Drug Industry Gets Chance to Share Off-Label Views With FDA in November


Drug and device manufacturers will soon have the chance to tell FDA officials face-to-face, at a two-day public meeting, announced Sept. 1, about changes they’d like to see the agency make to its off-label communications policy.

Industry wants changes to the current FDA policy on what manufacturers can tell health-care professionals about the off-label uses of their medical products because companies and company personnel can face criminal prosecution and civil liability if they run afoul of it.

Indeed, off-label marketing investigations have fattened government coffers over the past decade, bringing in billions of dollars in settlements and fines.

The two-day meeting, scheduled to begin Nov. 9, has been a long time coming. Industry has been pushing the FDA to clarify its policy in this area for a long time.

Although the FDA made repeated promises to issue revised guidance in the area—including one promise that it would have something out by the end of 2014—it never followed through.

“Sooner would have been better,” John Kamp, consulting counsel to Wiley Rein LLP and executive director of the Coalition for Healthcare Communication in New York, told me about the meeting’s timing, “but the fact that they're serious and moving ahead is a good sign for the agency.”

The agency’s sudden forward motion could be due to its recent losing streak in court on the issue of whether that agency's off-label promotion regulations violate manufacturers’ free speech rights by suppressing the sharing of truthful and nonmisleading scientific information.

“It's time for the agency to take back this issue from the courts,” Kamp said.

Written comments are due Jan. 9, 2017.

For More Information

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


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