California Biomedical Industry Leaders Urge Congress to Take Action on FDA User Fees for FY2014
(LA JOLLA, Calif., 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 make the necessary regulatory process improvements.
“As lawmakers begin to prioritize funding measures for FY14, it is essential that we safeguard the budget of the U.S. Food and Drug Administration,” said David L. Gollaher, Ph.D., CHI’s president and CEO. “Industry user fees are critical for the FDA to complete timely and effective reviews of new medical devices and medicines. We urge legislators in Washington to repair this unacceptable sequester of user fees, by restoring to the FDA all user fees paid in 2013, and also to take steps to ensure future cuts do not affect user fees paid to the FDA in the future.”
As California’s biomedical industry is an increasingly important component of our state’s economic engine, employing nearly 270,000 people, paying $15.5 billion in wages and accounting for $20 billion in exports annually, user fees are critical for FDA to meet its Congressionally-mandated responsibilities, and are also important for sustaining biomedical investment, innovation and improvements in patient care.
“We believe that the vibrancy of California’s biomedical industry depends heavily upon continued advances and progress in science, which are supported by a well-funded, science-based FDA,” said CHI President and CEO David L. Gollaher, Ph.D. “User fees contribute greatly to ensuring that the FDA is able to provide vigorous, predictable and efficient product reviews, which are necessary for biomedical investment, innovation and improvements in patient care.”
Click here to view the letter sent to House Appropriators and the California congressional delegation.
CHI represents more than 275 leading biotechnology, medical device, diagnostics, and pharmaceutical companies, and public and private academic biomedical research organizations. CHI’s mission is to advance responsible public policies that foster medical innovation and promote scientific discovery. CHI’s website is www.chi.org. Follow us on Twitter @calhealthcare, Facebook, LinkedIn and YouTube.