A notice was published today in the Federal Register regarding a two day public hearing that will be held on November 9-10, 2016 by the U.S. Food and Drug Administration (FDA) to obtain input from a wide range of stakeholders regarding communications by industry related to unapproved uses of FDA-regulated drugs, biological products and medical devices (collectively, “Medical Products”). The announcement noted that FDA has been engaged in a comprehensive review of its regulations and policies related to off-label communications of approved or cleared Medical Products since 2014, and input from the meeting will further inform FDA’s policy development.
The announcement lists 8 specific areas in which the FDA is seeking feedback regarding: (i) how increased communications from firms about unapproved uses could impact the public health; (ii) changes in the health care system outside of FDA’s role that provide an impetus for the development of high-quality data; (iii) the impact of the increasing availability of information regarding unapproved uses of approved/cleared products and other factors that firms may consider when making decisions about providing information about unapproved uses of their approved/cleared Medical Product; (iv) standards that should apply to unapproved use communications to minimize the potential of these communications to be misleading or otherwise cause harm; (v) factors that the FDA should consider in evaluating whether communications about unapproved uses of approved/cleared Medical Products are truthful and nonmisleading; (vi) whether information used in a communication should be required to be provided publicly and how transparency of this information should be monitored; (vii) how the FDA should monitor communications about unapproved uses of Medical Products, and what actions FDA should take with respect to communications that are determined to be false, misleading or otherwise raise public health issues; and (viii) additional changes FDA should consider in its regulations related to communications about Medical Products and the advantages/disadvantages of these proposed changes.
The Pharmaceutical Research and Manufacturers of America (PhRMA) issued a press release, emphasizing that it was “pleased that FDA has recognized that ‘relevant, truthful, and non-misleading scientific or medical information regarding unapproved uses of approved medical products may help health care professionals make better individual patient decisions.’” PhRMA released its Principles On Responsible Sharing Of Truthful And Non-Misleading Information About Medicines With Health Care Professionals And Payers in conjunction with the Biotechnology Innovation Organization (BIO) last month. It also is likely that any potential Congressional action through 21st Century Cures or otherwise will be postponed to provide FDA time to proceed with the forums and collection of comments.
Individuals who wish to attend or present at the public hearing must register by October 19, 2016. Interested parties also may submit written comments until January 9, 2017. A transcript will be made available after the meeting.