Or. Admin. Code § 836-200-0553 - Annual fees paid by drug manufacturers

(1) Each reporting manufacturer, as defined under OAR 836-200-0505, shall pay an annual fee to the Department of Consumer and Business Services to meet the costs of the department in administering ORS 646A.680 to 646A.697. The fee shall be based on the manufacturer's size as set forth in sections (3) and (5) of this rule.

(2) For purposes of section (1), the director shall determine the amount of revenue needed by considering expenditures in administering ORS 646A.680 to 646A.697 and cash reserves.

(3) Each reporting manufacturer shall be assigned to one of three size categories based on the number and FDA market category of the National Drug Code package codes (NDCs) for U.S. Food and Drug Administration (FDA) approved prescription drugs in the manufacturer's portfolio during the annual billing period.

(a) The annual billing period is the calendar year prior to the year the annual fee is imposed.

(b) The department shall determine the number of NDCs for a manufacturer by referencing the FDA National Drug Code directory to calculate the number of unique NDCs for the manufacturer and any known labeler the manufacturer uses.

(c) The size categories shall be delineated as follows:

(A) For all reporting manufacturers not subject to paragraph (3)(c)(B), there are three size categories: large (40 or more NDCs), medium (11 to 39 NDCs), and small (10 or fewer NDCs).

(B) For reporting manufacturers where every NDC used for billing purposes under this section (3), has an FDA market category of ANDA (abbreviated new drug application) or NDA authorized generic (new drug application for an authorized generic of a brand name drug) or is a biosimilar product where the proprietary and nonproprietary name are the same that is approved under a biologics license application (BLA), there are two size categories: medium (40 or more NDCs) and small (39 or fewer NDCs).

(4) The department shall inform manufacturers of their assigned size category and provide manufacturers the opportunity to request a change to their assigned size category prior to assessment. Manufacturers will have 30 days to submit the request, which must include information to demonstrate why their size category is not correct. If a manufacturer does not submit a request to change within 30 days, the assigned size category for the billing period is final.

(5) At the end of the annual billing period each manufacturer's annual fee will be calculated based on its size category, the amount of total revenue needed apportioned to its size category, and the number of reporting manufacturers in its size category.

(a) Manufacturers classified as large shall collectively be apportioned 62 percent of the total revenue needed.

(b) Manufacturers classified as medium shall collectively be apportioned 31 percent of the total revenue needed.

(c) Manufacturers classified as small shall collectively be apportioned seven percent of the total revenue needed.

Example: Total revenue needed for the year is $1,000,000. There are 100 manufacturers categorized as large. Each large manufacturer's fee will be $6,200 ($1,000,000 x 0.62/100 = $6,200).

(6) The revenue collected under this rule shall be deposited in the Prescription Drug Affordability Account established in ORS 705.146.

(7) A manufacturer shall pay its annual fee imposed under this rule no later than 30 days after the date of the assessment by the department. A manufacturer shall pay interest at nine percent per annum on any assessment that is not paid when due.

(8) Reporting manufacturers shall be subject to the assessment requirements set forth under OAR 836-200-0555 in sections (1) to (5) for billing periods through July 31, 2023. For billing periods on or after August 1, 2023, reporting manufacturers shall be subject to the annual fee set forth under this rule.

Notes

Or. Admin. Code § 836-200-0553

ID 14-2024, adopt filed 07/31/2024, effective 8/1/2024

Statutory/Other Authority: ORS 646A.693 & ORS 646A.695

Statutes/Other Implemented: ORS 646A.695