DIRECT-TO-CONSUMER ADVERTSING FOR PRESCRIPTION PHARMACEUTICALS IN THE UNITED STATES: CURRENT REGULATIONS GUIDELINES AND PERSPE

ARTICLE SUBMISSION TO

INTERNATIONAL BIOPHARMACEUTICAL ASSOCIATION PUBLICATION

DIRECT-TO-CONSUMER ADVERTSING FOR PRESCRIPTION PHARMACEUTICALS IN THE UNITED STATES: CURRENT REGULATIONS GUIDELINES AND PERSPECTIVES.

Mark D. Schmalz, MPhA, CPhT.

Abstract

To increase product acceptance, some pharmaceutical manufacturers utilize direct-to-consumer (DTC) advertising of prescription medication. In 2004, in the United States, manufacturers spent $11.9 billion in advertising, two-thirds, or 7.8 Billion directed toward physicians and $4 billion directed toward consumers. Between 1994 and 2004, there was a sixty-eight percent increase in prescription drug purchases by Americans, yet the U.S. population grew by just twelve percent during the decade. Drug companies view direct-to-consumer (DTC) advertising as an effective marketing tool, and as a way to contribute to the education of the public. They also realize the practice may antagonize health care professionals and government regulatory agency officials. This paper reviews existing drug advertising guidelines of the United States Food and Drug Administration and concerns raised by healthcare and public advocacy groups regarding product specific prescription drug advertising to the public.

Clinical Research Training-CRA

Kriger Research Group International

Mark D. Schmalz, MPhA, CPhT

DIRECT-TO-CONSUMER ADVERTSING FOR PRESCRIPTION PHARMACEUTICALS IN THE UNITED STATES: CURRENT REGULATIONS GUIDELINES AND PERSPECTIVES.

Mark D. Schmalz, MPhA, CPhT

Abstract

To increase product acceptance, some pharmaceutical manufacturers utilize direct-to-consumer (DTC) advertising of prescription medication. In 2004, in the United States, manufacturers spent $11.9 billion in advertising, two-thirds, or 7.8 Billion directed toward physicians and $4 billion directed toward consumers. Between 1994 and 2004, there was a sixty-eight percent increase in prescription drug purchases by Americans, yet the U.S. population grew by just twelve percent during the decade. Drug companies view direct-to-consumer (DTC) advertising as an effective marketing tool and as a way to contribute to the education of the public. They also realize the practice may antagonize health care professionals and government regulatory agency officials. This paper reviews existing drug advertising guidelines of the United States Food and Drug Administration and concerns raised by healthcare and public advocacy groups regarding product specific prescription drug advertising to the public.

Introduction

In 2003, the U.S. Food and Drug Administration released results of a policy survey on direct-to-consumer drug advertising.[1] Seventy-five percent of doctors stated DTC ads led patients to think the drug worked better than it does. Many doctors reported feeling pressure to prescribe when patients mentioned seeing ads. Eight percent of physicians reporting they felt “very pressured” to prescribe the specific drug when asked The survey also pointed to positives. The majority of doctors said because their patients saw a drug ad, they (the patients) asked more thoughtful questions during their appointment. Many thought the ads encouraged their patients to be more involved in their health care. Interestingly, the survey revealed that drugs with the highest direct-to-consumer ads were in the top of prescribed medications and sales of drugs with the highest direct-to-consumer ad spending rose more quickly than sales of other drugs.

A primary issue with direct-to-consumer advertising is whether the practice diminishes the altruistic medical goal of improving health. In the book, “Overdosed America,” [2] Dr. John Abramson, a clinical instructor of primary-care medicine at Harvard Medical School wrote, “As drug companies control more and more research, we’re getting a body of knowledge that focuses on improving big business, not objectively improving health.” Abramson cited a sixty percent increase in use of sleep drugs between 2000 and 2005, and attributed the increase to public promotion of patented sleep medications. “The real problem,” he stated, “is that drug companies fund the research. Initial partnering with nonprofit research organizations is to address treatment of sleep disorders. Later, the study is utilized by a manufacturer to persuade the public that sleepless nights can be avoided by taking a specified patented prescription medication.”[3]

At issue also is that DTC advertisements divert the public’s focus from diagnosis to treatment. Training for health care professionals postulates proper medical treatment is initiated upon thorough physical examination of the patient. Implicit to effectual practice of medicine, the care provider’s focus is diagnosis of disease. Consequently, during the doctor-patient encounter, the patient must be willing to look at the bigger picture of health maintenance. The physician should not feel compelled to prescribe a drug of preference by the patient.

