The last time the U.S. Food and Drug Administration gathered information on how it ought to regulate medical information on the Internet, it was 1996. Google wouldn’t exist for 2 more years, and Facebook founder Mark Zuckerberg was 12 years old.
That is all about to change. The FDA will, in mid-November, hold a hearing to get comments from the public on a huge list of questions as the agency considers whether to revise its approach.
Given the silence from the FDA about the rules of the road for online communication, this has been greeted with breathless excitement by FDA-watchers (the Federal Register notice is a “must-read,” read one
early comment on Twitter. “Nothing less than astounding,” gushed a blogger). And while the hearing will no doubt be looked back upon as a turning point in term of FDA rulemaking, there are a number of myths worth dispelling about where the FDA is headed:
Myth #1. The FDA Cares About Your Opinion: The 2-day hearing is going to be packed with speakers offering their own expert opinion on what the FDA should do. It’s entirely likely that those people will be entirely ignored by the agency. They care about data, and they ask participants to show “data” or “research” more than a half-dozen times in announcing the meeting. (They are also curious about real-world experiences.) If you have information about how users seek health info on the web, the FDA is going to pay close, close attention. The best example of this is a presentation by Duke’s Ruth Day in 2005, in which she offered a study that showed that distracting imagery in drug ads inhibited comprehension of risk information. Earlier this year, the agency tightened drug ad rules specifically citing … distracting imagery.
Myth #2: FDA is Ready For Wholesale Change: In announcing the meeting, the agency suggests that its current approach — that it is in the business of regulating the message, not the medium — remains a useful tool for dealing with a whole range of issues on the Internet. And while its clear that there some areas in which their it’s-the-message framework starts to break down, the hints in the meeting announcement is that they’re looking to patch holes, not change the game.
Myth #3: New Rules Are Right Around the Corner: The meeting might be happening soon, but there is no indication that the FDA is going to move with any kind of speed. They’ll take comments until the end of February and then will have to sift through what is bound to be a mountain of information. Perhaps they’ll get around to issuing some targeted guidance by the end of 2010, but it could well be closer to 2 years before what gets said in November is fully digested by the FDA. Remember, it was 4 years between Day’s presentation and new FDA rules.
Myth #4: The Agency is Taking a Hard Look at the Adverse Event Rules: From all indications, the agency feels pretty comfortably with its rules about what side effects need to be reported. What they don’t know is exactly how industry is approaching the issue. The questions the FDA is asking around adverse events makes it sound like its trying to pull the curtain back on what pharma is actually doing, not change the rules of the game.
Myth #5: Industry is the Only One with Skin the Game: The FDA’s questions hit the topic of transparency a lot, opening up the intriguing possibility that, even if rules are loosened, third-party groups are going to have to be a lot more explicit about where the funding and other support for their online initiatives are coming from. While unrestricted educational grants and unbranded campaigns have become popular ways to engage online without crossing the FDA, anyone that touches industry may soon be forced to think hard about relationships — however tenuous — with regulated industry.