If the new funding bill is signed by the president, the FDA will have some extra funds to support various initiatives.
A second government shutdown appears to have been avoided with President Donald Trump stating Thursday he intended to sign a funding bill to keep the government running. The new funding agreement includes a boost in funding to the U.S. Food and Drug Administration (FDA).
First reported by Regulatory Focus, the publication for Regulatory Affairs Professionals Society (RAPS), included in the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies 2019 appropriations bill is an additional $3 billion in discretionary spending. From that chunk of funding, the FDA is expected to receive an additional $269 million over the previous fiscal year. RAPS said that this increase for the FDA is the largest increase the agency has seen since 2010.
According to the RAPS analysis, if the president signs off on the funding bill, the FDA’s “total program level will be $5.67 billion.” That figure includes the approximately $2.5 billion in user fees that the FDA collects, RAPS said.
Citing an explanatory statement issued by Congress regarding the increased funding, RAPS reported that the lawmakers had some intentions for the increases. Of the $269 million, $47 million is intended to combat the opioid epidemic that has swept across the country in recent years. The funds are also expected to be used to promote domestic manufacturing of medicines. Congress earmarked $38.5 million for that purpose. Additionally, $12 million has been set aside for a new domestic drug industry, although what that means was not clear. Medtech manufacturing is also getting some support from the additional funds. Congress earmarked $6 million to support that endeavor. Additionally, the funding includes $50.7 million for new medical data enterprise and $25 million for the growth and transformation of digital health. The FDA’s new platform for drug development will receive $43.3 million, which includes a $5 million increase to fully fund the FDA’s Oncology Center for Excellence, RAPS said.
As the FDA continues to modernize its generic drug development and review efforts, the additional funding will provide the agency with $25.1 million to support that mission.
Lastly, the increased funding will provide $10 million for investment and innovation for rare diseases, according to the report.
During the last government shutdown, the FDA was hampered in many of its regulatory efforts. The agency was able to continue to approve new medicines due to the user fees that drug developers pay to the FDA as the agency begins to examine efficacy and safety for potential approval. Industry watchers were concerned as the shutdown continued past the one-month mark as those user fees were close to being exhausted, which would have significantly delayed potential approvals.
