Pharmaceuticals - Food and Drug Law

Venable has experienced food and drug attorneys who represent their clients before the FDA and Congress and in litigation. They guide companies that research, manufacture and market pharmaceutical, biotechnology, device, food and dietary supplement products. They have had significant experience in high positions in the FDA Commissioner’s Office, in the FDA Office of Chief Counsel, at the Federal Trade Commission, in a major industry trade association and on a key committee in the Congress.

Examples of significant representations include:

  • representing major pharmaceutical companies in numerous landmark cases involving the FDA: Pfizer v. Shalala (1999), Teva v. FDA (1999), Pharmanex v. Shalala (2000), Teva v. FDA (2000), Zeneca v. Shalala (2000), Novartis v. Thompson (2001), Sigma Tau v. Thompson (2001);
  • representing major companies before the Congress on legislation and other matters involving the FDA;
  • assisting companies to obtain product approvals, OTC switches, and clearances for clinical research;
  • assisting companies to obtain precedent-setting administrative rulings involving marketing and advertising, Hatch-Waxman product exclusivity, patent listing and certification requirements, pediatric exclusivity and labeling, and orphan drug exclusivity;
  • representing companies on major policy issues before the FDA Office of the Commissioner; and
  • representing companies in FDA and FTC enforcement actions.