Overview
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.
Representative Matters
- 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 the limited application of the DSCSA requirements to such dispensers.
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Events
Past Events
- October 12, 2022
- September 9, 2022
- August 25, 2022
- February 2, 2022
Insights
Insights
- Media CoverageJames Boiani Quoted in “Clinical Lab Consolidation Continues in 2023 While Key Policy Questions Go Unresolved” ...2 minute read
- Media CoverageDelia Deschaine Quoted in “How the FDA Could Boost Gender-Affirming Care”5 minute read
- Media CoverageRichard Hughes Quoted in “RSV Vaccines Aren’t Covered by Medicare for These Vulnerable Groups”2 minute read
- Media CoverageRichard Hughes Quoted in “Opinion: It Shouldn’t Be So Hard for Older Adults to Receive the RSV Vaccine”2 minute read
- PublicationsDietary Supplement Makers Face "Misbranding" Minefield, Need FDA Guidance7 minute read
- Firm Announcements
Jessika Tuazon Named to the 2023 Southern California Rising Stars List
6 minute read - PublicationsBy Leaving "Therapeutic Alternatives" Undefined, CMS Tilts the Playing Field of Drug Price Negotiations3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Trade Group Pushes Back on FDA’s Clinical Decision Support Guidance”3 minute read
- Media CoverageJames Boiani Quoted in “Congress Has a Chance to Close the FDA’s Theranos Loophole”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Software to Predict Risk of Sepsis, Stroke Should Be Regulated as a Medical Device ...4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Acknowledges Shortcomings of Pre-Cert Pilot in Report”6 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Lays Out CDS Stance”1 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Legal Expert: FDA’s CDS Software Guidance Is a ‘Disaster’ for Industry” ...3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Finalizes Guidance on How Clinical Decision Support Software Is Regulated” ...2 minute read
- Media Coverage
Bradley Merrill Thompson Featured in BioWorld: Discussion of FDA Guidance for CDS Software
1 minute read - Media CoverageBradley Merrill Thompson Quoted in “FDA Guidance Hikes Oversight of Clinical Decision Support Software”3 minute read
- Media CoverageBradley Merrill Thompson Quoted in “A ‘Disaster,’ or a ‘Clear Path’ Forward?: New FDA Guidance on AI in Medicine ...2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA’s Pre-Cert Pilot for SaMD Falters Over Lack of Statutory Authority” ...2 minute read
- Media CoverageMagic Mushrooms in the Garden State? A Look into the Proposed Psilocybin Legal Landscape in New Jersey2 minute read
- Media CoverageRichard Hughes, Kala Shankle Featured in “Viewpoint: Pharmacists Need Standard Pathway to Bill for Paxlovid” ...2 minute read
- PublicationsPharmacists Can Now Prescribe Paxlovid, but Barriers Persist4 minute read
- Media Coverage
Bradley Merrill Thompson Featured in Medtech Monthly Podcast: Breakthrough Device Analysis
7 minute read - Firm Announcements
Epstein Becker Green’s Amy Dow Honored in Crain’s 2022 Notable Women in Law
2 minute read - PublicationsMore Changes in Store for Pharmaceutical Supply Chain Following Passage of Inflation Reduction Act18 minute read
- Media CoverageEpstein Becker Green’s Unpacking Averages Report “Casts Doubt on Value of US FDA’s Breakthrough Devices Program” ...2 minute read
- Media CoverageDelia Deschaine Quoted in “Can States Legally Ban FDA-Approved Abortion Pills?”2 minute read
- PublicationsFTC’s PBM Study Signals Broader Federal Scrutiny of the Prescription Drug Sector23 minute read
- Media CoverageDelia Deschaine Quoted in “What a Lawsuit in Mississippi Tells Us About the Future of Abortion Pills”4 minute read
- Firm Announcements
Jessika Tuazon Named to the 2022 Southern California Rising Stars List
5 minute read - PublicationsFDA Releases Proposed Rule on National Standards for Drug Wholesaler Licensure18 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Biden Nominates Robert Califf to Return as FDA Head”2 minute read
- Firm AnnouncementsEpstein Becker Green Announces 2022 Promotions6 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Issues Long-Awaited Draft Software Guidance in Overhaul of 16-Year-Old ...4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “Clinical Decision Support Guidance Tops FDA’s Agenda for 2022”2 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA's 2022 A-List Guidance Plan Hits on Software, Post-Pandemic Future” ...4 minute read
- Media CoverageBradley Merrill Thompson Quoted in “FDA Resists Industry Push to Nix De Novo Inspections in Final Rule”2 minute read