Prescription Drug Industry

Holland & Knight's Healthcare Team has extensive experience representing all of the stakeholders in the drug supply chain including prescription drug manufacturers, pharmaceutical wholesalers, medical gas distributors, pharmacies, hospitals and practitioners. We have in-depth knowledge of both federal and state regulation of the industry, including the federal Prescription Drug Marketing Act, the Controlled Substance Act, and state-specific licensure and pedigree requirements. We represent wholesale distributors in a variety of matters, such as business transactions, licensure matters, regulatory and compliance issues, and litigation.

National

We have broad experience representing clients in federal regulatory matters, including regulatory compliance, fraud and abuse prevention, drug diversion, and federal licensing and registration issues. Additionally, we routinely represent clients in licensure and permitting issues in a number of states in response to denials of issuance or renewal of a permit. With regard to healthcare transactions, we have provided counseling for wholesalers and other distribution companies and pharmacies by assisting in the negotiation of distribution, technology, merger and acquisition related agreements and other transactions.


Florida

Regulation and enforcement of the manufacturing and distribution of prescription drugs is highly regulated in Florida. We frequently interact with regulatory staff at all levels, including permitting and licensure, investigative services, and regulatory enforcement. We also participate in policy-making initiatives in order to remain on the cutting-edge of decisions impacting the industry, such as attending public meetings related to rule-making, and Drug Wholesale Distributor Advisory Council meetings.

Our Tallahassee, Fla., office is located near the Department of Health's executive offices, allowing us to respond immediately to the regulatory needs of our clients. In addition to handling Florida pedigree, licensure, permitting and audit trail issues, we also have broad administrative litigation experience in defending wholesalers against the Florida Department of Health's full range of regulatory enforcement actions, such as Emergency Suspension Orders, Stop Sale Notices, Notices of Violation and Administrative Complaints.