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Claire O'Brien is an associate in the firm’s Washington, DC office, where she is a member of the Food, Drug, and Device Practice Group. She advises food, cosmetic, medical device, and pharmaceutical companies on a broad range of regulatory and compliance issues.

Ms. O’Brien has experience counseling clients on interactions with federal and state regulatory agencies, including the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the Federal Trade Commission (FTC), and state Boards of Pharmacy, as well as interactions with the National Advertising Division (NAD).

  • Conducted an internal investigation and assessed regulatory compliance, including with respect to claim substantiation, for a major cosmetic company.
  • Advised a major medical device manufacturer in a DOJ/FDA investigation concerning alleged violations of the Food, Drug, and Cosmetic Act.
  • Counseled a food manufacturer client through response to class action demand letter related to labeling claims.
  • Advised clients on strategic engagement with FDA related to approval of pharmaceutical products and clearance of medical devices, including drafting communication plans and requests for meetings with agency leadership.
  • Assisted clients in complying with Nutrition Facts Label (NFL) requirements.
  • Provided regulatory and policy guidance for food, dietary supplement, OTC drug, and cosmetic products, including labeling, marketing, and website design issues, and strategies for minimizing risk of consumer fraud or class action litigation and compliance with state requirements such as Proposition 65.
  • Advised client on FDA and FTC regulatory compliance issues related to social media posts, including assessment of risks related to social media influencers, comment monitoring, and adequate disclosure of safety information.
  • Analyzed state and federal regulatory compliance issues with respect to manufacturing, distribution, and other legal requirements.

Pro Bono

  • Counseled non-profit organizations on developing legal and legislative strategies to prevent gun violence.
  • Advised non-profit organization on the legal implications of returning the DC parole system to local control.
  • Represented low income tenant in DC Landlord and Tenant Court proceedings, including engaging in discovery, meditation, and successful settlement negotiations.

Previous Experience

  • Covington & Burling LLP, Associate (2016-2017)