2376226 To amend the Prescription Drug Marketing Costs requirements to exclude payments, which meet the conditionsspecified in the regulations, made to health care practitioners for participation in market research.
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DEPARTMENT OF HEALTH
NOTICE OF FINAL RULEMAKING
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, hereby gives notice of the adoption of the following amendments to chapter 18 (Prescription Drug Marketing Costs) of subtitle B (Public Health and Medicine) of title 22 (Health) of the District of Columbia Municipal Regulations (DCMR).
The purpose of this amendment is to exclude payments, which meet the conditions specified in the regulations, made to health care practitioners for participation in market research from the reporting requirements of the Act.
These rules were previously published in the D.C. Register as proposed rulemaking on October 14, 2011 at 58 DCR 8786. No written comments were received from the public in connection with this publication during the thirty (30)-day comment period and no changes have been made from the proposed rulemaking.
The Department took final rulemaking action on December 13, 2011. These final rules will be effective upon publication of this notice in the D.C. Register.
Chapter 18 (Prescription Drug Marketing Costs) of subtitle B (Public Health and
Medicine) of title 22 of the DCMR is amended as follows:
Section 1801, CONTENT OF ANNUAL REPORT, subsections 1801.3 through 1801.5 are amended to read as follows:
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.
A new section 1801.6 is added to read as follows:
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.
Section 1899, DEFINITIONS, subsection 1899.1, is amended by adding the following term and definition, in alphabetical order, to read as follows:
Independent survey research organization- a survey research organization, marketing research organization, or similar entity that is not owned or affiliated, directly or indirectly, with a pharmaceutical company, manufacturer, or labeler, and which does not share employees or independent contractors with a pharmaceutical company, manufacturer, or labeler.
