The Laws They are A-Changin’

By Malcolm Fleschner

It’s understandable why many drug reps today feel like they’re being squeezed on all sides. Whether from managed care, allegations of ethical lapses, inaccessible physicians or an oftentimes negative perception among the general public, pharmaceutical sales reps carry a lot more with them on a day’s calls than just briefcases and laptops. Now you can add the federal government to your list of concerns. That’s because sales reps now are subject to criminal prosecution for using once-common sales tactics such as promoting off-label uses or providing doctors with financial inducements to write prescriptions.

Erika Kelton, an attorney with the DC law firm Phillips & Cohen, mentions as a cautionary tale a case involving a group of sales executives with TAP Pharmaceuticals who were charged with conspiring to bribe doctors to prescribe Lupron. Though these salespeople were eventually acquitted, pharmaceutical industry salespeople need to be aware of the consequences they face for running afoul of the new stringent requirements describing what reps can and cannot do today.

In an effort to delineate just what those limitations are, Kelton offers up the following list of dos and don’ts.

Kickbacks. Put simply, you can’t offer a physician money or any other benefit to change a prescription if the drug is reimbursable by a federal healthcare program. In the TAP case, reps were accused of offering an HMO medical director $65,000 for changing the HMO’s coverage from Zoladex to the more expensive Lupron.

Reps also should understand that the feds may look closely at unusually high expense accounts or incentive bonuses as indicators of possible indirect payments to reward physicians for altered prescribing behavior.

Off-label uses. You’re probably already aware of the problems some drug companies are facing relating to concealing the adverse effects of some medications. For drug reps the problem more often arises from the promotion of off-label uses for drugs that the FDA has rejected. Pfizer/Warner-Lambert was fined $430 million for widespread marketing of the epilepsy drug Neurontin to treat everything from Lou Gehrig’s disease to attention deficit disorder.

While you cannot encourage doctors to prescribe a product for any ailments other than those it has been approved to treat, FDA guidelines do allow you to share with physicians articles from peer-reviewed journals about off-label uses.

Free samples. Samples have long been integral to the drug rep-physician relationship, but restrictions do exist. Free samples absolutely cannot be billed and reps can get into trouble for encouraging healthcare providers to bill Medicare or other federal programs for the samples as a means of profiting from medications they received for free.

Consulting agreements. A kickback is still a kickback, even when it’s disguised as a payment to a physician for acting as a consultant by attending a meeting or conference. You also can run afoul of the law by using healthcare professionals’ names for company-written papers or speeches.

Ghost-written articles. Pharmaceutical companies cannot promote the off-label use of a drug, but physicians can. Some companies have tried to skirt this rule by writing articles with just such information and then paying to attribute authorship to specialists in the field. This is prohibited.

Clinical studies. How drug research is conducted is even more strictly regulated than pharmaceutical sales efforts. Any research initiated or directed by a drug company’s sales agents and not the science team as a pretense for promoting a product is against the law.

Seeding trials. A seeding trial involves paying physicians to prescribe a drug for off-label use as a marketing tool with collected information typically not submitted to the FDA or used for publication. The primary goal is to get doctors prescribing that product more frequently.