Regulatory Focus™ > News Articles > What Causes Variations in Review at CDER? It's All About the Designation

What Causes Variations in Review at CDER? It's All About the Designation

Posted 21 August 2015 | By Michael Mezher 

What Causes Variations in Review at CDER? It's All About the Designation

Last year, a study by the Manhattan Institute for Policy Research (MIPR) found variations in review time at the US Food and Drug Administration's (FDA) various drug review divisions were caused by inefficiencies at the agency. Now, FDA representatives are making the case that the variation in review times can be explained by the proportion of applications receiving accelerated review in different therapeutic areas.

The MIPR study concluded that the variations in review time could not be tied to "greater resources or lesser complexity of task or reduced safety," and found the inconsistencies to be "a strong indication of inefficiency."

However, in an article appearing in Nature Reviews Drug Discovery, several FDA employees, including Andreas Schick, Kathleen Miller and Michael Lanthier at FDA's Office of the Commissioner, and Janet Woodcock, director at the Center for Drug Evaluation and Research (CDER), are defending the agency's practices by making the argument that the variations in review time at CDER's different divisions are strongly correlated with the proportion of applications to that division using one of the agency's accelerated review programs.

The Source of Variation

Using FDA's own internal data, Schick and his co-authors looked at 250 new molecular entities (NMEs) approved by CDER between fiscal years 2003 and 2014. Out of the 250 NMEs, the authors found "117 received priority reviews, 87 received fast-track designations and 3 received breakthrough therapy designations."

The authors then looked at the percentage of NMEs that qualified for priority review or fast-track designation in different therapeutic areas compared to the median review time in each area. Areas such as oncology and antiviral therapies had the highest proportion of accelerated reviews and by far the shortest median review times; whereas areas such as psychiatry, dermatology and dental had longer review times and no products with accelerated reviews.

After analyzing the approval data, the authors were able to demonstrate a "strong negative correlation between the percentage of priority review applications that a division receives and their median review times."

The variation in review times, they explain, is largely due to the agency's ability to prioritize high-impact products, such as cancer treatments and drugs to treat hepatitis C.



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