Subjects manufacturers of prescription drugs or medical devices who engage in direct-to-consumer advertising to liability where adequate warnings are not provided

Section 2. Effective date.

Justification

In 1997 the F.D.A. relaxed its guidelines for direct-to-consumer advertisement of pharmaceuticals. Since that time, there has been an onslaught of marketing in an attempt to influence a patient's choice of a drug. These efforts have become an essential part of manufacturer's marketing plans, resulting in an increase from $843 million in 1997 to annual costs in the billions for print and broadcast advertising. This change has also resulted in an increase in the number of prescriptions written: Fifteen months into the relaxation of the guidelines, one heavily marketed drug saw an increase in sales of more than one hundred times that of prescriptions written prior to advertisement. This controversial new marketing technique, opposed by the American Medical Association, undermines the patient-physician relationship by encouraging consumers to ask for advertised products by name. As "patient choice" becomes an increasingly popular concept physicians are being relegated to a passive role where, upon demand, the patient receives a prescription for the advertised drug 73% of the time. The benefits DTC advertising provides to the public are questionable at best, as misconceptions about this type of advertising appear to be extensive. A recent survey reveals that 43% of the individuals polled believed that only "completely safe" drugs could be advertised directly to consumers, while 21% thought only "extremely effective" drugs could be marketed in this way. An AARP Executive Summary notes that most persons fail to take away key information from the advertising and that consumers age 60 or older appear to obtain less information from the ads than others. Historically, with regard to prescription drugs, our courts have created an exception to the traditional duty of manufacturers to warn consumers directly of risks associated with their products because they warned health care providers of those risks. This made sense in an era of "doctor knows best," when pharmaceutical manufacturers directed all of their sales efforts at physicians and never at consumers. In light of the recent, and expensive, mass marketing of prescription drugs, manufacturers should no longer be relieved of the duty to properly warn their advertising targets about the dangers of their products. Just as the manufacturer can make direct claims about the efficacy of its products, so should that manufacturer warn of its risks. By advertising directly to the patient, manufacturers make the patient an active participant in the decision to use the drug and cannot, therefore, claim the potential adverse effects of using the drug are so complex that they can only be communicated to physicians. Advertising prescription drugs is effective. If it were not, manufacturers would not continue to pursue their annual multibillion dollar efforts to peddle their wares. It is shameful enough that pharmaceutical manufacturers continually pass these costs on to consumers, one effect of which is an annual increase in the costs of drug benefits of more than 20%. It would be reprehensible to couple this type of manipulation of the drug market with civil immunity. A drug manufacturer who engages in direct consumer advertising, and who reaps the financial benefits of so doing, should not be able to hide behind the physician whose role it has usurped. Understandably, proponents of DTC advertising may argue that additional civil liability would serve to merely add to the rising costs of prescription drugs. However, this presupposes that manufacturers would continue to employ the use of direct to consumer advertising, and to do so while failing to adequately warn patients of the potential risks associated with the use of their products. It is important to note that, under this legislation, manufacturers who market exclusively to health care professionals will continue to be afforded civil immunity through the learned intermediary doctrine.

Legislative history

New to Senate - In Assembly since 01-02

Fiscal implications

None to the State.

Effective date

This act shall take effect on the sixtieth day after it shall have become law.