The Food and Drug Administration ("FDA") recently announced that it is holding a public meeting regarding the "Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools," on November 12-13, 2009, in Washington, D.C. The meeting is intended to help guide FDA in making policy decisions on how the Internet and social media tools, such as blogs, microblogs, podcasts, social network sites, online communications, video sharing, widgets, and wikis can be used to promote FDA-regulated medical products in a truthful, non-misleading, and balanced manner. The meeting will focus on human and animal drugs and biologics and medical devices, and it will not address nonprescription drugs. FDA also is accepting written and electronic comments on the issue until February 28, 2010.
FDA believes that many promotional issues raised by the Internet and social media tools can be addressed by FDA's existing regulatory scheme. FDA has primary responsibility for ensuring that the "labeling" of prescription drugs, biologics, and medical devices is not false or misleading. The term "labeling" includes all "written, printed, or graphic" materials that supplement, explain, or are otherwise related to a regulated product. See 21 U.S.C. § 321(m) (Supp. 2009); see also Kordel v. United States, 355 U.S. 345, 349-350 (1948).
In addition, FDA has primary responsibility for regulating "advertising" for prescription drugs, biologics, and restricted devices. Although the Federal Food, Drug, and Cosmetic Act does not specifically define "advertisement," FDA generally interprets the term to encompass all promotional information, other than "labeling," issued by, or on behalf, of a manufacturer, packer, or distributor. Notably, the examples of "advertisements" listed in FDA's regulations are paid advertising, such as advertisements in journals, magazines, newspapers, and on broadcast media, such as the radio and television. See 21 C.F.R. § 202.1(l)(1) (2009).
However, the Internet has become a widely used medium for companies to promote, sell, and disseminate information about FDA-regulated medical products. The evolving nature of the Internet and social media tools have raised questions as how to apply existing regulations and policies to newer technologies, and the agency has conceded that in specific circumstances, additional guidance may be necessary.
Specific questions to be addressed at the meeting, or in written comments, include:
- For what online communications will manufacturers, packers, or distributors be held accountable? This includes the following issues:
- What criteria should be applicable to third-party communications on the Internet and through social media to determine whether those communications are substantially influenced by companies marketing products related to the communications?
- When should third-party communications be treated as being made by or on behalf of the companies marketing the product rather than being made by independent parties?
- How should companies disclose their involvement/influence over communications made on the Internet, particularly communications on third-party websites?
- Should different factors be considered depending on the specific social media platform used or the intended audience? If so, which factors?
- How can manufacturers, packers, and distributors fulfill regulatory requirements (e.g., fair balance) in their Internet and social network promotions? This includes the following issues:
- How should product information disseminated over social media tools be presented to ensure a balanced presentation of risks and benefits of medical products?
- Do different types of presentations have a positive or negative impact on public health?
- Are there solutions that would address concerns about using social media tools with space limitations or tools that allow for real-time communications to present product information?
- How should companies handle information posted on social media sites that may become outdated?
- What parameters should apply to the posting of corrective information on websites controlled by third parties? This includes the following issues:
- What criteria could be used to determine how much effort and what types of information a company must provide to correct misinformation posted on a website outside the company's control?
- Should those criteria differentiate between the prominence of the third-party site and its intended audience, purpose, and/or the authors of information on the site?
- When is the use of links appropriate? This includes the following issues:
- Are various methods of linking to research or other data about medical devices more apt to be misleading?
- Should criteria be established for links to and from websites?
- There also are a number of questions specific to Internet adverse event reporting. These questions include:
- How are entities with postmarketing reporting responsibilities and other stakeholders using the Internet and social media tools with regard to monitoring adverse event information about their products?
- How is adverse event information from these sources being received, reviewed, and processed?
- What challenges are presented in handling adverse event information from these sources?
- What uncertainties are there regarding what should be reported from these sources to meet FDA adverse event reporting obligations?
FDA welcomes the participation of all interested parties, such as patient groups, consumer groups, healthcare professionals, Internet vendors, advertising agencies, and the regulated industry. Registration to attend, or to participate in, the public meeting must be completed by the close of business on October 9, 2009, and it will be accepted on a first-come, first-served basis. FDA also is soliciting written or electronic comments on the subject from all interested parties. The deadline for filing comments is February 28, 2010.