Hyman Phelps and McNamara Hyman Phelps and McNamara
Practice Areas
Hyman, Phelps & McNamara's (HPM's) practice encompasses all entities, individuals, and product categories regulated by the Food and Drug Administration. We also advocate on behalf of HPM clients with respect to the Drug Enforcement Administration, the Federal Trade Commission, the U.S. Department of Agriculture, the Office of the Inspector General of the Department of Health and Human Services, the Centers for Medicare and Medicaid Services, the Department of Veterans Affairs, the Consumer Products Safety Commission, and other federal and state agencies. We represent HPM clients before Congress, state legislatures, and international bodies such as the World Health Organization and the European Commission, and in civil and criminal litigation in federal and state courts.

Hyman, Phelps & McNamara's attorneys counsel and assist HPM clients in gaining government approvals for new products and in developing strategies to support successful marketing in accordance with the requirements of the law and the enforcement policies of FDA and other regulatory agencies. The firm's lawyers routinely counsel companies on postmarketing issues such as compliance strategies, review and implementation of standard operating procedures, FDA reporting requirements, and inspections. We have extensive experience representing companies that face product recalls or government enforcement actions, including seizures, import detentions, limitations on legitimate controlled substance manufacture and distribution, injunctions and criminal prosecutions for alleged violations of the Federal Food, Drug, and Cosmetic Act and related statutes. Responding to the government's increasing role as a purchaser and payor for drugs and devices, the firm also represents companies on matters concerning Medicare and Medicaid fraud and abuse laws, pricing laws, coverage and reimbursement, and government contracting. In addition, as the role of the Internet expands as a vehicle for promotion, commerce and health care delivery, we counsel companies involved in the marketing and distribution of drugs, devices, foods (including dietary supplements) and cosmetics on the emerging regulatory environment affecting e-commerce.

Specialty Areas

The firm's substantive practice areas are described in more depth in the links below.

Advertising and Promotion

Prescription Drugs and Biologics

Controlled Substances

PDMA and State Licensing

OTC Drugs and Cosmetics

Medical Devices

In Vitro Diagnostic Devices

Foods and Dietary Supplements

Animal Drugs and Feeds

Tissue Products

Product Jurisdiction and Combination Products

Health Care

Consumer Product Safety Commission

Tobacco

Training Programs

Enforcement

Corporate Transactions