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Article Excerpt
INTRODUCTION
I. MARKETING AND REGULATION OF PHARMACEUTICALS FROM PAST TO PRESENT A. Concepts of Product Mislabeling and Pre-Market Regulation B. Establishment of the Modern Regulatory Regime for Approval and Marketing of Prescription Drugs C. DTC Advertising and Its Regulation Today D. The Relevance of History to DTC Advertising Today II. THE POTENTIAL BENEFITS AND PITFALLS OF DTC ADVERTISING III. TRADITIONAL RULES OF LAW REMAIN VIABLE, SOUND PUBLIC POLICY TODAY A. Ask Your Doctor: The Learned Intermediary Doctrine 1. Learned Intermediary Fundamentals 2. Traditional Limited Exceptions to the Rule 3. A Few Recent Decisions Chip Away at the Learned Intermediary Rule 4. Exceptions for DTC Marketing Represent Unsound Policy B. Effect of Compliance with FDA Requirements on Liability 1. Common Law Principles 2. Statutory Consideration of the Effect of Regulatory Compliance on Liability a. Presumption of Nondefectiveness b. Preclusion of Punitive Damages for FDA-Approved Pharmaceuticals c. Placing Regulated Conduct Beyond the Scope of Consumer Protection Laws C. Conflicts with Federal Authority: Preemption 1. Methods of Preemption 2. The FDA's Changing Priorities in a DTC Environment 3. Public Policy Supports Expanding Scope of Preemption CONCLUSION
INTRODUCTION
According to a recent article in the New England Journal of Medicine, total pharmaceutical industry spending on direct-to-consumer (DTC) advertising of prescription drugs rose from $985 million in 1996 to $4.2 billion in 2005--an increase of 330%. (1) As a result, advertisements for prescription drugs are pervasive and consumers regularly view them in magazines and online, watch them on television, and listen to them on the radio.
This figure, however, must be put in perspective. Research also shows that during the same period, spending on pharmaceutical marketing increased not only for DTC advertising, but also across the board, from about $11.4 billion to $29.9 billion. (2) In fact, although DTC advertising has increased steadily both in absolute terms and as a percentage of pharmaceutical sales, promotion of drug treatments directly to physicians and other health care professionals still far outweighs DTC advertising. (3) In 2005, $7.2 billion was spent on promotion to physicians alone. (4) Relatively speaking, DTC advertising is concentrated on a small number of brands. (5) Its reach, however, is considerable, and DTC advertising is the subject of significant debate among courts and commentators. (6)
In light of these changes in the marketing environment, this Article examines whether traditional legal principles governing the duty to warn of the risks of pharmaceutical products remain sound public policy. First, the Article considers the early history of the sale and marketing of pharmaceutical products, discussing the initial tragic absence of regulation, followed by the establishment of the FDA and the pre-market approval process. It then examines the modern age of pharmaceutical advertising, including the FDA's relatively recent guidance on DTC broadcast advertising and the extent of its regulation. Finally, the Article examines rules of law that establish the legal landscape for warnings and advertising in the pharmaceutical context. This includes the learned intermediary doctrine, the effect of regulatory compliance on product liability and consumer protection claims, and the application of conflict preemption principles to tort law claims involving FDA-approved products.
The Article finds that the two foundational tenets underlying these doctrines have not changed. First, on a societal level, the FDA continues to regulate the pharmaceutical industry closely, both in approving pharmaceutical products as safe and effective for certain classes of patients and in mandating disclosure of risks so that physicians can accurately counsel their patients. Second, physicians remain individually responsible for diagnosing each patient regardless of advertising and for helping each patient make an educated treatment decision in light of the risks and benefits of a drug. Because of their authority to write prescriptions, physicians have ultimate responsibility for deciding whether a given drug is appropriate and beneficial for the patient. Prescription drug manufacturers, therefore, have obligations to report all material information to the FDA, both before and after approval, so that the FDA can make a fully informed decision about what products should be available to the market and can convey adequate information to physicians for patient counseling purposes.
The Article concludes that, irrespective of the rise of DTC advertising, traditional principles of law fully retain their viability in the post-DTC world both as a matter of jurisprudence and sound public policy.
I. MARKETING AND REGULATION OF PHARMACEUTICALS FROM PAST TO PRESENT
A. Concepts of Product Mislabeling and Pre-Market Regulation
Before examining modern regulation of pharmaceutical products and their advertising, placing the current system in historical context is useful. Companies that sell medications have advertised their products directly to consumers since the beginning of medicine. The increasing regulatory scrutiny regarding approval, marketing, and sale of prescription drugs, however, is a relatively recent development. The new oversight is meant to ensure that drugs are safe and effective and that drug advertising does not mislead the public.
