The FDA hearing process rarely results in immediate issue resolution and usually generates additional questions, which are then followed by a lengthy decision-making process. While the result one hopes for is clear direction, it is seldom quick in coming. The recent public hearing to discuss promotion of FDA-regulated medical products on the Internet, however, marks a shift from the FDA’s long-standing position that its regulations apply to all media and do not need to be modified for the Internet. This recent hearing resulted in acknowledgment that FDA attention is needed here – and soon.
The hearing titled “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools” occurred on Nov. 12 and 13 in Washington, D.C. What follows is a brief, big-picture overview of the FDA public hearing. If your company would like to add its voice, it can do that by way of written comment to the docket, which will remain open until Feb. 28, 2010. The notice of public hearing and request for comments including background and issues for discussion can be found at www.regulations.gov.
Two main issues were covered at the hearing:
Among the 77 presentations, four pharmaceutical companies were represented: Eli Lilly, Sanofi-Aventis, Johnson & Johnson and Pfizer. Trade organizations represented included PhRMA and AdvaMed. The remainder included tertiary stakeholders including Web companies, consumer health advocates, public relations firms and bloggers.
- How do the requirements in 21 CFR Parts 201 and 202 relate to certain Internet and social media–related activities?
- What are the responsibilities of manufacturers to monitor and report adverse events identified on the Internet and/or through social media tools?
The message from the pharma companies was consistent and, by now, as expected. The common theme was a reluctance to fully participate in social media and the Internet due to lack of clarity from the FDA about company obligations and responsibilities. With regard to accountability and how far any responsibility extends to monitoring the Internet for activity such as off-label discussions, adverse event reports and correcting misinformation, the industry clearly does not want to be responsible for the entire Internet. One presenter suggested a 3 Cs Rule of accountability for brands and online content: that the brand be accountable if it created the content, collaborated with the creator, or compensated the creator in some way. The presentations by tertiary representatives were repetitive and often self-serving. Their message: “We want, even expect, pharmaceutical and medical device companies to have an Internet presence and engage in social media.”
Still outstanding are answers to questions such as:
The overall request from most participants was a call to action for the FDA to exercise leadership and issue guidance on these topical questions. Eli Lilly suggested that the FDA consider more creative approaches to managing regulation, including holding regular workshops to address emerging issues. The company pointed out that the traditional process is too slow to effectively address the rapidly changing Internet, citing the recent quagmire created by Sidewiki. There were suggestions that the FDA can borrow from or work within existing guidance and regulation.
- Should companies be held responsible for brand references in consumer-created content, false information posted online, or monitoring online posts for adverse events?
- Should companies proactively monitor online discussions?
- Is it sufficient to have a disclaimer that your company does not monitor consumer posts?
- How will off-label comments and other inappropriate discussions be corrected?
- How will potentially identifiable adverse events be handled and how far does a company need to go to identify an anonymous post?
Specific to the issue of managing fair balance, PhRMA introduced a solution it calls a universal safety logo, either the FDA logo itself or an FDA-approved symbol embedded in Internet content symbolizing that the risk information has been FDA-reviewed. PhRMA’s solution includes a general risk statement that hyperlinks to FDA-approved full product information and favors a two-link design, one link to product information and the other to risk information.
Google shared its belief that the 14 untitled letters issued by the FDA in April 2009 have resulted in less clear, less transparent, less useful and less clicked-on advertising. Google unveiled a proposed paid search format to replace the faux “one-click rule” that includes an extra line for disclosures intended to capture an abbreviated statement of major risks, 62 characters long, adjacent to a second link taking the user directly to risk information. Google also proposed a solution for products carrying a boxed warning, which includes a tag that reads: “Click to see full safety and prescribing information, including boxed warning.” Similar to Google, Yahoo discussed its new format for display ads that includes a link inside the ad for safety information.
Tom Abrams, director of the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), acknowledged that “what we have heard is, it’s a different medium.” And in a post-meeting interview, he indicated that it is clear that enunciation of policy, perhaps through guidance, is getting closer to reality.
At the moment, the industry and its use of the Internet is stalled in a process overshadowed by legal and regulatory considerations. Clearly, there is hesitancy to engage. However, increasing numbers of companies are launching social media initiatives and piloting new search ads in an effort to find a satisfactory solution to the concerns expressed by the FDA. While many concerns were alluded to, they were not completely vetted in these recent hearings.
Your company may wish to take an active role in shaping policy by submitting comment on the FDA docket. It will remain open until Feb. 28, 2010, and can be accessed via www.regulations.gov.
In the interim, your path forward will depend largely on your company’s culture and tolerance for risk. Whether your company is satisfied to be on the sidelines, is actively engaging the 91 million Americans who turn each month to the Internet for health information or is somewhere in between, it is wise to begin defining a path that engages the Internet.
To get started, consider:
If you have questions about the promotion of medical products on the Internet and the use of social media, please contact Debra S. Dunne, R.Ph., Esq., Partner and Chair of Life Sciences Practice Group.
- building a cross-functional team of advisors to discuss your company’s challenges and to identify solutions;
- evaluating risks and keeping your activities in the area of low risk until you are knowledgeable and have taken sound steps to mitigate risk;
- customizing your social media strategy – one program does not fit all brands or all products;
- listening to and understanding your audience before you engage; and
- developing clear corporate policies and education platforms for employees.
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