On September 10, 2013 the Cancer Support Community’s Cancer Policy Institute sent a letter of thanks and support to those Members of Congress who recently introduced legislation to protect the Food and Drug Administration’s (FDA) user fees from sequestration.
In 2012, Congress passed the FDA Safety and Innovation Act (FDASIA). As a result, new fees – paid by drug and device manufacturers – were instituted to provide the FDA with a much needed funding stream to provide for improvements to their drug and device review processes. This dedicated funding stream was designed to facilitate timely patient access to safe and effective new and generic medicines, medical devices and diagnostics.
However, as a result of a provision of the Budget Control Act of 2011, on March 1, 2013, automatic spending cuts went into effect. Known as sequestration, these cuts have affected Medicare, the National Institutes of Health, and the FDA budgets–negatively impacting patient care. Unfortunately this sequestration of federal spending is also specifically preventing the FDA from accessing its nearly $83 million in industry-paid user fees in the current fiscal year. These user fees cannot, by law, be used for any other purpose and their sequestration does not decrease the nation’s deficit.
Preventing FDA from fully accessing this funding only serves to worsen the severe budgetary constraints of a historically underfunded agency, and harm patients and public health.
CSC’s letter shows support for The FDA Safety Over Sequestration Act, which guarantees FDA access to those user fees and that those fees are spent as intended. The letter also urges Congress to continue its promise to provide the FDA with sufficient funding so that it may continue to facilitate timely access to chemotherapy drugs while also approving new and ground-breaking medicines, medical diagnosis and devices following rigorous evaluation. Our letter further argues that it is unacceptable for the FDA to struggle to keep up with increasing scientific complexity of the drugs and devices they evaluate as well as properly train and empower its staff when the user fees are still being collected, yet remain quarantined.
To support FDA’s access to its user fee funds, email or call your Members of Congress in support of the FDA User Fee Protection Act (S. 1413 and H.R. 2725). Be sure you tell your Senators and Representatives that in addition to preventing future sequestration of these user fee funds, Congress should find a bipartisan solution for releasing the sequestered FY13 user fees as Congress continues its work on the FY14 appropriations process.