Howard Sklamberg Quoted in Pink Sheet on FDA’s Use of “Potential OAI” Status in Drug Reviews

Howard Sklamberg, Arnold & Porter Life Sciences & Healthcare Regulatory partner and former Deputy Commissioner for Global Regulatory Operations and Policy at the U.S. Food and Drug Administration (FDA), was quoted in the recent Pink Sheet article, “US FDA Use of ‘Potential Official Action Indicated’ Flag Raises Concerns About Facility-Based CRLs,” examining the FDA’s increasing use of pOAI status in connection with drug application reviews.

The article explores concerns among industry stakeholders about the FDA’s use of the interim pOAI inspection designation as a basis for issuing facility-related Complete Response Letters (CRLs).

Howard explained that the pOAI designation provides the FDA with added flexibility in managing application reviews and facility compliance matters. “If you want to look at it on the bright side, you can say flexibility is not a bad thing,” he told Pink Sheet, noting that the agency may benefit from having additional tools to address complex manufacturing issues without immediately resorting to formal enforcement classifications.

However, he highlighted a key trade-off, observing that if the FDA relies on pOAI rather than formal OAI classifications, “it can make decisions much more flexibly and without facing the consequences as much,” which could reduce the procedural discipline that previously accompanied facility-based approval decisions.

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