Marissa Hill Daley is an associate in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati, where she is a member of the firm’s U.S. Food and Drug Administration (FDA) regulatory, healthcare, and consumer products practice. Her work focuses on advising clients on a variety of matters in the healthcare and FDA regulatory space, including compliance with government investigations and compliance with FDA marketing requirements. She also assists clients in defending against whistleblower qui tam suits involving the False Claims Act and the Anti-Kickback Statute.
Marissa volunteers with and is on the Junior Board for the D.C. Volunteer Lawyers Project (DCVLP), an organization whose mission is to provide high-quality, free legal services to low-income D.C. residents in family law cases. Marissa provides pro bono legal representation in protection order, custody, divorce, and guardian ad litem work for survivors of domestic violence and at-risk children.
Prior to joining the firm, Marissa served as Senior Counsel in the Office of Counsel for the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG), where she advised on criminal and administrative investigations and compliance matters. Earlier in her career, she worked in investigations at another major D.C. law firm, prior to which she clerked at the District of Columbia Court of Appeals.
Marissa is an adjunct professor at her alma mater, American University Washington College of Law, where she teaches a seminar on interviewing and counseling. During law school, Marissa served as editor-in-chief of the American University International Law Review.
Marissa Hill Daley is an associate in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati, where she is a member of the firm’s U.S. Food and Drug Administration (FDA) regulatory, healthcare, and consumer products practice. Her work focuses on advising clients on a variety of matters in the healthcare and FDA regulatory space, including compliance with government investigations and compliance with FDA marketing requirements. She also assists clients in defending against whistleblower qui tam suits involving the False Claims Act and the Anti-Kickback Statute.
Marissa volunteers with and is on the Junior Board for the D.C. Volunteer Lawyers Project (DCVLP), an organization whose mission is to provide high-quality, free legal services to low-income D.C. residents in family law cases. Marissa provides pro bono legal representation in protection order, custody, divorce, and guardian ad litem work for survivors of domestic violence and at-risk children.
Prior to joining the firm, Marissa served as Senior Counsel in the Office of Counsel for the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG), where she advised on criminal and administrative investigations and compliance matters. Earlier in her career, she worked in investigations at another major D.C. law firm, prior to which she clerked at the District of Columbia Court of Appeals.
Marissa is an adjunct professor at her alma mater, American University Washington College of Law, where she teaches a seminar on interviewing and counseling. During law school, Marissa served as editor-in-chief of the American University International Law Review.
- J.D., American University Washington College of LawEditor-in-chief, American University International Law Review
- B.A., Political Science and Art History, Villanova University
- Bar of the District of Columbia
- J.D., American University Washington College of LawEditor-in-chief, American University International Law Review
- B.A., Political Science and Art History, Villanova University
- Bar of the District of Columbia
Select Publications
- Co-author, “Off-Label Communications Back in the Spotlight at the FDA,” Wilson Sonsini Alert, November 3, 2023
- Co-author, “FDA's Threat of Lab-Developed Test Oversight Is Back on the Table with Proposed Rule,” Wilson Sonsini Alert, October 5, 2023
- Co-author, “U.S. Food and Drug Administration Kicks Off Fall with Several Impactful Medical Product Guidances,” Wilson Sonsini Alert, October 4, 2023
- Co-author, “Drug Use-Related Software Back in the Spotlight at the U.S. Food and Drug Administration,” Wilson Sonsini Alert, October 2, 2023
- Co-author, “California Prepares First-of-Its-Kind Food Additive Ban in the United States,” Wilson Sonsini Alert, September 18, 2023