Background

In 1906, the U.S. Congress passed the Pure Food and Drug Act, making it unlawful to manufacture adulterated or misbranded foods and drugs. The Act also prohibited the shipment of altered products in both interstate and foreign commerce. Power of regulation and enforcement were uniformly distributed among the Departments of Treasury, Agriculture and Commerce. The 1906 Act judged drugs to be adulterated when sold having a difference from the declared standards. (Unless the label specifically expressed the difference.) Drugs were considered misbranded when there was name imitation of an accepted food or drug, or when there was a removal/substitution of the package’s contents. Other violations included: 1) A failure to state on the label the quantity or proportion of narcotics or 2) A false statement of curative or therapeutic effect.[4]

The Federal Food, Drug and Cosmetic Act of 1938 established the Food and Drug Administration (FDA) to regulate food and drugs in the United States. The Act requires that manufacturers, packers and distributors (sponsors) who advertise prescription drugs/biologic products, disclose certain information about the product’s advertised uses and risks. Disclosures must include “information in brief summary relating to side effects, contra-indications, and effectiveness.”[5]

Though the Act does not specifically define what constitutes a prescription drug advertisement, the FDA generally interprets the term to include information (other than labeling) that is sponsored by the manufacturer and is intended to supplement or explain a product. This includes, for example, “advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such a radio, television, and telephone communication systems.[6] The act and regulations specify that drugs are deemed misbranded if their labeling or advertising is false or misleading in any particular way, or fails to reveal material facts.[7]

Not until 1962 did the FDA receive sole jurisdiction for regulating advertisements and prescription drugs. Previously, authority to regulate all domestic commodities in interstate commerce was vested by federal statute in the Federal Trade Commission. The 1962 Amendment relegated FDA authority over all aspects of prescription drugs and all promotional and advertising policy related to therapeutic pharmaceuticals.[8]

Initially the pharmaceutical industry was limited to public advertising for over-the-counter medicaments. Promotion of prescription medications was reserved to professional medical journals and/or physician face-to-face promotional materials used by pharmaceutical sales representatives. However, in the 1980’s a “right to know” social mentality evolved in the United States. Under the auspices of “informed health care,” marketing attention shifted from health care professionals to the general public. Accordingly, the FDA has since issued new regulations to respond to differences in levels of education and understanding between physicians and the public.

FDA Regulations for Direct-To-Consumer (DTC) Advertising of Prescription Drugs

The FDA has provided a list of guidelines to which pharmaceutical manufacturers voluntarily adhere in directly marketing to consumers. The provisions for DTC advertising are currently specified in the Code of Federal Regulations, Title 21. Section 202.[9] It is interesting to note that all requirements are predicated on the assumption a sponsor’s intent is to be truthful and present a fair balance. If the advertisement is false, misleading, and/or misbranded, the product is in violation of the Food and Drug Act. Requirements include:

1. The ingredient information shall appear together without any intervening written, printed, or graphic matter.

2. The order of the listing of ingredients in the advertisements shall be the same as the order of the listing of ingredients on the label of the product.

3. The advertisement shall not use a fancy proprietary name of the drug or any ingredient to imply that the drug or ingredient has some unique effectiveness or composition, when, in fact, that drug or ingredient is a common substance.

4. The advertisement shall not feature inert or inactive ingredients in a manner that creates an impression of value greater than their true functional role in the drugs formulation.

5. The advertisement may not use a proprietary name that, because of spelling or pronunciation, might be confused with an established different drug or ingredient.

6. The side effects and contraindications disclosed may be limited to those pertinent to those using the drug in its’ appropriate dosage and for its’ recommended usage.

7. Advertising requires truth in comparisons to other drugs for effectiveness measures and must use the most up-to-date and valid study information about the drug or ingredient.[10]

Prescription drug regulations distinguish between print and broadcast advertisements and require that both be written and/or spoken in a manner that allows the audience to understand the statements. Regardless of format, advertisements may not contain false or misleading claims and must provide fair balance of risks and benefits. In addition, they must contain a brief summary of information as specified in the regulations. These components have been deemed “essential” parts of DTC advertisements. If an ad is missing any of these components, the sponsor can be subjected to FDA enforcements.

