On November 9-10th, the Food and Drug Administration (“FDA”) held a two-day hearing to collect feedback regarding whether drug and device manufacturers should be allowed to promote their products for uses outside of their FDA-approved treatments (i.e., “off-label”). The FDA announced that it is “engaged in a comprehensive review of its regulations and policies governing firms’ communications about unapproved uses of approved/cleared medical products, and the input from this meeting will inform FDA’s policy development in this area.” See announcement. While the hearing marks only the very first steps towards potentially lifting the ban against off-label marketing, the FDA’s invitation to engage in such a dialogue marks a significant shift in the agency’s enforcement regime that has been firmly in place for nearly half a century.
The ban on advertising off-label uses of drugs dates back to 1962 when Congress barred the practice after the off-label promotion of a drug to treat morning sickness in pregnant women led to birth defects. By contrast, no law prohibits a physician or other healthcare profession, using her professional judgment, from prescribing a medication for a use other than its FDA-approved indication. Indeed, research proves that 10 to 20 percent of drug prescriptions written in the United States are for off-label purposes. See article. The reason for this significant percentage of prescriptions is that doctors want to take advantage of new uses of drugs that may be supported by strong clinical evidence, but have not yet been approved by the FDA for the identified issues.
Perhaps the most notorious formerly off-label prescription drug is Botulinum Toxin, or Botox. The drug was originally developed and approved to treat crossed eyes and eye-twitching. Nearly two decades later, the FDA approved the drug as a wrinkle relaxer to treat eyebrow furrows. Today, the FDA has approved Botox for a number of applications from wrinkle relaxers to treatments for excessive sweating.
In recent years, the debate surrounding off-label drug promotion has entered courtrooms across the United States. Courts have struggled to control the limitations on government regulation of pharmaceuticals, especially where they feel it becomes an infringement on the First Amendment free speech guarantee. Most notably, the Second Circuit ruled in 2012 that a drug sales representative had suffered a violation of his freedom of speech where he was criminally prosecuted for promoting the off-label use of the drug Xyrem to treat muscle conditions other than the approved-indication for narcolepsy. See United States v. Caronia, 703 F.3d 149 (2d Cir. 2012). Moreover, many physicians are proponents of encouraging a free-flow of information that makes them informed about beneficial treatment options.
However, many consumers on the other side of the debate fear the consequences of allowing unfettered promotion of off-label indications. The main concern is that pharmaceutical companies may seize the opportunity to market their products for a variety of uses where there is incomplete or—potentially worse—poor-quality research.
From a products liability perspective, pharmaceutical companies should consider how the relaxed restrictions regarding off-label drug advertising will potentially increase their litigation risks. Although misbranding actions initiated by the FDA may decrease, companies could still be exposed to a potentially higher volume of consumer-based claims for false advertising. We will continue to monitor this important development in FDA policy.