Off-label shouldn't be off-limits.

In a recent issue brief my colleague, Jim Copland, and I discussed the impacts of the recent U.S. Court of Appeals for the Second Circuit's landmark ruling in U.S. v. Caronia - that criminalizing the communication of truthful information about an FDA-approved drug was an unconstitutional impingement on free speech.

The decision highlighted two emerging, but competing, trends in medicine and law: the growing use of FDA-approved medicine for off-label prescriptions and the increased criminalization of pharmaceutical promotion. As it turns out, off-label use is already quite common - some 21 percent of commonly used drugs are prescribed off-label. Nonetheless, the FDA has adopted very restrictive and complex regulations for when pharmaceutical companies can discuss off-label uses for their products, even when those uses are routine in the medical community. And these restrictions only apply to pharmaceutical companies - independent physicians, academic researchers, and consumer groups are entirely free to say what they want about the risks and benefits of FDA-approved medicines.

No one is arguing that companies should be able to say anything and everything about their products. We argue that that the FDA should create a safe-harbor for truthful, scientific information about the emerging uses of their products - allowing for the dissemination of information on drug benefits, as well as risks. (Currently, the FDA requires companies to communicate known information about off-label risks - it's the benefit information that companies can't communicate, with some very narrow exceptions.)

More information means more informed physicians and better care for the patients they treat.

Unfortunately, the FDA isn't the only agency restricting the communication of truthful information about new medicines to consumers. Medical schools and health systems are increasingly restricting pharmaceutical company representatives from communicating with doctors about new products. The result is that physicians have less access to emerging information about both the risks and benefits of medicines.

In fact, a 2012 study published in the Journal of Clinical Hypertension by Chressanthis et al found that physicians with high access to pharmaceutical representatives - who would inform them about better-performing, innovative drugs as well as new warnings about the risks of older drugs (i.e., those of their competitors) - adopted the new treatment between 1.4 and 4.6 times faster and reduced the use of the older treatment 4 times faster.

To put it in simple terms, truthful communications between pharmaceutical companies and doctors (already heavily monitored by the FDA) is generally good for patients. While marketing abuses should be curtailed (and the industry has ended its practice of wooing doctors with expensive trips and meals), we shouldn't throw the baby out with the bathwater and restrict information from companies that can save lives and improve health.

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