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Washington, D.C.Rachel L. Sher
Rachel Sher is a prominent Food and Drug Administration (FDA) regulatory leader with sophisticated experience in policy and legislative strategy who helps support life sciences companies as they navigate the broader FDA regulatory process across all stages of a product’s life cycle.
With nearly 20 years of experience in the health policy space, specifically in the pharmaceutical and medical device arenas, Rachel provides a multifaceted approach to solving issues clients face in the medical products area, advising on compliance with the many complex legal and regulatory requirements governing successful product review, launch and marketing. She also helps clients facing serious challenges in this process consider a subsequent or corresponding legislative strategy to advance any additional needs surrounding their development programs.
Rachel previously served as the Vice President of Policy and Regulatory Affairs for the National Organization for Rare Disorders (NORD), where she led its federal policy and regulatory work with respect to the FDA and other federal agencies, as well as on Capitol Hill and in the states. Sher also served as Deputy General Counsel at the Association for Accessible Medicines (AAM), where she helped oversee the AAM’s legal affairs, including the review of advocacy and policy statements. Prior to her time at AAM, Sher worked in the Commissioner’s Office at the FDA where she led the agency’s engagement on the 21st Century Cures Act legislative process, which involved working directly with FDA leadership and medical product centers to give strategic advice and guidance. Prior to heading to the FDA, Rachel spent ten years on Capitol Hill working as FDA Counsel for the Committee on Energy and Commerce, where she had the rare opportunity to oversee the entire FDA-related portfolio, drafting and negotiating all major FDA legislation enacted during her tenure.
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