Senate Committee Advances Bill Boosting FDA’s FY2019 Budget by $159M
The Senate Appropriations Committee on Thursday signed off on a $159 million increase in discretionary funding for the US Food and Drug Administration (FDA), though that increase was about $150 million less than the increase proposed in the House.According to the Alliance for a Stronger FDA, the additional funds requested by FDA are planned to promote domestic manufacturing (House committee bill has about $27 million more in it for this), expand FDA engagement with outsourcing facilities (House called for $12 million but the Senate committee did not offer any new funds) and medical device manufacturing (House bill would provide $12 million vs. Senate bill’s $6 million).
For advancing the use of real-world data, as a way to potentially lower the cost of drug and device development, the House committee would provide $60 million but the Senate committee bill did not provide any new funding.
Similarly, on the regulation of digital health tools, the House committee would provide $40 million but the Senate committee did not offer any new funds.
As far as ensuring FDA has the most up-to-date scientific standards and assessment tools, the House committee would offer $45 million while the Senate bill would provide a little more than $8 million.
And one area where the Senate bill would provide more funding than the House bill ($37.6 million for the Senate vs. $27 million from the House) is in modernizing the generic drug development and review system.
Additionally, $30 million in the additional funding proposed on the House side would go to addressing the opioids crisis, while the Senate version would offer $59 million for opioid programs. FDA’s new Oncology Center for Excellence would also receive a $5 million boost from both the House and Senate bills, and both would add $20 million for rare diseases.