The pace of new statutory and rulemaking requirements and an environment of increased enforcement scrutiny create challenges for manufacturers, distributors, and providers regulated by the U.S. Food and Drug Administration, the U.S. Department of Agriculture, the Federal Trade Commission and other government agencies. When clients face government investigations and enforcement actions, our experienced team of lawyers provides effective and thorough assistance to minimize business disruption, cost, and damage to brands.
We represent clients in a range of matters including:
- Defending enforcement actions in federal and state courts, including FDA actions for seizure, injunction, and criminal prosecution and actions brought under the Federal Meat Inspection Act, the Poultry Products Inspection Act, the Perishable Agricultural Products Act, the False Claims Act, the Anti-Kickback Act, the Foreign Corrupt Practices Act, and actions brought by state attorney generals.
- Responses to government investigations, including the negotiation of Consent Decrees and Settlements
- FDA and USDA/FSIS inspections
- FDA-483 observations and warning letters
- Recalls and market withdrawals
- Adverse event reporting
- Import detentions
- Internal audits and investigations
- Compliance policy and plan development
- Voluntary disclosures and corporate integrity agreements
- Complaints by or about competitors (Lanham Act and state unfair competition laws)
For many years, we have served as general counsel to a number of trade associations representing the food, pharmaceutical and medical device industries. In those representations, we are often called upon to provide legal advice to the association’s staff, officers, executive committee, and board of directors and to provide antitrust monitoring and guidance of association activities and meetings. We also often provide assistance in drafting comments and citizen petitions concerning proposed regulations and counsel association staff on applicable federal and state regulatory requirements and proposed legislation and rulemaking that affect association members.