Draft guidance from the U.S. Food and Drug Administration (FDA) on real-world data (RWD) and real-world evidence (RWE) was released in May to mixed reaction from stakeholders.
The draft guidance is called “Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics,” with the intent to encourage sponsors who are using RWD and RWE to be part of a regulatory submission. Reaction came from many in the industry including Gilead Sciences, Inc., Novartis Pharmaceutical Corp., Biotechnology Innovation Organization and the Pharmaceutical Research and Manufacturers of America.
Gilead Sciences believes the guidance needs a broader list of submissions, including supplemental new drug applications and supplemental biologics license applications. Novartis Pharmaceutical wants to broaden the scope of guidance including pharmacy claims as a source of RWE and thinks sources of clinical evidence should include patient reported outcomes.
On the other hand, Biotechnology Innovation believes that proposals may be delayed or impeded by implementation challenges. The organization wants the FDA to share learnings and best practices with other regulators.
Additionally, The Pharmaceutical Research and Manufacturers of America wants to increase consistency and regulatory predictability from the FDA by having the agency implement tracking and reporting of aggregate data about RWD and RWE applications.
