7 October 2019 - From industry to academia, commenters have argued that the US FDA's drug approval standards are becoming inappropriately low and that the required post-approval evaluations are either inadequate or left undone.

But three senior FDA officials offered several counterpoints on Monday at the fifth annual Biopharma Congress in Washington, DC.

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, explained that the agency is working on its own analyses to provide “a more robust response” to these critiques. She also explained how the high number of approvals in recent years for rare diseases may be influencing this perception of a lower bar, especially as more treatments are approved on the basis of a single-arm study or with an external control group. In addition, she pointed to the “astoundingly” high launch prices for some of these rare disease treatments that may also be part of the reason for the pushback.

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