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District of Columbia
overview transparency obligations

Latest update: 14 September 2018 | Important Notes

Report Due Date

July 1 ($5,000 annual fee)

Authority

D.C. Department of Health – Prescription Drug Marketing Costs Guide

Who Must Report

Pharmaceutical manufacturers

Covered Recipients

• All licensed healthcare providers (HCPs), including nurses, certified diabetes educators (CDEs), registered dieticians, licensed nutritionists, radiology technicians, etc.
• Non-teaching hospitals/clinics
• Universities
• Patient advocacy associations
• Professional associations
• All licensed healthcare facilities, including hospice, long-term care, dialysis, etc.

Pharmaceutical Companies

What is reported:

  • All expenses associated with advertising, marketing and direct promotion of prescription drugs through radio, television, magazines, newspapers, direct mail and telephone communications to D.C. residents
  • Any expenditure for consulting and honoraria fees, charitable grants, educational programs, gifts, meals or entertainment over $25 in value, and travel reimbursement for District healthcare professionals
  • Aggregate cost of employees or contractors who directly or indirectly engage in reportable activity

The required data to be disclosed will vary depending on whether the expense is attributable to gifts, advertising or aggregate cost.

How to Report

  • Email the Excel workbook (in Excel format) containing the “Company Information,” “Gift Expenses,” and “Advertising Expenses” worksheets to DC.Accessrx@dc.gov. Although you are required to utilize the “Aggregate Cost” worksheet to perform your calculations, you are not required to submit the worksheet itself. You may elect instead to submit only the total based on your calculations using the “Aggregate Cost” worksheet. In addition, print out the “Company Information” worksheet only, provide wet signature certification, and mail it to the Department of Health accompanied by a check for $5,000 made payable to “D.C. Treasurer.”
  • The report must be submitted by July 1, and the signed statement and check must be received within 7 days of the report’s submission.
  • Mail signed “Company Information” worksheets and checks to:

Department of Health
Pharmaceutical Control – AccessRx ATTN: Shauna White
899 N. Capitol Street, NE
Second Floor
Washington, D.C. 20002

Important notes:
  • This information is provided for your convenience and should not be construed as legal advice. The applicability of these requirements to your organization depends on individual circumstances. The information is not exhaustive.
  • Kindly check with your legal department and do not depend solely on the information provided here. Moreover, the rules mentioned could be subject to interpretation of local authorities/courts in the applicable jurisdiction. Lastly, be mindful of the latest update mentioned above. These rules and regulations change frequently, so it is important to determine whether the information reflects that most recent changes and is still applicable.
  • Reporting dates are related to the transparency obligation regarding transfers of value by pharmaceutical companies and/or medical device companies (excluding suppliers of in vitro diagnostics) to HCPs and HCOs. These often are based on laws or rules in codes of conduct of industry associations. (In such cases, your company only needs to disclose the transfers of value on the mentioned due date if your company is a member of that association).
  • “Due date” means the date on which the transfers of value need to be published. For example, the deadline for submitting/sending the complete information to the authority could be before the due date to give HCPs/HCOs the opportunity to check the data that the pharmaceutical companies/medical device companies are going to disclose.
  • The information does not take into consideration:
    • Transparency related to clinical trials (unless it concerns transfers of value as mentioned above)
    • Transparency related to patient organizations (unless the patient organization is considered an HCO)
  • If your company is a member of MedTech/EFPIA (or if the industry association your company belongs to is a member of MedTech/EFPIA), the due dates are as mentioned above for MedTech/EFPIA (end of June), unless a law/regulation specifically states otherwise (e.g., the jurisdiction is suspended/exempted from following MedTech/EFPIA).

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