What We Didn't Hear at the FDA Part 15 Meeting on Social Media

Well, we heard a lot  week before last at the FDA's Part 15 Meeting on Social Media and Medical Product Promotion.

For example, we heard consensus that medical product manufacturers probably shouldn't be held responsible for what unrelated third parties write - i.e., wikis.  We heard that there may be an alternative to the paid search ads that got the Notice of Violation letters from FDA in April.  We heard that the encyclopedic disclosure of print ads (not an evidence-based intervention, by the way, but nevertheless imposed by FDA as if it is) are not practical on the Internet.  We heard that people are going more and more to the Internet for health information and making decisions based on that information, something we already knew, but which was perhaps still news to the FDA.  We even heard some references from the FDA panel to "the Internet World" which was reminiscent of one famous U.S. Senator who referred to the Internet as a bunch of tubes. 

We heard from far too few pharma companies, and far too many bloggers.   

But what we did not hear was actually more important in some ways than what we did hear.  What we didn't hear was:

• Between now and the time of any supposed eventual guidance, what are we supposed to do?  The FDA is pretending that the real world, and yes, even the Internet World, attends to matters at their pace.  It doesn't.  Sidewiki launched in late September, Google Wave will presumably launch late this year and even Google's operating system which will probably have all sorts of new bells and whistles (one hopes) will launch sometime soon.  In other words, new Web 2.0 applications are launching that will raise new and important questions in the intervening weeks, while the FDA still wanders around in the Web 1.0 desert.  What are companies to do between now and whenever the FDA gets around to doing something (anything) about the Internet?  Even the time between now and the time the docket closes is frankly, too long to wait.  But we didn't hear anything about what companies, not to mention consumers, should do now.  Brands and public health move at a snail's pace.  Is that wise?
• In this era of FDA's new transparency initiative, the FDA was completely mum about the process going forward.  "We're here to listen, not to talk" said Tom Abrams.  Well, ok, but frankly that isn't good enough.  What is the process going forward?  Who will be making the decisions about "Internet World"?  What is the timeframe?  Is it really a good idea to let all this ride and fail to use this as an opportunity to display the FDA's new transparency initiative?
• Europe.  We didn't hear a darn thing about Europe.  And yes, it was a U.S. agency and a U.S. focus, so that seems appropriate.  I'm not suggesting otherwise.  But all of the statistics and talk was about the U.S.  But one has to wonder, what are other regulatory authorities doing?  By comparison, the FDA is positively Internet savvy and geeky compared to the EMEA.  Granted, we have DTC and more relaxed rules than other countries, but really - is the EMEA just going to proceed pretending that the Internet doesn't exist or that, despite regulatory confines, people in Europe aren't getting health care information from the Internet World because the EMEA doesn't want them to?  It is absurd.  

So as the dust from the meeting settles, and everyone is still analyzing what was said, it seems just as important, if not more, to focus on what was not said and what still needs to be said, even after over 70 presentations and two days worth of meetings in a buried room in Washington with no Internet access.  Or, perhaps we'll just have to wait for the next Dan Brown novel to get answers.   

Comments

[locus]

I'm beginning to think that you don't understand the concept of "public meeting" in the overall regulatory process.

I can appreciate that you went to the Part 15 meeting looking for answers. That was probably the wrong expectation to have going into it.

Public meetings are very formal processes set up by regulatory agencies to hear back from their stakeholders. It is NOT a two-way conversation.

Before the meeting, the agency (read FDA) makes a big announcement that it is seeking public input. It poses a series of questions in the FR, and goes to some expense to set up a room to listen to anyone and everyone who sign up to speak. (Since FDA is not talking directly to the public, they don't feel its necessary to accommodate the press--sorry, no media room.) FDA will NOT discuss the questions/topic at hand. FDA will NEVER respond to a comment given by a presenter (other than asking additional clarifying questions). FDA will NOT discuss what it's thinking while it's considering regulation on this topic. In fact, I believe it's ILLEGAL for them to do any of these things. They are only there to receive comments. I've been to a number of government public meetings and they're all the same.

If you went to the meeting seeking additional clarity in the use of social networks, the problem was not with the FDA. The problem was with your expectations on what the meeting would do.

I can appreciate that you're unhappy with the pace of FDA, however, you should be happy that FDA is moving the process forward. The alternative is that FDA advance its regulations without your input.

[Mark Senak]

Interesting and valid points all. But frankly, an agency that wants to be transparent, needs to practice it, not talk about it. That may be the way Part 15 meetings have been handled in the past. That is probably part of the problem. But the agency needs to change, change lots, and change quickly.

[David Harlow]

Locus (commenter above) is right. The only way to light a fire under the FDA on this issue is to get Congress to do so; the legislative branch can say: issue a rule within 6 months, and the agency has to do it. Cf. HIPAA breach notification rules issued by HHS under the HITECH Act as one recent example. That said, there is still a clear need to put together a plan of action for the time being -- and possibly for the long term, since FDA's initial publication seemed to say that the agency wasn't really convinced that they needed to be any more explicit than they already are in their existing rules. The more likely outcome is that we'll see glimpses of the FDA's position as individual companies venture out in front of the pack and elicit slaps on the wrist (or maybe worse) from the agency. Many agencies are willing to discuss (more or less formally, depending on the agency) specific proposed courses of action with individual regulated entities, and are sometimes willing to give some measure of comfort regarding proposed actions (that sounds good, that is definitely not OK, etc.). The FDA may be more sphinx-like, but there may be some opportunity for scoping out some rules of engagement between now and the eventual issuance of some mythic hoped-for new rule.

[Mark Senak]

Thank you David. I think you are probably right. But I think it is painful and non-productive to watch regulation by warning letter. Thanks for the comment.