The Potential Outcomes of a Strong Alliance Effort Are ...

The Alliance has held approximately 150 meetings with House and Senate staffers, representing appropriations and authorizing committees, as well as leadership. Our messages -- FDA is a national priority; more resources are needed to meet the agency’s responsibilities -- have been well-received in most offices.We can already count our House authorizing committee meetings as “successful.” Regardless of the final form of H.R. 6 -- or even if it becomes law or not -- the House Energy and Commerce Committee has adopted the position that requiring more from FDA must be offset by additional resources to get the job done. Given the number of major new laws affecting FDA over the last 6 years that were unfunded, this is a new and welcome conclusion.However, nothing about H.R. 6 diminishes the centrality of the appropriations process in providing FDA with the resources to do its job. The trillion dollars that the budget committees allot to the appropriations committees may seem like a lot of money. But more than half goes to defense and the rest gets split among 10 subcommittees and hundreds of non-defense programs, almost all of which have their own stakeholder constituencies pleading their case.The House Agriculture/FDA appropriations subcommittee is likely to mark-up its bill later in June. The subcommittee has already warned FDA (during hearings) that it will be difficult to raise the agency’s appropriation, even in the face of obvious need for resources to implement FSMA. However, there have been years when FDA received increases in the face  of even more dire statements or where FDA did well in the House when you account for the smaller non-defense allocation that the appropriations committee had to deal with. So, we are hopeful, but we are not optimistic about the House.Over the last few years, the Senate has more often come in with a higher funding level for FDA than the House and then prevailed at conference. However, the subcommittee has both a new Republican majority, as well as a new chair and a new ranking member. It is hard to know -- when available dollars are so scarce -- whether they will continue to see FDA as much of a priority as the subcommittee has in the past.The fact that our arguments have prevailed (thus far) with House Energy and Commerce provides a basis for believing that appropriators might have the same vision of a high-priority FDA with resource needs in FY 16 that are greater than they were in FY 15. The Alliance will continue to lead the effort to make this so.P.S.: A small clarification about the “mandated” funding in H.R. 6, which amounts to $550 million per year for 5 years. These monies come with a statutory provision to prevent these additional funds being used to replace appropriated dollars. Simply put, the mandated funds would not be available if the appropriations committees were to cut $110 million from FDA’s annual appropriation. Further, as drafted, the mandated monies start in FY 16 and run through FY 20. However, by the time the mandated funding could become law (assuming it does), the FY 16 funding cycle is likely to be well under way. Most likely, later versions of the legislation (at least several months from now) will re-set the monies to begin in FY 17.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.