After years of anticipation, the Food and Drug Administration US will hold a public, two-day meeting in November to examine the extent to which the so-called off-label drug information can be disseminated to physicians.
off-label information is the regulatory jargon for materials describing unauthorized uses of a drug. Doctors are, in fact, can prescribe a drug for an unapproved use, but drug makers have irritated a lot of restrictions on their ability to distribute such information – reprints of medical studies, for example – and have pressured the Congress and the FDA to loosen regulations.
Despite these efforts, the FDA has taken a firm stance towards the issue. One of the main concerns is that public health could be at risk if a company to distribute information about an unapproved use had not been proven safe and effective, a standard for regulatory approval.
The issue became highly questionable, however, after a fault 2012 by a federal appeals court that dump criminal conviction of a sales representative Jazz pharmaceutical, which was processed by encouraging doctors to prescribe a drug for unapproved uses. The court ruled his speech was protected, because the information was truthful and not misleading.
Since then, drug makers have argued that the transport of certain types of information is protected by the First Amendment. The debate accelerated last year when Amarin filed a lawsuit arguing that he had the right to off-label marketing, provided that the information provided to doctors is truthful and not misleading. A federal judge agreed with the company and the FDA recently reached an agreement with Amarin.
Throughout these events, the FDA said it would issue regulations on off-label marketing and hold a public meeting to review the countless topics.
However, drug manufacturers and their fans have grown impatient and fear that several court rulings could become a de facto standard. Last winter a independent review panel was launched as a way to address the issue. Last May, two lawmakers accused the United States Department of Health and Human Services to delay new rules and issued a bill that allow companies to market products for unapproved uses.
the next meeting will take place on November 9 and 10 at the offices of the FDA in Silver Spring, Md., is supposed to give the public the long-awaited opportunity to convey their views and discuss the issue. In a notice published Wednesday in the Federal Register, the agency raises several potential which expects to receive answers about the pros and cons of off-label marketing questions.
“The FDA is interested in commenting on the extent to which additional communications companies about unapproved uses can provide access to information that is relevant, scientifically sound, presented responsibly, and it provides the most complete understanding possible about the limitations of the available evidence and comments to the extent that health professionals are currently facing impediments to access such information, either from businesses or from other sources, ” says the notice.
Among the questions: What are the benefits for clinical decision-making, research, coverage, reimbursement, or for other purposes if companies communicate health professionals, taxpayers, researchers and patients more information, including preliminary or inconclusive information, about unauthorized uses of medical products approved / cleared? What are the disadvantages and risks? Are there any guarantees or requirements that effectively reduce any inconvenience or risks?
Another question: How can the communication of information on unauthorized uses of medical products approved affect incentives for patients to enroll in clinical trials
And another “to what extent the changes occurring in the health system that give payers and committees form more influence on prescribing decisions (including deny, limit, or support coverage unauthorized uses of approved products) provide incentives for companies to generate the high quality of the data needed to demonstrate the safety and efficacy of new uses “
and a little further:” What criteria should take the body into account in determining whether a study or analysis that is the basis of communication of a company is scientifically appropriate to support presentations or conclusions in communication “
” What professional health care in general understand about the quality and usefulness of different types or levels of scientific evidence related to unapproved uses? It may be the same misleading information to some audiences of health professionals and not others? “
It is not clear how long it will take the FDA to issue new regulations.