Alliance Overcomes Shutdown (of DC Metro System)

This year’s highly successful Hill Day is now in the books. Despite the shutdown of DC’s Metro train system, more than 40 Alliance members were able to complete more than 50 meetings with Hill offices. Meetings were held with staff appropriations committee members, authorizers, and Congressional leadership. We give a special thanks to everyone who participated.What was most noticeable: Hill staffs’ understanding of FDA. Recognition of the agency’s broad mission and growing responsibilities has never been higher. In some instances, it was clear that the staffer knew FDA’s situation as well as we did.Here are some of the items that resonated well with Hill staff:

• The Alliance is a unique coalition representing all of FDA’s stakeholders. There is a reason why there is an Alliance for a Stronger FDA and not similar organizations for other regulatory agencies, such as EPA or SEC.
• FDA’s budget needs to grow because its responsibilities keep growing. This is so because of: new/evolving legislative mandates, scientific complexity, and globalization.
• “Regular order appropriations” are desirable because they give Congress the opportunity to set priorities. The Alliance is confident that FDA will do well if Congress asks: “Which agencies produce the most value?“
• The Food Safety Modernization Act (FSMA) is driving a critical overhaul of America’s food safety protections and continues to need significant funding.
• Medical product innovation provides an increasing opportunity to improve patient outcomes. More needs to be done and that will require additional funding. Most staffers understood this and, accordingly, provided positive feedback on the proposition that “a strong NIH needs a strong FDA, and vice versa.”

No agency funded by discretionary monies is immune from strong downward budgetary pressures, but our request for a $120 million increase for FDA (vs. the Administration’s request for $15 million) didn’t draw any lectures about being unrealistic. On the other hand, no one assured us that this amount could be considered a certainty.In a number of offices, we asked about the process going forward and the timing. In response, staff chuckled, frowned, looked quizzical, etc. Staff just don’t know yet, other than that there is a premium on moving quickly ... and a lot of uncertainty about whether the appropriations process can be completed at all this year.In sum, Alliance Hill Day was remarkably positive. We increased understanding about FDA’s important public health mission and there is better understanding about its resource needs. In many instances, we reinforced the views of many others who already had good understanding.Lots more work is going to be needed and the Alliance will continue to lead the charge -- as indicated above, May 4 is an important next day to help in this effort.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.