Biopharmaceutical and Medical Device Associations Strongly Support the FDA Safety Over Sequestration Act

  • Contact: Tracy Cooley
  • Phone: 202-312-9274
  • Email: tcooley@bio.org
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Washington, DC – August 1, 2013 – Today, 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) introduced S. 1413 to exempt future Food and Drug Administration (FDA) user fees from sequestration. A similar bill, H.R. 2725, was introduced in the U.S. House of Representatives earlier this month by Representatives Leonard Lance (R-NJ), Anna Eshoo (D-CA), Mike Rogers (R-MI) and Doris Matsui (D-CA).

The Advanced Medical Technology Association (AdvaMed), Biotechnology Industry Organization (BIO), Generic Pharmaceutical Association (GPhA), Medical Imaging & Technology Alliance (MITA) and Pharmaceutical Research and Manufacturers of America (PhRMA), trade associations representing biopharmaceutical and medical device companies, praised Sens. Pryor, Blunt, Coats, Franken, and Moran for their efforts to prevent the sequestration of future FDA user fees and urged Congress to find a bipartisan solution for releasing sequestered FY13 user fees as Congress continues its work on the FY14 appropriations process.

“Our member companies make the medicines and technologies that diagnose and treat thousands of conditions, ranging from cancer to HIV/AIDS to heart disease to diabetes. Bringing novel and generic medicines, medical devices and diagnostics to patients requires a sufficiently-funded FDA that has the resources required to keep pace with scientific advances.

“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.”

 

About AdvaMed
AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.

About GPhA
GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 84 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at www.gphaonline.org.

About MITA
The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the collective voice of medical imaging equipment, radiation therapy and radiopharmaceutical manufacturers, innovators and product developers. It represents companies whose sales comprise more than 90 percent of the global market for medical imaging technology. For more information, visit www.medicalimaging.org.

About PhRMA
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research and biotechnology companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested approximately $550 billion in the search for new treatments and cures, including an estimated $48.5 billion in 2012 alone. For more information, please visit www.phrma.org.

About BIO
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.