Yesterday, the House Appropriations Committee unveiled the fiscal year 2016 Omnibus Appropriations bill, which will provide discretionary funding for the federal government for the current fiscal year.
The new legislation provides more than $2.7 billion in discretionary funding to the FDA – $132 million over the FY2015 enacted level, and an increase of $10,608,000 for medical product safety initiatives.
Specifically, the bill includes funding for the Combating Antibiotic Resistant Bacteria (CARB) initiative ($8,732,000), the precision medicine initiative ($2,392,000), and the Orphan Product Development Grants Program ($2,500,000).
According to the text, “The agreement provides increases for orphan drug development grants given that the number of requests for orphan designation has more than tripled since 2000.”
Additionally, “The agreement acknowledges some progress in FDA's effort to address issues with products that are biosimilar to and interchangeable with FDA-licensed biological drug products.”
The Labor, Health and Human services, and Education portion of the bill invests in biomedical research and disease prevention, as well as educational programs.
The bill includes a $32 billion program level for the NIH, $2 billion above the 2015 enacted level. This includes increases specially for Alzheimer’s disease research, brain research, antibiotic research, and the Precision Medicine Initiative.
All NIH Institutes and Centers will also receive a general increase in order to continue basic bio-medical research and translational research.
Alliance for a stronger FDA - a pressure group that advocates for increased agency funding - said Bill is a victory.
"FDA will receive $132 million above its FY 15 appropriation. This is roughly $90 to $100 million above the House and Senate committee bills passed earlier this year. From a percentage perspective, it is a 5% increase, in comparison to the NIH 7% increase."
"While we are doing further analysis, we can definitely say that this is a victory. Distribution of funds appears to largely mirror the priorities of the Administration’s request."