The Broken FDA and Thoughts of Stakeholder Governance
There’s a thoughtful piece by , in which he does a very nice job of laying out the conflicts at work in the current configuration of the primary functions, and how they are carried out, in the FDA. For instance,
…the longer they put off fixing any particular issue that crops up with a drug, the more money the drug company makes. It may not be intended to work that way, but that’s how it is. Drug companies realize this, so also drag their heels whenever possible, since the minute the FDA makes a decision about its drug, it could tank sales…
He focuses on the point “that any government agency tasked with both regulation and policing of an industry is going to be ineffective,” and cites the FAA as being in a similar position. The FCC is another one that comes to mind, which, under its current chairman, has pretty much ceased to police or regulate, using its power to profit large media corporations instead. In Vermont the Department of Labor, as one old hand explained to me, walks a careful line between safeguarding the rights of workers and not upsetting employers so much that they pull out of the state. So this sort of dual, conflicting role is inherent in many government agencies, at many different levels.
Dr. Grohol recommends splitting the FDA into two separate agencies, one with the role of policing and the other with the role of regulating the drug industry. (Or three, or four? There is the food aspect of the FDA, too.) Perhaps that’s the best solution when we’re talking about an agency as huge in size and scope as the FDA. I can’t help but think, though, that there might be a better, less adversarial model that might work—something that involves stakeholder organizations being in active dialogue throughout each phase of both policing and regulatory functions.
It’s not a new idea–or at least not a brand new idea, as Al Gore was promoting stakeholder governance models when he was Vice President. (See here.) But it’s new enough to not yet register as one of the first things we consider when bureaucracies are broken.
Here’s to the day that changes.
Peace.
Deborah Alicen
