CHI Issues Statement on President Obama Reauthorizing User Fee Acts

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Timely FDA Review Critical for Advancing New Therapies

CHI-California Healthcare Institute President and Chief Executive Officer David L. Gollaher, Ph.D., issued the following statement today regarding President Barack Obama signing into law S. 3187, the Food and Drug Administration Safety and Innovation Act:

“President Obama today signed into law legislation reauthorizing the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA). The legislation doubles the user fees medical device companies currently pay FDA to review their applications, from $295 million over five years to $595 million. It also increases fees for the drug industry, to $700 million in 2013 and increased amounts in subsequent years.

“The increases come in exchange for the FDA meeting certain performance goals and process reforms to ensure patients receive timely access to new therapies. Included in the agreement are first-time review division-level drug reporting requirements, the importance of which CHI highlighted in its recent report, “Managing Priorities: Therapeutic Area Variation in FDA Drug Regulation."

“The user fees will improve FDA's ability to provide timely and expedited review and approval of applications for prescription drugs and medical devices. The legislation extends and modifies FDA authorities related to drugs intended for use by children, improves the drug and device approval processes and offers new incentives for innovators to develop antibiotics.

“CHI is looking forward to continuing to work with FDA to improve the regulatory process to ensure continued investment and research and development of treatments for patients in California.

“CHI will host a complimentary webinar at 10 a.m. Pacific Aug. 22 featuring Amy Kneifel, director of regulatory affairs for Aptiv Solutions. “Reauthorization of the Prescription Drug User Fee Act (PDUFA): How will you be Affected?” will address the provisions of the Agency-industry negotiated agreement, as well as additional and related provisions added during congressional consideration, and what it all means for the biopharmaceutical industry. Visit CHI's events page on next week to register. ”

About CHI

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 Follow us on Twitter @calhealthcare, Facebook, LinkedIn and YouTube.

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Nicole Beckstrand
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