Our Food and Drug Practice includes representation before the Food and Drug Administration (FDA), Federal Trade Commission (FTC), and United States Department of Agriculture (USDA), and litigation at all levels in the federal courts. In addition, the firm has represented numerous clients in state food and drug law matters. The firm represents clients in each of the product categories regulated by FDA, including food, human prescription and nonprescription drugs, biological products, animal feeds and drugs, medical devices, cosmetics, and electronic radiation products.
A distinct component of the practice is advice on matters related to Medicare and Medicaid, including complying with the Medicare Anti-Fraud and Abuse Act, the impact of the Medicaid rebate legislation for prescription drugs, and Medicare coverage and reimbursement decisions. These matters include practice before the Centers for Medicare & Medicaid Services (CMS) and litigation in federal courts.
The firm serves as general counsel or principal outside counsel to over 20 trade associations in the food and drug area and related fields, including the Animal Health Institute, the American Bakers Association, the American Forest & Paper Association, the Compressed Gas Association, the Corn Refiners Association, the Cosmetic, Toiletry and Fragrance Association, the International Dairy Foods Association, the Food Products Association, the National Pharmaceutical Council, the Consumer Healthcare Products Association, and the Tobacco Institute. In addition, we represent on specific projects a number of other trade associations, including the Grocery Manufacturers of America and the Pharmaceutical Research and Manufacturers of America (PhRMA).
Representative Matters
- Acted for all four vaccine manufacturers in the Swine Flu episode in 1976, assisting with contract negotiations, helping draft the legislation that protected manufacturers against liability, and assisting in the defense of cases in which the constitutionality of that legislation was challenged in the federal courts.
- Represented PhRMA in creating the PhRMA Code.
- Represented companies and individuals on GMP consent decrees involving drugs, biologics and blood products, including analysis of quality systems, limiting scope of decree and protecting individual defendants.
Accolades
- PLC Cross-border Super League (2005-2008)
- Ranked 1st in the Life Sciences Industry Super League.
- Ranked 1st in the Life Sciences Regulatory Super League.
- The Practical Law Company (PLC) - Life Sciences, Which Law Firm? (2006-2007)
- Leading: Regulatory firm, EU and USA
- Highly Recommended: Regulatory firm, England
- Highly Recommended: Product Liability, England
- Recommended: Product Liability, USA
- The Practical Law Company (PLC) - Life Sciences, Which Lawyer? (2006-2008)
- Regulatory: Peter Bogaert, Grant Castle, Peter Barton Hutt, Richard Kingham, Michael Labson, Eugene Lambert, and Peter Safir
- Regulatory (Medical Devices): Ellen Flannery
- Product Liability: Ted Voorhees and Anne Ware
- PLC awarded Covington the Best International Practice Award 2006 in the life sciences area.
- Chambers Europe (2007)
- Recognized as having a leading practice in the category of Regulatory Pharma/Life Sciences for Europe.
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