Profile

Ann counsels clients facing legal and regulatory challenges involving products regulated by the U.S. Food and Drug Administration (FDA). Her particular expertise includes issues related to food ingredients, over-the-counter (OTC) drugs, and clinical research practice, and her practice also covers conventional foods, dietary supplements, pharmaceuticals, cosmetics, and medical device products. At the international, U.S. federal, and state levels, Ann represents clients on a variety of FDA and Federal Trade Commission (FTC) matters.

Experience

Representative Matters

  • Counsels clients on regulations and policies involving product lifecycle, beginning with product formulation, manufacturing facilities, supply chain, labeling, compliance claims, and advertising.
  • Counsels food and animal feed organizations on FDA and U.S. Department of Agriculture (USDA) policies and regulations regarding food/feed ingredient petitions and notifications, labeling requirements, and advertising substantiation requirements.
  • Advises clients on FDA and Federal Food, Drug, and Cosmetic Act (FFDCA) requirements for OTC monograph drugs and new drugs, including the Cares Act OTC monograph reform requirements, Abbreviated New Drug Applications (ANDAs), New Drug Applications (NDAs), Investigational New Drug Applications, and Investigational Device Applications.
  • Advises institutional review boards (IRBs), sponsors, and investigators regarding regulations and policies governing FDA-regulated and federally funded clinical research, including regulations enforced by the Office for Human Research Protections (OHRP).
  • Advises organizations on managing U.S. medical and food supply chain disruptions due to rapidly developing and changing policies from the U.S. Department of Health and Human Services (HHS) and other federal agencies as a result of COVID-19.
  • Represents and guides clients in responding to FDA enforcement actions such as Warning Letters, Untitled Letters, recalls, import detentions and alerts, and clinical investigator disqualification proceedings.
  • Represents and guides clients facing challenges to their promotional activities from the FDA, the FTC, and the National Advertising Division (NAD) of BBB National Programs (formerly known as the Council of Better Business Bureaus).

Professional Experience

  • Private Law Practice (1995-2020)
  • Public Citizen Litigation Group (1994-1995)

Affiliations

  • Secretary and General Counsel, Enzyme Technical Association
  • General Counsel, Homœopathic Pharmacopœia Convention of the United States
  • Member, Food and Drug Law Institute
  • Board Member, Inova Health Systems Institutional Review Board

Credentials

Education

J.D., cum laude, Georgetown University Law Center

B.S.N., Georgetown University

Bar and Court Memberships

  • District of Columbia

    U.S. Court of Appeals for the District of Columbia Circuit

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