A Cry for Uniformity

By: Chrissy Spicer, CIS Senior Manager
chrissyspicer@cis-partners.com

As states issue regulations one-by-one to promulgate requirements related to pharmaceutical marketing activities, manufacturers in the industry have been challenged to uniformly satisfy the state requirements in their compliance programs. In the future, it is expected that more and more states will continue to issue regulations; at the same time, the push for transparency in interactions with physicians will continue to shape the agenda of the new administration.

Now more than ever, Corporate Compliance Departments have revisited their compliance programs, including their codes of conduct, policies & procedures, training programs, and monitoring & auditing plans. Although the future may hold uniformity in some of the market disclosure rules, other new state requirements around corporate compliance programs will need to constantly be reevaluated to ensure alignment within the organization. The codes of conduct adopted by states like California, Nevada, and Massachusetts are great examples of this lack of uniformity.

In California Codes SB 1765, the regulation states:

(a) Every pharmaceutical company shall adopt a Comprehensive Compliance
Program that is in accordance with the April 2003 publication "Compliance
Program Guidance for Pharmaceutical Manufacturers," which was developed by the
United States Department of Health and Human Services Office of Inspector
General (OIG). (b) Every pharmaceutical company shall include in its Comprehensive Compliance Program policies for compliance with the Pharmaceutical Research and Manufacturers of America (PhRMA) "Code on Interactions with Health Care Professionals," dated July 1, 2002. The pharmaceutical company shall make
conforming changes to its Comprehensive Compliance Program within six months of
any update or revision of the "Code on Interactions with Health Care
Professionals."[i]

In this example, California applies the guidance published by the OIG and PhRMA Code in establishing rules for pharmaceutical manufacturers conducting business in California.

On January 30, 2008, regulations promulgated by the Nevada State Pharmacy to implement AB 128 required “a written marketing code of conduct which establishes the practices and standards that governs the marketing and sale of its products.”[ii] Adoption of the most recent version of the Code on Interactions with Healthcare Professionals developed by the Pharmaceutical Research and Manufacturers of America (PhRMA) satisfies these requirements. If a manufacturer chooses not to adopt the PhRMA code, then a marketing code of conduct must be submitted and approved that addresses the following:

1. The basis for interactions;
2. Informational presentations by or on behalf of a manufacturer;
3. Third-party educational or professional meetings;
4. The use of consultants;
5. Speaker training meetings;
6. Scholarships and educational funds;
7. Educational and practice-related items;
8. Independence of decision making; and
9. Adherence to the marketing code of conduct.

In summary, Nevada suggests the adoption of the PhRMA code; however, if a different code is adopted, then Nevada must approve that marketing code of conduct.

Lastly, Massachusetts will be issuing a Marketing Code of Conduct that will go into effect July 1, 2009. The Marketing Code of Conduct is currently being drafted; it will address the same activities outlined in the PhRMA Code, but with heavier restrictions. [iii]

To summarize, the requirements related to establishing a marketing code of conduct:

1. California: The OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers and PhRMA Code are mandated requirements for pharmaceutical compliance programs.
2. Nevada: The adoption of the PhRMA Code as established, or if the manufacturer develops a marketing code of conduct, then the Code needs to be reviewed and approved by Nevada.
3. Massachusetts will develop and issue a code of conduct that must be followed.
In the end, manufacturers have found themselves starting with the OIG Guidance as a foundation, and slowly integrating the additional or more restrictive requirements state-by-state. It does not look like the future holds any promises for providing a federal law that preempts all state laws for the adoption of a marketing code of conduct, requirements for a compliance program and marketing financial disclosures.

Sources:
[i] California SB 1765
[ii] Nevada State Board of Pharmacy Compliance Packet for Manufacturers, Wholesalers of Drugs, Medicines, Chemicals, Devices, or Appliances
[iii] Massachusetts Part I. Title XVI, Chapter 111N., §2. Marketing Code of Conduct; Adoption; Prohibited Practices