- Co-author, “FDA Cracks Down on Unapproved Eye Products,” Wilson Sonsini Alert, September 18, 2023
- Co-author, “Cannabis Summer Recap: Potential Rescheduling, Congressional Requests for Information, and Enforcement Activity,” Wilson Sonsini Alert, September 14, 2023
- Co-author, “HHS Names the First 10 Drugs for Medicare Price Negotiation,” Wilson Sonsini Alert, September 5, 2023
- Co-author, “Next Step for Cosmetic Products' Regulatory Makeover,” Wilson Sonsini Alert, August 17, 2023
- Co-author, “CMS Proceeds Full Steam Ahead with Medicare Drug Price Negotiation Program,” Wilson Sonsini Alert, July 12, 2023
- Co-author, “CMS Proposes a Novel Replacement for Rescinded Pathway to Expedited Reimbursement of Breakthrough Devices,” Wilson Sonsini Alert, June 28, 2023
- Co-author, “Lab to Table Dining—Coming Soon to a Kitchen Near You,” Wilson Sonsini Alert, June 27, 2023
- Co-author, “U.S. Supreme Court Closes Door on Objective Reasonableness Defense in Healthcare False Claims Act Cases,” Wilson Sonsini Alert, June 8, 2023
- Co-author, “FDA Accelerates Approval of Animals with Investigational Intentional Genomic Alterations (IGAs),” Wilson Sonsini Alert, June 5, 2023
- Co-author, “Medicare Contractors Buy Additional Time for the Digital Health Industry,” Wilson Sonsini Alert, May 31, 2023
- Co-author, “FDA Passes the Buck (Back) to Congress for Legislative Solution on CBD Regulation,” Wilson Sonsini Alert, May 15, 2023
- Co-author, “HHS OIG Announces Modernization of Compliance Program Guidance Documents,” Wilson Sonsini Alert, April 28, 2023
Select Speaking Engagements
- Co-presenter, “Introduction to Advertising and Promotion for Medical Products,” Food and Drug Law Institute, November 1, 2023
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Co-presenter, “North Carolina Biotech Center – Wilson Sonsini Life Science Bootcamp,” North Carolina Biotech Center, October 27, 2023
Select Publications
- Co-author, “Off-Label Communications Back in the Spotlight at the FDA,” Wilson Sonsini Alert, November 3, 2023
- Co-author, “FDA's Threat of Lab-Developed Test Oversight Is Back on the Table with Proposed Rule,” Wilson Sonsini Alert, October 5, 2023
- Co-author, “U.S. Food and Drug Administration Kicks Off Fall with Several Impactful Medical Product Guidances,” Wilson Sonsini Alert, October 4, 2023
- Co-author, “Drug Use-Related Software Back in the Spotlight at the U.S. Food and Drug Administration,” Wilson Sonsini Alert, October 2, 2023
- Co-author, “California Prepares First-of-Its-Kind Food Additive Ban in the United States,” Wilson Sonsini Alert, September 18, 2023
- Co-author, “FDA Cracks Down on Unapproved Eye Products,” Wilson Sonsini Alert, September 18, 2023
- Co-author, “Cannabis Summer Recap: Potential Rescheduling, Congressional Requests for Information, and Enforcement Activity,” Wilson Sonsini Alert, September 14, 2023
- Co-author, “HHS Names the First 10 Drugs for Medicare Price Negotiation,” Wilson Sonsini Alert, September 5, 2023
- Co-author, “Next Step for Cosmetic Products' Regulatory Makeover,” Wilson Sonsini Alert, August 17, 2023
- Co-author, “CMS Proceeds Full Steam Ahead with Medicare Drug Price Negotiation Program,” Wilson Sonsini Alert, July 12, 2023
- Co-author, “CMS Proposes a Novel Replacement for Rescinded Pathway to Expedited Reimbursement of Breakthrough Devices,” Wilson Sonsini Alert, June 28, 2023
- Co-author, “Lab to Table Dining—Coming Soon to a Kitchen Near You,” Wilson Sonsini Alert, June 27, 2023
- Co-author, “U.S. Supreme Court Closes Door on Objective Reasonableness Defense in Healthcare False Claims Act Cases,” Wilson Sonsini Alert, June 8, 2023
- Co-author, “FDA Accelerates Approval of Animals with Investigational Intentional Genomic Alterations (IGAs),” Wilson Sonsini Alert, June 5, 2023
- Co-author, “Medicare Contractors Buy Additional Time for the Digital Health Industry,” Wilson Sonsini Alert, May 31, 2023
- Co-author, “FDA Passes the Buck (Back) to Congress for Legislative Solution on CBD Regulation,” Wilson Sonsini Alert, May 15, 2023
- Co-author, “HHS OIG Announces Modernization of Compliance Program Guidance Documents,” Wilson Sonsini Alert, April 28, 2023
Select Speaking Engagements
- Co-presenter, “Introduction to Advertising and Promotion for Medical Products,” Food and Drug Law Institute, November 1, 2023
-
Co-presenter, “North Carolina Biotech Center – Wilson Sonsini Life Science Bootcamp,” North Carolina Biotech Center, October 27, 2023