Regulatory Focus™ > News Articles > Report: FDA Taking Longer to Approve Drugs With 'Unmet Medical Needs'

Report: FDA Taking Longer to Approve Drugs With 'Unmet Medical Needs'

Posted 09 May 2012 | By Alexander Gaffney, RAC 

A new report published jointly by the California Healthcare Institute (CHI) and the Boston Consulting Group (BCG) is claiming the US Food and Drug Administration (FDA) is taking longer to approve pharmaceutical products for some areas of unmet medical need as the result of unclear regulatory standards.

The report, "Managing Priorities: Therapeutic Area Variation in FDA Drug Regulation," is a follow-up to one co-authored by CHI and BCG in 2011. The 2011 report notes FDA's review times increased between 2006 and 2008, increasing on average from roughly 13 months to nearly 20 months.

Those findings were largely consistent with a later review by the Government Accountability Office (GAO), which noted the same increase and attributed it largely to new statutory requirements under the FDA Amendments Act of 2007.

The new CHI/BCG report released 9 May goes one step further than GAO's report by segmenting the mean approval times of the agency by product area. While FDA has done a good job approving certain product areas-including oncology drugs-the agency has lagged in other therapeutic areas, said CHI and BCG.

"[T]here 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," said CHI in a statement.

Central Nervous System (CNS) drugs and Gastrointestinal (GI) drugs , of which 27 and 15 have been respectively approved by the agency via its priority review pathway, have taken more than 22 months on average to approve.

Compared with oncology drugs, of which 54 were approved via the priority review pathway taking on average just 11 months each, CNS and GI drug approval times are sorely lacking, said the authors.

Far from being blanket criticism, CHI said the discrepancy represents an "opportunity for the FDA to replicate best practices in high performing areas throughout the agency."

While the CHI/BCG paper notes there are limits to seeking out parallel practices, particularly as the agency is more accepting of high-risk oncology products due to the limited lifespan of some patients, it maintains there are still improvements to be made.

The paper calls for "robust tracking mechanisms and analysis" to be developed to understand where those efficiencies might come from-what CHI calls the "time-honored principle of management [of] what gets measured gets done."

Read more:

Managing Priorities: Therapeutic Area Variation in FDA Drug Regulation

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

CHI, BCG Issue Report on FDA's Drug Review Performance

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