Advocacy at a Glance

Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.

• President Trump’s FY19 Budget Request: Major Boost for Medical Products, No Increase for Food Safety. On February 12, the President sent Congress his FY 19 budget request, which includes a $473M increase in taxpayer (BA) funding, for a total ask of $3.25B. In a press release (here), the Alliance applauded the Administration’s proposal and notes that, in dollar terms, it is the largest increase in BA funds ever proposed for FDA by a President. As expressed by Ladd Wiley, the Alliance’s executive director, “This budget represents an enormous vote of confidence in FDA, a recognition that the agency is doing its job well and making a critical public health difference.”

Under the President’s proposal, virtually all of the new monies would go to medical programs and it appears that CFSAN and food programs would see no increase. Once OMB publishes the detailed budget justification for FDA, the Alliance will be able to identify key areas where the agency needs new and additional resources. In general, we would expect to support the President’s request for medical products funding and build the case for why additional food safety funding will also be needed.

• Analysis and Commentary: FY19 Budget -- Change in Philosophy, Details Missing, New User Fees Not a Focus. This week’s Analysis and Commentary discusses why the Alliance’s budget analysis is not more detailed, how a different philosophy is behind this year’s request, and why additional user fee revenue is largely non-controversial.

• Proposed New Medical Products Monies to Improve FDA Decision-making and Stimulate Innovation. In the absence of a detailed budget justification for FDA, Commissioner Gottlieb released a statement that describes the FDA initiatives that would be funded if the President’s request is adopted by Congress. Broadly speaking, the additional monies would be used to strengthen the systems that guide and support FDA decision-making and provide FDA with more ways in which it can stimulate and support innovation. Topics covered include: advances in drug and device manufacturing, better support for safe drug compounding, advancing the use of real world evidence, changes in the regulatory framework for digital health technology, creating and sharing new systems that support FDA decision-making, expanding research methodologies needed for work on rare diseases, and improving the regulatory process surrounding generics.

Part of the Alliance’s job will be to explain how these fairly “wonky” concepts translate into real benefits for the American people.  As an example, embedded in the proposal is a major effort to improve the influenza vaccine development process. Our understanding is that funds are for system changes at FDA and will not directly support the agency’s reviews of specific drug and device submissions.

• What Happens Next for the President’s Budget Request. The priority for appropriators is to complete an FY 18 omnibus appropriations bill and have it signed by the President before the current CR expires on March 23. Once that is accomplished, we expect the normal appropriations cycle: hearings on agency budget requests, followed by subcommittee and committee mark-ups. The process will be able to move faster because the recent budget agreement set spending caps for FY 19, as well as FY 18.

Even while FY 18 is being completed, Congress is moving forward with the initial stages of the FY 19 process. Next week, the Alliance has scheduled its first set of Hill meetings on the FY 19 budget and most of the staff are ready to meet. Also, individual appropriators are announcing deadlines for submitting requests for their support and the subcommittees are announcing deadlines for submitting statements for the record. The process and specific deadlines will be discussed in more depth in next week’s Friday Update.