Pharmaceutical Industry and Pharmacy Practice

Located in the geographic hub of New Jersey’s pharmaceutical industry, Schenck, Price, Smith & King is familiar with the issues related to the manufacturing, distribution and dispensing of drugs, medical devices and dietary supplements, including the regulatory review of corresponding promotional and marketing materials.  Members of the Firm’s Pharmaceutical Industry and Pharmacy Practice Group have significant in-house and outside counsel experience assisting clients with these matters.

Many of the attorneys in the Schenck, Price, Smith & King Pharmaceutical Industry and Pharmacy Practice formerly served as in-house counsel at well-known companies including a global pharmaceutical company, the pharmacy division of a Fortune 100 corporation, and two global manufacturing companies.  Two Practice Group attorneys hold Master’s degrees in Health Law (LL.M.), one served as the general counsel of a large healthcare system and one is a former Chief of Regulatory Affairs for the New Jersey State Division of Consumer Affairs.  The Practice Group is supplemented by the full resources of the Firm, including our Health Care Law Practice Group and Commercial Litigation Group.

TYPES OF CLIENTS

  • Pharmaceutical companies (brand and generic)
  • Biotechnology companies
  • Medical device companies
  • Pharmacies
  • Contract manufacturing organizations
  • Contract sales organizations
  • Pharmacy benefit managers
  • Pharmacists

TYPES OF SERVICES

  • Transactional: 
    • Negotiation, drafting and review of complex commercial transactions:
      • Manufacture, supply, development, repackaging and quality assurance agreements
      • Distribution, managed care, preferred provider and customer contracts
      • Sales force agreements
      • Consultant and service provider agreements
      • Product launch documents
      • Information technology and software agreements
      • Clinical trial and research agreements
      • Procurement agreements
      • Lease agreements
    • Corporate formation:
      • Formation and licensure of entities
      • Partnership, shareholder, operating, employment and management agreements
      • Compliance program policies and procedures
  • Regulatory review of promotional and marketing materials:
    • Prescription and over-the-counter (OTC) drugs (human and veterinary)
    • Prescription and OTC medical devices
    • Dietary supplements
  • Regulatory compliance (federal/state)
  • Fraud and abuse counseling (federal/state)
  • Reimbursement matters (Medicare, Medicaid, third party private payors)
  • Representation before State Professional Boards (e.g., Pharmacy, Optometrists, Ophthalmic Dispensers and Ophthalmic Technicians, Medical Examiners)
  • Licensing issues (e.g., individuals and business entities; initial and licensing renewals; licensure by endorsement)
  • HIPAA/HITECH compliance
  • Corporate compliance
  • Mergers and acquisitions

PRINCIPAL AREAS OF CONCENTRATION

  • Regulation of drug products, medical devices and dietary supplements.
  • Regulatory review of promotional and marketing materials.
  • Representation before New Jersey, New York and Pennsylvania state boards.
  • Manufacture and supply agreement negotiation and drafting.
  • Distribution, managed care and customer contract negotiation and drafting.
  • Pharmacy benefit manager agreements.
  • Clinical trial and research-related agreement negotiation and drafting.
  • Information technology and software agreement negotiation and drafting.
  • HIPAA/HITECH laws and regulations. 

REPRESENTATIVE MATTERS

  • Represent a start-up pharmaceutical company in its corporate formation and the acquisition of new products and corresponding manufacturing transactions.
  • Advised an outsourcing company in negotiations with a pharmaceutical company related to management of its interactions with healthcare providers.
  • Corporate counsel for a medical device company with offices in New Jersey.
  • Represent a DME supplier in contracting, regulatory and licensing issues.
  • Represent medical professionals in licensing matters before New Jersey Licensing Boards.
  • Represent clients regarding clinical trial and research agreements.
  • Panelist on webinar discussing medical device “UDI and GDSN - Leveraging GS1 Standards”.

PUBLICATIONS & PRESENTATIONS

  • FDA Proposes Unique Device Identification System for Medical Devices, Deborah A. Cmielewski, Jan 3, 2013, Learn More
  • UDI AND GDSN - LEVERAGING GS1 STANDARDS, Deborah A. Cmielewski, Jan 15, 2013 , Learn More