FDA effort aims to speed up drug development
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The Food and Drug Administration is launching a pilot program intended to speed up the process of bringing new drug candidates from discovery into human clinical trials.
Why it matters: Early-stage drug development in China is cheaper and faster than in the U.S., and that's one reason China has quickly become such a formidable competitor within the biotech sector.
- There's widespread agreement among experts that for the U.S. to maintain its competitive edge, it needs to streamline its drug development process.
- The pilot is part of Operation TrialBlazer, the Trump administration's initiative to restore American leadership in clinical trials.
Driving the news: The pilot envisions partnering drug companies with qualified research institutions that will help them submit new drug applications to the agency.
- The FDA would review components of the application on a rolling basis, rather than waiting for a full submission to begin a review.
- This rolling review will "creat[e] certainty and reduc[e] unnecessary delays," Karim Mikhail, director of the FDA Center for Biologics Evaluation and Research, told reporters.
- The agency will select up to 10 pairings of drug sponsors and research institutions for the pilot.
What we're watching: The agency said the pilot could potentially inform efforts to establish a formal accreditation model in the future, which would recognize research institutions capable of supporting drug development.
Our thought bubble: A pilot program is, at the end of the day, limited and experimental. But lessons learned will drive future policy, and early-stage development has emerged as a clear area in need of improvement if the U.S. wants to keep up with China.
