ArentFox Schiff Welcomes Former FDA Regulator in Washington

Abha most recently served as a Team Lead with FDA’s Center for Drug Evaluation and Research, Office of Compliance, Office of Drug Security, Integrity, and Response where she was responsible for guiding implementation of the landmark Drug Supply Chain Security Act (DSCSA). She played a pivotal role in developing accompanying guidance for the pharmaceutical industry on compliance with the DSCSA. Enacted in 2013, the DSCSA provides tracing requirements for prescription drugs that are aimed at protecting patients by preventing harmful drugs from entering the US pharmaceutical supply chain. Over the course of her tenure at the FDA, Abha also served as regulatory counsel and as a public health advisor.

“We are delighted to add Abha to our nationally recognized FDA practice,” said Brian Waldman, ArentFox Schiff’s Firmwide Managing Partner and former FDA Practice Group Leader at the firm. “Her leadership at the FDA, commitment to patient safety, and extensive knowledge of the DSCSA as one of the most consequential regulatory programs for pharmaceuticals will be of great value to our pharmaceutical industry clients throughout the supply chain.”

Given her instrumental role shaping guidance for industry stakeholders during the DSCSA’s multi-phase implementation, Abha will advise pharmaceutical clients on a range of FDA regulatory issues, with a particular emphasis on DSCSA compliance and regulatory strategies.

“Abha’s arrival significantly strengthens our ability to counsel clients at a time when DSCSA readiness is top of mind,” said Karen Ellis Carr, Partner and FDA Practice Leader. “Her insights into federal oversight of pharmaceutical distribution and serialization-related mandates will make her a key advisor to companies navigating the law’s implementation complexities.”