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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Rachel L. Sher

Washington, D.C.

202.624.3302

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Manatt Health

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Washington, D.C.

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Bio

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.

Accomplishments

Speaker, “The Decentralized Trials Club on LinkedIn Live Audio – How can Academic Health Centers inject innovation back into clinical trial conduct?” The Decentralized Trials Club, October 2024.

Speaker, “Legislative and Regulatory Updates on Clinical Trial Diversity Issues,” Clinical Research as a Care Option Conference, September 2024.

Moderator, "Current Issues in Drug Development for Rare and Neurodegenerative Diseases," Food and Drug Law Institute 2024 Annual Conference, May 16, 2024.  Panelist, “Expanded Access Policies and Compliance in an Ever-Changing Environment,” NYU Langone Health, CUPA Webinar, October 20, 2023.

Panelist, “Rare Disease Drug Development: Present Problems and Solutions,” Food and Drug Law Institute 2023 Annual Conference, May 17, 2023.

Speaker, “The FDCA Impact of Dobbs,” 2022 Enforcement, Litigation, and Compliance Conference: For the Drug, Device, Food, and Tobacco Industries, Food and Drug Law Institute, December 7, 2022.

Moderator, “Updates in Orphan Drug Regulation and Litigation,” Food and Drug Law Institute, June 15, 2022.

Speaker, “Breaking New Ground: Innovations in Alzheimer’s Research,” The Hill, March 2, 2022.

Panelist, Strategies to Support Rare Disease Product Development During COVID-19, Rare Disease Day 2021, FDA, March 5, 2021.

Speaker, Rare Disease Day, National Institutes of Health (NIH), March 1, 2021.

Speaker, Rare Disease Policy Webinar, MDA Advocacy Institute, February 25, 2021.

Moderator, COVID-19 Vaccines Update: FDA and CDC Leaders Address the Rare Disease Community, NORD, January 15, 2021.

Moderator, Perspectives From The Hill: The Year to Date and What’s Ahead, Rare Diseases and Orphan Products Breakthrough Summit, NORD, October 8, 2020.

Speaker, Webinar On Resilience Approach Towards Rare Disease Policy In India, People to People Health Foundation (PPHF) and GRID Council, August 4, 2020.

Speaker, Public Meeting on the Reauthorization of the Prescription Drug User Fee Act (PDUFA), FDA, July 23, 2020.

Speaker, FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law, Food and Drug Law Institute, May 2, 2019.

Panelist, Tissue Agnostic Therapies: Regulatory Considerations for Orphan Drug Designation; Public Workshop, FDA, May 9, 2018.

Panelist, Updating Outdated Product Labels, Friends of Cancer Research Annual Meeting, Friends of Cancer Research, November 15, 2017.

Panelist, Market Access, Market Success, 2017 Leading on Biosimilars Conference, AAM, September 12, 2017.

Panelist, Developing a National Registry of Pharmacologic and Biologic Clinical Trials, Committee on Clinical Trial Registries, Board on Health Sciences Policy, Institute of Medicine, June 27, 2005.

Admitted to practice in the District of Columbia

Quoted, “Breaking Down The Supreme Court's Abortion Pill Arguments,” Law360, March 26, 2024.

Quoted, “High Court Mifepristone Battle Goes Beyond Abortion,” Law360, March 22, 2024.

Quoted, “US FDA Considers Making More Guidance Final Without Public Comment,” Pink Sheet, January 3, 2024.

Quoted, “Supreme Court Could Curtail Mifepristone Access, Lay Out ‘Road Map’ To Challenge FDA Approvals,” Pink Sheet, December 13, 2023.

Quoted, “CMS urged to change GLP-1 drug coverage determination,” Fierce Healthcare, September 25, 2023.

Co-author, “Anti-Obesity Medications as Medicare Part D Drugs: Legal and Health Policy Rationales,” a white paper prepared in collaboration with the Obesity Action Coalition and The Obesity Society, September 2023.

Co-author, “Achieving Diversity in Clinical Trials: Expanding Hospital Capacity to Offer Clinical Trials in the Community,” a white paper prepared for Manatt Health, August 2023.

Quoted, “Fifth Circuit Mifepristone Ruling May Temporarily Halt Pharmacy Dispensing, Generic Approval,” Pink Sheet, April 13, 2023.

Quoted, “Abortion case could spell trouble for FDA,” National Journal, April 11, 2023.

Quoted, “Can Courts And States Override FDA’s Drug Regulatory Authority?,” Pink Sheet, February 27, 2023.

Quoted, “Abortion lawsuits place federal drug authority in the crosshairs,” National Journal, February 9, 2023.

Quoted, “FDA restores orphan-exclusivity system after 18-month stall in wake of legal feud,” MM+M, January 31, 2023.

Quoted, “Medtech regulation outlook in 2023: Faster approvals among priorities as AI moves to fore,” MedTech Dive, January 26, 2023.

Quoted,” FDA Refuses to Apply Catalyst Decision to All Orphan Drugs,” Bloomberg Law, January 23, 2023.

Quoted, “Diversity in Clinical Trials at FDA Gets a Boost From New Law,” Bloomberg Law, January 19, 2023.

Quoted, “What Will FDA Do In Battle Over Medication Abortion Access?,” Pink Sheet, December 12, 2022.

Quoted, “US OTC Oral Contraceptive Access Could Mirror ‘Patchwork’ Of States’ Limits On Abortion Drug,” Pharma Intelligence, December 12, 2022.

Quoted, “As deadline for FDA user fees bill nears, Congress weighs continuing resolution,” MedTech Dive, September 22, 2022.

Quoted, “The Hottest Topics For Health Attys In 2022's Homestretch,” Law360, September 2, 2022.

Quoted, “Congress Might Add ‘Clean’ FDA User Fee Bill To Stopgap Funding To Buy Time,” InsideHealthPolicy, September 1, 2022.

Quoted, “6 questions for the medtech industry if Congress doesn’t reauthorize FDA user fees on time,” MedTech Dive, August 3, 2022.

Quoted,” Senate unveils user fee reauthorization draft, leaves out accelerated approval reform,” MM+M, May 19, 2022.

Quoted, “Woodcock To Chair FDA’s Cannabis Council As It Implements Data Plan,” InsideHealthPolicy, May 3, 2022.

Quoted, “Accelerated Approval: How The Aduhelm Probes Will, And Won’t, Impact The Debate,” Pink Sheet, April 11, 2022.

Featured, “Health Care Appears Top Priority in DC as Law Firms Deepen Rosters,” The National Law Journal, January 20, 2022.

Washington, D.C.

The George Washington University – School of Public Health, M.P.H., 2004

University of Florida – Levin College of Law, J.D., 2000

Duke University, B.A., 1995

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