Why Advocate for FDA Funding?
Current treatment for Parkinson’s is based on a 50-year-old therapy, which treats only some symptoms for some people and eventually loses its effectiveness. There’s no treatment available to stop or slow the progression of the disease, which is why PAN supports robust funding for the FDA because it plays a key role in reviewing new drugs and devices as they are developed.
The FDA is funded through a combination of Congressional appropriations and user fees paid by drug and device sponsors, as regulated by Congress.
FY 2015 Funding
Congress has passed a continuing resolution to keep the government funded at FY 2014 levels through December 11, which means that current funding for the program is approximately $2.55 billion.
President Obama’s FY 2015 budget proposal requests $2.6 billion in regular funding for the FDA.
The House Appropriations Committee has recommended $2.583 billion for the FDA for FY 2015, and the Senate Appropriations Committee has recommended $2.588 billion. While both recommendations are modest increases, neither chamber has scheduled a vote on the broader appropriations bill.
PAN is requesting $2.784 billion for the FDA in FY 2015 in order to meet the growing demands on the Agency.
FY 2014 Funding
The FDA is being funded at $2.55 billion for FY 2014, a $91 million increase over FY 2013 spending before sequestration. This is slightly lower than the funding requested, but it is a significant increase given broader spending challenges. The final FY 2014 budget agreement restored $85 million in industry-funded user fees that were held in FY 2013 because of sequestration.
User fees are paid by companies when they file a new drug or device application with the agency and have contributed to the advancement of new therapies and medical devices. As noted above, these fees were subject to sequestration in 2013. PAN supported legislation pending in the House and Senate to exclude FDA user fees from sequestration starting in FY 2014 and into the future.
FDA Safety Over Sequestration Act
On July 18, 2013 Reps. Eshoo (D-CA), Lance (R-NJ), Matsui (D-CA), and Rogers (R-MI) introduced the FDA Safety Over Sequestration Act (H.R. 2725), which would exempt FDA user fees from sequestration starting in FY 2014 and beyond.
PAN sent a letter in support of the legislation on July 25.
FDA User Fee Protection Act
On July 31, 2013 Sens. Pryor (D-AR), Blunt (R-MO), Coats (R-IN), Franken (D-MN), and Moran (R-KS) introduced the FDA User Fee Protection Act (S. 1413), legislation similar to the measure introduced in House that would exempt FDA user fees from sequestration starting FY 2014 and beyond.
PAN sent a letter in support of the legislation on August 7.