As far as your last comment, it’s true the regulatory people aren’t making this stuff up. I’ve always tried to say it more like “the FDA won’t let you do X” instead of “your regulatory team won’t let you do X.” I know you’re just enforcing the rules in the end, so I don’t envy the position you’re in. Having said that, many regulatory teams are evaluated (both with performance reviews and incentives) based on whether or not the company receives any actions from DDMAC. Of course, it’s really easy to deliver this objective. If you don’t approve anything, you’ll never get a letter. On the other hand, brand teams are evaluated on product performance and so they have to look for new ways to grow the brand. These two sets of evaluation criteria are in direct opposition to one another. Perhaps this is intentional, but it creates overly conservative people on one end and overly aggressive people on the other. I’d like to see each group share objectives. Imagine if the regulatory people were also graded on product performance and the brand people were also evaluated on compliance with DDMAC policies, etc. What would that look like?

Enjoy the post. I agree there must be a solution to the issue of more real time dialogue in situations analagous to your example. The two way conversation that occurs in a user comment is very much similar to conversations that occur in oral speech. Your customer service call is a great example. Why would that conversation between two people be any different at all? A conversation is a conversation. (you and me right here)

Except that one conversation is different than the other in a substantial way. Oral conversations dissipate into thin air. In most cases, there is no reliable record of the speech, and it is virtually impossible for the speech to be considered labeling or printed or broadcast advertising (the three categories of material FDA/DDMAC regulates). I won’t bore you with all of the other details regarding the objective requirements of labeling, advertising, and the postmarketing reporting requirements for these. But, as a practical matter, most of these requirements do not apply mechanically (it is still illegal to “speak” promotionally in a false or misleading or off-label manner).

Accepting that a two-way conversation by keyboard, telephone, face-to-face or by telephone all accomplish the same EXACT thing, there is the big difference that oral speech is not recorded and then posted for others (to read and forward and retweet etc) who were not part of the original intimate conversation. Because of this, its not so much that the information is printed, as it it that the information is enduring (and can be redistributed at an exponential pace), and FDA could consider the posting and posterity of the comment to be an endorsement of what was said.

I’m sympathetic though, because I find myself in a rediculous cycle of explaining (at least two or more different reasons why comments pose additional problems). I have to stop myself, because part of me begins to wonder indeed why this should be so complicated. Yes all of the above issues I brought (and others I didn’t bring up)up are important, but they relate to a lot of processes and mechanics that although required by FDA regulations, don’t really seem to justify the effort and restraint on information. They’re just requirements that have endured over time (as a result of regulations written in the 60s), but can’t really be addressed unless FDA’s regulations change or FDA officially interprets that they don’t apply.

These issues are indeed irrational, but it isn’t the company lawyers and regulatory people just making stuff up. They have a duty to ensure that the company complies with the state of the law and the regulations. FDA itself acknowledges that these issues are real by simply calling the public meeting. Hopefully smart people like you can help to create a new model that FDA can accept. Believe me, my regulatory and legal friends throughout industry recognize the many absurdities. But they also have duties, and lets face it, enough inappropriate stuff has occurred over the years that makes everyone (including FDA) approach all of these issues with very cautiously.

John Murray

Actually, I think we “do” have scripts for many routine things in our lives… and most user questions fall into buckets as the call center folks can surely attest…

Having said that, I hear what you’re saying re: trust.

One thing about Reps though… Reps aren’t talking to patients, they are talking to skilled doctors who are trained to be skeptical, so it is natural they are given more leeway.

The elephant in the room is, of course, the FDA. They have the power to penalize the pharma companies if they step out of line… but they refuse the clearly draw the line. The hearings in November *may* clear things up… we’ll see.

My point is that there is probably a middle ground that can be pursued that is between the fully open model and the closed Medical/Regulatory/Legal model.

You actually unwrap the answer to your question through the post. No, you probably cannot just “trust” someone (anyone) to ad-lib responses to all and sundry blog comments (or Sidewiki for that matter)… however you can have a fairly exhaustive response script just like the call centers. In fact, call centers have branched out into interactive text support, so how is that really different (except that it *should* be considered even more risky than blog comments).

Great topic!