Weekly Policy Update: FDA Funding and Other News
By: Colorado BioScience Association Date: 08/10/2018
FDA Receives Funding in Senate Passed Appropriations Bill
Last week the U.S. Senate overwhelmingly passed a $154.2 billion spending bill that includes more than $3 billion for the FDA. When industry fees are included, the FDA would have $5.49 billion in total funding next year. H.R. 6147 is the seventh appropriations bill the Senate has passed this year for the 2019 fiscal year, leaving two spending bills for the Senate to vote on in the next few weeks, includ funding for other Health and Human Services Agencies.
Now where will the funding go? Nearly a third of the FDA funding—about $1.721 billion—will go to the Center for Drug Evaluation and Research. The Center for Biologics Evaluation and Research will receive about $369.9 million. The Center for Devices and Radiological Health will get nearly $496 million and the National Center of Toxicological Research will get more than $65.5 million.
Other FDA allocations in the bill include $70 million for the agency to carry out its responsibilities under the 21st Century Cures Act. An additional $20 million will advance telemedicine and distance learning services to help address the nation’s opioid epidemic. Money is also dedicated for modernizing generic drug development and review and to FDA’s oncology center of excellence and rare disease work.
A bulk of the funding for the FDA originates from user fees. Under the bill, the agency is authorized to spend nearly $960.6 million in prescription drug fees, about $501.4 million in generic drug fees, more than $40.9 million in biosimilar fees and nearly $196.7 million in medical device fees. These fees bring the total FDA funding received next year to $5.49 billion.
Although the bill passed in the Senate, we must wait until the House returns from their Labor Day recess to approve the Senate funding additions which include funding for the FDA. Once the House approves the Senate’s version, the bill will go to the President for signature.
For more details on these programs and how the Senate bill compares to what House laid out for FDA, see this breakdown here.
Read what is happening in the bioscience news this week!
- Politico – FDA published the user fee rates for prescription drugs, biosimilars, and medical devices for fiscal year 2019. RAPS has a chart comparing the rates to FY 2018.
- AdvaMed – AdvaMedDx Applauds Hill’s Release of FDA’s Technical Assistance to Advance Legislation to Modernize Regulation of Clinical Diagnostics