The Pharmaceutical Research and Manufacturers of America (PhRMA) has revised its voluntary guidance document, the Code on Interactions with Healthcare Professionals. The revised PhRMA Code,1 which will take effect in January 2009, imposes new restrictions on gifts, meals, consulting venues and support for educational programs and includes new guidelines regarding the use of prescriber data. In addition, the revised PhRMA Code establishes guidelines for fostering compliance with the Code, including an annual certification process.

Many pharmaceutical companies have adopted the 2002 version of the PhRMA Code or have otherwise developed policies and procedures for compliance with the Code to help ensure that their relationships with healthcare professionals meet industry ethical standards. In addition, laws in California and Nevada, and legislation pending in other states, tie adoption of, or compliance with, the PhRMA Code to requirements for some companies that operate in the state. In the coming months, we expect that pharmaceutical manufacturers will be evaluating the revised PhRMA Code and assessing what changes to existing business practices may be necessary in order to certify compliance with the revised PhRMA Code when it becomes effective.2

The revised Code follows the same form as the previous version, with general guidance organized by type of interaction with healthcare professionals, followed by some illustrative questions and answers (Q&As). The following is a summary of key modifications in the revised Code.

Basis for Interactions

While affirming the importance of interactions with healthcare professionals, the revised Code now more specifically addresses the purpose of and limits on these interactions. The revised Code also affirms that promotional materials provided by or on behalf of the company should be accurate, balanced, make only properly substantiated product claims, and comply with all other Food and Drug Administration (FDA) requirements.

Gifts

The revised Code dramatically alters the standards with regard to permissible gifts. The revised Code no longer permits reminder items or patient treatment items, but continues to permit gifts of educational materials. The new prohibition means that companies should not continue their longstanding practices of providing practice-related items of minimal value (e.g., pens, mugs, notepads), even if those items accompany educational materials. One Q&A makes clear that noneducational items may not be given to healthcare professionals for patient use even if they are of minimal value (e.g., pedometers, stopwatches). Another Q&A specifically reverses PhRMA’s position on stethoscopes, stating that medical equipment designed for patient treatment, rather than education, is prohibited. The revised Code still permits occasional gifts designed primarily for the education of patients and healthcare professionals, provided that the item is valued at $100 or less and does not have value to the healthcare professional outside of his or her professional responsibilities. Examples of permissible gifts described in the Q&As include: medical text books, subscriptions to scientific journals, copies of treatment guidelines, anatomical models, informational sheets and brochures, patient starter kits and written materials for professionals and patients about adherence to medicine regimens.

Meals

The revised PhRMA Code affirms that meals may be offered as a business courtesy in connection with informational presentations, but imposes new restrictions on these meals. Under the revised Code, field sales representatives and their immediate managers may provide an occasional modest meal only if the meal and presentation occur in the healthcare professional’s office or a hospital setting. The Q&As confirm, however, that the Code does not prohibit other company employees from offering occasional, modest meals at other venues that are conducive to informational communication. In addition, the revised Code clarifies that in-office meals may be provided to the staff attending the informational presentation.

Recreation and Entertainment

Unlike the prior version, the revised Code expressly prohibits entertainment and recreation to any healthcare professional who is not a salaried employee of the company. Previously, recreation and entertainment were generally prohibited, but were permitted in the context of consulting meetings. The revised Code states that entertainment and recreation should not be offered regardless of the value of event and may not be offered even where the practitioner is providing a legitimate service to the company (e.g., speaker training or consultant meeting) or the event is subordinate to a gathering with an educational purpose (e.g., promotional scientific presentations).

Educational Events

While the 2002 Code contained a single set of guidelines for educational events and professional meetings, the revised Code distinguishes between support for continuing medical education (CME) and support for third-party educational and professional meetings. Although the guidance with regard to third-party educational and professional meetings is largely unchanged, the revised Code contains additional guidance on support of CME.

