Review of Ophthalmology's blog
The Off-Label Plot Thickens
By Christopher Glenn, Editor in Chief, Review of Ophthalmology
The interface between physician practice and industry messaging, an untidy and changeable nexus at best, took a couple of interesting turns in recent weeks. The long-term implications are probably best left to the long-term, but they could be significant.
In early December, the U.S. Court of Appeals for the Second Circuit reversed a lower court ruling and held that the long-standing Food and Drug Administration prohibition on off-label marketing was a violation of manufacturers’ freedom of speech. This week, the agency announced that it would not seek an appeal, fearing, say some experts, that a loss would have national implications and throw the entire concept of FDA approval into question.
For example, why seek a time-consuming, expensive indication if you can get an easier one and then market it as you wish? If you can legally market off-label to physicians, then why not direct to patients?
The expectation is that there are better cases on which to make a stand making their way through the courts, and the government chose to limit the damage to the second circuit for the time being.
Off-label marketing of branded drugs is clearly attracting greater interest as more blockbuster drugs go off patent and potential generic replacements emerge. An FTC report this week found that 2012 saw the highest number ever of “pay to delay” settlements, in which patent-holders pay generic drugmakers not to develop or to delay marketing an authorized generic.
Against that backdrop, a Harvard University study published in January’s JAMA Internal Medicine finds that nearly 40 percent of the 1,900 surveyed physicians said they accede to patient demands for branded drugs even when a generic equivalent is available. Drug samples and meetings with pharmaceutical company representatives appeared to boost that rate, according to the study. The good news, say the authors, is that 60 percent of respondents say they resist such influences.
This month, the FDA made much of the launch of its new Medical Device Innovation Consortium, an independent, nonprofit corporation that will receive input from industry, government, and other nonprofit organizations. MDIC will prioritize the regulatory science needs of the medical device community and fund projects to help simplify the process of medical device design and pathway to market for these innovations.
Let’s hope it works, and that it may even serve as a model. Why not apply the same approach to the question of expanding the uses of approved pharmaceutical products based on scientific evidence instead of marketing hype, and to fill real medical needs instead of just additional sales opportunities?