Give Us Something We Can Support!

When the Alliance was formed a decade ago, every part of FDA had far more responsibilities than resources. Thanks to the Congress, and particularly the Appropriations Committees, FDA is no longer in such dire straits. Nonetheless, the experience has left us wary of any expansion of FDA programs that is not accompanied by money to pay for the increased workload.In that spirit, last week’s Analysis and Commentary ended with the Alliance’s position on Senate Innovations legislation:

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.

While we focused these comments on the Senate, our message is to all Members of Congress who have been involved in the House’s Cures legislation and the Senate Innovations bills. Both initiatives represent a significant expansion of FDA responsibilities and Congressional expectations.

We know the champions of this legislation actually want it to be implemented. They don’t want a law on the books -- they want results. But it is clear it can’t be implemented -- and the results can’t occur -- without funding. So, to the champions of the legislation, we say: “What is the plan for FDA funding?

”There are no easy answers. The House Energy and Commerce Committee accepted the challenge and came up with a plan for mandatory funding. Unfortunately, most of the offsets for the House’s funding have already been used by budget negotiators, and in any event, are not offsets controlled by the Senate HELP Committee. Mandatory funding is still possible, but the structural and political barriers are substantial.

Increased appropriations is the logical and traditional alternative to mandatory funding. However, authorizers and appropriators are rarely the same people. Both need to be convinced that Cures/Innovations is worth the effort to find funding. Yet, we are in a desperately tight budgetary environment, with most subcommittees having less money to spend than they did last year.

Further, the Administration chose not to make FDA a priority in the FY 17 President’s Request. This puts even more pressure on appropriators to find monies for existing needs, such as the Food Safety and Modernization Act, rather than fund new programming.We appreciate that funding Cures/Innovations is difficult, but we cannot pretend it is someone else’s problem. We encourage champions on both sides of the aisle to get together and come up with a realistic funding plan. Give the FDA stakeholder community something we can support and we will help make it a reality.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.