What the Alliance Is Asking for for FY 20

As described in this week's Advocacy at a Glance, the President’s budget is late this year, but some appropriators are asking for stakeholder requests and not waiting. The list of offices and their format and deadlines are here. In the meantime, the Alliance has composed a “placeholder” request that we will keep updating as submissions are due and which will eventually be replaced by our formal ask.Some of you may want to submit requests that highlight special needs within your areas of FDA. Our language may still be helpful, but, in any case, please note that you are part of the Alliance for a Stronger FDA and will be supporting the Alliance’s overall FDA request.For those who want to speak to the overall needs of the agency, please do. Here is the language we are working from. In many cases, we will be required to submit twice: once on food safety funding and once on medical products funding. In other cases, requests cannot be longer than a certain number of characters, so we are editing accordingly:

FDA touches the lives of every American multiple times each day. It oversees 75% of the food supply and 100% of the drugs, biologics, devices, vaccines, diagnostics, cosmetics and dietary supplements. Altogether, 20% of all consumer spending in the US (about $2.5 trillion) involves products under the jurisdiction of the agency. The Ag/FDA subcommittee has been very supportive of the needs of the agency—turning it from a massively underfunded agency a decade ago to an agency that could engage and solve more problems if it had more resources.In FY 19, the Congress committed almost $1.4 billion to food safety, nutrition, cosmetics, dietary supplements, animal foods and other food elements of the FDA’s mission. Since enactment of the Food Safety Modernization Act (FSMA) in 2011, FDA has worked collaboratively with the states, as well as consumer, public health, and food industry stakeholders to advance implementation centered around seven foundational rules and the need for imported and domestic foods to be held to the same safety standards. The National Association of State Departments of Agriculture and others confirm that the agency will need increased baseline resources to meet state funding requirements in FY 20. Additionally, import safety remains a particularly high priority, as do the tools and training needed by regulated stakeholders to comply with the new federal standards.In FY 19, the Congress committed more than $1.6 billion to support drug, devices, biologics and other medical product elements of the FDA’s mission, plus $70 million for the FDA Innovations Fund (21st Century Cures). This included adopting Administration proposals to fund innovative initiatives in manufacturing, outsourcing, real world evidence, digital health, knowledge management, generics and rare diseases. We envision that FY 20 funding increases will be needed to build upon these initial investments. Additionally, advances in regulatory science and the challenges of complex science and globalization will need to be fully funded in FY 20.

The Alliance will have a more specific “ask” after we have seen the President’s FY 20 Budget Request, which should be available within one to three weeks.Note that at least one office is asking for offsets, to which we intend to reply:

Absent the President’s FY 2020 budget request, we are unable to respond.

For more information, contact Roger Szemraj or me, Steven Grossman.Editorial note: The Analysis and Commentary Section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.