FDA Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media – Webcast and Testimony
During the next two days we will be hearing from experts around the country at the FDA Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media, a number of good ideas will be presented.
There are a number of websites with links to testimony covering the event and the live webcast.
One twitter site has live tweets (thanks to the reader who set me straight on this)
For a live video and audio feed of the hearing:
http://www.capitolconnection.net/capcon/fda/111209/FDAlive.htm#
FDA Agenda, Speakers, and Other Documents.
We have highlighted several testimonies. As more testimonies come in we will provide links to them.
Arnold Friede
Speaking from over 35 years of food and drug law experience, Arnold I. Friede, a former Associate Chief Counsel in the FDA’s Office of Chief Counsel, offered a refreshing look at a regulatory pathway to advance public health by enabling robust marketing by regulated companies, and at the same time coordinating effective enforcement against health fraud on the Internet.
In his written testimony before the panel, Mr. Friede noted three primary interpretive impediments to FDA policy on the use of Social Media and the Internet. First, where and how risk information must be disclosed in advertising and promotion. Second, whether and when statements should be attributed to a medical product “sponsor” for purposes of the prohibition on “off-label” promotion. Finally, mandatory reporting requirements whenever a sponsor becomes “aware of” information suggesting that an adverse event may have been caused (or “contributed to”) by one of the sponsor’s products.
During his first day of testimony Mr. Friede offered a framework of how to approach these hurdles. He noted that FDA’s position to requrie instantaneous and contemporaneous disclosure of all risk information whenever a product name and any mention of any product attribute appear together in a sponsored medium, is problematic. Mr. Friede explained that such a requirement is not “always possible or even desireable.”
Instead, he offered a an alternative: FDA should focus on context in determining the adequacy of risk disclosur. Such a notion Mr. Friede reminded the panel, is consistent with the approach FDA has taken to “bookending” of help seeking and reminder advertisements, where FDA has said that it will look to overall context, including perceptual similarity, in deciding if the two in proximity to each other should be considered a single “advertisement” subject to risk disclosure requirements.
The focus on context would also be consistent with the statutory definition of “labeling”, which looks at overall “context” in determining when an item “accompanies” a product so that it is deemed, by law, to be “labeling”.
Another argument for the use of context are existing regulations that apply to direct-to-consumer (DTC) television advertising, where FDA acknowledges that contemporaneously available complete risk information, even if not physically or technologically connected in any way to the advertising in question, can nevertheless satisfy statutory risk disclosure requirements. This so called “adquate provision” should be used for Social Media, Mr. Friede asserts.
Moving onto the topic of off-label promotion, Mr Friede acknowledged that not all “off-label” statements by anyone on an Internet web site or Social Media site operated or sponsored by a pharmaceutical or medical device manufacturer are inappropriate. In fact, to suggest so would seriously hurt the “information marketplace” where many consumers and patients have learned to depend on social media.
The liability of having such statements on sponsored sites could hurt companies, “such as Sidewiki, where information can be posted to, and effectively become part of, a web site without any involvement whatsoever by the manufacturer and can thereafter be viewed by anyone with the appropriate Internet tools.”
When a manufacturer has done nothing more than provide a a facility whereby someone posts an unsolicited off-label comment, there should be no liability. Sponsored sites should however, have the ability to direct or control the content of the posting, or delete it or disclaim it. In fact, the “FDA, has acknowledged in a variety of circumstances that a manufacturer is not automatically liable for third party behavior that it does not dictate or have the ability to control.”
Likewise in the context of its Guidance on Continuing Medical Education (CME), FDA has implicitly acknowledged that agency law principles of “direction and control” are relevant in determining if “off-label” CME will be imputed to a manufacturer who provides funding for a CME program. With regards to social media, Mr. Friede believes FDA should also direct and control “the content of a communication, for when a company that maintains or sponsors a Social Media or other Internet web site is legally responsible for “off-label” communications posted there.”
Consequently, Mr. Frieder also recommends the FDA adopt the Federal Trade Commission (FTC) policy where “by third party bloggers are imputed to a product “sponsor” only if there are indicia of direction and control by the sponsor over the content of the communication. Otherwise, the product sponsor will not be liable for the endorsement.”
On his second day of testimony, Mr. Frieder spoke about the Adverse Event Reporting System (AERS or AE). He explained how “the concern about AE reporting stems from FDA rules that mandate reporting whenever a sponsor becomes “aware of” information of sufficient specificity showing that the sponsor’s product may have caused, or contributed to, an AE.”
In addressing this concern, he asserted that there is no need to worry about such requirements for two reasons. First, because “some of this information is likely duplicative of what has already been reported.” Second, “because some is undoubtedly cumulative in the sense that the incidence and severity of the AE is already fully and completely addressed in the product’s labeling and the additional information does not add meaningfully to what we know about the product’s risks and how to manage them.”
He also appeased such a concern by noting that “companies probably spend 99% of the time in safety monitoring in finding and reporting the very last AE.” In addition, the FDA also spent $2.7 million on study these reports. As a result, Mr. Frieder simply asked that the agency to wait until the system has been “empirically validated as a meaningful basis for regulatory decision making,” before worrying about how social media impacts such reporting.
Coalition for Healthcare Communications
Also presenting at the meeting was John Kamp, Executive Director of the Coalition for Healthcare Communication. Mr. Kamp’s remarks were also on behalf of The American Association of Advertising Agencies (AAAA).
Mr. Kamp propsed that FDA’s policy should foster increased, more reliable health information on the Internet. Such an increase is necessary because professionals consumers, companies and social media sites are relying on industry partnerships to support provision of trusted health information.
These health care providers, through industry support, are using social media to have conversations online to improve patient care, and provide a venue for persons to have group discussions regarding treatments and emotional needs.
Since industry information and financial support are so vital to different forms of social media, Mr. Kamp called for transparent industry involvement. Sites should include places for consumers and professionals to find FDA regulated information (FRI), and use new intra-industry and inter-agency efforts to fight widespread Web healthcare inaccuracy and fraud.
Organizations like the Coalition and AAAA recognize the power and public health promise of social websites, and would use these new efforts to show consumers and professionals that industry promotion on these sites is overseen by FDA.
Accordingly, Mr. Kamp noted that when dealing with potential problems, not all of the blame should be placed on industry, especially when many of the social media sites are in control by the individual user. New efforts must control the information being shared. There should not be a feeling of big brother where there is already control by FDA regulations for company sites and advertising.
Concluding his presentation, Mr. Kamp asserted that the best way of addressing these issues is to enable and strengthen the incredible information and conversations on the Internet these social media allow through industry support and collaboration that has clear guidance for users. These standards should be applied on a national level, and regulatory policies should be supported by linking techniques to make FDA regulated details more accessible to professionals, patients and care givers.