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FDA launches new office to rethink how drugs are reviewed


The FDA will develop more standardized, streamlined, and structured processes for reviewing new drugs, FDA commissioner Dr. Scott Gottlieb announced Tuesday.

To do that, the agency will create a new group, the Office of Drug Evaluation Science, whose 52 members will assess drug efficacy and safety, explore how to use information technology, and monitor how biomarkers are researched.

“This is going to be a new paradigm as we modernize the drug review process,” Gottlieb said, speaking to an audience at the J.P. Morgan Healthcare Conference in San Francisco. Gottlieb was supposed to appear in person at the conference, but because of staff shortages resulting from the government shutdown, appeared via video conference from Washington.

The new group will take a more structured approach to data analysis, Gottlieb said. The data they study will come from the cloud, which could make them more numerous and more readily available. The office will begin its work with a structured review of data that examines the safety of new drugs. It will also evaluate biomarkers, bioinformatics, and patient-reported outcomes.

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The creation of the office is part of a broader restructuring of the Office of New Drugs, which itself is in the Center for Drug Evaluation and Research. Gottlieb hopes to launch the new group in the coming months.

Gottlieb also spoke about drug costs and the agency’s role in curbing them. As a product regulator, the FDA wants to increase competition. That includes expediting the approval of generic drugs, which the FDA is encouraging with a “more structured approach” in applications, Gottlieb said.

Drug review and competition aren’t the only areas the FDA has been addressing lately. On Monday, the FDA released a draft test plan and regulatory framework for its software precertification program. The FDA will test how precertification would work to regulate digital health devices with a faster, multi-stage review process.

“We recognize we can’t regulate them the same way we regulate traditional medical devices,” Gottlieb said of modern, digital products. Some of these products are updated as frequently as once a day, he said, which calls for a different kind of review process.

That review process will help bring novel software to patients, according to the Connected Health Initiative.

The FDA has also been active in the device safety arena. In April 2018, it released its Medical Device Safety Action Plan, in which regulators called for tracking a product’s safety throughout its life-cycle.

These changes indicate the overall direction the FDA is moving in. The agency intends to ease the burden of regulatory processes, speeding how software, devices, and drugs go from development to market.