California Life Sciences Association Releases New Infographic Detailing Improved FDA Drug Review Performance

CLSA & BCG Analysis Illustrates Drug Review Time Improvements Since 2013; Opportunities for Improvement Remain

SOUTH SAN FRANCISCO — March 29, 2016 — California Life Sciences Association (CLSA), the leading voice to drive innovation for California’s statewide life sciences sector, today released a new infographic report on the U.S. Food and Drug Administration’s (FDA) drug review and approval times over the last 15 years. Produced in partnership with The Boston Consulting Group, the infographic, titled, “Tracking FDA Drug Review Performance,” shows that the FDA has accelerated review times, descending from an average of 21 months in 2009 to 10 months in 2015. The infographic is available to view and download at

“The FDA plays a critical role in the drug review and approval process, with twin goals of employing rigorous scientific and safety standards to ensure new medicines get to patients as quickly as possible,” said Sara Radcliffe, President and CEO, California Life Sciences Association (CLSA). “As demonstrated by the continued reduction in overall average review times, the Agency is deserving of applause and recognition for these real improvements, driven in part, too, by the constructive engagement of Congress, patient groups, industry and others.”

Since 2009, drug review time has steadily declined, with particularly fast review times seen in the therapeutic areas of oncology, infectious, and rare diseases. At the same time, the data suggests that, despite consistent decreases in overall average approval times, therapeutic areas such as endocrine, central nervous system and gastrointestinal diseases still have room for improvement. Increased approval times can also be attributed the new ‘Breakthrough Therapy Designation’ pathway, established as part of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), which offers 60-day review timelines for qualifying product submissions.

Key facts and infographic highlights:

  • Following a dramatic slowdown, average FDA review times have steadily improved since 2009, dropping from 21 months to 10 months
  • Oncology and immunomodulatory (immunomod) and anti-infective products have seen the strongest consistent review performance. Endocrine, gastrointestinal, central nervous system and musculoskeletal products continue to see the most consistent lag relative to the overall average.
  • 2015 marked an increase in the diversity of breakthrough approvals since the inception of the ‘Breakthrough Therapy Designation.’ Historically, breakthrough therapies have been concentrated in oncology, rare diseases and infectious conditions.

“California has nearly 1,200 biopharmaceutical companies with more than 1,200 medicines in the development pipeline,” said Todd Gillenwater, Executive Vice President, Advocacy & External Relations, California Life Sciences Association (CLSA). “Improvements in overall FDA review times offers encouragement to these companies and, most important, to patients and their families. The Agency, Congress, patient groups and industry deserve credit for working together to get review processes back on track. But more can still be done. As we approach the next FDA user fee reauthorization, CLSA will work to support continued review process improvements and consistency, while also supporting enhancements to the drug development process, such as through patient-focused drug development and regulatory science tools like biomarkers and adaptive trials.”

The full infographic is available on CLSA’s website:

About California Life Sciences Association (CLSA)

California Life Sciences Association (CLSA) is the leading voice for California’s life sciences sector. We work closely with industry, government, academia and other stakeholders to shape public policy, drive business solutions and grow California’s life sciences innovation ecosystem. CLSA serves over 750 biotechnology, pharmaceutical, medical device, and diagnostics companies, research universities and institutes, investors and service providers. CLSA was founded in 2015 when the Bay Area Bioscience Association (BayBio) and the California Healthcare Institute (CHI) merged to create the state’s most influential life sciences advocacy and business leadership organization. Visit CLSA at, and follow us on Twitter @CALifeSciences, Facebook, Instagram, LinkedIn and YouTube.

About 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 85 offices in 48 countries. For more information, please visit 

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