FDA Solicits Comments Regarding Promotion of FDA-Regulated Medical Products Alert - September 24, 2009
FDA Announces Public Hearing and Solicits Comments Regarding the Promotion of FDA-Regulated Medical Products Through the Internet and Social Media
September 24, 2009
Jonathan E. "Jon" Anderman- Boston
Michael R. Manthei- Boston
The Food and Drug Administration (FDA) recently announced a public hearing to discuss various issues related to the promotion of FDA-regulated medical products through the Internet and social media.1 In conjunction with the public hearing, the FDA is seeking written and electronic comments from all interested parties. The FDA intends to use the resulting information and comments to guide it in making future policy decisions on the promotion of medical products through the Internet and social media.
In addition to collecting general information regarding social media marketing, the FDA identified several questions to help obtain specific input from consumers, patients, healthcare professionals, Internet vendors, advertising agencies, regulated industry and other interested parties. Specifically, the FDA identified the following five issues for discussion:
- For what online communications are manufacturers, packers, or distributors accountable?
- How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, postmarketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g., microblogs, mobile technology)?
- What parameters should apply to the posting of corrective information on websites controlled by third parties?
- When is the use of links appropriate?
- Questions specific to Internet adverse event reporting.
The FDA will accept written and electronic comments on these issues until February 28, 2010. The announced public hearing will occur on November 12 and 13, 2009, from 8:00 a.m. to 5:00 p.m. in Washington, D.C. Those interested in attending must submit a written or electronic registration by October 9, 2009.
Electronic registration and electronic comments must be identified with the docket number FDA-2009-N-0441 and submitted to http://www.regulations.gov.
Written registration and written comments must be submitted to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fisher Lane
Room 1061
Rockville, MD 20852
The decisions that follow from these hearings could set standards by which healthcare and life sciences companies will have to abide for many years to come. Participation by stakeholders in the process is essential in order to promote the adoption of a rational regulatory framework.
To better inform you of the issues and of your opportunity to participate in the process, Holland & Knight’s Health Law & Life Sciences Team will be issuing a series of alerts that will discuss in greater detail each of the five issue areas identified by the FDA.
1 Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools; Notice of Public Hearing, 74 Fed. Reg. 48,083 (Sept. 21, 2009); http://edocket.access.gpo.gov/2009/pdf/E9-22618.pdf.
About the Editor: Michael R. Manthei
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