After years of anticipation, the Food and Drug Administration will hold a public, two-day meeting starting on Wednesday to review the extent to which so-called off-label information about medicines may be disseminated to physicians.
Nothing will get decided, though. The meeting is designed simply to give the public — drug makers and patient advocates alike — a long-awaited chance to convey their opinions and debate the issue.
Off-label information refers to materials that describe unapproved uses of a drug. Doctors are allowed to prescribe a medicine for an unapproved use, but drug makers have long battled restrictions on their ability to distribute this type of information — such as reprints of medical studies — and have lobbied Congress and the FDA to loosen regulations.
The FDA, however, has avoided doing so. The agency has regularly voiced concern that public health could be jeopardized if a drug maker distributes information about an unapproved use that has not been proven safe or effective.
As we have reported previously, the industry effort accelerated after a 2012 ruling by a federal appeals court that overturned the criminal conviction of a Jazz Pharmaceutical sales rep, who was prosecuted for encouraging doctors to prescribe a drug for unapproved uses. The court ruled his speech was protected, since the information was truthful and not misleading.
Ever since, drug makers have argued that conveying certain types of information is a free speech issue. But the debate gained steam last year when Amarin filed a lawsuit arguing it had the right to off-label marketing, so long as the information provided to doctors is truthful and not misleading. A federal judge agreed with the company, which reached a settlement with the FDA.
“I believe this meeting will clear the way for the FDA to issue thoughtful guidance on a more liberal sharing of truthful, accurate, and non-misleading off-label information,” said Peter Pitts, a former FDA associate commissioner who heads the Center for Medicine in the Public Interest, a think tank that is funded, in part, by industry. “This is particularly important with a new administration coming in January.”
A parade of a few dozen people will speak, according to the FDA agenda, and agency officials are expected to incorporate their comments in finding answers to some key questions. Among them: what are the benefits for doctors, researchers and payers if they receive off-label information? And how might off-label information affect prescribing, as well as research into new products?
What else does FDA hope to sort out?
The agency wants to know how companies evaluate whether off-label information is scientifically appropriate — and not misleading — for communicating to doctors. And the FDA is also interested in assessing which criteria should be considered in determining whether a study used by a company is scientifically appropriate to support conclusions that are distributed.
A few more questions: What other information should be disclosed to ensure audiences are not misled? How effective are disclosures in ensuring that limitations concerning data about unapproved uses are adequately conveyed and understood? And what kinds of surveillance and monitoring should be done to measure and assess the public health impacts of unapproved use communications and by whom?
Critics say that widely disseminating off-label information would be dangerous to consumers.
“What’s the point of having an FDA then?” said Sid Wolfe of Public Citizen, the advocacy group, who will speak at the meeting. “Instead of providing rigorous evidence that a drug is safe and effective, the company could just hand out articles that don’t meet the test of efficacy. If the FDA does what industry wants, it will damage federal law that upholds safety standards.”
And Kim Witczak, an independent consumer advocate who will also speak, said “there are real life consequences. Patients need to know they can trust the medicines they’re given and that these are, in fact, approved by the FDA for the particular use. We shouldn’t be guinea pigs.”