AN ACT to create and enact a new subsection to section 43-15.3-08 of the North Dakota Century Code, relating to prohibited acts of drug manufacturers; and to provide a penalty.
Summary
HB 1473 adds a new subsection to North Dakota Century Code section 43-15.3-08 to regulate certain conduct by drug manufacturers, their agents or affiliates, virtual manufacturers, and third-party logistics providers. The bill focuses on drugs purchased under the federal 340B drug discount program and used by covered entities, including their contract pharmacies. It makes it a Class B misdemeanor for covered manufacturers and related entities to interfere with a contract pharmacy’s ability to acquire, dispense, or access these drugs on behalf of a covered entity, unless federal law allows the restriction.
The bill also prohibits manufacturers and related entities from conditioning access to 340B drugs on the submission of claims, encounter, or utilization data unless federal law requires that information. It further bars interference with dispensing to eligible patients and prohibits offering the drug as a rebate rather than as a discount at the time of sale, unless federal law authorizes that structure. The bill expressly excludes limited distribution drugs required under federal law, including drugs subject to federal risk evaluation and mitigation or other restricted distribution requirements.
Impact
HB 1473 expands state law protections for 340B covered entities and their contract pharmacies by creating a criminal penalty for manufacturer conduct that restricts access to discounted drugs. It amends section 43-15.3-08 of the North Dakota Century Code and adds a new set of prohibited acts tied to the federal 340B program, affecting drug manufacturers, their affiliates, virtual manufacturers, and third-party logistics providers operating in the state. The measure is intended to preserve access to discounted medications for eligible patients and to limit manufacturer practices that could undermine contract pharmacy dispensing arrangements.
Sentiment
The bill appears to have received broad legislative support, passing the House 71-17 and the Senate 41-4. The strong margins suggest general agreement with the goal of protecting access to 340B drugs and preventing manufacturer interference with covered entities and contract pharmacies. The absence of committee transcript material limits insight into detailed debate, but the vote totals indicate the measure was not especially controversial overall.
Contention
The main points of contention likely center on whether the state should impose criminal penalties on drug manufacturers and related entities for conduct tied to a federally regulated drug pricing program. Opponents may have concerns about state interference in pharmaceutical distribution, compliance burdens, data-sharing restrictions, or conflicts with federal law and manufacturer contracting practices. Supporters, by contrast, appear to have viewed the bill as necessary to prevent manufacturers from limiting access to discounted drugs for safety-net providers and their patients.