Additional funding for FDA; more Qs and As

Q: FDA received $61 million in the new coronavirus supplemental appropriation. What do we know about it?A: FDA has a big job to play in combating coronavirus and the threat of pandemic. It has a pivotal role in the development and approval of diagnostics, therapeutics, vaccines, and medical devices that will be needed.  Further, FDA is the lead agency in addressing any medical product shortages that result from global supply chain disruptions.  We have not yet seen any description beyond what is in the legislation, that the monies are to: “prevent, prepare for, and respond to coronavirus, domestically or internationally, including the development of necessary medical countermeasures and vaccines, advanced manufacturing for medical products, the monitoring of medical product supply chains, and related administrative activities.”At this point, neither the Executive Branch nor Congress know how much money will be needed to address the COVID-19 threat. If FDA or CDC or the Secretary of HHS find they need more resources to fight the coronavirus, we are confident the money will become available, either from transfers within the Executive Branch or through additional appropriations.Q: How did the Alliance arrive at the FY 21 “ask” of $120 million above FY 20 enacted levels?A: From the very beginning of the Alliance, our annual funding “ask” has been based on two competing considerations. The first is the need to be aspirational. Given the needs and opportunities inherent in FDA’s mission and responsibilities, we want to be stimulating Congress’ thinking about the agency’s role and help broaden their view of how a well-resourced FDA best serves the American people. The second is the need to be taken seriously and remain a part of the ongoing discussions with Congress about FDA’s budget. Our numbers need to respect that the overall budget for non-defense discretionary (NDD) spending grows very slowly, at least in most years.After an extended discussion, taking account of the overall budget situation (described here) and the President’s budget request for FDA (also described here), the Board decided that $120 million over the FY 20 enacted levels was the right balance of aspiration and budget realities. Our “ask” is just under a 4% increase over FY 20 levels and $72 million more than the President’s FY 21 request.Q: What is the Alliance’s most important message?A: “Growing responsibilities require a budget that grows.” Our advocacy emphasizes ways in which the agency’s responsibilities have grown (breadth) and ways in which the job has become more complex (depth). The agency needs an increased budget, more scientific and technical staff, and better analytic tools to support scientific-based decision-making and innovation in both food safety and medical products.Q: What else can Alliance members do to help spread the message that FDA needs additional funding?A: An immediate action would be to sign up for the Alliance’s March 18 Hill Day. The Hill is always (and rightfully) impressed by the extraordinary diversity and size of support for FDA funding. That message is reinforced if we have a great turn-out for Hill Day and Congressional staff see representatives from all the stakeholder communities. To sign up, contact Reed. For those wanting to know more about FDA funding prior to Hill Day, contact Reed about participating in our webinar on March 12 at 1:00 p.m.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.