We understand the drug and pharmacy sector. Our attorneys have extensive knowledge of all segments of the drug supply chain and assist manufacturers, distributors, retailers, and pharmacy benefit managers in all facets of legal representations including regulatory, transactional, government investigation, and litigation matters.
A sampling of the legal services we provide to the drug and pharmacy industry:
Heathcare Regulatory Matters
Legal review of vendor agreements with drug manufacturers, drug wholesalers, PBMs, retail pharmacies and managed care organizations, including but not limited to, anti-kickback and government pricing issues.
Audits of wholesaler and pharmacy operations to ensure compliance with OIG requirements. Audits and assessments of Standard Operating Procedures for dealing with compliance issues, and defense of pharmacies.
Pharmacy Management Agreements
Constructing contracts that meet state and federal requirements respecting management of pharmacy services, including drafting of advice letters.
Acquisition and disposition of wholesale distribution and pharmacy business enterprises including complex transactions/negotiations.
Privacy and Security Issues
Assessing pharmacy privacy and security legal issues implicated by the handling of patient/customer privacy information, addressing regulatory compliance issues; litigation representation.
Supply chain compliance with state and federal laws/regulations involving distribution of drugs.
Compliance analysis and implementation of electronic prescribing requirements in connection with both state and federal laws/regulations.
Establishing in-store health clinics, assuring compliance with state and federal laws/regulations.
DEA Registration Matters
Defending wholesalers and pharmacies with respect to diversion issues; compliance with state and federal controlled substance laws/regulations; obtaining/maintaining/retiring DEA registrations; and handling of controlled substances.
Licensure and Miscellaneous Pharmacy Practice Matters
Preparing clients for board of pharmacy licensure proceedings, including obtaining state-authorized controlled substance licensure; compliance and implementation requests pertaining to drug therapeutic interchange/drug substitution issues for long-term care facilities and health systems; pharmacy practice act issues on behalf of wholesalers, pharmacies and pharmacy management companies; pharmacy credentialing matters, including advanced-level credentials and specialty certification; collaborative drug therapy management issues; tele-pharmacy; supply chain and third-party contracting; medication error reporting and NABP credentialing of VIPPS and VAWD.
Specialty Pharmacy Matters
Address unique issues of specialty pharmacy formation, logistics in drug distribution, pricing and clinical program delivery.
Representing wholesalers and pharmacies in protecting against state and federal reimbursement cuts for prescription drugs, including engagement in litigation and government relations activity.
Federal Trade Commission
Wholesaler and pharmacy assistance in addressing advertising issues.
State Consumer Protection Laws
Managing legal issues with State Attorneys General enforcing broad state consumer protection laws.
Food and Drug Administration
Assistance with drug, biologicals, and medical device approvals. Assistance in handling consumer product recalls; notifications to consumers and the public; handling supply chain issues such as product counterfeiting; re-importation and product tracking issues.
Assisting drug industry companies response to Congressional inquiries in connection with “hot button” government program topics, including Medicare Part D.