Experienced FDA regulatory leader Rachel Sher brings robust legal, policy and legislative background to Manatt’s national Health group
Manatt, Phelps & Phillips, LLP, a multidisciplinary, integrated professional services firm, announced today that Partner Rachel L. Sher has joined the Firm’s Health group in its Washington, D.C., office. Through her work in both the private and public sectors—including most recently as Vice President for Policy and Regulatory Affairs at the National Organization for Rare Diseases (NORD) and also her ten years as FDA Counsel on the House Committee on Energy and Commerce prior to her nearly three-year term at the Food and Drug Administration (FDA)—Sher has sophisticated experience in regulation and legislative strategy, deepening Manatt Health’s ability to support prominent life sciences companies as they navigate the broader FDA regulatory process across all stages of a product’s life cycle.
“Rachel’s time working on Capitol Hill paired with her private-sector leadership and innovation experience has given her a unique business, policy and legal perspective that mirrors Manatt’s approach to client service,” said Donna L. Wilson, Manatt CEO and Managing Partner. “She is a terrific new addition to our rapidly growing health, FDA and life sciences team, and her background and skill set will greatly benefit our clients.”
Sher has nearly 20 years of experience in the health law and policy space, specifically in the pharmaceutical and medical device areas. She provides a multifaceted approach to solving issues clients face with respect to medical products, 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.
“As we support our clients across all corners of the life sciences sector, we are focused on strengthening our ability to provide unmatched and integrated strategic business and legal counsel,” said Manatt Health Leader Bill Bernstein. “Rachel’s arrival is a reflection of that, given her nuanced understanding of the laws and regulations that govern life sciences companies from her time in government, as well as her familiarity with navigating those regulations and approval processes. She will be an invaluable asset to our team.”
Early in her career, Sher spent ten years on Capitol Hill as FDA Counsel, where she had the rare opportunity to oversee the FDA-related portfolio for the Committee on Energy and Commerce, drafting and negotiating all major FDA legislation enacted during her tenure. After leaving Capitol Hill, Sher joined 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. She also served as Deputy General Counsel at the Association for Accessible Medicines (AAM), where she helped oversee the AAM’s legal affairs. Most recently, Sher led NORD’s federal policy and regulatory work with respect to the FDA and other federal agencies, as well as on Capitol Hill and in the states.
“Manatt offers a unique opportunity to work alongside an incredibly talented team of professionals who bring a 360-degree view of the health care industry to bear when providing life sciences clients with legal and business strategies that drive success,” said Sher.
Sher joins recent additions to Manatt Health’s roster of health care legal and business consulting professionals, including Dr. Christina Jenkins and Claudia Page, who joined earlier this month. Other recent additions include seasoned physician and researcher Dr. Amy Salerno, health care and civil litigation Partner Megan Thibert-Ind, antitrust and litigation Partner Stephen D. Libowsky, former New York State Department of Health Director Tracy F. Raleigh, former CEO and COO of NYC Health + Hospitals/Harlem Eboné M. Carrington, D.C.-based health care professionals Linda Elam and Blair M. Cantfil, President Emeritus of the Association of American Medical Colleges Dr. Darrell G. Kirch and health care Partner Brian D. Bewley. The group also recently announced the expansion and rebrand of its premium health care information service, Manatt on Health: Insights You Trust, which distills the latest legal, policy and market-based developments on the issues that matter most to health industry stakeholders.
Sher received her Master of Public Health from The George Washington University, her J.D. from University of Florida and a B.A. in literature from Duke University.