Gottlieb Touts Launch of New FDA Office to Improve Drug Review Process

The FDA is changing how it reviews drugs with the addition of a new office of drug development science that Commissioner Scott Gottlieb, MD, said will modernize and bring more predictability and structure to the drug review process.

“We envision a world where we’re going to move toward a much more structured review process where the data will be available in a cloud-based environment,” said Gottlieb during the 37th Annual JP Morgan Healthcare Conference in San Francisco, California. The hope is that the FDA will then be able to pull the data from cloud and do a more structured analysis of the data.

The group will begin this year with a structured review of safety data. It will also evaluate elements that have been playing an increasing role in the drug review process, including the use and validation of biomarkers, bioinformatics, and patient-reported outcomes.

He likened the inclusion of these elements to when the FDA in 2003 created a modeling and simulation office based on recognition that it was becoming a more important component in the drug review process. At the time, Gottlieb explained, very few companies were using it, but they recognized the need for both guidance and an office to review applications that used the component. Now, 15 years later, more than 90% of applications have some aspect of modeling and simulation built into them.

“That’s the goal of these new drug development science offices we’re creating,” said Gottlieb. He added: “This opportunity is here. This is going to be the new paradigm and it’s going to be how we modernize the drug review process.”

According to STAT News, the 52-person group, called the Office of Drug Evaluation Science, will have its own director and 3 divisions: an 18-person Division of Clinical Outcomes Assessment that will evaluate safety and efficacy measures, an 18-person Division of Biomedical Information and Safety Analytics that will evaluate new ways of using information technology, and an 11-person Division of Research and Biomarker Development that will monitor blood samples and genetic scans.

The office is just one component of a very broad reorganization of the Office of New Drugs, according to Gottlieb.

Other components of the modernization include creating more therapeutic offices so that there are more targeted offices focused on specific disease areas. The reorganization will also create a discrete function within the Office of New Drugs that will be focused on policy generation and clinical guidance generation, said Gottlieb.

Switching focus to drug pricing, Gottlieb explained “price competition is product competition” and that the FDA is looking at places where they don’t see competition, including complex generics. He also mentioned improving the generic drug process itself by moving toward a more templated and structured approach to generic drug applications, as well as moving toward a global application so when companies file for generic approval, they can file simultaneously in the European Union and in the United States.

The FDA will also look at patent issues and whether or not there are instances where there are patents are not serving a public health purpose and instead are being used as a way to thwart competition.