Life Science Compliance Update

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May 28, 2014

FDA to Consider Expanding Scientific Exchange

At the 2014 FDLI Annual Conference, senior officials at FDA noted that the agency is not taking lightly industry's concerns that its existing off-label policies are out of line with the most recent First Amendment case law. We have recently covered FDA off-label policies.

As reported by the Coalition for Healthcare Communication, Leslie Kux, FDA's assistant commissioner for policy and director of the Office of the Commissioner's Office of Policy, cited some of the off-label promotion policies that the FDA is reconsidering in response to industry's concerns. These include policies pertaining to unsolicited requests for information, scientific exchange, communication with formulary committees and payers, healthcare economic information and third-party clinical practice guidelines.

Kux indicated that the agency has "taken a number of steps to start down this road," such as opening a docket on scientific exchange (and developing draft guidance documents on the matter "relatively soon"), working on the final unsolicited requests draft guidance and drafting a guidance on healthcare economic information.

"We are looking more broadly, so I do want to assure everybody that we are taking the First Amendment concerns that we've heard very seriously," Kux told the FDLI meeting attendees. She noted that the agency is accepting comments on the draft reprint guidance until May 2. "We'd be very glad to have everyone's comments on that, too," she said.

Coalition for Healthcare Communication Executive Director John Kamp stated: "Clearly FDA has officially moved from the denial phase into a more realistic and productive mode in response to the reality that the First Amendment applies to its rules and policies."

"The CHC and others are anxious to dialogue with the agency on how best to reform the rules for the benefit of patients," he said.

The Coalition's report continued: The agency's collective actions in light of First Amendment issues raised by industry in comments and in a citizen petition filed by the Medical Information Working Group in September 2013 – which requested that the agency review the recent developments in First and Fifth Amendment case law, as well as ongoing changes in the delivery of medical services (see – indicate that the agency is not turning a blind eye to First Amendment concerns."

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