The FDA is holding a public hearing to discuss online promotion of FDA-regulated medical products – including prescription drugs, prescription biologics, and medical devices. The hearing will be November 12 and 13, 2009 in Washington, DC (registration closes October 9 – see also registration instructions from Eye on FDA), but public comments can be submitted in writing or electronically now through February 28, 2010. View the docket details and full Federal Register notice.
A common reaction around the Web has been “Finally!” – with remarks like “This is NOT a Hoax!” and “Just in time for Web 3.0,” the FDA has set a date to start figuring out “how to deal with Web 2.0.” (NPR Health Blog).
But after the initial shock and sarcasm subsides, the potential significance of the FDA’s (albeit long overdue) move forward this week starts to sink in – this could result in the most significant set of regulations since the FDA’s guidelines for broadcast direct-to-consumer (DTC) advertising in the late 1990s. We’re talking industry-changing stuff here – or rather, industries-changing, because you can be sure that pharmaceutical companies, physicians, consumers, Internet and social media companies, the advertising and public relations industries, and everyone whose revenue includes online advertising are all major stakeholders in this public policy debate.
So what has the FDA highlighted as the key elements for discussion of this issue? (List below drawn from the 9/21/2009 FR notice)
1. For what online communications are manufacturers, packers, or distributors accountable?
(paraphrased) What communications and discussions should be considered “by, or on behalf of” versus independent of influence from these companies – and when and how should companies “disclose their involvementor influence,” particularly “on third-party sites”? Should different types of online media platforms and different intended audiences of these platforms be considered differently when addressing these questions – if so, how?
2. How can manufacturers, packers, or distributors fulfill regulatory 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)?
(paraphrased) How should product information be presented on these platforms so that users have appropriate access to both risks and benefits?
3. What parameters should apply to the posting of corrective information on Web sites controlled by third parties?
4. When is the use of links appropriate?
(paraphrased) Should there be rules about the use of “links to and from Web sites,” including links to or from unbranded websites to or from clearly branded company websites? And what research and data exists about the click-rates in different contexts of users seeking information about medical products?
5. Questions specific to Internet adverse event reporting
(paraphrased) How are companies that are obliged to report adverse effects of products using online media tools, if at all, to monitor information about adverse effects of their products? Should these companies be obliged to monitor and/or report information from online communications concerning adverse effects of their products?
We – and the FDA – want to know what you think. What are your gut reactions to all of this – do you find anything particularly worrying, are there any potential outcomes you’re especially hoping for?
More information about the public hearing and submitting comments is available here.
Robin Strongin blogs regularly at Disruptive Women in Health Care.