FDA Matters’ State of the FDA—January 2012 identified agency funding as the greatest threat to the FDA’s future. The agency received a very small increase in FY 12 appropriated funding, reflecting the severe budgetary pressure on all U.S. federal agencies. That pressure continues and FDA faces potential cuts in FY 13 (starting October 1, 2012).
Advocacy by the Alliance for a Stronger FDA and other stakeholder groups is critical to sustaining the agency’s appropriated funding and pressing Congress for increases to meet the growing demands on FDA. This column explains the budget situation and calls upon all stakeholders to support increased FDA funding.
FDA was massively underfunded for two decades. Since 2007, Congress has reversed course and increased the agency from $1.5 billion to $2.5 billion in annual appropriated (non-user fee) funding. The agency is also viewed much more favorably than it was then.
However, the agency received a miniscule $50 million increase in FY 12 appropriated funding. Although this was more than many federal agencies, it is inadequate for FDA’s growing responsibilities. Even still, the agency made good progress on its key objectives in FY 12, mostly by stretching the dollars as best it could.
FY 13 funding could be much worse, while the agency’s responsibilities continue to grow. New Congressional mandates include the Food Safety Modernization Act (FSMA), the Biologics Price Competition and Innovation Act (biosimilars), and bio-defense. In addition, amendments to the user fee reauthorization legislation will impose new requirements (unfunded mandates) on the agency beyond what will be paid for by user fees.
The other sources of growth in FDA’s responsibilities are unrelated to Congress. These include: continuing growth and increased demands of globalization; science’s growing complexity; agency initiatives to promote innovation and regulatory science; and “the unexpected,” whether new foodborne pathogens, drug shortages, or new scientific discoveries that add to the agency’s responsibilities.
FDA must overcome two barriers to obtain more funding. The first relates to how Congress views FDA. Does Congress recognize FDA as providing essential governmental services that must be supported, regardless of budget cuts? Does Congress view FDA as doing a good job with the money it receives? In particular, has it used the increased funding over the last 6 years to improve its effectiveness? Does Congress feel any urgency about funding those FDA activities (e.g. implementation of FSMA) that can only occur if funding is increased in FY 13?
The second barrier is the overall environment in which budget decisions are being made, especially the aggregate amounts Congress is willing to spend on domestic discretionary programs. The FY 12 appropriations process was driven by pressures to reduce spending. Largely because of lower House spending ceilings, FDA faced the possibility of a $275 million cut under the House-passed bill. FY 13 now looks like it may become a repeat of last year, with the House again choosing lower aggregate spending levels than the Senate. This sets up the possibility (maybe even likelihood) that the House will again vote for a large cut in FDA funding, while the Senate may be barely able to maintain current funding levels.
This is not an acceptable situation. FDA oversees nearly 25% of all consumer spending and touches the lives of every American every day. It’s not just the food, drugs and devices that we commonly think about, but also vaccines, diagnostics, cosmetics, pet food, dietary supplements and so on.
Further, as this blog’s growing global readership attests….FDA’s decisions affects the lives of hundreds of millions of people outside the U.S. Many countries rely on FDA’s standards of quality and its regulatory decisions. Further, every country in the world is part of the global market in the import and export of FDA-regulated products.
Belonging to the Alliance for a Stronger FDA helps demonstrate support for the FDA. The Alliance’s membership includes all stakeholders —consumer, patient and research advocacy groups, professional societies, companies and trade groups, consulting firms and individuals. A stronger FDA is the only thing they all agree upon…and this carries great weight with Congress. The Alliance’s views on FY 13 FDA funding can be found here.
adapted and republished with permission by FDA Matters, a weekly blog covering FDA policy and regulation