Pharmaceuticals

Nelson Hardiman represents makers and resellers of pharmaceuticals, as well as so-called “cosmeceuticals” and “nutraceuticals,” meaning products not subject to FDA drug oversight. Nelson Hardiman also advises makers and resellers of other FDA-regulated items, including medical foods. Nelson Hardiman counsels and assists product makers with a range of business, regulatory, and strategic challenges, including:

  • Business Transactions
    • Formation of entities and business structure
    • Food and Drug Administration (FDA)  requirements, including New Drug Applications (NDA’s) and Investigational New Drug submissions (IND’s)
    • Post-approval regulation of marketing and manufacturing of drug products
    • Product labeling requirements
  • Regulatory Defense
    • FDA investigations and enforcement actions
    • Defense of Drug Enforcement Administration (DEA) investigations and enforcement proceedings related to controlled substances
    • Defense of FDA actions against unapproved drug importation and “pedigree” issues arising under the Prescription Drug Marketing Act of 1987 (PDMA)
    • Defense of 483 inspections
    • Response to warning letters
    • Reimbursement audits and investigations by governmental payors, including Medicare and Medi-Cal
  • Compliance
    • Avoidance of off-label claims making
    • Marketing and promotion of drug products, supplements, and other products, including review of promotional materials, promotion directed to consumers, and communications with pharmacies and physicians
    • Counseling on labeling, advertising, record-keeping, reporting obligations, inspections, best practices in marketing warning letters, and recalls.
    • FTC communication compliance
    • HIPAA and state patient data privacy and security requirements
    • Drug grandfathering
    • Current Good Manufacturing Practice (cGMP)
    • Stem cell therapy issues and human cell and tissue products (HCT/P)
  • Litigation
    • False Claims Act/qui tam whistle-blower litigation defense
    • Payor and reimbursement disputes
    • Disputes related to transactional misrepresentations
    • Business litigation, including shareholder disputes