FY 19 Appropriations the Alliance Seeks to Support

The Alliance is pleased that both House and Senate appropriators showed strong support for the FDA. However, they did so with substantially different levels of funding and, by implication, different priorities. We are told that the Senate’s lower numbers were mostly driven by a lower spending allocation for the Ag/FDA subcommittee compared to their House counterparts.As it stands now (committee-passed bills in both House and Senate):

• The House proposed an increase of $308 million in budget authority (BA) spending for FY 19. Of that, $259.5 million is for new medical product initiatives. Additionally, $30 million would go to programs to address opioids and another $20 million is aimed at infrastructure development and White Oak expansion. There is a $2 million offset from elsewhere in the FDA budget.
• The Senate proposed an increase of $159 million in BA spending. Of that, $88.5 million is for medical product initiatives. Additionally, $59 million would pay for opioid programs and $15.5 million for food safety initiatives. The food increases would go for FSMA cooperative agreements with states, food import safety, food safety outbreaks, and testing antibiotic resistance in imported seafood. There is a $4 million offset from elsewhere in the FDA budget.

Here is what we would like appropriators to consider:

• Both bills would provide a $5 million increase to fully fund the Oncology Center for Excellence and add $20 million for investment and innovation in rare diseases. We support inclusion of this funding, which mirrors the Administration request.
• Both bills provide funding for four Administration proposals:
  1. Two advanced manufacturing initiatives (one for drugs/biologics and one for medical devices). We support the higher funding levels in the House bill.
  2. An initiative to modernize the generic drug review process.  We support the higher funding level in the Senate bill.
  3. A new drug development platform to advance science in drug development. We support the higher funding level in the House bill.
  4. Combatting opioid abuse. We support the higher funding level in the Senate bill.
• The House funded -- but the Senate did not fund -- three more initiatives proposed by the Administration. In each case, we support the funding levels in the House bill.
  1. Expand engagement with the outsourcing industry.
  2. Advance the use of real-world evidence (RWE) to better inform patient care promote innovation.
  3. Grow and transform digital health.

• The Senate funded -- but the House did not fund -- additional funding for food safety programs. We support the funding level provided in the Senate bill.
• The House provided funding for infrastructure and White Oak expansion.  We support the funding level provided in the House bill.

A group letter containing much of this information will be ready next week. Please consider signing on.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.