In July, the Pharmaceutical Researchers and Manufacturers of America (PhRMA) released its revised "Code on Interactions with
Healthcare Professionals," which addresses the scope of permissible pharmaceutical company interactions with and marketing
to healthcare professionals.
In 2002, PhRMA published its original, voluntary code of ethics that established standards of conduct for pharmaceutical companies
dealing with healthcare professionals. The theory behind the Code is clear: The risk is that providing certain benefits to
healthcare professionals may cause them to prescribe a drug or product based on receiving these benefits rather than using
independent clinical judgment.
The new Code, effective January 1, 2009, will replace PhRMA's 2002 Code and further restrict the types of permissible interactions
between pharma reps and healthcare professionals. The revised Code includes additional processes by which pharmaceutical companies
electing to comply may be publicly recognized by PhRMA. Companies that publicly announce their commitment to abide by the
provisions of the Code will be recognized on PhRMA's Web site upon the completion of an annual certification signed by the
company's CEO and chief compliance officer. Moreover, the revised Code encourages companies to seek independent verification
of their compliance with the PhRMA Code by having an external source verify, at least once every three years, that the company
has adopted and implemented policies and procedures to foster compliance.
These changes come at time of increased government scrutiny over the marketing practices of the pharmaceutical industry. Many
of these practices may also violate federal and state healthcare fraud and abuse laws, potentially leading to civil and/or
Non-Educational Items In contrast to the 2002 Code, the revised Code prohibits a pharmaceutical company from providing healthcare professionals
with any items that do not advance disease or treatment education. Even practice-related items of minimal value, such as pens,
notepads, mugs, hats, t-shirts, mouse pads, and similar items with a product or company logo, are prohibited. Likewise, pharmaceutical
companies should refrain from sending boxes of cookies, candy, and gift baskets to physicians' offices. (Pharmaceutical companies
may still provide items designed primarily for education, such as anatomical models.) This new prohibition represents a major
departure from PhRMA's previous position with respect to practice-related items.
Informational Presentations and Meals Pharmaceutical companies are now precluded from providing restaurant meals to healthcare professionals. Occasional meals
may still be offered, but only if both they are both attending a bona fide informational presentation during the working day,
and such presentation takes place at either a physician's office or hospital. Sending lunch to a physician's office is, in
general, no longer permissible.
Entertainment and Recreation The revised Code strengthens PhRMA's prohibition on providing entertainment and recreation items to healthcare professionals,
such as tickets to theater and sporting events, treating physicians to golf, and providing free sports equipment (such as
golf clubs, golf balls, or general sports memorabilia) and leisure trips (i.e., vacations, boating, fishing/hunting trips,
or any other travel-related excursion). These items should not be offered to any healthcare professional who is not a salaried
employee of the pharmaceutical company, regardless of: the item's value, whether the healthcare professional is engaged as
a speaker or consultant, or whether the benefit is secondary to an educational purpose.
Retention as Consultants The importance of pharmaceutical companies entering into consulting arrangements with healthcare professionals is still recognized.
However, decisions regarding the retention of healthcare professionals as consultants should be based on defined, objective
criteria such as medical expertise, reputation, and experience. Compensation should be for legitimate services (i.e., not
a reward for prescribing or recommending a particular product), and should be reasonable and fair market value in all respects.
In order to document and verify that the compensation paid to consultants is fair market value for bona fide speaking and
consulting services, pharmaceutical companies should carefully monitor the tasks that the consultant performs, the approximate
amount of time spent on such tasks, and the compensation paid to the consultant. One further caveat: The 2009 Code imposes
additional requirements on arrangements with healthcare professionals who participate in committees that develop formularies
or clinical practice guidelines. Before a pharmaceutical company engages such a professional as a speaker or consultant, the
professional must disclose his/her prospective relationship with the pharmaceutical company to the committee in which he/she
participates. This disclosure requirement should be ongoing, and extend for a period of two years after the termination of
the professional's arrangement with the pharmaceutical company.
CME Grants Further guidance is provided regarding the circumstances under which a pharmaceutical company may provide certain support
for CME, such as: Decisions regarding CME program grants should be separated from (and not influenced by) sales and marketing
departments; objective criteria should be established for CME grant decisions; the independent judgment of the CME provider
should be respected, and applicable accreditation standards should be followed; and no advice or guidance should be provided
to the CME provider regarding the content or faculty of a particular program, even if such advice is solicited.