Commercial risk will be a critical catalyst of progress – it’s complicated, but is it possible? We think so.


January 11, 2019

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

Daily Briefing

    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]).

    What executives need to know about pharmacy

    While historically pharmacy may have been viewed as a cost center, today pharmacy services generate a significant portion of system revenues and are essential to the achievement of strategic system-level priorities.

    To better understand increasingly complex pharmacy issues and the critical role pharmacy plays in overall health system success, download our executive briefings on hot pharmacy topics.

    Download the Briefings

    Have a Question?


    Ask our experts a question on any topic in health care by visiting our member portal, AskAdvisory.