Section 22-B1801. CONTENT OF ANNUAL REPORT

 

1801.1The annual report shall include the following information as it pertains to prescription drug marketing costs and activities expended by the manufacturer or labeler in the District in a form that provides the value, nature, purpose, and recipient of the expense:

 

(a)All expenses associated with advertising, marketing, and direct promotion of prescription drugs through radio, television, magazines, newspapers, direct mail, and telephone communications as they pertain to District residents;

 

(b)With regard to all persons and entities licensed to provide health care in the District, including health care professionals and persons employed by them in the District, carriers licensed under Title 31 of the D.C. Official Code (Insurance and Securities), health plans and benefits managers, pharmacies, hospitals, nursing facilities, clinics, and other entities licensed to provide health care in the District, the following information:

 

(1)All expenses associated with educational or informational programs, materials, and seminars, and remuneration for promoting or participating in educational or informational sessions, regardless of whether the manufacturer or labeler provides the educational or informational sessions or materials. This includes but is not limited to:

 

(i)Support for independent or continuing medical education programs (IME or CME) to the extent of participation by such persons and entities, including payments to medical education companies;

 

(ii)Printing costs of patient education materials and disease management materials distributed to such persons and entities. Design and other production costs also must be reported for materials designed specifically for District users;

 

(iii)Payment of consulting fees and expenses directly or indirectly to such persons and entities, subject to exceptions in § 1801.2 of this chapter;

 

(iv)Payments made directly or indirectly to such persons and entities for participation in speakers' bureaus and honoraria or other payments for time while speaking at or attending meetings, lectures or conferences;

 

(v)Payments made directly or indirectly to such persons or entities for writing articles or publications;

 

(vi)Charitable grants, either directly or earmarked, to such persons and entities, even if unrestricted; and

 

(vii)Payments made directly or indirectly to such persons or entities in connection with market research surveys or other activities undertaken in support of developing advertising and/or marketing strategies.

 

(2)All expenses associated with food, entertainment, gifts valued at more than $25, and anything provided to a health care professional for less than market value;

 

(3)All expenses associated with trips and travel; and

 

(4)All expenses associated with product samples, except for samples that will be distributed free of charge to patients; and

 

(c)The aggregate cost of, including all forms of payment to, all employees or contractors of the manufacturer or labeler who directly or indirectly engage in the advertising or promotional activities listed in paragraphs (a) and (b), limited to that portion of payment to the employees or contractors that pertains to activities within the District or to recipients of the advertising or promotional activities who are residents of or are employed in the District.

 

1801.2The following expenses are not subject to the reporting requirements of this chapter:

 

(a)Marketing expenses of twenty-five dollars ($25) or less per day and per health care provider or entity;

 

(b)Reasonable compensation and reimbursement for expenses in connection with a bona fide clinical trial of a new vaccine, therapy, treatment, or indication;

 

(c)Scholarships and reimbursement of expenses for attending a significant educational, scientific or policy-making conference or seminar of a national, regional, or specialty medical or other professional association if the recipient of the scholarship is chosen by the association sponsoring the conference or seminar; and

 

(d)Expenses associated with advertising and promotional activities purchased for a regional or national market that includes advertising in the District if the portion of the costs pertaining to or directed at the District or cannot be reasonably allocated, distinguished, determined or otherwise separated out.

 

1801.3 Beginning with the July 2012 filing, for the 2011 reporting period, payments made to health care practitioners for participation in market research shall not be subject to the reporting requirements of the Act and this chapter if the following conditions are met:

 

(a) The market research is conducted by an independent survey research organization;

 

(b) The pharmaceutical client does not know the identity of the practitioners who participate in the research; and

 

(c) The payments are determined and made directly by the survey research organization.

 

1801.4 All costs reported in the annual report must be determined using  Generally Accepted Accounting Principles (GAAP).

 

1801.5 Each manufacturer or labeler subject to the provisions of the Act shall, as part of its annual report:

 

(a) Report the name and contact information of the individual responsible for the company’s compliance with the provisions of this chapter, and accuracy of the annual report;

 

(b)  Identify by name and position title the individual submitting the report; and

(c)  Submit separately in conjunction with the filing of the report under § 1802.1, a wet signature certification that states that “under penalty of law the information contained in the report is to the best of my knowledge after due diligence to inquire about the truthfulness and accuracy of the report, accurate” and an acknowledgment that providing false information or omitting required information on the report is unlawful.

 

1801.6 The individual identified in § 1801.5(a) of this chapter shall be a member of senior management or senior level company official within the manufacturer’s or labeler’s company or corporate structure.

 

 

authority

The Director of the Department of Health (Department), pursuant to § 307 of the District of AccessRx Act of 2004, effective May 18, 2004 (D.C. Law 15-164; D.C. Official Code § 48-833.07 (2008 Repl.)) (the Act), and Mayor’s Order 2006-60, dated June 7, 2006.

source

Notice of Final Rulemaking published at 54 DCR 5287 (May 25, 2007); as amended by Notice of Final Rulemaking published at 59 DCR 535 (January 27, 2012).