District of Columbia Excludes MR Physician Payments from Reporting Requirement
Prompted by CASRO Lobbying Effort, Decision Clears Way for Return of Pharma Research

August 4, 2011

Washington, D.C. - Today, the District of Columbia's Board of Pharmacy approved revisions to its regulations to broadly exempt market research from D.C.'s physician payment reporting statute. The decision clears the way for pharmaceutical market research to return to D.C. and marks the successful conclusion of a six-month lobbying effort by CASRO.

D.C.'s AccessRx Act of 2004 (the "Access Rx Act") required pharmaceutical manufacturers and labelers to annually report all payments made in connection with marketing. While by its terms the AccessRx Act did not apply to payments made to health care practitioners as part of market research, D.C.'s Board of Pharmacy had explicitly extended the disclosure obligations to payments made in connection with market research surveys.

The revisions approved today by the Board of Pharmacy exempt payments made to health care practitioners for participation in market research from the reporting requirements of the AccessRx Act if:

• (i) the market research is conducted by an independent survey research organization;
• (ii) the pharmaceutical client does not know the identity of the practitioners who participate in the research; and
• (iii) the payments are determined and made directly by the survey research organization.

This new language applies to the next filing in July 2012, for the 2011 reporting period. "Consequently, this means that the reporting obligation is effective immediately and, in fact, retroactive to the beginning of 2011," said Richard Day (Richard Day Research), Co-Chair of CASRO's Government & Public Affairs (GPA) Committee.

Along with CASRO's Washington lobbyist, Ed Matricardi (Allied Public Affairs), the CASRO GPA leaders met with the D.C. Board of Pharmacy's Executive Director and the full Board several times over the past six months to explain the research industry's position. CASRO had argued that market research payments to physicians for their participation in research are separate from direct marketing and should not be subject to the reporting requirement. The Board of Pharmacy recognized the distinction between market research and marketing and suggested only modest changes in the language proposed by CASRO. "The Board inserted the language that the independent survey research organization cannot be owned by or affiliated with a pharmaceutical manufacturer," said Rick Seale (Shugoll Research), "and this change was completely acceptable to CASRO. "

Following on the heels of Maine's repeal of its physician payment reporting statute last month (see CASRO Legal Update), the only jurisdiction with a statute that broadly affects the research industry is Vermont, where such payments are now prohibited. CASRO is continuing to monitor and respond to similar legislation in other states, but it is hoped that the new Federal law will stifle state legislation on this issue. So long as the identity of the physician respondent is blinded to the manufacturer, payments made to physicians as compensation for participation in market research are now not reportable under the Federal Physician Payment Sunshine Act, D.C.'s AccessRx Act and under Minnesota's similar statute. Massachusetts, which has considered repealing its own physician payment reporting statute several times, also exempts market research payments when the research is conducted in a double blind fashion.

CASRO Government & Public Affairs Committee: Richard Day (Richard Day Research), Co-Chair; Larry Ponemon (The Ponemon Institute), Co-Chair; Duane Berlin (Lev & Berlin, P.C.), CASRO General Counsel; Diane Bowers, CASRO President; Russell Anderson (Lev & Berlin, P.C.); Bill Little (Delta Marketing Dynamics); Ed Matricardi (Allied Public Affairs); Susan McDonald (National Analysts Worldwide); Bill McInturff (Public Opinion Strategies); Kevin Menk (Strategic Resource Partners); Bob Moore (Moore Information)