Off-Label Promotion —To Speak or Not To Speak?

By Tricia Kaufman

Earlier this month, the U.S. Food and Drug Administration (FDA) announced a two day public hearing to take place November 9 and 10 aimed at obtaining input from industry to help shape FDA's policy regarding communications about off-label uses of approved drug and device products. While recognizing the importance of allowing heath care providers to use products off-label and the need for access to scientific information regarding those uses, FDA scrutinized manufacturers, packers and distributors communicating about unapproved uses of approved/cleared products.

In its announcement, FDA stated that the review will help ensure that its implementation will best "protect and promote the public health in view of ongoing developments in science and technology, medicine, health care delivery, and constitutional law." Indeed, in light of recent cases finding First Amendment protection for truthful and non-misleading off-label promotion by firm representatives, there is a need for FDA to revisit what it considers acceptable.

FDA is asking stakeholders to provide information regarding its regulation of firms' off-label communications. In the meeting notice, FDA posed several potential questions for which it hopes to have responses. Some of the topics for which FDA is seeking input include:

  • How communications about unapproved uses will affect public health in general and across different categories of medical products
  • How changes in the health care system that give payors more influence over prescribing decisions provide incentives for firms to generate safety and effectiveness data and seek FDA approval
  • The impact of the increasing availability of information, especially from electronic communication platforms, on firms' incentives to provide information about unapproved uses
  • The standards that should apply to unapproved use communications and how to evaluate whether the information is scientifically appropriate
  • The information firms should be required to disclose to ensure audiences are not misled as to the product's premarket history relating unapproved use, product risks, the nature and weight of the evidence for the unapproved use and the financial involvement of firms in the research
  • Determining what is appropriate information for patients and consumers
  • How communications regarding unapproved uses should be monitored and how rules should be enforced by FDA
  • Policy and regulation changes FDA should consider to provide more certainty and clarity regarding the issues

This is an opportunity for stakeholders to voice their opinions and potentially impact the creation of safe harbors for firms to circulate vital information that can ultimately benefit patients.

Participants who want to attend in person must register by October 19 to ensure seating. Instructions for presenters can be found at FDA's website. Electronic copies of presentations are due by October 26. FDA will continue to accept electronic and written comments through January 9, 2017. More information on participation can be found at

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