Food & Drug
Food & Drug
 

Food & Drug

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Our internationally leading 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 human prescription and nonprescription drugs, food, medical devices, human and veterinary biological products, animal feeds and drugs, cosmetics, tobacco products, and electronic radiation products.

Firm lawyers have participated in matters relating to drug and device approvals, clinical trials, hearings on drug approval withdrawals, and various enforcement and rulemaking proceedings.  We have extensive experience in GMP and quality system compliance, review of labeling and advertising claims, FTC regulatory and enforcement proceedings, Lanham Act false advertising cases, and self-regulatory advertising proceedings before the National Advertising Division (NAD) of the Council of Better Business Bureaus.

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 Biotechnology Industry Organization (BIO), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Corn Refiners Association.

We assist our food, drug and device clients in crisis management, advising on the many legal issues that are raised by FDA inspections, quality failures, recalls, tampering, extortion demands, and other episodes raising potential threats to public health.  Our involvement has included advice and representation on such matters as: evaluation of a company’s obligation to initiate a recall; consultation with FDA and USDA enforcement officials; potential exposure of companies and employees to criminal or other enforcement sanctions; recall notifications and statements to the media and product liability considerations.  We regularly provide assistance on FDCA compliance issues in connection with criminal and civil investigations by the U.S. Department of Justice, the Office of Inspector General of the Department of Health and Human Services, and state attorneys general of issues relating to the manufacture, sale and promotion of pharmaceuticals and medical devices.

Firm legislative activities include legislative analysis, preparation of draft legislation, Congressional testimony, interaction with Congressional members and staff, and evaluation of recent statutory enactments.

Our attorneys advise on international food and drug law matters, through the London, Brussels, and Washington offices, including advice on national requirements and monitoring European Community activities.

Representative Matters

  • 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, devices, and blood products. Covington has negotiated several of the most notable consent decrees for drug manufacturers (including for Schering Plough, Genzyme and one of the largest manufacturers of OTC drugs in the US)
  • 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, device, and food industries through recalls and market withdrawals, including on a global scale, to minimize business disruption, cost, and damage to brands.

Accolades

  • Law360
  • Chambers Global (2014)
    • Firm
      • Life Sciences, Global-wide
      • Life Sciences, Europe-wide
    • Individual
      • Life Sciences, Regulatory/Compliance, Global-wide: Peter Bogaert, Grant Castle, and Richard Kingham
      • Life Sciences, Corporate/Commercial, Global-wide: John Hurvitz and Weishi Li
  • Chambers USA (2013)
    • Firm
      • Food & Beverages, Regulatory & Litigation, Nationwide
      • Life Sciences, Nationwide
      • Healthcare, Pharmaceutical/Medical Products Regulatory, DC
      • Life Sciences, CA
    • Individual
      • Life Sciences, Regulatory/Compliance, Nationwide: Richard Kingham and Peter Safir
      • Life Sciences, Corporate/Commercial, Nationwide: John Hurvitz, Emily Leonard, and James Snipes
      • Food & Beverages, Regulatory & Litigation, Nationwide: Clausen Ely, Miriam Guggenheim, and Peter Barton Hutt
      • Products Liability & Mass Torts, Nationwide: Mike Brock, Pat Davies, Paul Schmidt, and Theodore Voorhees
      • Healthcare, Pharmaceutical/Medical Products Regulatory, DC: Ellen Flannery, Peter Barton Hutt, Richard Kingham, Michael Labson, Gerald Masoudi, and Peter Safir
      • Life Sciences, Corporate/Commercial, CA: Emily Leonard, James Snipes, and Amy Toro
  • Chambers UK (2014)
    • Firm
      • Life Sciences, UK-wide
      • Life Sciences, Regulatory, UK-wide
      • Life Sciences, Transactional, UK-wide
      • Product Liability, Food, UK-wide
      • Product Liability, Mainly Defendant, UK-wide
    • Individual
      • Life Sciences, Regulatory, UK-wide: Grant Castle
      • Life Sciences, Transactional, UK-wide: Paul Claydon, James Gubbins, and Daniel Pavin
  • Chambers Asia (2013)
    • Firm
      • Life Sciences (International Firms), China
    • Individual
      • Life Sciences (International Firms), China: Shaoyu Chen and Weishi Li
  • 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 (2013)
    • Firm
      • Healthcare – Life Sciences
      • Healthcare – Health Insurers
      • Product Liability and Mass Tort Defense – Pharmaceuticals and Medical Devices
    • Individual
      • Healthcare – Life Sciences: Catherine Dargan, Ed Dixon, Ellen Flannery, John Hall, Geoffrey Hobart, John Hurvitz, Richard Kingham, Emily Leonard, Gerald Masoudi, Matthew O’Connor, and Peter Safir
      • Healthcare – Health Insurers: Anna Engh and David Goodwin
      • Product Liability and Mass Tort Defense – Pharmaceuticals and Medical Devices: Mike Brock, Pat Davies, Michael Imbroscio, and Paul Schmidt
  • Legal 500 UK (2013)
    • Firm
      • Pharmaceuticals and Biotechnology
      • Product Liability – Defendant
    • Individual
      • Pharmaceuticals and Biotechnology: Grant Castle, Paul Claydon, James Gubbins, Lucinda Osborne, Morag Peberdy, and James Ryan
      • Product Liability – Defendant: Grant Castle and Brian Kelly
  • Legal 500 EMEA (2013)
    • Firm
      • EU Regulatory – Pharmaceuticals and Biotechnology
      • EU Regulatory – Food
    • Individual
      • EU Regulatory – Pharmaceuticals and Biotechnology: Peter Bogaert and Cándido García Molyneux
      • EU Regulatory – Food: Peter Bogaert
  • LMG Life Sciences (2013)
    • Firm
      • Lifecycle Firm
      • Highly Recommended: Regulatory, FDA (Pharmaceutical)
      • Recommended: Regulatory, FDA (Medical Devices)
    • Individual
      • Regulatory: Ellen Flannery, Peter Barton Hutt, Richard Kingham, Anna Kraus, Michael Labson, Gerald Masoudi, and Peter Safir

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eflannery@cov.com
202.662.5484

psafir@cov.com
202.662.5162

gmasoudi@cov.com
202.662.5063