Thursday, February 16, 2012

The Impossible Dream

It’s been a long while, but I have a reasonably legit excuse. It’s been crazy busy, including a sellout for the second annual Startup Downhill. I have several topics started, but this one trumps them.

This morning I attended the Mass High Tech BioForum. The topic was quite broad – how to get your life sciences product to market. As you can imagine, the discussion was similarly wide-ranging, though nicely kept apace by the co-chair of Foley Hoag’s life sciences practice, Jeff Quillen.

When it was announced that another Foley Hoag attorney was going to give the keynote, I didn’t have high hopes, since my experience is that in this type of setting, lawyers get way too deep into technical details, and lose sight of the objective. I was pleasantly surprised when Paul Kim gave a great overview, with particular focus on the FDA and some of the challenges of commercializing products in this highly regulated context.

There wasn’t time for my question, but as you know by now, I sure had one. It was intended mostly for Paul, and here’s the issue:

Years ago, my kids were watching some DVDs in the back of the car while I was driving, so I was only half paying attention. There was a scene with what must have been an ad on TV for a drug. One character says to the other, “Wow, all those nasty side effects.” The other says, “Oh, they just say all that. Those side effects never happen.” “Well, then why do they put them on the ad?” Pause. “In case they happen.” I was secretly chuckling to myself, because it is precisely true.

So my question for Paul was, “Is it possible to have an agency that works?” On one hand, the public wants absolute safety. The role of the FDA is to ensure that drugs and devices that make it to market are safe. We don’t want to think of ourselves as Guinea Pigs. On the other hand, patient advocacy groups and others exert constant pressure to get drugs to market rapidly, and criticize the agency for unnecessary delays. So what’s it gonna be? Safety or access? I would argue that you can’t have both. If someone from the agency is going to get dragged in front of a Congressional Sub-Committee every time someone has an adverse reaction (or death) from a drug product, who at the agency would ever take any risk? There was a time, in the memory of some of us, where the mood at FDA was to evaluate products based on safety and efficacy. The feeling was that it was not their job to determine whether or not the market needed another me-too product. That pendulum has swung completely in the other direction to a far more paternalistic attitude, where me-too products now need to show a clinical benefit that exceeds that of existing approved products. (Which begs the question, is it ethical to do a placebo controlled trial when there are approved products for the condition?)

I’m not a huge fan of the FDA in general, but agree with panelist Bruce Booth that they do shine in certain areas of regulation. In their defense, I don’t see how a government agency can effectively navigate the balance between protecting the public and facilitating rapid deployment, within a political climate where a single misstep is grounds for dismissal.

Once again, no solution, just framing the problem.

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