Academic journal article Journal of Law and Health

Consumer-Directed Prescription Drug Advertising: Effects on Public Health

Academic journal article Journal of Law and Health

Consumer-Directed Prescription Drug Advertising: Effects on Public Health

Article excerpt

I. INTRODUCTION

Over the past two decades, and to a greater extent recently, society has been increasingly exposed to prescription drug advertisements aimed directly at the consumer. The industry's gradual shift in focus from "physician-directed" to "consumer-directed" advertisements poses a threat to the public health because it may have the effect of misleading consumers by understating a drug's adverse reactions and overstating the benefits.

The increase in consumer-directed advertising has helped to foster a health care atmosphere in which it is the patient, and not the medical practitioner, who initiates a discussion regarding possible drug therapy.(2) Consumer-directed advertising also has a profound impact on the doctor-patient relationship and results in patients consuming drugs with attractive benefits and undisclosed possible adverse reactions. This creates an increased dependence on prescription drugs, and the falsified notion that there is a prescription drug to cure most any condition.(3) The effects that consumer-directed advertising of prescription drugs have on the health care system warrant a thorough review and modification of the existing United States Food and Drug Agency (FDA) regulations in order to preserve the public health.(4)

To date, the FDA regulations have remained unresponsive to this change in advertising focus. In a draft guidance(5) issued by the FDA, the agency has actually made advertising of prescription drugs easier by making disclosure requirements of adverse drug reactions(6) less stringent for broadcast advertisements. The current regulatory system in place by the FDA(7) is inadequate to deal with current issues surrounding consumer-directed advertising. This is due in large part because the regulations currently in effect were implemented in 1938 before the advent of this new breed of advertising.(8) There is no doubt that the nature of advertising has changed significantly since that time and an updated version of regulations is needed to protect the public.

Consumers' quest for and access to information has been accompanied by an increase in the patient's role in his or her health care treatment.(9) Prescription drug advertisements directed to the consumer have the potential to be excellent sources of consumer information and should therefore not be banned outright.(10) Greater access to patient information certainly enables the patient to take a more active role in their treatment.

The public health problems discussed in this Paper are undoubtedly caused by a number of concurrently occurring problems. The solution set out here is to construct a more stringent FDA regulatory scheme which seeks to minimize this problem, while acknowledging that it will not eliminate it.

This Paper will evaluate the effectiveness of the current FDA regulatory scheme regarding consumer-directed prescription drug advertising. Part II discusses the relevant history of consumer-directed advertising of prescription drugs which is a relatively new practice in the United States. Possible explanations are reviewed for why the change in focus from physicians to consumers as the targets of such advertising has occurred.

Part III explains the major classifications of consumer-directed advertising that the FDA has categorized and examines the differences existing among them.

Part IV focuses on the current FDA regulatory scheme and begins to expose some of the difficulties of applying the current regulations to consumer-directed advertisements.

Part V explores specific effects the FDA regulations have on our current healthcare system. These include: (1) downplayed adverse drug reactions; (2) inconsistent scope and quantity of adverse drug reactions advertised; (3) the increased cost to society; (4) deterrence; and (5) increased strain on the doctor-patient relationship.

Recommendations for effectively strengthening the FDA regulations are included in Part VI. …

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