It's better. But is it reform?
The title of the legislation is "The Enhancing Drug Safety and Innovation Act of 2007." Let's look at innovation first.
Title II of the bill, the "Reagan-Udall Institute for Applied Medical Research" remains the most interesting part of the bill. It's, de minimus, a down-payment on the Critical Path. The major change from Kenzi 1.0 is that the funding/governance structure has changed to more closely model the NIH and CDC Foundations. In accordance with this change, the appropriations structure has also been modified.
The Institute would be headed by an Executive Director, under the guidance of the Board of Directors. The Board would develop the policies and by-laws of the Institute, and set the general direction of the Instituteâ€™s activities. The Board would be composed of individuals from the pharmaceutical and device industries, academic researchers, patient advocacy organizations, and members of the provider community.
Much like the NIH Foundation, the Instituteâ€™s administrative functions would be supported by Federal funds, while contributions from the pharmaceutical and device industries as well as from philanthropic organizations would be used to carry out the activities of the Institute.
But here's the question -- do we stiffle outside critical path efforts by NIH-tizing the process? Something to think about.
The "enhancing safety" side of the bill is somewhat more problematic. While REMS still bats lead-off, it gives the FDA almost complete flexibility in how to apply the various "mandates." While this will alleviate the angst of some, it doesn't do anything new. And the odious DTC section remains. Drugwonks does not believe that the FDA should have the authority to "mandate" that certain drugs can't advertise. Mandates lead to bad places -- and particularly when you're dealing with the First Amendment.
The section dealing with advisory committee conflict of interest issues is better than it was. That's good. But it doesn't help the process get any better either. Not so good. Better that the resolution of this issue be left to the forthcoming agency guidances on advisory committee process.
What do we think about Kenzi 2.0? We can do better. We must do better.
And time is running out.