What You Should Know about Direct-to-Consumer Advertising of Prescription Drugs

While there is an assault on the applicability of the learned intermediary doctrine in DTC cases, defense counsel can employ positive positions "Let no physician teach the people about medicines or even tell them the names of the medicines, particularly the more potent ones. ... For the people may be harmed by their improper use."--Royal College of Physicians, circa 1550. DIRECT marketing of pharmaceutical and biological products to consumers has come a long way since the 16th century, but it is still a relatively new phenomenon. For manufacturers and distributors, direct-to-consumer (DTC) advertising requires a careful balancing of risks and benefits, much like the decision that must be made by a patient and physician in prescribing medication. The potential benefits run not only to the pharmaceutical company in terms of market share and revenue, but also to the consumer who potentially benefits from, among other things, awareness of new treatment modalities and occasionally from a heightened awareness of an undiagnosed condition. However, as with prescription drugs themselves, there are potential side effects to direct promotion of prescription products. The manufacturer or distributor who chooses to advertise a product directly to consumers must navigate through U.S. Federal Drug Administration regulations to ensure that the product's advertisements are true and not misleading in all respects, while fairly balancing information concerning risks and effectiveness. DTC advertising also carries liability risks, as the plaintiffs' bar has made some footholds in convincing courts to abandon the learned intermediary doctrine. Proponents and opponents of direct-to-consumer advertising have established their rhetoric and staked out their positions. Proponents generally point out that DTC advertising raises public awareness of new treatments and reaches segments of the population--for example, rural physicians--that might not otherwise be aware of a new drug's availability. Greater awareness may lead patients to begin or resume treatment for conditions after old treatment modalities have been abandoned or avoided. Pharmaceutical advertisements also may alert consumers to previously undiagnosed diseases. Ultimately, a better-informed patient is better equipped to make informed healthcare choices. Detractors of pharmaceutical advertising contend that consumer-directed marketing alters the physician-patient relationship by forcing physicians to succumb to patient pressure in making prescribing decisions. It is argued that advertising leads consumers to seek medications they do not need, or to forgo more appropriate, less expensive and safer treatment options. DTC advertising, the opponents contend, promotes consumer self-diagnosis to the point that patients are pitted against their physicians, leading patients to doctor-shop for willing prescribers. On a slippery slope, it then is argued, physicians will face an economic incentive to relax their prescribing criteria in an effort to retain patients. Opponents further suggest that in an age of managed care, physicians spend less time with their patients, consequently leaving inadequate time for the physician to convey adequate warnings about a prescription product to the patient, so that the patient can make an informed choice about whether to use the drug. Essentially, the opponents of pharmaceutical advertising believe that advertising produces a fundamental change in the physician-patient relationship that relegates the physician to the role of a script-writing automaton. Finally, DTC detractors note that most pharmaceutical products promoted to consumers are "lifestyle" drugs and that drugs for more complex conditions and diseases receive less promotion. For the pharmaceutical company engaging in direct-to-consumer advertising, these are the types of arguments that will be advanced by plaintiffs' attorneys seeking abolition of the learned intermediary doctrine. …