Chapter 18 [PDF] of Title 22 of the District of Columbia Municipal Regulations (DCMR), entitled “Prescription Drug Marketing Costs” requires manufacturers and labelers of prescription drugs dispensed in the District who engage in marketing in the District of Columbia (“District”) to report to the Department of Health (“Department”) their costs for pharmaceutical drug marketing in the District. Those regulations are consistent with Title III of the AccessRx Act of 2004 [PDF]. Each manufacturer or labeler is required to report their prescription drug marketing costs in an annual report filed with the Department on or before July 1 of each year.
The annual report is to be accompanied by a filing fee in the amount of five thousand dollars ($5,000). This fee is an annual fee that is to be paid by each manufacturer or labeler who files the required annual report. The filing fee is payable exclusively by check, and checks are to be made payable to the DC Treasurer.
IMPORTANT: Change To Gift Expense Reporting Requirements
The District has changed its gift reporting requirements in light of the new federal Open Payments reporting requirements (http://go.cms.gov/openpayments). Gifts given to physicians and teaching hospitals after July 31, 2013 must be reported to the US Department of Health and Human Services (HHS). A physician is a doctor of medicine or osteopathy, a doctor of dental surgery or medicine, a doctor of podiatric medicine, a doctor of optometry, or a chiropractor. See, 42 U.S.C.A. § 1395x(r). Companies should not report gifts reported to HHS (i.e., gifts to physicians and teaching hospitals) to the District of Columbia
Gifts made to recipients other than physicians and teaching hospitals must still be reported to the District. Reporting requirements for aggregate and advertising expenses remain unchanged.
Companies that have filed reports in past years should use the Microsoft excel file published below as changes and updates are made to the worksheet each year.
- Instructions for Drug Manufacturers and Labelers [PDF]
- The 2014 Prescription Drug Marketing Costs workbook contains four Excel sheets that the company must fill out: Company Information, Gift Expenses, Advertising Expenses, and Aggregate Cost. Complete instructions for filling out these forms are available in the PDF document and also in the fifth worksheet of the Excel document.
The Company Information, Gift Expenses, Advertising Expenses, and Aggregate Cost sheets should be filled out completely according to the instructions and submitted electronically to email@example.com. In addition, the Company Information sheet should be printed and sent to the Department along with a $5,000 filing fee check made payable to DC Treasurer.