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Perrigo Names Regulatory Head

Webber to lead consumer, Rx applications with FDA

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Keith Webber has been named head of Regulatory Review at Perrigo. This new role will have responsibility for advancing the approval of all of Perrigo’s Consumer Healthcare (CHC) and Prescription Pharmaceutical (Rx) regulatory applications pending with the FDA, providing guidance on scientific and regulatory strategy for new pipeline products under development, and continuously advancing the quality of new regulatory applications, according to a Perrigo statement.

Mr. Webber previously served as acting director of the Office of the FDA’s Pharmaceutical Science in the Center for Drug Evaluation and Research (CDER). Prior to that, he served as director of Office of Generic Drug (OGD), where he directed FDA regulation of generic pharmaceuticals including, legal, chemistry, bioequivalence, microbiology, clinical and labeling. He also served in several leadership roles within the FDA responsible for regulating pharmaceutical quality, biopharmaceutical drug development and monoclonal antibody-related biopharmaceuticals research and review.

Perrigo’s chairman, president and chief executive officer, Joseph C. Papa, stated, “I am excited to welcome Keith to the Perrigo family. He brings to us a wealth of strategic, scientific and regulatory experience from his years working with the FDA. Keith will work closely with regulatory leadership to support new product selection and develop strategies and processes to achieve high quality applications and timely approvals, enabling us to bring quality, affordable products to the market.”

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