La Jolla, CA (PRWEB) May 09, 2012
CHI-California Healthcare Institute and The Boston Consulting Group (BCG) this morning released a report that provides an update on performance of the U.S. Food and Drug Administration (FDA) with respect to its approval of drugs and biologics, building on our earlier study, Competitiveness and Regulation: The FDA and the Future of America’s Biomedical Industry (2011). The report presents new data that illustrate important differences in FDA performance from one therapeutic area to another and examines misalignment between regulation and public health needs.
The report, titled “Managing Priorities: Therapeutic Area Variation in FDA Drug Regulation,” comes as Congress considers critical legislation that would renew and expand fees paid by drug and medical-device companies to help fund the FDA. Current legislation allowing the FDA to collect fees from drug and medical-device companies expires Sept. 30. The fees help pay for the agency to review applications for new drugs and medical devices.
The report released today examines review times for drugs and biologics for various diseases and conditions, looking at how they compare to one another. Oncology, for instance, is a high priority and the agency has used various procedures to accelerate the approval of cancer drugs. But there are other diseases and conditions that pose serious public health threats, including cardiovascular disease, obesity and diabetes, where regulatory standards remain unclear and the agency’s performance has lagged.
“As Congress reauthorizes user fees, we suggest that these discrepancies among therapeutic areas may, in fact, represent an opportunity for the FDA to replicate best practices in high performing areas throughout the agency,” said CHI President and CEO, David L. Gollaher, Ph.D. “Bringing drug approvals into better alignment with public health needs will require continuous improvements in agency management, infused with science and common sense.”
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 http://www.chi.org. Follow us on Twitter @calhealthcare and Facebook.
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