This Week the Alliance Needs Help from ALL Its Members

Last week’s column focused on the dual nature of our fight for better FDA funding. We need to be able to justify that FDA has been a good steward of the increases over the last 6 years that have taken it from a $1.5 billion appropriation to a $2.5 billion appropriation ... and demonstrate persuasively why there are still multiple needs for which additional funding is required. I termed this process "micro-budgetary politics." At the same time, we cannot ignore the larger forces of budget deficit reduction, which I have termed "macro-budgetary politics.

"We have very little control over the latter (deficit reduction), but lots of important things to say about the importance of FDA and its funding needs. Indeed, if we can’t succeed on the micro-budgetary political level (making the case for FDA), then we are almost certain to have a bad outcome in the macro deficit reduction process.This is what makes Alliance Hill day (next Wednesday, March 28) so very important. This is our opportunity to meet with a lot of offices in a single day, to educate them about FDA and to make our case for its exceptional funding needs.Broad participation by Alliance members is critical because the strength of our voice is that ALL stakeholders support the agency. We always point out that FDA is unique among regulatory agencies in this regard. PLEASE sign up to join us for Alliance Hill day, even if it is only for a meeting or two. Details for how to sign up appear in the post entitled "2012 Stronger FDA Hill Day on March 28."

Here are some of the key points we will be making about FDA next Wednesday ... and which consistently appear in all Alliance materials and presentations. Note that we emphasize the agency’s needs (micro), without ignoring its place within the larger federal budget (macro).

Background. FDA was massively underfunded for two decades. Since 2007 a combination of House and Senate, Democrats and Republicans have led the charge in repositioning the agency and taken the agency to a significantly higher funding level. Significant challenges remain.FDA will be required to carry out new activities in FY 13 that are not paid for in the FY 12 base funding ... and are sufficiently large that they cannot be offset by any kind of belt-tightening. One source of growth comes from Congress. New mandates include the Food Safety Modernization Act, biosimilars, and medical countermeasures. In addition, we anticipate new requirements (unfunded mandates) that will be added onto the user fee reauthorization legislation.The other sources of growth are unrelated to Congress. These include: continuing growth and increased demands of globalization; growing complexity of science; 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.

Economic Implications. Because the world has become so much more complex and interrelated, it is hard for FDA to achieve and maintain global leadership. Yet, this is critical to a favorable US trade balance, job creation, and the control of future healthcare spending. If FDA does not have needed funding resources, there are also negative economic impacts, such as recalls, foodborne illnesses, and treatments that don’t reach market that could lessen disability and improve quality of life.

Our Appropriations "Ask." The Alliance is asking for FY 13 funding that is a 6% increase above FY 12 levels. Given the budget environment, we understand the downward pressures ... without this environment, we could have justified an even greater increase.At this point, no one knows what the budgetary/appropriations endgame will be -- whether there will be any monies, who will decide, and especially what the criteria will be for exceptions. Our true "ask" is for recognition that FDA is truly a priority, deserving of exceptional status when appropriations decisions are made.

Please participate in Lobby Day. Your help is needed.

Note: This analysis and commentary is written by Steven Grossman, the Deputy Executive Director of the Alliance for a Stronger FDA.