The new bill would require better planning of how drugmakers and the Food and Drug Administration are going to identify and manage risks after the approval of new drugs. For instance, it might require drug companies to include a risk-management plan with their drug approval submissions, and would also require drug companies to disclose the full results from major clinical drug trials.
This bill is being pushed by Mike Enzi, Senate Health, Education, Labor and Pension Committee Chairman of Wyoming, and Senator Edward Kennedy of Massachusetts.
The FDA has been without a permanent leader for most of the Bush administration’s time in office. You know, we had more important things to worry about like, umm… finding Osama Bin Laden. No wait… oh forget it.