Is Off Label on the Table?

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  • 03/26/2014
From the pages of the Wall Street Journal ...

Pharma and the First Amendment: A Proposal From the FDA

By Ed Silverman

On one hand, the agency is being praised for trying to move the ball forward, given ongoing uncertainty over disseminating material that contains off-label uses. Although physicians may prescribe a drug as they see fit, many drug makers have been fined for promoting their medicines for uses not approved by the FDA.

Yet at the same time, the FDA is being criticized for being overly restrictive concerning some materials and for also failing to specifically address First Amendment issues that have figured prominently in some recent court rulings about drug marketing.

“The fact that they’re starting to pay attention and open up off-label communications indicates they know they have to do a better job of defending the limits they have, and specifying what can and can’t be used and how that’s done,” says John Kamp, executive director for the Coalition for Healthcare Communication, a trade group for medical publishers and advertising agencies. “There are steps forward here. But in some cases, baby steps.”

One portion that was welcomed by industry representatives pertains to clinical practice guidelines, the official recommendations for patient treatment that are issued by professional medical societies. Until now, the FDA had not addressed these guidelines, which are closely tracked by doctors and may include off-label uses. The guidance says that CPGs must be distributed separately from promotional information and should display a statement that some of the products described might not approved or cleared by the FDA, among other things.

By devoting a portion specifically to clinical practice guidelines, the agency has now carved out a separate road map for distributing these missives to physicians.

“They’ve brought some clarity to this issue, which is very important,” says Alan Bennett, an attorney who represents more than a dozen drug makers that last fall filed a citizen’s petition (PDF) with the FDA in hopes of gaining clarity on distributing materials that contain references to off-label uses. The drug makers include Eli Lilly, Novartis, Sanofi, Genentech, Purdue Pharma, Pfizer and Johnson & Johnson.

But the FDA raised some hackles with its other dictums. For one, the agency did not add much understanding to an earlier guidance from 2009 that was devoted to medical and scientific journal reprints containing off-label information. This time around, though, the FDA noted that it does want companies to limit reprints to “adequate and well-controlled clinical” studies.

The earlier guidance also mentioned pharmacokinetic, pharmacodynamics and meta-analysis studies.

This would appear to preclude almost anything other than a double-blind, placebo-controlled study, according to Richard Samp, chief counsel at the Washington Legal Foundation, a nonprofit that frequently agitates for commercial free speech rights. “Against the great weight of medical opinion, FDA continues to insist that other types of studies have no scientific validity,” he says.

There was also disappointment that the FDA did not address the simmering debate over distribution of off-label materials that may be protected by the First Amendment. One closely watched case involved the 2008 conviction of a former pharmaceutical sales rep, who was prosecuted for encouraging doctors to prescribe a drug on an off-label basis.

A federal appeals court, however, overturned the conviction in late 2012 after agreeing that his First Amendment rights were violated because the federal government failed to prove his remarks were false or misleading. But the FDA did not discuss free-speech issues in its guidance at all. “They were silent on this and at some point they’re going to have to address it,” says a disappointed Bennett.

For now, the guidance may be sufficiently restrictive to discourage drug makers from taking many chances. “The hurdles for any meaningful dissemination of peer-reviewed information on off-label uses are very high,” says Arnie Friede, a former FDA associate chief counsel and former senior corporate counsel at Pfizer, who is now at Sandler, Tavis & Rosenberg, a law firm based in Miami.

And he notes that many drug makers may already be gun shy due to Corporate Integrity Agreements. These stem from settlements relating to off-label promotion, and many already regulate the dissemination of this material. “In theory,” he says, “a company subject to a CIA will have to run a dual gauntlet – compliance with the CIA and compliance with the draft guidance. So it becomes a fair question to ask: why bother?”


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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