(LA JOLLA, Calif.) (PRWEB) May 24, 2013
CHI-California Healthcare Institute today submitted a letter to House Appropriators and the California congressional delegation, joined by over 40 biomedical companies, urging them to restore sequestered industry user fees paid to the U.S. Food and Drug Administration in 2013, and to ensure that future across-the-board cuts will not include user fees paid to FDA, as part of the FY14 Agriculture, Rural Development and FDA Appropriations Bill. CHI is a non-profit public policy research and advocacy organization for California’s biomedical R&D industry.
California is the worldwide leader in biomedical investment, research and development, with more than 2,300 biomedical companies and public and private research institutions advancing scientific knowledge and developing new diagnostics tools, treatments, and technologies addressing diseases and conditions including cancer, diabetes, HIV/AIDS, chronic pain, and cardiovascular, respiratory and infectious diseases.
Last year, Congress passed the FDA Safety and Innovation Act (FDASIA) which renewed the FDA’s authority to collect user fees from industry. These funds were to provide much-needed improvements to drug and device regulatory review processes. CHI supported this important legislation, as it was developed with input from the industry, the Agency, patient groups and other stakeholders, and signed into law with overwhelming and bipartisan support.
Unfortunately, congressionally-mandated across-the-board spending cuts now threaten the implementation of the FDASIA legislation, which could lead to a slowdown at FDA, with delays in patient access to innovative new technologies and further aggravating an already significant downturn in life sciences venture capital investment. Specifically, sequestration prevents FDA from accessing and using nearly $83 million in industry-paid user fees to conduct review activities and
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