Oregon Proposes New Annual Fee for Drug Manufacturers
On May 29, the Oregon Department of Consumer and Business Services (DCBS) issued a Notice of Proposed Rulemaking setting forth a proposed rule to establish annual fees for manufacturers of prescription drugs sold in Oregon. These fees are being collected to cover the expenses incurred for administering the Drug Price Transparency program and The Prescription Drug Affordability Board under ORS 646A.680 to 646A.697 (established upon passage of SB 192 in 2023). If finalized, reporting manufacturers will be subject to the annual fee set forth under this rule for all billing periods on or after August 1, 2023.
Under this proposed rule, manufacturers will be assigned to a company size category, as determined by the number of National Drug Codes (NDCs) for U.S. Food and Drug Administration (FDA) approved prescription drugs the company has listed in FDA’s NDC Directory:
- “Large” Company Category – 40 or more NDCs
- “Medium” Company Category – 11 to 39 NDCs
- “Small” Company Category – 10 or fewer NDCs
Each manufacturer’s annual fee will be calculated upon: (1) its size category; (2) the amount of total revenue needed apportioned to its size category (i.e., 70% for Large companies, 25% for Medium, and 5% for Small); and (3) the number of reporting manufacturers in the size category.
Notably, manufacturers will be informed of their company size category prior to fee assessment and will have 30 days to request a change and provide information to demonstrate why their size category is not correct.
Fee payment will be due within 30 days of an assessment. Manufacturers will be required to pay interest at 9% per annum on any assessments not paid when due.
A hearing on this proposed rule is set to take place on June 25, 2024 (11-11:45am PST), with comments to the proposed rule being accepted until July 2, 2024 (5:00pm PST).
If you need help drafting or submitting comments to this proposed rule, or need help determining the impact of recent and upcoming developments in federal and state laws, Buchanan’s Life Sciences Industry Group is here to help.