Gottlieb Updates Lawmakers on Drug Review Enhancements
On the heels of a substantial budget boost (see story) for this fiscal year, FDA commissioner Scott Gottlieb has outlined for U.S. House of Representative appropriators significant modernization efforts underway in CDER’s Office of New Drugs (OND). Beginning in the next few months, CDER will adopt new standard templates for its 30-day IND safety reviews and protocol reviews, Gottlieb told a 2/28 subcommittee hearing. “This will better integrate the work of clinical and scientific reviewers, improve the consistency of the IND review process, reduce duplicative paperwork, provide greater efficiency and predictability to product developers, and enable the FDA to be more effective and strategic in premarket safety discussions with sponsors during its review of these INDs,” he said.
On the drug safety side, Gottlieb said FDA is soon launching a “safety signal tracker” to serve as a repository of important potential safety issues throughout a drug’s lifecycle, from early in IND development through application review and into the post-market setting. “This consolidates information about safety concerns during drug development in a single location,” he said in his testimony. “In this way, safety questions can be more consistently tracked, annotated, and continuously evaluated through every stage in the life cycle of a new medical product. Reviewers don’t need to hunt for information across multiple databases and documents. All team members share a common view of key information. This helps cement a more systematic approach to how we continue to evaluate certain safety questions throughout the new drug or biological product application review and could measurably improve the drug development process.”
Under this process, OND is now holding meetings early in the drug review cycle to identify potential and known safety issues. This “facilitates more proactive planning to evaluate or mitigate known or perceived risks,” he said. “Finally, we’re making the process more effective by adding clinical data scientists to our new drug and biological product safety review process, and incorporating standard tables and figures supporting the team’s analysis of safety data. Once again, the aim is to make the entire process more structured and predictable.”
Gottlieb also said that for the first time in more than 20 years, FDA is undertaking a guidance update to outline how reviewers assess a drug’s clinical effectiveness. “A lot has changed since we first recommended in guidance in 1998 how investigators should conduct trials to support a drug’s effectiveness,” he said. “Our approval standard remains unchanged. But the science and data that we evaluate as part of drug review, and the diseases that are more often being targeted by new medicines, has changed a lot. We have much more opportunity to use a broader array of data as confirmatory evidence to help support product review. This includes real world evidence and real world data.”
Moving to post-market drug safety, Gottlieb told the hearing that FDA has launched a new effort to analyze more safety data more efficiently across the entire drug lifecycle. “We’re implementing changes to capture more types of safety data, enhance our data analytics, and grow Sentinel’s ability to detect potential new safety problems,” he said. “We’ll be working to link claims data in Sentinel to electronic health records, to improve our ability to conduct active surveillance and use real world data to improve patient outcomes... By linking information from electronic health records to the data we have on medical claims through our existing Sentinel system, we’ll be able to get a much more complete picture of potential safety issues post-approval and to advance the use of real world data to study drug effectiveness.”
Additionally, Gottlieb told lawmakers that FDA’s Adverse Event Reporting System for drugs will be expanded to cover more types of safety data, such as pre-market drug safety data. The system will include IND safety reports, product quality defect reports, and generic bioequivalence trial safety reports. These reports are now stored and reviewed individually.