The Pharmaceutical Research and Manufacturers of America's revised marketing code will use an executive certification standard similar to Sarbanes-Oxley to assure compliance.

The new PhRMA rules were unveiled July 10 and take effect in January. The ¹ new code on company interactions with health care professionals is considerably stronger than the association's ² 2002 code.

A notable feature is the use of a compliance mechanism modeled on the Sarbanes-Oxley securities law, which requires top executives of publicly traded companies to personally attest that company financial records are accurate. The Sarbanes-Oxley requirement has drawn some complaints from corporations that it is too burdensome. PhRMA's adoption of a similar approach signals the strength of the association's effort to eliminate perceptions that companies' dealings with doctors might be inappropriate.

Going to such lengths to provide assurances that industry can be trusted to market its products responsibly could be the key factor in forestalling any potential legislation to limit marketing powers, perhaps even more so than the specific new provisions of the code itself.

The previous code allowed companies to provide doctors items of minimal value, such as pens and notepads, while the new code prohibits any "reminder" gifts whatsoever as well as preventing reps from treating doctors to meals outside the office (see ³ Also see "Drug Rep Repasts Are In The Past: PhRMA Code Further Restricts Free Meals" - Pink Sheet, 14 July, 2008.).

Appearances Matter, As Do Web Postings

"Whether or not anybody will ever admit, concede or believe that this influences in a bad way what doctors do with the medicine, the perception is bad, and getting rid of it we think is important if we are going to build credibility back into what is a very serious and important interaction," PhRMA President Billy Tauzin said during a briefing with reporters to review the new code.

The code also mandates that support for continuing medical education should follow the standards set by the Accreditation Council for Continuing Medical Education. In addition, the use of prescriber data in marketing should be limited, and firms must respect the wishes of physicians to opt-out from any programs that allow use of their data, as recommended by the American Medical Association.

On the compliance standard, the code states that firms should complete an annual certification that "must be signed by the company's chief executive officer and chief compliance officer."

PhRMA will create a Web site that lists companies who commit to abide by the code and provides contact information for their chief compliance officers. "Any comments received by PhRMA relating to a company's observance of the code or conduct that is addressed by the code will be referred by PhRMA to the relevant company's chief compliance officer."

"In addition, companies are encouraged to seek external verification periodically, meaning at least once every three years, that the company has policies and procedures in place to foster compliance with the code," the document states. "PhRMA will prepare general guidance for such external verification and will identify on its Web site if a company has sought and obtained verification of its compliance policies and procedures from an external source."

Tauzin said that antitrust issues prevent the association from setting sanctions for firms that violate the code. He suggested that private boardroom pressure would help assure compliance.

The certification element could also have implications if any firms are investigated by government authorities for marketing violations.

PhRMA's marketing code takes a different approach to assuring compliance than the association's guiding principles for direct-to-consumer advertising. Under the DTC code, PhRMA established an outside board of advisors charged with producing an annual report of how the principles are being implemented.

Tauzin explained that breadth of the marketing code necessitated the difference. "We are talking about a code that covers everything from interactions with hospitals ... to consultants and speakers. This is a pretty complex set of arrangements." Tauzin noted that PhRMA is also preparing revisions to its DTC advertising code (⁴ Also see "Drug Firms To Adopt AMA Guidelines On Physicians In DTC Ads" - Pink Sheet, 23 June, 2008., p. 6).

However, PhRMA does not appear to have established a public mechanism for disclosing specific instances where the marketing code is violated, even without naming the companies involved, as it did with its DTC principles.

- M. Nielsen Hobbs (n.hobbs@elsevier.com)

PhRMA’s Marketing Code Touts Sarbanes/Oxley-esque Compliance Mechanism

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