A new FDA office aims to make the drug approval process 'look a lot different'

FDA Commissioner Scott Gottlieb on Tuesday said the agency will create a new office tasked with developing a standardized approach for evaluating drugs, Modern Healthcare reports.

The new Office of Drug Evaluation Science, which Gottlieb hopes to launch in coming months, will consist of 52 members. The office's main priorities will be to develop a more structured approach to data analysis for drug approvals. For example, the office will review data used to determine drug safety and efficacy, as well as patient-reported outcomes. According to Gottlieb, the office also will explore how to better use information technology and will evaluate other performance metrics, such as biomarkers, bioinformatics, and biostatistics.

Gottlieb said the new office is part of a broader shift to restructure the drug review process.

"Eventually the drug review process will look a lot different," Gottlieb told STAT News. Gottlieb said his goal is to achieve a process in which drug companies upload drug safety data to the cloud so FDA can use its own analysis methods to examine the raw data. Currently, FDA relies on the charts and tables companies create themselves, STAT News reports.

"That is where we are heading," Gottlieb said, "starting with the evaluation of safety data" (Arndt, Modern Healthcare, 1/8; Herper, STAT News, 1/7; Roza, Inside Health Policy, 1/8 [subscription required]).

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