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
Federal Trade Commission
Consumer Product Safety Commission
Enforcement
Other Matters
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