New California Healthcare Institute Report on FDA Shows Longer Review Times for Drugs for Unmet Medical Needs

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Highlights Need to Revise Performance Metrics to Bring FDA into Better Alignment with Patient Needs

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.”

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 and Facebook.

About The Boston Consulting Group
The Boston Consulting Group (BCG) is a global management consulting firm and the world's leading advisor on business strategy. We partner with clients from the private, public, and not-for-profit sectors in all regions to identify their highest-value opportunities, address their most critical challenges, and transform their enterprises. Our customized approach combines deep insight into the dynamics of companies and markets with close collaboration at all levels of the client organization. This ensures that our clients achieve sustainable competitive advantage, build more capable organizations, and secure lasting results. Founded in 1963, BCG is a private company with 75 offices in 42 countries. For more information, please visit

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Nicole Beckstrand

Alexandra Corriveau
BCG Media Relations Manager, The Americas
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