Federal drug advertising guidelines do not differentiate target audience. The interpretation of a specific regulation however, can differ depending on whether the ad is directed towards healthcare professionals or towards the general consumer. The FDA allows regulations to be subject to different interpretation because of what is considered fair balance of risk and benefit information for consumers versus that for health care professionals.[11]

Standard Procedures for Violation of FDA Advertising Guidelines

Currently, the FDA does not have the authority to pre-screen advertising messages that drug companies advance to the public. The Agency requests that advertisements be voluntarily submitted for pre-clearance, so determination of compliance can be made. The approach assumes the sponsor is willing to make revisions prior to release. Most typically, the FDA regulates after the fact, when an advertisement is determined to be misleading or providing false evidence. Regulatory actions begin with a letter requesting that the sponsor cease/desist use of the current misleading ad and correct claims in future promotional activities. In actuality, recorded incidences show drug companies do comply with requests. Certainly, maintenance of a cooperative relationship with an Agency which controls new drug applications is good business practice. In rare cases of repeat violation, the FDA can take further measures. A warning letter is usually written, and if necessary followed with a strongly worded “notice of non-compliance.” If ignored, the Agency can threaten the pharmaceutical manufacturer with seizure and injunction. Failure of voluntary compliance can eventually result in the stipulation of a corrective campaign and/or pre-clearance of subsequent advertisements. The FDA can also ultimately require a manufacturer send a letter of correction directly to the parties who may have been influenced by false or misleading claims.[12]

Future Regulatory Outlook

In July, 1997, the FDA drafted guidelines pertaining to direct-to-consumer broadcast advertising.[13] The draft guidance was intended to provide consumers with adequate communication of required risk information, while facilitating the process used by sponsors (drug manufacturers) to advertise their products to consumers. These guidelines were revised April 1, 2005 and published as “Guidance” in the Code of Federal Regulations Title 21. “Guidance” has been chided by the medical community with allegations “the FDA is shirking its responsibility to the public health by allowing any DTC advertising, and is exacerbating effects of prior actions concerning DTC promotion by inappropriately loosening restrictions on broadcast advertisements.” [14] The FDA is on record stating it is unaware of any data supporting the assertion that the public health or animal health is being harmed, or is likely to be harmed by the Agency’s actions in facilitating consumer-directed broadcast advertising.[15] It is a truism that, despite years of print DTC advertising, no rigorous evidence has been presented to demonstrate that such advertising has had public ill effects. In the absence of such data, it is likely the FDA will not change its position that a broadcast environment encourages communication of both benefits and risks of advertised products.

Direct-To-Consumer Advertising Economics.

In a free market economy, the emergence of drugs with similar mechanisms of action (including generics) theoretically leads to competition, and ultimately cost savings for health care institutions and consumers. However, in the U.S. as in other countries, the pharmaceutical industry operates in a heavily regulated environment. This situation creates an incentive for drug manufacturers to initiate DTC advertising. The pharmaceutical marketplace is so enormous, if a proprietary drug, (though it may have the same composition as a competitor) can capture a section of the market through direct consumer selling, the seemingly small percentage increase in market share can lead to significantly greater profits for the manufacturer.

Positive Outcomes of DTC Advertising

Proponents believe there is an educational value in direct-to-consumer advertising and the practice improves the physician-patient relationship by sparking conversation relating to treatment options. It is theorized that DTC ads also allow consumers to have a more direct role in deciding which treatment regimens are best for them. Advocates tout that advertising directly to consumers prompts some to seek medical care that otherwise might not be aware that they suffer from a disease for which effective treatment exists. This type of advertising also increases patient compliance in taking medications, because patients feel they have a more direct stake in treatment. Lastly the argument is made that direct consumer advertising increases profitability of the drug industry, ultimately leading to expanded drug research and new therapy development.

Negative Outcomes of DTC Advertising

Critics of direct-to-consumer advertising point to the many potentially harmful effects that result from marketing prescription drugs to patients. Opponents argue that such promotion is often misleading by inherently failing to communicate risk information. Additionally, as patients learn about treatments directly, physician-patient relationships are undermined as the former attempts to either self-medicate, or dictate the terms of specific treatments. Neither situation encourages good medical practice or beneficial consumer health care. Opponents also fear that direct-to-consumer advertising leads to excessive demands on physician time, over-medication of patients, and drug abuse (patients demand a remedy for every symptom that ails them.)

Conclusion

In the United States, the prescription drug climate is such that in the short term, no immediate reversal of direct-to-consumer marketing will likely occur. At the same time, private and public sectors of American society adamantly oppose policy that contributes to health risk associated with prescription drugs. DTC advertising may provide patients with information to use in discussions with physicians. However, because the consumer/patient is not in a position to diagnose or make medical judgments about relative safety and/or effectiveness of prescription drugs, the FDA will be held at knifepoint by allied healthcare industries to scrutinize DTC advertising. Manufacturer sponsored prescription drug advertising will continue, but with regulation to assure balance, accuracy and completeness of information.

References