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US FDA's Abernethy 'Cautious' About Real-World Evidence

 
• By Derrick Gingery

FDA's principal deputy commissioner, who used to work in the real-world evidence field, said momentum is building, but more successful use cases are needed.

FDA Principle Deputy Commissioner Amy Abernethy speaking to a Pharmaceutical Research and Manufacturers of America conference
US FDA Principal Deputy Commissioner Amy Abernethy said companies must "pressure test" RWE ideas to prove their viability. • Source: Derrick Gingery

The US Food and Drug Administration's No. 2, who came to the agency from a company pushing for increased use of real-world evidence, is not convinced the data is ready for full implementation in drug development.

Amy Abernethy, the agency's principal deputy commissioner, told an industry audience that momentum is building for increased use of RWE,...

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