California Healthcare Institute (CHI) Applauds Congresswoman Eshoo and Members of the California Delegation on Their Leadership on the FDA SOS Act

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(LA JOLLA, Calif., July 18, 2013) – California Healthcare Institute (CHI) commends and applauds the leadership of Representative Anna G. Eshoo (D-Palo Alto) on leading the charge to support California’s biomedical industry by introducing the FDA SOS (Safety Over Sequestration) Act. Together with a bipartisan collection of California Members, including Reps. Tony Cárdenas (D-San Fernando Valley), Sam Farr (D-San Francisco), Doris Matsui (D-Sacramento), Scott Peters (D-San Diego), David G. Valadao (R-Hanford) and Henry A. Waxman (D-Santa Monica), Eshoo’s legislation will eliminate future sequestration of industry-paid user fees that support the Food and Drug Administration (FDA) drug and device product review activities.

As the statewide public policy organization representing California’s leading biomedical innovators, CHI strongly supports the FDA SOS Act. “Having worked closely with Congresswoman Eshoo on measuring and improving FDA performance as part of last year's user fee law renewal, we appreciate her continued leadership, and we strongly support this measure to ensure that industry-paid user fees go to their intended use, supporting the Agency's timely review of new medicines and technologies for patients in need,” said CHI President and CEO, David Gollaher, Ph.D.

With more than 2,300 biomedical companies and institutions clustered throughout the state, CHI and its more than 300 members including medical device, diagnostic, biotechnology and pharmaceutical companies, research universities and private, nonprofit institutes, and venture capital firms are global leaders in life sciences research and development. The sector is an increasingly vital component of California’s economic engine, employing nearly 275,000 people, paying $15.5 billion in wages and accounting for $20 billion in exports.

A well-funded FDA with consistent, timely and transparent product review processes is necessary for biomedical investment, innovation and improvements in patient care. With diseases such as Alzheimer’s, cardiovascular disease and obesity growing rapidly in the United States, patients’ access to new therapies depends on a clear and predictable drug and device approval pathway within the FDA.

Last year, passage of the FDA Safety and Innovation Act (FDASIA) renewed FDA’s authority to collect user fees and fund much-needed improvements to drug and device regulatory review processes. In fact, industry agreed to pay increased user fees in order to facilitate the needed system and process improvements. This important legislation was developed with input from industry, the Agency, patient groups and other stakeholders, and passed into law with overwhelming bipartisan support. These industry-paid user fees contribute substantially to supporting FDA’s drug, biologic, biosimilar, medical device and diagnostic product review activities and are critical to supporting FDA’s mission and Congressional mandate to protect and support public health.

While sequestration has cut approximately five percent of FDA’s appropriated budget, it has also locked up an estimated $85 million in user fees in FY2013. This is disrupting FDA’s product review processes, threatening to delay patient access to innovative new technologies, and further aggravating an already significant downturn in life sciences venture capital investment. CHI applauds California’s Members of Congress and Reps. Leonard Lance (R-N.J.), Mike Rogers (R-Mich.) Joe Barton (R-Tex.), Michael C. Burgess, M.D. (R-Tex.) and Gus Bilirakis (R-Fla.)that have introduced this legislation to stop sequestration of FDA user fees in FY2014 and in the future.

About CHI

California Healthcare Institute (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. To learn more, visit our website and follow us on Twitter @calhealthcare, Facebook, LinkedIn and YouTube.

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