Consumer-directed prescription drug advertising: effects on public health.

• Author: Holtz, William E.

1. 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 In a draft guidance(5) issued by the FDA, the agency has actually made advertising of prescription drugs easier by making disclosure requirements of adverse drug reactions(6) less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. These include a standardized percentage over which all adverse reactions must be reported to provide uniformity in the industry and to allow consumer comparison. In addition, all prescription drug advertisements should be in terms easily understood by the ordinary consumer. An illustration is included to demonstrate the proposed effectiveness of such increased regulation.

   This Paper concludes that the time has come for the FDA to consider updating or amending the current regulations that affect advertising of prescription drugs, particularly those advertisements which are directed at consumers.

2. HISTORY OF CONSUMER-DIRECTED ADVERTISING

   Drug manufacturers have "advertised" their products since the industry's inception. Until the early 1980's, however, drug manufacturers primarily relied upon promoting their products directly to medical practitioners.(11) This was in the form of scientific literature, mailings, and visits by representatives to speak directly to the practitioner.(12) These methods are still used today in conjunction with consumer-directed advertising.

   Consumer-directed advertising first began to occur in response to a Federal Register notice in 1985 which stated that current regulations governing prescription drug advertising provide sufficient safeguards to protect consumers.(13) The Agency, in effect, indicated that existing standards created to regulate marketing of drugs to physicians would apply to consumer-directed advertising also.(14) Thus, the FDA did not enact any specific regulations or requirements pertaining solely to consumer-directed advertising.

   A possible explanation for the change in focus from prescribers to consumers may be due to the advent of managed care organizations.(15) Many managed care entities such as health maintenance organizations (HMOs) have put consumer restrictions on access to certain prescriptions.(16) Thus, through the use of drug formularies, due to direct contracts between HMOs and manufacturers, many patients and doctors are effectively denied a possible treatment because of payment restrictions. For example, doctors prescribing medications for patients in certain HMOs may have the option of only one or two drugs in a particular therapeutic class, instead of the full range of available drugs on the market. The resultant shift in marketing focus by the manufacturers has enabled pharmaceutical companies to regain control of the prescription drug market.(17)

   Consumer-directed advertising began primarily in the print medium because of the ease with which advertisers could comply with FDA labeling requirements.(18) As a practical matter, under current FDA regulations, there is no difference between a print advertisement in a physician's journal and a popularly circulated entertainment magazine.

   More recently, manufacturers have tapped into the enormous market of broadcast advertising to promote their drug products.(19) These advertisements are typically several-minute commercials on television and, to a lesser extent, on radio. Here, the FDA has issued a recent draft guidance(20) to instruct manufacturers on how they may comply best with existing regulations for drug advertising and how to apply them to broadcast advertising.

   The computer realm of advertising on the World Wide Web seems to be the next target for drug manufacturers. The Internet poses many of the same issues surrounding print advertising with the additional dynamic of rapidly changing technology.(21)

3. TYPES OF CONSUMER-DIRECTED ADVERTISING

   The FDA has classified consumer-directed advertising in three categories: (1) "product-claim" containing safety and efficacy statements; (2) "help-seeking" containing information about a condition and recommending that the consumer consults a medical practitioner (while not mentioning the name of the drug or treatment); and (3) "reminder" containing the drug name and limited information, while excluding all representations about the drug.(22)

   1. Product Claim

      Product claim advertisements contain safety and efficacy claims about a specific prescription drug product.(23) These advertisements are limited to one specific drug product and currently have not compared drugs, or classes of drugs, with each other.(24) Proponents of this noncomparative format argue that consumers do not have the contextual knowledge to evaluate such comparative claims.(25) Opponents contend that consumers can evaluate comparative claims that present a fair balance between benefits and adverse reactions.(26)

   2. Help-Seeking

      Help-seeking advertisements encourage consumers with particular symptoms, conditions, or diseases to consult their doctor to discuss general treatment options, but do not mention the name of any specific drug products.(27) If there is only one available treatment for a condition, help-seeking advertisements may not be used because, by implication, they would be advertising for the product.(28) In such an instance, the FDA would regulate the help-seeking materials as product claim materials.(29)

      The FDA does not currently regulate help-seeking materials. Opponents to this stance feel that consumers are able to link a sponsoring manufacturer to a specific prescription drug.(30)

   3. Reminder

      Reminder advertisements merely reinforce name recognition and brand loyalty.(31) These advertisements have been traditionally targeted toward prescribers in an effort to increase the number of prescriptions by increasing the frequency that a prescriber recalls a drug's name and its clinical function.(32)

      The effect that reminder advertisements have on consumers has not yet been established since consumers are less likely to associate the clinical function of a drug and its brand name.(33)

4. THE CURRENT FDA REGULATION OF CONSUMER-DIRECTED ADVERTISING

   As previously stated, the FDA has set forth one set of regulations for all prescription drug advertising.(34) There are three provisions of (the Code of Federal Regulations) section 202.1(e) of concern here: (1) the "brief summary" provision; (2) the "major...