During much of the eighteenth and nineteenth centuries, companies regularly advertised patent medicines, which were available without a prescription, directly to consumers in American newspapers. Indeed, during the 1800s, patent medicine advertisers spent more on newspaper advertisements than any other group. (7) At the time, no regulatory structure existed to provide for pre-market review of these medicines to ensure their safety or efficacy or to substantiate the claims their producers made in these advertisements. The grifting snake oil salesman, a character that still pervades the mythology of the American West, dates to this unregulated period.
In 1906, Upton Sinclair published his novel, The Jungle, with its detailed account of the unsanitary conditions of the Chicago stockyards. (8) Prompted by the resulting public outcry from the book and public reaction to similar disclosures in the nation's newspapers about poisonous preservatives and dyes in foods and cure-all patent medicines, Congress passed the original Pure Food and Drugs Act. (9)
But if the 1906 Act was meant to curb the deceptive practices of snake oil salesmen, it was poorly equipped for the task. First, the 1906 Act did not prevent manufacturers from placing worthless medicines on the market because proof of safety or efficacy was not required. Second, the Act was directed only at product labels, not extra-label advertising. (10) It defined a drug as "misbranded" only if the stated claims on the label regarding its curative or therapeutic qualities were proven false or fraudulent. (11)
These inadequacies became tragically apparent some three decades later. In June 1937, a salesman for the S.E. Massengill Co. reported that his customers sought a liquid version of the drug sulfanilamide, which had been used to treat streptococcal infections and had been proven to have dramatic curative effects in tablet or powder form. (12) Responding to the market need, a chemist and pharmacist for the company experimented with sulfanilamide's solubility and found that it would dissolve in diethylene glycol. (13) Although the company tested the product for flavor, appearance, and fragrance, it did not test the product's toxicity. (14) In sufficient doses, diethylene glycol is toxic to humans and animals, causing renal failure, encephalopathy, and death. (15) A scientific literature review or a few simple animal tests would have revealed its lethal properties. (16) S.E. Massengill, however, shipped the product without taking these precautions. Between September and October 1937, more than one hundred people across the country obtained the product from their doctors or bought it from a pharmacy and died after consuming it. (17) After news of the strange deaths began surfacing, the FDA investigated and intervened, seizing shipments from pharmacies and doctor's offices across the country. But the FDA's sole authority for these seizures was not--as one might expect--that the drug was manufactured and sold without any pre-market toxicity review. Ironically, the FDA only had authority to intervene through the 1906 Act's prohibition against label misbranding. (18) The term "elixir" on the product's label implied that the product was an alcohol solution when, in fact, it contained no alcohol. (19) Had the product instead been labeled a "solution," the FDA would have had no authority under the 1906 Act to intervene. (20)
In response to the crisis, Congress repealed the 1906 Act and replaced it with the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA). (21) The increased protections of the new act included an FDA pre-market notification (but not approval) requirement for all "new drugs." (22) In order to market a new drug, a manufacturer would submit a New Drug Application (NDA) to the FDA. If the FDA did not affirmatively deny the application within sixty days, then the manufacturer could market the drug immediately. (23) Unsurprisingly, given the Elixir Sulfanilamide incident, this pre-market notification system focused solely on proof of the new product's safety, not its efficacy. (24) Thus, the FDA retained jurisdiction over the product label and it obtained authority under the 1938 Act to conduct a pre-market safety review.
In the same year Congress expressly vested jurisdiction over all drug advertisements with the Federal Trade Commission (FTC). (25) Congress had created the FTC in 1914 with the passage of the Federal Trade Commission Act. (26) Under that Act, Congress authorized the FTC to regulate advertising generally, though the Supreme Court's interpretation of the statute limited the FTC's purview to deceptive advertising that harmed a competitor company. (27)
Earlier proposals to amend the 1906 Act had sought to regulate DTC advertising of drugs. The legislative history of those attempts reveals the nature and extent of DTC advertising at the time. Legislation introduced in 1933 named some thirty-six particular disease states or conditions for which any advertising would be necessarily deemed false, including measles, mumps, scarlet fever, sexual impotence, tuberculosis, and venereal diseases. (28) The bill included an exception, however, if the advertisement was "disseminated to members of the medical and pharmacological professions only or [if the advertisement] appears in scientific periodicals." (29) The list of diseases and the need for a direct-to-physician exception suggest that DTC advertising was pervasive in the early 1930s and provide clues as to the conditions these products were marketed to address.
