Suppliers and distributors of regulated health care products must comply with a patchwork of state and federal legal and regulatory requirements. These requirements govern all aspects of their operations, including contracting, storing, tracing, and delivering health care products. Our drug and medical device distribution lawyers represent a range of manufacturers, distributors and wholesalers, third-party logistics providers, and group purchasing organizations, whose products include drug and biologic products, medical devices, durable medical equipment, cannabis and cannabidiol (CBD) products, and tissue products.
Addressing Compliance Issues
Our clients count on us to help them understand and implement their obligations in an ever-changing regulatory landscape. We advise them on complying with Food and Drug Administration and Drug Enforcement Administration (DEA) regulations as well as drug importation, and state-by-state licensing requirements. In mergers and acquisitions involving manufacturers and distributors, clients rely on us to assess the adequacy of the target’s existing licenses and to advise on and execute the filing of notices and new applications that can significantly impact timelines and the clients’ ability to continue operations post-closing.
Understanding Enforcement Efforts
With the stepped-up enforcement efforts and widespread litigation surrounding opioids and other controlled substances, manufacturers, distributors and wholesalers are under increasing pressure to identify and monitor suspicious ordering. In the absence of clear guidance from the DEA, we help clients stave off enforcement actions by developing suspicious order monitoring and reporting programs that are robust and defensible. We also advise clients of their obligations under the still-evolving Drug Supply Chain Security Act (DSCSA), and its goal of tracing drugs at every distribution point, from the manufacturer to the consumer.
Taking a Wider View
Drug and device distribution doesn’t exist in a vacuum. Our distributor and wholesaler clients are sophisticated players in a complex marketplace, and they rely on our deep bench of lawyers, consultants, and other professionals to navigate it. Our view of the entire health care ecosystem gives us a distinct perspective in helping distributors address not only the issues affecting their operations, marketing efforts, financial relationships, and overall business strategies but also the tangential challenges and obligations faced by their customers.
- Drafted and negotiated the entire spectrum of commercial contracts between wholesalers, drug manufacturers, group purchasing organizations, pharmacies, and other health care providers.
- Reviewed wholesaler portfolio program contracts and assessed the government pricing impact of multiple discount and rebate arrangements.
- Provided counsel to several distributors in connection with audits and investigations by federal and state government agencies and government contractors.
- Represented multiple wholesaler clients in high-profile government investigations and litigation related to the wholesalers’ compliance with DEA’s suspicious order monitoring and reporting requirements.
- Represented distributors in administrative appeals and litigation.
- Created a suite of model supply and distribution agreements for a controlled substances’ distributor.
- Conducted health regulatory due diligence of a distributor of infusion equipment and related products for home infusion providers in connection with its acquisition by a private equity investor.
- Advised a distributor on state and federal laws related to pharmaceutical returns.
- Conducted multiple state surveys on state drug/biologic distributor licensing requirements and transfer of ownership requirements.
- Advised distributors on the federal preemption of state drug wholesaler licensing laws in the wake of Congress’s enactment of the federal DSCSA.
- Counseled manufacturers and distributors on the scope of products exempt from federal DSCSA requirements.
- Advised a pharmacy on structuring contracts for drug product ownership transfers to align with DSCSA requirements.
- Advised non-pharmacist dispensers regarding limited application of the DSCSA requirements to such dispensers.