Direct to Consumer advertising, for the purposes of this article, refers to any advertisement developed by the pharmaceutical industry including radio, print and/or television of prescription medication that targets the consumers/patients. Traditionally, the pharmaceutical industry targeted their marketing efforts to the physician and healthcare providers. Despite the huge debate regarding DTC, the majority of spending from the pharmaceutical industry still remains focused on the physician. According to a recently published study in the New England Journal of Medicine, more than 80 % of the promotion of prescription drugs remains targeted towards the physician, with 15% targeted towards consumers. The focus on physicians has become more difficult given the changing environment of medicine and the advent of managed care, however, the industry continues to use ads in the medical journals, direct mail and individual pharmaceutical representatives that visit the physician in the office in addition to other venues. However since the early 1980s there has been a continued increase in advertisements directed to the patients. From a historical prospective the first DTC advertisements appeared in the United States in the early 1980s and since their very inception, there has been rigorous debate surrounding the advertisements.

The US Food and Drug Administration (FDA) has been diligent in attempting to monitor and protect the interests of the patient. The FDA has issued guidelines with the intent of providing patients a fair balance of risk versus benefits as it relates to the prescription medications featured in the advertisements. The FDA has continued to closely monitor DTC advertisements in an attempt to protect patients. The agency publishes Guidance for Industry; Consumer-Directed Broadcast Advertisements, which serves to steer the pharmaceutical industry in the path of balanced promotion of products. The most recent ” Guidance for Industry” was published in August 1999 and provides for the following:
The prescription drug advertising regulations (21 CFR 202.1) distinguish between print and broadcast advertisements. Print advertisements must include the brief summary, which generally contains each of the risk concepts from the product’s approved package labeling. Advertisements broadcast through media such as television, radio, or telephone communications systems must disclose the product’s major risks in either the audio or audio and visual parts of the presentation; this is sometimes called the major statement. This guidance does not address the major statement requirement. 

Sponsors of broadcast advertisements are also required to present a brief summary or, alternatively, may make “adequate provision … for dissemination of the approved or permitted package labeling in connection with the broadcast presentation” (21 CFR 202.1(e)(1)). This is referred to as the adequate provision requirement. The regulations thus specify that the major statement, together with adequate provision for dissemination of the product’s approved labeling, can provide the information disclosure required for broadcast advertisements.

The purpose of this guidance is to describe an approach that FDA believes can fulfill the requirement for adequate provision in connection with consumer-directed broadcast advertisements for prescription drug and biological products. The approach presumes that such advertisements:

  • Are not false or misleading in any respect. For a prescription drug, this would include communicating that the advertised product is available only by prescription and that only a prescribing healthcare professional can decide whether the product is appropriate for a patient.
  • Present a fair balance between information about effectiveness and information about risk.
  • Include a thorough major statement conveying all of the product’s most important risk information in consumer-friendly language.
  • Communicate all information relevant to the product’s indication (including limitations to use) in consumer-friendly language.

The guidelines should be observed by the pharmaceutical industry and the FDA has the authority to regulate any false or misleading advertisements. These guidelines serve to attempt to protect the patient and serves only as a guide while not being overly restrictive to private industry. In addition, the FDA has conducted surveys in 1999 and 2002 to assess the impact of DTC on consumers and continues to exert oversight and scrutiny. These surveys provide invaluable data on DTC advertisements and are the benchmark by which othersattest to the need for continued scientific research in this area. cialis canadian pharmacy

The authors’ initial formal investigation into this issue resulted in a national survey of physicians of the National Medical Association, which was previously reported in the Journal of the National Medical Association? We reported the following:

  • The majority of physicians have been asked their medical opinion by patients because of the ads.
  • The majority has been asked for a specific treatment based solely on the ads.
  • The majority of respondents believe that DTC ads promote increased communication between physicians and patients.
  • The majority believes that DTC ads do have a benefit to patients, particularly as it relates to education regarding disease states.
  • The majority of the respondents do not believe that the ads make the patient more compliant with medications and/or treatment.
  • Overwhelmingly physicians deny having changed their prescribing habits because of the ads.
  • A significant number of physicians felt additional pressure to justify their prescribing habits, while the majority does not feel such pressure.

Due to the demographics of the NMA, this survey was of African American (AA) physicians, which resulted in the largest survey of this cohort to date. It is important to note that our results were not vastly out of line with the perceptions of our non-AA colleagues. As we gathered credible data on physicians, we wanted to also look at the physician-patient relationship and instead of perception, peer into what actually occurred during an office visit. As we have stated, this very trusted and complex relationship is impacted by several factors and since the early 1980s; we postulate that DTC ads have become one of the many factors that influence the activities within in the physician’s office. This study is unique in that we enlisted five offices around the country with multiple physicians and patient demographics to help assess this issue. We relied on patients providing information at the time of their regularly scheduled doctor’s appointment and the physician providing feedback immediately after the visit. We believe that this is one of the most relevant studies surrounding DTC ads since the debate began and report the outcomes. This study is also unique in that it provides for a large cohort of minority patients, which to date has not been fully heard. online pharmacy uk

Other private entities such as the Kaiser Foundation and Prevention Magazine have also investigated the impact of DTC via survey instruments. All of the major studies investigating this issue have been conducted via telephone interviews, internet/Web and mail surveys. To date, we have not seen any major study that was conducted in a physician’s office at the time of the patients visit. The goal of this study was to investigate patient perceptions about DTC ads, as well as their actions as a result of the exposure (i.e. call to schedule appointment, ask their physician about or for a medication, etc.). Additionally, we queried patients about their perceived compliance because of the ads and their role in informing them about their health. We believe that the results from this study will lead to increasing the understanding of the impact of DTC ads on patients and will give succinct data regarding the doctor/patient relationship. Plus, African American physicians with direct patient care and a large population of minority patients headed the sites involved and, thus> we provide the largest cohort of AA patient responses to date regarding the impact of DTC ads. The surveys were administered at multiple sites throughout the United States (California, Maryland, New York, North Carolina and Texas) and in a variety of specialty settings including Internal Medicine, Family Practice, Geriatric Medicine, and Obstetrics/Gynecology.