B. Establishment of the Modern Regulatory Regime for Approval and Marketing of Prescription Drugs
Before 1951, there was no recognized category under federal law for prescription drugs. That year, Congress enacted the Durham-Humphrey Amendments to the FDCA, which required licensed pharmacists to dispense drugs that cannot be safely used without medical supervision. (30) It is uncertain whether the prescription requirement put an immediate halt to DTC advertising. If we assume that the history of the 1933 legislation is indicative of the nature and extent of DTC advertising at the time of that bill's consideration, then we can extrapolate on the legislative history of the next major alteration to the FDCA, the 1962 Kefauver-Harris Drug Amendments. That legislative history suggests that implementation of a prescription-drug regulatory scheme in 1951 curbed DTC advertising for prescription drugs and shifted the industry's marketing focus to physicians and heath care professionals.
In 1962, the Kefauver-Harris Drug Amendments authorized the FDA to regulate the marketing of prescription drugs. (31) By this time, Congress was drawing a distinction between the advertising of over-the-counter (OTC) medicines, which are directed at consumers, and the marketing of prescription drugs, the bulk of which, in Congress's estimation, was already directed at the medical community. (32) (A memorandum of understanding between the two agencies governs this allocation of responsibilities in which the FTC continues to regulate OTC advertising, whereas the FDA regulates the marketing of prescription drugs. (33)
The 1962 Amendments and their implementing regulations set two major requirements for all prescription drug advertising. (34) First, advertisements must contain a "summary" that provides a description of the drug's side effects, contraindications, warnings, and precautions, as well as its directions for use. (35) Second, the advertisement, when viewed in its entirety, must present a "fair balance" between the information relating to the drug's efficacy and information relating to its safety and risk profile. (36)
The 1962 Amendments also strengthened the FDA's pre-market review process, implementing the procedure that remains largely in effect today. Once again, the prompt for regulation arose out of a public health crisis. Thalidomide, a drug approved for marketing in various European countries, was discovered to be a teratogen, an agent that can cause malformations of an embryo or fetus. (37) A manufacturer had submitted an NDA to market the drug for use in the United States, which was pending at the time of this discovery. Congress responded by amending the FDCA to require affirmative approval by the FDA for NDAs, replacing the notification and automatic-approval system put in place by the 1938 Act. (38) In addition, Congress required manufacturers submitting NDAs to prove not only that a drug was safe, (39) but also that the product was effective. (40) For its part, the FDA now had to reach an affirmative conclusion that the drug was both safe and effective before the drug could be marketed. (41) The standards for approval have remained relatively unchanged in the decades following their implementation and continue to guide both the industry and the FDA in their daily decisions to the present. (42)
Procedurally, the FDA's Center for Drug Evaluation and Research (CDER) reviews and approves NDAs, (43) and then evalutes the drug's proposed labeling. (44) The FDA must find that the results and data submitted in the NDA justify each statement proposed for drug labeling. (45) Federal regulations require dividing the label's content into sections, including a list of the drug's approved indications and usage, (46) contraindications, (47) warnings, (48) precautions, (49) and adverse reactions. (50) The FDA must approve the label's content before it accepts the NDA and the company begins marketing the drug.
