Industry Comment Summary: Two Key Reasons Medical Device Companies Need Clear Guidance on Off-Label Communications

Two Key Reasons Medical Device Companies Need Clear Guidance on Off-Label Communications

November 1, 2012

At AdvaMed’s annual conference this year, medical device industry leaders urged the Food and Drug Administration (FDA) to establish a clear policy on the scientific exchange of information regarding off-label or unapproved uses of devices. The renewed request follows a joint citizen petition (CP) filed by seven drug and device companies on July 5, 2011, arguing that the lack of clear regulatory guidance involving off-label information places manufacturers at a risk of criminal and civil sanctions because they are unable to accurately gauge whether FDA will consider certain communications and responses illegal off-label promotion. In initial response to the CP, FDA issued a draft Guidance for Industry on Dec. 28, 2011, regarding how drug and device manufacturers should respond to unsolicited requests for off-label information. In addition, through a Federal Register notice, FDA sought comments and information on the industry’s views of the draft guidelines. The comments submitted to FDA have noted the need for a clear FDA policy for two main reasons:

  1. Spur Innovation: FDA’s eventual guidance will define what type of communications will be considered scientific exchanges of information and which will be considered illegal off-label promotion. If FDA severely limits the definition of “scientific exchanges,” medical device industry leaders warn that innovation would be stifled. FDA has previously recognized the value of off-label discussion, stating that scientific exchange can benefit the public health. Healthcare practitioners often require access to scientific information regarding both investigational products and off-label uses of approved products to make informed decisions and ensure quality care. Broadening the definition of “scientific exchanges” to encompass more than journal articles will foster intelligent discussions about new products coming down the pipeline and spur innovation.
  2. Protect Industry: In addition, clear guidance from FDA will protect practitioners and representatives of drug and device manufacturers and will assist their ability to educate practitioners and convey information without putting the representatives or the practitioners at risk. When a practitioner relies on these off-label discussions to provide adequate care for their patient population, clear guidance will permit a clinician to correctly seek information that will ultimately provide better care for his or her patients.