Gil Roth08.02.13
Several pharma, biopharma, device and diagnostic associations threw their support behind new legislation intended to exempt FDA's user fees from sequestration.
Sen. Mark Pryor (D-AR), chairman of the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, and Sens. Roy Blunt (R-MO), Daniel Coats (R-IN), Al Franken (D-MN), and Jerry Moran (R-KS) have introduced S. 1413 to exempt future FDA user fees from sequestration. A similar bill, H.R. 2725, was introduced in the House of Representatives earlier this month by Reps. Leonard Lance (R-NJ), Anna Eshoo (D-CA), Mike Rogers (R-MI) and Doris Matsui (D-CA).
Pharmaceutical Research and Manufacturers of America (PhRMA), Biotechnology Industry Organization (BIO), Generic Pharmaceutical Association (GPhA), the Advanced Medical Technology Association (AdvaMed), and Medical Imaging & Technology Alliance (MITA) praised the sponsors of S. 1413 and urged Congress to find a bipartisan solution for releasing sequestered FY13 user fees as Congress continues its work on the FY14 appropriations process.
A joint statement from the associations stated, “Last year, Congress passed the FDA Safety and Innovation Act (FDASIA), which reauthorized the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA), and created the Generic Drug User Fee Act (GDUFA) and Biosimilar User Fee Act (BsUFA). User fee levels were increased to provide much-needed improvements to the regulatory review processes at FDA in order to facilitate timely patient access to safe and effective new and generic medicines, medical devices and diagnostics.
“However, sequestration is preventing FDA from accessing 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 these user fees only serves to exacerbate the severe budgetary constraints of a historically underfunded agency, to the detriment of patients and public health.
“We call on the Congress to quickly consider and pass this important legislation and to continue to work to release the user fees from FY2013 which have been sequestered.”
Sen. Mark Pryor (D-AR), chairman of the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, and Sens. Roy Blunt (R-MO), Daniel Coats (R-IN), Al Franken (D-MN), and Jerry Moran (R-KS) have introduced S. 1413 to exempt future FDA user fees from sequestration. A similar bill, H.R. 2725, was introduced in the House of Representatives earlier this month by Reps. Leonard Lance (R-NJ), Anna Eshoo (D-CA), Mike Rogers (R-MI) and Doris Matsui (D-CA).
Pharmaceutical Research and Manufacturers of America (PhRMA), Biotechnology Industry Organization (BIO), Generic Pharmaceutical Association (GPhA), the Advanced Medical Technology Association (AdvaMed), and Medical Imaging & Technology Alliance (MITA) praised the sponsors of S. 1413 and urged Congress to find a bipartisan solution for releasing sequestered FY13 user fees as Congress continues its work on the FY14 appropriations process.
A joint statement from the associations stated, “Last year, Congress passed the FDA Safety and Innovation Act (FDASIA), which reauthorized the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA), and created the Generic Drug User Fee Act (GDUFA) and Biosimilar User Fee Act (BsUFA). User fee levels were increased to provide much-needed improvements to the regulatory review processes at FDA in order to facilitate timely patient access to safe and effective new and generic medicines, medical devices and diagnostics.
“However, sequestration is preventing FDA from accessing 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 these user fees only serves to exacerbate the severe budgetary constraints of a historically underfunded agency, to the detriment of patients and public health.
“We call on the Congress to quickly consider and pass this important legislation and to continue to work to release the user fees from FY2013 which have been sequestered.”