Reports: FDA Intends to Establish a New Office to Improve Review Process of New Drugs

Scott Gottlieb editorial

Albert H Teich /

The U.S. Food and Drug Administration (FDA) will create a new office to improve the process of reviewing new drugs for approval.

According to reports, FDA Commissioner Scott Gottlieb will outline the formation of the Office of Drug Evaluation Sciences, a 52-member group, during his talk at the J.P. Morgan Healthcare Conference in San Francisco later today. Gottlieb, according to STAT News, will deliver his talk via teleconference due to fallout from the government shutdown that has impacted travel for many officials.

While the office has yet to be officially established or set up, there are some reports of how the structure may be set up. FierceBiotech noted that one-fifth of the new office’s staff will focus on “creating more structured approaches to the evaluation of biomarkers.” The use of biomarkers will play an even more important role in development and review of drugs, Gottlieb said. About one-third of the office will work on the biomedical and safety analytics, Fierce reported.

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The new office will develop a standardized approach to using personalized medicine, digital data and the health reports from patients in determining approvals, STAT noted. In his interview with the publication, Gottlieb said the new Office of Drug Evaluation Sciences will revolutionize the way that medications are reviewed for regulatory approval. Gottlieb sees greater integration of big data and patient records within the process. He told STAT that the massive amounts of data will be uploaded to the cloud and then reviewed directly by the FDA, as opposed to reviews currently assembled by drug developers. The FDA will create its own standards for the review process and it will begin with safety data, Gottlieb said.

As STAT outlined, the idea of patient reports are becoming even more necessary a part of the conversation when it comes to drug approvals. As an example, the publication pointed to patient reports from Pfizer’s lung cancer treatment Xalkori. Reports from patients show that the medication can have a negative impact on the eyes, but reports also show that the medication may reduce shortness of breath.

The new office in the FDA will be under the umbrella of the Office of New Drugs, part of the FDA’s Center for Drug Evaluation and Research. The new office is still going through a review process, but Gottlieb said he intends to begin the program in the first half of 2019, according to the report.

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