American Journal of Law & Medicine

Direct-to-consumer prescription drug advertising.

I. INTRODUCTION

The Food and Drug Administration (FDA) regulates the promotion of pharmaceutical products.(1) The FDA's regulations issued under the Food, Drug and Cosmetic Act (FDCA)(2) require that prescription drug broadcast advertisements include the following: (1) a major statement of the product's risks in at least the audio part of the advertisement; and (2) that an adequate provision for the dissemination of the approved package labeling be made "in connection with the broadcast presentation," if the brief summary is not also part of the advertisement.(3) Under the FDCA, the brief summary provides information concerning the major risks of the drug.(4)

Even with these regulations, the FDA decided it was not possible that a broadcast advertisement could comply with the adequate provision, therefore, the FDA provided two choices.(5) Manufacturers could either follow a special FDA exception to the brief summary requirement that did not permit them to mention the product's indications, or they could include the brief summary as part of any direct-to-consumer (DTC)(6) broadcast advertisement that mentioned the product's indications.(7) Nearly all manufacturers chose the first option.(8)

On August 8, 1997, the FDA changed how it regulates DTC advertising(9) by promulgating a new guidance, Guidance for Industry: Consumer-Directed Broadcast Advertisements (hereinafter "Guidance") that clarifies existing prescription drug advertisement requirements for broadcast media.(10) The Guidance requires manufacturers to: "provid[e] an effective mechanism by which the majority of a potentially diverse audience can receive the advertised product's approved labeling."(11) To comply with the Guidance, specifically the adequate provision requirement mentioned above, pharmaceutical advertisements in broadcast media must contain: (1) a toll-free number, (2) a reference to DTC print advertisements, (3) an Internet web page address and (4) a statement that directs consumers to physicians and/or pharmacists for additional information about the product.(12) The Guidance is in draft form; the FDA is seeking comment and ultimately plans to create an extensive set of regulations for prescription drug advertising.(13) Although substantial time has passed since the release of the draft Guidance, there is no indication that a permanent guidance will be promulgated.(14) As such, pharmaceutical companies should treat the draft Guidance as a final rule, because the FDA is using the provisions in the document to regulate the industry. To comply with these regulations, an advertisement would have to include all four of these components.(15)

This Note examines the recent changes in DTC advertising of prescription pharmaceuticals, and their effects on the health care industry. Part II provides background information concerning pharmaceutical product promotion and recent developments in DTC advertising and regulations. Part III reviews the FDA history regarding the regulation of DTC drug promotion, examines the FDA's effectiveness in regulating the promotion of prescription drugs to consumers in the rapidly changing health care industry and questions whether other groups such as the Federal Trade Commission (FTC) may effectively assist in this regulation. Part IV examines the Guidance and its effect on different segments of the health care industry, including patients as ultimate consumers, physicians, managed care organizations (MCOs), pharmaceutical companies, advertising media and public health generally. Part V concludes that the FDA is the correct agency to regulate prescription pharmaceutical promotion, and the draft Guidance is a step in the right direction.

II. BACKGROUND OF PHARMACEUTICAL PRODUCT PROMOTION

Domestic health care costs represent fourteen percent of the gross national product, which is more than one trillion dollars.(16) Of this amount, roughly seven to ten percent, or $70 to $100 billion, is spent on prescription drugs.(17) Drug companies spent $595.5 million on DTC advertisements in 1996, a ninety percent increase from 1995.(18) This figure exceeded $1 billion in 1997,(19) and it is estimated that pharmaceutical manufacturers invested $1.4 billion in 1998.(20)

Pharmaceutical companies have dramatically increased their DTC advertising over the past few years, for three primary reasons. First, the increased penetration of managed care plans into the health care market has affected patients' relationships with their physicians.(21) Pharmaceutical companies market directly to patients, allowing them to become more educated and empowered in making their health care choices.(22) Second, DTC advertising reaches inaccessible patients and physicians. Finally, increased competition in the marketplace has led to the marketing of many new drugs in order to secure a healthy market share.(23) The FDA's new guidelines will significantly affect many of the players in the health care industry because they give concrete guidance and rules for advertisers to follow.

