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  • Rachel L. Sher
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Rachel L. Sher

Partner

Manatt Health
Contact
  • rsher@manatt.com
  • Phone: 202.624.3302
  • Download vCard
  • Washington, D.C.
Bar Admissions
  • Washington, D.C.

Education
  • 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

Industries
  • Digital Health
  • Manatt Health

Show Full Bio

  • Profile
  • Speaking Engagements
  • Memberships
  • Publications
Profile

Profile

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.

Speaking Engagements

Speaking Engagements

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.

Memberships

Memberships

Admitted to practice in the District of Columbia

Publications

Publications

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.

Rachel in the News

  • 01.31.23

    Sher Quoted in MM+M on FDA Orphan Drug Exclusivity System

    Manatt Health Partner Rachel Sher was quoted in an MM+M article about the Food and Drug Administration’s (FDA) recent action that has ...

  • 01.19.23

    Sher and O’Brien Quoted in Bloomberg Law on FDA Clinical Trial ...

    Manatt Health Partner Rachel Sher and National Advisor Donna O’Brien were quoted in Bloomberg Law on a new law aimed at improving ...

  • 09.22.22

    Sher Quoted in MedTech Dive on FDA User Fee Reauthorization

    Manatt Health Partner Rachel Sher was quoted in MedTech Dive on Congress’ September 30 deadline to reauthorize the Food and Drug ...

  • 09.02.22

    Sher Quoted in Law360 on State-Based Bans for Medication Abortion

    Manatt Health Partner Rachel Sher was quoted in Law360 on states’ efforts to restrict access to mifepristone, the drug commonly utilized ...

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Rachel's Newsletters

  • 01.30.23

    FDA Stands By Long-standing Interpretation of the Orphan Drug Act…For ...

    On January 24, the Food and Drug Administration made a long-awaited announcement with major implications for how the agency awards exclusivity for ...

  • 01.23.23

    ICYMI: A New Year and New Guidance From FTC on ‘Health Products’ ...

    On December 20, 2022, amidst a flurry of end-of-year activity on Capitol Hill, the Federal Trade Commission’s (FTC) Bureau of Consumer ...

  • 01.17.23

    FDA and DOJ Take Significant Steps Designed to Expand Access to ...

    On January 3, the Biden Administration took additional steps to ease access to FDA-approved abortion medication in the United States, further wading ...

  • 12.13.22

    Abortion Pill Opponents Challenge FDA’s Approval of Mifepristone

    Since the Supreme Court overturned the constitutional right to abortion in Dobbs v. Jackson Women’s Health Organization earlier this year, ...

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Rachel's Events and Webinars

  • 02.01.23

    Reimagining Medicine: Can Policy Keep Pace With Scientific Advances?

    Speakers From AbbVie, National Institutes of Health, National Organization for Rare Disorders, NYU Grossman School of Medicine and Verily Share ...



  • 12.07.22

    Sher to Speak at the 2022 FDLI Enforcement, Litigation, and ...

    Manatt Health Partner Rachel Sher will speak in a session titled “The FDCA Impact of Dobbs ” at the 2022 Enforcement, Litigation, and ...



  • 10.12.22

    Achieving Clinical Trial Diversity: An Overview of the Policy ...

    Although increasing representation of underserved populations in clinical trials has been a long-standing goal for industry, providers and patients ...



  • 04.29.22

    A Fireside Chat With FDA Leadership

    We are just one quarter into 2022 and the Food and Drug Administration (FDA) already has experienced a number of significant changes and ...

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