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 and USDA, including food, human prescription and nonprescription drugs, human and veterinary biological products, animal feeds and drugs, medical devices, cosmetics, tobacco products, and electronic radiation products.
We advise pharmaceutical and device manufacturers and other health care providers on matters related to Medicare and Medicaid, including obtaining favorable Medicare coverage and reimbursement, Medicaid drug rebate requirements, and compliance with the Medicare Anti-Fraud and Abuse Act. Our in-depth knowledge of the inner workings of the FDA and the Centers for Medicare & Medicaid Services (CMS) enables us to assist our clients in developing optimal strategies for product development, approval and reimbursement. In appropriate circumstances, these strategies may include a legislative component, developed in collaboration with the firm’s Public Policy and Government Affairs practice.
The firm has served 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 Personal Care Products Council, the International Dairy Foods Association, the National Pharmaceutical Council, and the Consumer Healthcare Products Association. In addition, we represent on specific projects a number of other trade associations, including the Grocery Manufacturers Association, the Biotechnology Industry Organization (BIO), and the Pharmaceutical Research and Manufacturers of America (PhRMA).
- We have been involved, on behalf of regulated industry, in the stakeholder negotiations and legislative process leading to every major amendment to the FDCA since its enactment in 1938.
- We acted for a coalition of innovative biopharmaceutical manufacturers during the multi-year process that led to enactment of the Biologics Price Competition and Innovation Act of 2010 (BPCIA) and played a similar role for the pharmaceutical industry prior to enactment of the Hatch-Waxman amendments of 1984.
- We represented PhRMA in the initial creation of the PhRMA Code, and we continue to advise regulated industry on compliance with the Code, with state pharmaceutical marketing laws, and with the relevant federal laws (such as the Medicare Anti Fraud and Abuse Act and the Sunshine Act).
- We have for decades represented companies and individuals during the negotiation of GMP consent decrees involving drugs, biologics, and blood products. Recent consent decrees on which we were counsel include the 2010 consent decree relating to Genzyme’s Allston Landing manufacturing facility. We were also counsel for another major drug manufacturer in the negotiation of a 2011 consent decree regarding OTC manufacturing facilities.
- We have represented vaccine manufacturers on every major federal enactment relating to vaccine liability since the Swine Flu episode in 1976, including the National Childhood Vaccine Injury Compensation Act in 1986 and the PREP Act in 2005.
- We have counseled numerous clients in the drug and food industries through recalls and market withdrawals, including on a global scale, to minimize business disruption, cost, and damage to brands.
- Law360, John Hurvitz - Life Sciences MVP (2012)
- Law360, Life Sciences Group of the Year (2012)
- Chambers Global (2012)
- Life Sciences, Global-wide
- Life Sciences, Corporate/Commercial, Global-wide: John Hurvitz
- Life Sciences, Regulatory/Compliance, Global-wide: Grant Castle and Richard Kingham
- Chambers USA (2012)
- Life Sciences, Nationwide
- Food & Beverages, Regulatory & Litigation, Nationwide
- Life Sciences, CA
- Healthcare, Pharmaceutical/Medical Products Regulatory, DC
- Life Sciences, Corporate/Commercial, Nationwide: John Hurvitz, Emily Leonard, and James Snipes
- Life Sciences, Regulatory/Compliance, Nationwide: Richard Kingham and Peter Safir
- Food & Beverages, Regulatory & Litigation, Nationwide: Clausen Ely, Miriam Guggenheim, and Peter Barton Hutt
- Life Sciences, Corporate/Commercial, CA: Emily Leonard, James Snipes, and Amy Toro
- Healthcare, Pharmaceutical/Medical Products Regulatory, DC: Scott Cunningham, Ellen Flannery, Peter Barton Hutt, Richard Kingham, Michael Labson, Gerald Masoudi, and Peter Safir
- Chambers UK (2012)
- Life Sciences, UK-wide
- Life Sciences, Regulatory, UK-wide
- Life Sciences, Transactional, UK-wide
- Product Liability, Food, UK-wide
- Life Sciences, Regulatory, UK-wide: Grant Castle and Richard Kingham
- Life Sciences, Transactional, UK-wide: Paul Claydon, James Gubbins, James Halstead, and Daniel Pavin
- Chambers Asia (2012)
- Life Sciences (International Firms), China
- Life Sciences (International Firms), China: Shaoyu Chen and Jason Ma
- PLC Cross-border Super League
- Ranked 1st in the Life Sciences Regulatory Super League (2004-2011)
- Ranked 1st in the Life Sciences Industry Super League (2005-2010)
- PLC - Life Sciences, Which Law Firm? (2012)
- Leading: Life Sciences, England, EU, and USA
- Leading: Regulatory, Belgium, England, EU, and USA
- Leading: Regulatory (Medical Devices), USA
- Highly Recommended: Life Sciences, Belgium
- PLC - Life Sciences, Which Lawyer? (2012)
- Regulatory: Peter Bogaert, Grant Castle, Peter Barton Hutt, Richard Kingham, Michael Labson, Gerald Masoudi and Peter Safir
- Regulatory (Medical Devices): Ellen Flannery
- Legal 500 US (2012)
- Healthcare – Life Sciences
- Healthcare – Life Sciences: John Hurvitz, Richard Kingham, Peter Safir
- Legal 500 UK (2012)
- Pharmaceuticals and Biotechnology
- Legal 500 EMEA (2011)
- EU Regulatory: Pharmaceuticals and Biotechnology
- EU Regulatory: Food
- LMG Life Sciences (2012)
- Lifecycle Firm
- Highly Recommended: Regulatory, FDA (Pharmaceutical)
- Recommended: Regulatory, FDA (Medical Devices)
- Regulatory: Ellen Flannery, Peter Barton Hutt, Richard Kingham, Anna Kraus, Michael Labson, Gerald Masoudi, and Peter Safir