When it comes to pharmaceutical sales ethics, the pendulum has swung between very lax and very strict over the years.
With the latest ethics and compliance programs implemented by the Pharmaceutical Research and Manufacturers of America and the Office of Inspector General, pharmaceutical sales representatives are once again working in a stricter ethical environment.
Or are they? There's been plenty of publicity about how sales reps are toeing the ethical line with respect to accessing physicians and promoting pharmaceuticals, but attorneys claim some companies are evading the guidelines with an eye to securing profits.
Renewed Focus on Relationship Building
Without being able to offer prime seats to a baseball game or some other gift or perk, getting a physician's ear can be difficult, says Eric Bolesh, senior analyst at Cutting Edge Information, a pharmaceutical research firm in Durham, North Carolina.
For that reason, industry consultants report pharmaceutical sales reps are putting new emphasis on relationship building. One way in which some sales reps are working to create and strengthen ties with doctors is by positioning themselves as educational resources on narrowly defined therapeutic areas and complicated diseases.
"One sales force might focus solely on respiratory problems," Bolesh says. "Having a firm grasp of the scientific medical material and being able to tell [doctors] something they don't know is becoming important. When [they start] to recognize you as someone who really is a medical resource, they are going to be a lot friendlier."
The Letter of the Law
Alcon Laboratories, an ophthalmic drug maker in Fort Worth, is prescribing a sales strategy that it says is in line with the current ethics code. The company used to invite physicians to attend lectures, which were followed by some special event such as a ball game or golf outing, according to Carol Duke, the company's professional education director.
"Our dinner meetings now feature a modest meal and a lecture by a guest speaker," Duke says. "We try to tie our meetings in with local societies so that the program is governed by those affiliates and not by our company or our sales reps."
Alcon is driving the majority of its efforts toward continuing medical education (CME) programs and away from promotional programs that provide entertainment. Duke says that in the past, the company spent about 45 percent of its educational budget on CME activities and the remainder on promotional activities. Today, 70 percent of the budget is spent on CME, she reports.
Skirting the Issue
While many pharmaceutical companies appear to be making adjustments to follow the new ethics, attorneys say some are skirting the issue with secret strategies such as off-label marketing, the marketing of drugs for purposes other than those approved by the Food and Drug Administration (FDA).
The FDA approves all prescription drugs sold in the United States for a particular indication. Once approved for that indication, pharmaceutical companies may market the drug for other purposes only by following strict FDA guidelines.
"The rep is not supposed to go out there and tell a doctor to use a drug for off-label purposes," says Joel Androphy, a partner with the law firm Berg & Androphy in Houston. "The doctor is supposed to make the initial inquiry, but it doesn't always happen that way. Drug companies may be cutting back on the actual overt payments and golf trips, but I have cases where reps are paying doctors to prescribe drugs for off-label purposes just to boost sales and with no proof of the drug's efficacy for that off-label purpose."
Still, for the many companies that are making changes to comply with the latest ethics guidelines, the question becomes: Will the changes last, or will pharmaceutical sales practices loosen up again?
"These guidelines will affect long-term behaviors," predicts Bolesh. "Some of the trappings will fall away in the short-term, but these new codes will ultimately direct behavior, because the public outcry [over the perception that pharmaceutical companies are influencing how doctors prescribe drugs] has gotten the attention of the FDA."
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