Lieff Cabraser Civil Justice Blog
Upcoming FDA Public Hearing on Off-Label Drug and Device Use

Upcoming FDA Public Hearing on Off-Label Drug and Device Use

The U.S. Food and Drug Administration (FDA) has announced a public hearing forum to take place on November 9-10, 2016 with regard to the enforcement of rules relating to off-label drug and medical product use in the public health industry. The registration deadline to present at the hearing is October 19, 2016, and the deadline for written commentary after the hearing is January 9, 2017.

Current First Amendment law relating to commercial speech includes protections for non-misleading communications from manufacturers even when those statements relate to off-label product use. Off-label use of medical products presents an area of great concern to all parties involved, including patients, physicians, insurers, and manufacturers. Many are looking to the FDA for signals on whether it will issue additional formal guidance on how manufacturers can and cannot talk to prospective users and physicians about such off-label use of their products. Some off-label use has historically led to significant problems, including unanticipated or unwarned side-effects, injuries, and attendant lawsuits.

According to Health Law Advisor, “topics on which FDA is seeking feedback are broad, but generally include:

• The impact of off-label communications on public health,
• The impact of changes in the health care system on the development of high-quality data on new uses of cleared or approved products,
• Preserving incentives for manufacturers to seek approval for new uses, standards for truthful and non-misleading information,
• Factors FDA should consider in monitoring and bringing enforcement actions based on off-label communications by manufacturers,
• The extent to which data on which off-label communications are based should be publicly available, and
• The changes FDA should consider to existing regulations governing manufacturers’ communications regarding their products.”

Increased pressure from lawmakers and public interest groups — as well as from other groups of stakeholders — is falling on the FDA to address the commercial speech protections for pharmaceutical and medical device manufacturers under the First Amendment law. In particular, off-label use of drug and medical device products that have been approved, licensed, or cleared. Also in demand with regard to manufacturer communications is the inclusion of economic healthcare information when it comes to promotional labeling, marketing, and advertising of these drugs to the public. The FDA’s guidance agenda was most recently updated on August 6, 2016.