Integration a key focus of FDA's new drug review model
- The Food and Drug Administration is implementing a new regulatory model detailing how its various units will review drug approval applications, with a large emphasis on integrating the forces responsible for evaluating the medicines themselves and the sites at which they're manufactured.
- The central goal of the agency's new concept of operations is to better align the Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs (ORA), according to an Aug. 31 blog post written by FDA Commissioner Scott Gottlieb.
- As part of those updated operations, the agency is creating Integrated Quality Assessment (IQA) teams tasked with judging the quality of marketing applications, and consequently providing recommendations to drugmakers and the FDA. The teams will include a drug substance reviewer, a drug product reviewer and an assessor from the Office of Process and Facilities, as well as other members as needed.
IAQ teams appear to be the latest tool aimed at streamlining FDA regulations. One of the agency's recent focuses, and especially so since it came under Gottlieb's leadership, has been eliminating inefficiencies in drug manufacturing oversight.
Just last month, for instance, the FDA entered into a new agreement with the European Medicines Agency that gives European regulators more commercially confidential information about pharmaceutical production. The deal furthered earlier work aimed at building greater trust between the agencies as well as optimize manufacturing site inspections.
The FDA's new concept of operations would affect a wide range of inspections: pre-approval facility examinations, post-approval inspections, surveillance facility inspections (which pertain to sites that produce monograph drugs, in-process materials and drug substances used in marketed products) and for-cause facility inspections (which happen when an event calls into question whether a site is compliant with the agency's manufacturing standards).
In general, CDER representatives on the IQA teams decide whether a production plant requires inspecting or simply an evaluation. If an inspection is needed, an ORA member then takes the lead — benefiting from his or her greater access to pertinent CDER information, such as what parts of the manufacturing process may pose the most risk to drug product quality.
"Increasing information sharing ... allows our field force to better target their inspectional work based on what they learn from our review staff about the points of vulnerability related to how a product is manufactured," Gottlieb wrote in the Aug. 31 blog post. "By the same virtue, our review staff can gain insight from our field staff, for example, to better focus how they evaluate information submitted as part of the manufacturing portion of new drug product application."
The expected benefits don't stop there, however.
"Our inspectional force will benefit from insights that might be offered by the review teams who have carefully evaluated products being manufactured," Gottlieb wrote. "Meanwhile, our review staff will benefit from the deeper understanding they will glean through more direct and regular contact with the professionals who are inspecting facilities and seeing the kinds of things that can go wrong during the manufacturing process."
CDER and ORA officials worked on the new operational procedures together. According to Gottlieb, they are geared toward helping the agency meet some of its larger goals, including a speedier and more efficient review process for generic medicines and drugmakers.
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