C. DTC Advertising and Its Regulation Today
The Division of Drug Marketing, Advertising, and Communications (DDMAC), a separate component of CDER, reviews pharmaceutical marketing practices. There are no formal regulations that distinguish DTC advertising from direct-to-physician advertising. (51) Rather, the FDA recognizes three distinct types of advertising, based on the advertisements' content. First, "reminder" advertisements are promotional pieces that call attention to a product or brand name, but contain no reference to the purpose of the drug, its benefits, or risks. (52) Reminder advertisements are exempt from the brief-summary requirement. (53) Second, "help-seeking" advertisements describe a disease or condition and direct the consumer to see his doctor, but do not mention the drug's name. (54) Finally, product-claim advertisements reveal both the product's name and its contraindications. (55) These product-claim advertisements must satisfy the "brief summary" and "fair balance" requirements. (56)
In the twenty years following enactment of the 1962 Amendments, pharmaceutical manufacturers directed advertisements and promotional practices almost exclusively toward physicians. (57) It was not until the early 1980s that manufacturers began to place advertisements for prescription medicines in mainstream print media. (58) Soon after these advertisements began to run, the FDA asked for a voluntary moratorium of the practice. (59)
In 1985, the FDA decided to permit DTC advertising so long as the manufacturer complied with the "brief summary" and "fair balance" requirements applicable to physician-directed advertising. (60) Historically, in print media, the product's approved physician labeling was reprinted in the advertisement to satisfy the "brief summary" requirement. This practice, however, presented challenges for broadcast advertising. A thirty-second TV spot was both too expensive and too short for a manufacturer to read the brief summary or scroll through the product's package insert. (61)
In response to industry inquiry, the FDA held public hearings on DTC broadcast advertising in 1995. The agency issued a Draft Guidance document in 1997, which became its final position in 1999. (62) The Guidance document removed barriers to broadcast advertising largely by transforming the "brief summary" requirement for print advertising into what is now known as the "major statement" requirement for broadcast advertising. (63) Under that requirement, the advertisement need not repeat all potential side effects, contraindications, warnings, and precautions associated with the product, but it must, in consumer-friendly language, disclose the drug's major risks in either the audio or visual component. (64) Further, to make "adequate provision" of the approved product labeling, the Guidance document makes clear that the advertisement must publicize a toll-free telephone number through which the patient can obtain a copy of the product's label, refer the patient to a print advertisement or other non-web-based resource for additional information, include a web address providing access to the product's labeling, and refer the patient to his doctor or pharmacist. (65) Although the Guidance document does not have binding legal effect, the FDA essentially placed manufacturers on notice that it would not take regulatory action when a broadcast advertisement complies with the Guidance document's terms. (66)
Additionally, as with all advertisements, the broadcast messaging must not be false or misleading in any respect. Beyond assessing the pure content, DDMAC may also consider the form of the audio and video production and presentation (for example, the graphics and superimposition of text, the pacing and clarity of voiceovers, the visual editing, and sound effects or music) to ensure that the advertisement is "fairly balanced" and that risk information is adequately communicated. (67)
Should DDMAC determine that an advertisement or promotional piece in distribution violates the law or FDA guidelines, it sends one of two types of letters to the offender. (68) Minor violations are noted in a Notice of Violation (NOV) letter. (69) A recipient of an NOV letter typically discontinues the offending marketing practice and responds to DDMAC in writing within ten days, informing it of the discontinuation. (70) For more serious violations, DDMAC sends a warning letter. (71) These letters put the recipient on notice of the FDA's intent to initiate further regulatory action against the recipient if it refuses to rectify the offending practice promptly. Manufacturers have consistently taken the appropriate corrective action indicated in such letters, without the need for further action from the FDA. (72) In addition, the Food and Drug Administration Amendments Act of 2007 (FDAAA) gave the FDA the authority to impose civil penalties directly for false or misleading advertisements. (73)
Federal law does not currently mandate pre-market review of DTC advertising. Rather, unless the FDA provides otherwise, (74) manufacturers are required to submit their marketing materials to the agency at the time of the product's distribution in the marketplace. (75) Many manufacturers, however, routinely submit proposed advertisements before dissemination on a voluntary basis. This provides the FDA with an opportunity to review advertisements before they are released publicly and to suggest improvements. (76) For example, between 2000 and 2006, the FDA received an average of approximately 150 television advertisements each year for advisory review, (77) In fact, the Pharmaceutical Research and Manufacturers of America (PhRMA), the leading industry group of drug manufacturers, encourages its members to submit all television advertising to the FDA for review before airing. (78) Manufacturers have widely adopted the PhRMA code and continue the longstanding practice of submitting DTC advertisements to the FDA before dissemination. (79)
Some critics, including the General Accounting Office (GAO), have highlighted shortcomings in the regulatory process overseeing pharmaceutical marketing and have suggested that DDMAC needs additional resources. In 2002, a GAO study examined two deficiencies in the regulation of DTC advertising: the FDA's inability to be certain that manufacturers submit their advertisements to the agency and the lengthy period before the FDA reviews advertisements and issues warning letters for misleading information. (80) When the GAO revisited the issue four years later, it found that this lag time had worsened considerably, leading to a situation where, more often than not, the publication or broadcast of the misleading advertisement had already concluded before the FDA issued its violation letter. (81) It also noted that the FDA had the capacity to review only a small portion of the increasingly large amount of the DTC materials submitted. Therefore, the FDA closely examined only advertisements for those drugs with the greatest potential to impact the public health. (82) As the FDA recently noted, "[t]he lack of timely, predictable FDA review times for DTC television advertisements has hindered companies' ability to accurately set timeframes for their marketing campaigns and has discouraged companies from taking advantage of the DTC advisory review process." (83)
Congress attempted to address the inability of the FDA to keep pace with the increasing number of DTC...
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