Gottlieb: How a cultural shift is transforming FDA’s drug reviews

Guest Commentary: Former FDA commissioner says real world evidence will transform agency’s drug reviews

A decade ago, the FDA secured new tools, resources, and authorities to implement a watershed change in how the agency approached the drug review process.

The novel framework turned on a more active approach to managing drug safety, based on new authorities that the FDA sought and secured, to require drugmakers to impose requirements on doctors to assure the safe use of certain riskier drugs. As part of the new framework, Congress passed a new law that gave the FDA the authority to impose Risk Evaluation and Mitigation Strategies (REMS) and Elements to Assure Safe Use (ETASU). These measures were meant for certain drugs that had serious safety concerns associated with their use. The agency’s aim was to help ensure that the benefits of drugs with known safety issues would outweigh their risks.

At the same time, the agency secured new resources to advance these same goals. The money was used to build out a novel platform for collecting and mining postmarket safety information, using data gleaned from the claims filed with payers. This was the origin of the FDA’s Sentinel Database. The agency also pursued, and acquired, the authority to require drugmakers to conduct postmarket studies

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