Let FDA top performers set pace, study says

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Janet Woodcock
Janet Woodcock

A Manhattan Institute analysis says that helping underperforming FDA drug review divisions match the output of high-performing divisions could cut development costs and speed approval of new treatments.

The authors found, for example, that the neurology division takes three times as long to approve drugs as the oncology division. “These differences cannot be explained by differences in workload, the type and complexity of the drugs reviewed, or the safety of the drugs approved,” the report declares.

Among the study's recommendations are identifying policies and procedures that work in high-performing divisions, expanding transparency efforts and special designation programs, and forming a cadre of FDA “shock troops” to help alleviate workload fluctuations.

Reacting to the report, FDA drugs director Janet Woodcock said that it is hard to compare drug reviews when different indications are being sought, and that oncology reviewers just have better drugs to look at. The war on cancer has “paid off,” she said, adding that oncology drug developers are targeting the root cause (i.e., aberrant cellular pathways). The Oncology Review Division has their “bit between the teeth and they are inspired,” she said.

Woodcock added that part of why some review divisions don't look as good as the oncology division is due to how problematic some development programs are—something the Manhattan study didn't quantify.

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