The discussion of CME affirms the principles set forth in the Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers (OIG Guidance), including that the company should separate its grant making from its sales and marketing and should establish criteria to ensure that financial support for CME is not an inducement to prescribe or recommend a particular medicine or treatment. The revised Code indicates that companies should follow the standards for commercial support established by the Accreditation Council for Continuing Medical Education (ACCME) or other entity that accredits the CME. Consistent with the most recent revisions to the ACCME Standards for Commercial Support, the revised PhRMA Code makes plain that the company should not provide any advice or guidance regarding the content or faculty for a particular CME program funded by the company, even if such input is sought by the CME provider. Moreover, although a CME provider may allocate financial support to meals for all participants, under the revised Code a company should not provide meals directly to healthcare professionals at CME events.

Consultants

The revised Code offers additional details regarding the selection and compensation of consultants. Companies are advised to base decisions regarding the selection and retention of consultants on defined criteria such as general medical knowledge and reputation or knowledge and experience in a therapeutic area. Building on the prior guidance that compensation to consultants must be reasonable, the revised Code expressly states that any compensation or reimbursement made in connection with a consulting arrangement should be based on fair market value. The revised Code deviates from prior guidance by stating that resorts are not appropriate venues for consulting meetings.

Speaker Programs

As in the prior version, the revised Code offers specific guidance on company speaker programs. The revised Code asserts that each company should have policies on the appropriate use of speakers and cap the total amount of annual compensation it will pay to a healthcare professional in connection with all speaking arrangements. The revised Code also addresses the content of speaker programs, observing that companies and speakers should be clear that company speaker programs are distinct from CME and should include disclosures regarding the company’s involvement. In addition, the revised Code states that companies should periodically monitor speaker programs for compliance with FDA requirements. In keeping with the new prohibition on recreation or entertainment, a revised Q&A expressly prohibits providing golf or expensive meals to healthcare professionals in speaker training programs.

Formulary and Clinical Practice Committee Members

The revised Code includes a new section addressing relationships with members of committees that set formularies or develop clinical practice guidelines. The revised Code states that companies that use healthcare professionals who serve in these roles as speakers or consultants must require these healthcare professionals to disclose to the committee the existence and nature of their relationships with the company. The disclosure obligations should extend for two years beyond the termination of the consulting relationship and should obligate the healthcare professional to follow any applicable committee procedures, including recusal from decision-making where required.

Prescriber Data

There is a new section in the revised Code on the appropriate use of prescriber data. The revised Code calls for companies to respect the confidentiality of prescriber data and develop the infrastructure to ensure that the company uses these data responsibly, including policies on data use, employee education, a designated internal contact for data use inquiries, and identified penalties for misuse of data. The revised Code also provides that companies should abide by the decisions of any healthcare professional who asks that her or his data not be made available to company sales representatives and suggests that this may be accomplished by following the rules of voluntary programs that facilitates prescribers’ ability to make this choice.

Fostering Compliance

The revised Code add new sections on employee training and adherence to the Code. In keeping with the OIG Guidance, the revised Code provides that all representatives who visit healthcare professionals on behalf of the company should be trained on the applicable laws, regulations, and industry codes that govern their interactions as well as on the information necessary to ensure compliance with FDA requirements. Additional and updated training should be provided as needed. Companies also should assess representatives periodically to ensure compliance with company policies and standards of conduct and take appropriate action to address noncompliance.

The revised Code provides that each company should adopt procedures to ensure adherence with the Code. PhRMA is creating a process through which each company’s Chief Executive Officer and Chief Compliance Officer may sign an annual certification that the company has policies and procedures to foster compliance with the Code. Companies are encouraged to obtain external verification at least once every three years that it has such policies and procedures. PhRMA will establish a website that lists the names of those companies submitting annual certifications along with the contact information for their Chief Compliance Officers. In addition, once PhRMA establishes guidance regarding external verification, its website will state if a company has obtained verification of its compliance policies from an external source.

Effective Date of the Revised Code

The revised PhRMA Code will take effect in January 2009.