FDA is undertaking a comprehensive review of its regulations and policies governing product communications,” Deborah M. Shelton, deputy general counsel for healthcare at the Biotechnology Innovation Organization (BIO), told Bloomberg BNA Aug. 31.

“Removing current regulatory barriers, and clarifying the ability of companies to share truthful and nonmisleading information about medicines, is essential to our collective ability to realize the full potential of 21st century medicines and helping to ensure that patients are able to get the right medicines at the right time for them,” she added.

The drug industry's lobbying group, PhRMA, said in an Aug. 31 statement that it's “pleased that FDA has recognized that ‘relevant, truthful, and non-misleading scientific or medical information regarding unapproved uses of approved medical products may help health care professionals make better individual patient decisions.’ ”

“[G]reater sharing of information between biopharmaceutical companies, payers and health care professionals can benefit patient care and insurance coverage by ensuring more patients receive the best treatment for them,” Andrew Powaleny, the Pharmaceutical Research and Manufacturers of America's senior manager for communications, said.

Limits Still Needed

Meanwhile, Public Citizen told Bloomberg BNA that limits on off-label communications are still needed.

“It is tremendously important that the FDA strongly regulate manufacturer communications regarding unapproved uses of approved or cleared medical products to protect public health,” Michael Carome, director of Public Citizen's Health Research Group, told Bloomberg BNA Aug. 31.

“Without strong limits on such industry communications, our long-standing regulatory framework for ensuring that drugs and medical devices are safe and effective for their intended uses would be undermined, threatening patient health,” Carome added.

Industry Still Awaiting Guidance

Under long-standing policy at the FDA, companies can be subject to criminal prosecution and civil liability if they promote their products for uses the FDA hasn’t specifically approved. The agency had promised to issue revised guidance by the end of 2014, but industry is still waiting.

“The industry for years has been focused on this issue and has been pushing the FDA to issue additional guidance on this topic,” Carome said. “The agency’s notice provides a nice overview of the scope of the topic and appropriately poses key questions that need to be considered.”

Similarly, Richard Samp, chief counsel of the Washington Legal Foundation, told Bloomberg BNA Aug. 31 that “the broad set of questions posed by FDA” in the announcement “are thoughtful and suggest that FDA is addressing many of the appropriate issues that will affect its new off-label speech policy.”

FDA's Court Losses

Meanwhile, recent court cases challenging the constitutionality of the agency's off-label promotion regulations have raised doubts about whether the federal government can continue to restrict manufacturers from sharing truthful information about the off-label uses of drugs and medical devices.

In the past, Samp said, “FDA has adopted unrealistic definitions of truthfulness.” And, he said, the agency's restrictive definitions of truthful speech wouldn't pass muster under the First Amendment.

“As WLF has argued many times, the First Amendment does not tolerate such a restrictive definition of truthful speech, nor is that the way the scientific community has ever operated,” Samp said.

First Amendment Issues

Samp observed that the FDA's questions don't mention the First Amendment at all.

“FDA obviously recognizes that its extended losing streak in the courts on First Amendment issues requires the current re-examination of agency policy,” he said. “Accordingly, I think it’s important for FDA to seek as much input as possible regarding First Amendment policy.”

But Samp said he's pleased that the FDA’s questions “seemed to contemplate that different standards ought to be applied to off-label speech depending on the audience.”

“WLF has long argued that in light of the reduced danger that truthful speech may mislead when it is directed at doctors, FDA restrictions on such speech should be minimized,” he said.

WLF is a Washington-based public interest group with a free-market/free-enterprise orientation. WLF has been the named plaintiff in several cases challenging government policy on off-label promotion.

“It's time for the agency to take back this issue from the courts,” John Kamp, consulting counsel to Wiley Rein LLP and executive director of the Coalition for Healthcare Communication in New York, told Bloomberg BNA Aug. 31. “Sooner would have been better,” he said, “but the fact that they're serious and moving ahead is a good sign for the agency.”

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

A copy of the meeting notice is at http://src.bna.com/iaZ.

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