Starting in January 2009, the delivery of pens, notepads and coffee mugs bearing the name or logo of a pharmaceutical company will no longer be a matter of course when a drug representative visits a physician's office. Why? The Pharmaceutical Research and Manufacturers of America (PhRMA) recently announced a ban on such gifts, as well as a number of other physician-directed marketing activities, in its revised
Code on Interactions with Health Care Professionals ("Code") set to take effect at the start of next year.
The Code states that promotional materials provided to healthcare professionals by or on behalf of a company should: (a) be accurate and not misleading; (b) make claims about a product only when properly substantiated; (c) reflect the balance between risks and benefits and (d) be consistent with all other Food and Drug Administration (FDA) requirements governing such communications.
Among its changes, the revised Code:
- Prohibits distribution of non-educational items (such as pens, mugs and other "reminder" objects typically adorned with a company or product logo) to healthcare providers and their staff. The Code acknowledges that such items, even though of minimal value, may "foster misperceptions that company interactions with healthcare professionals are not based on informing them about medical and scientific issues."
- Prohibits company sales representatives from providing restaurant meals to healthcare professionals, but allows them to provide occasional meals in healthcare professionals' offices in conjunction with informational presentations. The Code also reaffirms and strengthens previous statements that companies should not provide any entertainment or recreational benefits such as tickets to the theater or sporting events, sporting equipment, or leisure or vacation trips to any healthcare professional who is not a salaried employee of the company. Such entertainment or recreational benefits should not be offered, regardless of (1) the value of the items; (2) whether the company engages the healthcare professional as a speaker or consultant or (3) whether the entertainment or recreation is secondary to an educational purpose.
- Includes more detailed standards regarding the independence of Continuing Medical Education (CME). Since the giving of any subsidy directly to a healthcare professional by a company may be viewed as an inappropriate cash gift, the Code states that any financial support should be given to the CME provider, which, in turn, can use the money to reduce the overall CME registration fee for all participants. The company should respect the independent judgment of the CME provider and should follow standards for commercial support established by the Accreditation Council for Continuing Medical Education (ACCME) or other entity that may accredit the CME. Financial support should not be offered for the costs of travel, lodging or other personal expenses of non-faculty healthcare professionals attending CME, either directly to the individuals participating in the event or indirectly to the event's sponsor. Similarly, funding should not be offered to compensate for the time spent by healthcare professionals participating in the CME event. A company should not provide meals directly at CME events, except that a CME provider at its own discretion may apply the financial support provided by a company for a CME event to provide meals for all participants.
- Includes more detailed standards regarding the use of non-patient-identified prescriber data and additional guidance for speaking and consulting arrangements with healthcare professionals. For example, any compensation or reimbursement made to a healthcare professional in conjunction with a speaking arrangement should be reasonable and based on fair market value.
The Code also sets forth disclosure requirements for healthcare providers who are members of committees that set formularies or develop clinical practice guidelines and who serve as speakers or consultants for a pharmaceutical company. To avoid even the appearance of impropriety, companies should require any healthcare professional who is a member of a committee that sets formularies or develops clinical guidelines and also serves as a speaker or commercial consultant for the company to disclose to the committee the existence and nature of his or her relationship with the company. This disclosure requirement should extend for at least two years beyond the termination of any speaker or consultant arrangement.
While compliance with the Code is voluntary, a significant number of pharmaceutical companies have announced their intention to abide by new guidelines when they take effect. These include, but are not limited to: Abbott, Amgen, Johnson & Johnson, Eli Lilly, Merck, Pfizer and Wyeth.
For more information about the new guidelines, as well as a copy of the revised Code, visit the PhRMA Web site at:
http://www.phrma.org/
Jim Hoover is a partner with Burr & Forman LLP and practices exclusively within the firm's Health Care Practice Group.
