Botox is, without question, one of the most versatile drugs on the market today. It boasts three FDA-approved indications and Botox Cosmetic has one. Yet each product is employed outside of these indications for a number of “unapproved uses.” While the FDA doesn't restrict physicians from using Botox off-label—such as for the treatment of migraine—it can block manufacturer Allergan from promoting such uses. Allergan says that restriction infringes on its first amendment right to free speech, and the company is suing for the right to inform medical professionals about off-label uses.
Lacking legal training, I can't assess the merits of Allergan's Constitutional argument, but I support the spirit of the initiative. There's a line between educating and promoting that current FDA regulations simply disregard. Given its charge to assure the safety of drugs on the market, the Federal agency must have the power to prevent companies from marketing their drugs inappropriately. But why prevent the company from presenting scientific data to physicians in a responsible manner?
Current restrictions only serve to divert rather than block the flow of information, anyway. Industry often is forced to disseminate data through artificial channels just to create a separation between themselves and scientifically-derived information about their products. Even when data has been vetted through peerreview processes in some of the most prestigious journals in medicine, some companies will not distribute copies of those publications to avoid the appearance of off-label promotion.
The FDA says it wants to increase transparency. What could be more transparent than the direct delivery of scientific research from the drug companies to the physicians who use their products? Physicians and patients would benefit in the long-term.
Despite the best efforts of the FDA, it is obvious that current policies and procedures simply cannot protect the public from every risk. Regardless of the final judgment, maybe Allergan's suit could bring us one step closer to a new kind of FDA that, rather than serving as a strict gate-keeper to the market, provides a resource for drug data, safety reports, and guidelines for patients and doctors. Alex Tabarrok, of The Independent Institute (www.Independent.org), calls this the “Consumer Reports” model, and it might be just the solution to improving safety while empowering patients and respecting the rights of industry.