III. THE FDA AND DTC ADVERTISING: PAST, PRESENT AND FUTURE

Because pharmaceutical promotion in the form of DTC advertising is a relatively new area, it presents the FDA with many challenges. The FDA's regulation of pharmaceutical promotion must protect the consumer and promote and benefit public health.

The FDCA requires prescription drug advertisements to include information in a brief summary describing contraindications and side-effects of the product.(24) Although the FDCA does not define advertising, under FDA regulations, advertising includes not only print advertisements appearing in journals, magazines and newspapers, but also broadcast advertisements through media such as radio, television and telephone communication systems.(25)

In 1983, the FDA called for a voluntary moratorium on DTC advertising campaigns for pharmaceutical products, because the agency lacked a formal policy concerning DTC advertising.(26) The moratorium's primary purpose was to allow time for a dialogue on the complex subject of DTC advertising among consumers, health professionals and the industry.(27) In addition, the moratorium would allow time for research that would provide data on a number of fundamental questions concerning the effect of DTC advertising.(28) However, since the moratorium in 1983, the FDA never adopted formal rules governing DTC advertisements.(29)

In 1985, the FDA withdrew its moratorium and announced it would apply the same standards to DTC advertisements as those in place for advertisements directed to physicians, which must meet the standard for fair balance and full disclosure, thus regulating DTC advertising under the same rules as all prescription drug advertising.(30) The 1985 rules applied to physician-directed advertisements and required a balancing of a product's benefits with its risks.(31) The rules also require that a brief summary of the FDA-approved package insert be included.(32)

In August 1997, the FDA promulgated a draft Guidance changing the requirements for radio, television and telephone communication system prescription drug advertisements.(33) The FDA drafted the Guidance to provide consumers with adequate communication about required risk information so consumers could make informed decisions, while facilitating the process used by sponsors to advertise their product to consumers.(34) Although no clear definition of adequate communication exists, the FDA's apparent intent is that the advertisement must contain a fair balance between descriptions of both the benefits and side-effects of the product being advertised.(35) The Guidance does not change any FDA regulations; rather, it spells out requirements for broadcast advertisement structures so that they comply with regulatory objectives.(36) Under the new provisions, prescription drug broadcast advertisements must specify the product's most important risk information as part of its major statement, with an adequate provision for the dissemination of approved labeling to the consumer.(37)

The Guidance is currently in draft form.(38) The FDA requested feedback on the new Guidance concerning the following issues: (1) the effects of DTC promotion on the public health, (2) the degree to which consumers are taking advantage of the mechanisms for obtaining approved package labeling in connection with broadcast advertisements and (3) how risk messages can best be integrated into broadcast advertisements.(39) The FDA's Division of Drug Marketing, Advertising and Communications is overseeing the implementation of the new policy.(40) Although the draft Guidance has already been in effect for over a year, there has been no indication that the FDA is ready to promulgate permanent guidelines. Therefore, the industry should treat the draft Guidance as regulations.

Although the FDA does not require preclearance of advertising materials, it has the authority to review pharmaceutical companies' advertising materials.(41) Possible sanctions include the following: sending violative pharmaceutical companies an untitled letter delineating the FDA's objections to current advertisements, issuing a warning letter that asks the company to cease the violative advertising and to take other remedial measures, "seizing the affected products or enjoining the use of promotions that make the same or similar claims," or criminally prosecuting the violative pharmaceutical company or individuals involved.(42) The FDA has already warned many pharmaceutical companies that their advertisements do not fully comply with the Guidance regulations.(43) The FDA reprimanded one pharmaceutical company, Schering-Plough, the leading television advertiser of prescription drugs, because two of its Claritin allergy drug advertisements were deemed misleading.(44) Following this warning, the television networks immediately pulled the advertisements.(45) The FDA warned Schering-Plough of its concern that viewers did not receive adequate descriptions of risk information to balance the advertised benefits.(46) The FDA cited one advertisement where the required risk disclosure was obscured by using white type against a white background.(47) The other Claritin advertisement only referred viewers to the Internet for detailed information.(48) However, most consumers do not have Internet access and the advertisement provided no other resource.(49) In addition, while both advertisements presented the benefits of the product slowly and clearly, the presentation of risk information was quick and obscured by competing messages; characteristics essentially ensuring that viewers would not fully comprehend any of the messages. …

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