The Impracticalities of Uneconomics

On April 6, the Senate Health Education and Pension (HELP) Committee marked up the last tranche of bills intended to be part of the Senate Innovations initiative. This effort is designed to be parallel with the House Cures initiative.At the moment, the Senate effort is scattered through about 15 bills, each of which addresses substantive policy issues and programmatic initiatives for FDA and NIH. The intention is that these bills will be consolidated on the Senate floor into an omnibus bill, pass the Senate, and then go to conference with the House. Not surprisingly, this situation is generating a lot of optimism among proponents of the Cures/Innovations efforts.However, as is being widely discussed, there is lack of resources for FDA and NIH to carry out the substantial new responsibilities envisioned by both Cures and Innovations. Senate HELP chairman Alexander has acknowledged, multiple times, that committee Democrats will block the legislation unless funding is provided. How funding would be accomplished has been the source of considerable discussion. For example, no one is certain where the offsetting “pay-for” would come from for any mandatory funding the committee might consider.While the Alliance for a Stronger FDA does not take a position on the merits of the underlying authorizing legislation, we are concerned that the Senate Innovations initiative does not contain a funding plan for FDA to implement the significant new responsibilities required by the legislation. If the FDA does not receive funding for these new responsibilities, it means they will not be properly implemented or funds must be diverted from existing FDA programs.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.