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This weekly column offers opinions on the latest pharmaceutical industry news.

Drug makers have long argued that the Food and Drug Administration is squelching their free speech rights by barring off-label promotion of their medicines. A new proposal may give them a voice.

This month, a think tank at Duke University called for a new independent entity to review claims and recommend exactly what off-label information drug and device makers should be allowed to share with doctors.

Companies say current regulations prevent them from distributing important data to physicians about unapproved, off-label uses of their medicines. The FDA worries public health can be compromised if marketing claims aren’t backed up by solid evidence. A neutral third party, the authors of the white paper say, could provide much-needed arbitration.


“There’s a lot of accurate and scientifically robust information that can be shared,” said Peter Pitts, a former FDA official who now heads the Center for Medicine in the Public Interest and is one of the authors of the proposal. “But the FDA can’t be expected to review everything itself.”

That’s true. The agency does have limited resources. But the real issue is whether an independent body would, ultimately, undermine FDA authority and serve as a marketing tool as much as anything else.


Industry critics have long worried companies are looking for ways to distribute promotional fluff. And such concerns divided the working group at the Duke-Margolis Center for Health Policy, which hosted a conference two weeks ago where the paper was issued and discussed (watch session one and two).

“I think this proposal is asking the wrong question,” said Dr. Joshua Sharfstein, a former deputy FDA commissioner and an associate dean at the Johns Hopkins Bloomberg School of Public Health, who did not help write the proposal.

“I fear this is all about asking how we can allow companies to promote as much as possible,” he said. “Instead, we should be asking: How can we create the correct incentives so that good research is done and we get the best information to distribute?”

A key reason the notion emerged now is the ongoing uncertainty over industry free-speech rights.

Four years ago, a federal appeals court overturned the criminal conviction of a pharmaceutical sales rep for promoting off-label uses of a drug. The court ruled that his actions constituted protected speech, since the information was truthful and not misleading. The FDA never challenged the decision, but it only extends to three states. Drug makers may have won, but they are gun-shy about testing the decision’s limits.

Last August, meanwhile, a federal judge picked up on the theme and ruled that a drug maker called Amarin can promote the benefits of a prescription fish oil pill, so long as the company does not give doctors false or misleading information. (Settlement talks are under way and a progress report is expected this month.)

And last week, a federal court jury in Texas decided that the medical device maker Vascular Solutions and its president were not guilty of off-label promotion since the information the company gave to doctors about a laser therapy device was deemed truthful and not misleading (read the jury instructions).

To what extent these results will broadly affect drug and device makers, for now, is unclear. But one thing that’s coming into view is that the FDA is ill-equipped to vet all of the off-label information that drug companies would want to distribute — and to some, it’s not just a question of resources.

According to Coleen Klasmeier, an attorney at Sidley & Austin who specializes in FDA regulatory issues, the pharmaceutical industry is convinced the regulatory agency is unlikely to adopt sufficiently flexible standards for reviewing off-label information.

“So then the question becomes: ‘Why does it have to be FDA that assesses the information?’” said Klasmeier, a coauthor of the Duke white paper. To her, the proposal offers a way forward because “We’re in limbo.”

To ameliorate concerns that an independent review body might be a proxy for industry, the white paper suggested recommendations would not be binding on the FDA. In effect, this would give the agency veto power. But such a scenario could also yield the sort of stalemate that currently frustrates companies.

Of course, for now, the white paper is only a white paper. There are no details, for instance, on how the review body would be funded or on the criteria for choosing panel members. Coauthors like Dr. Richard Schilsky just want to start a broader discussion.

“I’m not particularly in favor of this myself. Ideally, this should be a function reserved for the FDA,” said Schilsky, chief medical officer at the American Society of Clinical Oncology. “But sometimes only a company is aware of the full range of information that could be of benefit and should have a mechanism to convey that.”

“This tries to strike the right balance and stimulate the conversation,” Schilsky added. “And more conversation is needed.”

Indeed, it is. The white paper attempts to address legitimate industry concerns. And, generally, having more information is a good thing. But a third-party entity should not be allowed to become the proverbial Trojan Horse and diminish patient safety.