We have reviewed the article entitled: “Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing “ by Korenstein et al (PLoS One 6(8) e23336:1-7, 2011) and have the following comments. The authors’ primary thesis centers around the ideas that 1) FDA “guidelines” are “subjective and challenging to enforce” and that 2) while many of the advertisements reviewed in the sample were compliant with FDA guidelines, because some ads did not contain sufficient information to allow for safe prescribing they were in some way false and/or misleading. The authors also indicate that, based on their review, “over half (of the advertisements reviewed in the sample) fail to quantify serious risks. Lastly, the authors seem to imply that medicines that contain so-called “black boxes” in their labeling should not be advertised in professional journals.
The advertising of prescription pharmaceutical products in the United States is a highly regulated activity. Pharmaceutical manufacturers employ highly trained specialists in the fields of medicine, regulatory affairs, law and marketing to produce, review and approve advertisements before they are distributed for use. In addition to this operational oversight by manufacturers, FDA also employs skilled experts in the Division of Drug Marketing, Advertising and Communications who are trained in the laws and regulations in place to oversee and enforce these activities. Finally, certain other agencies within the United States government, such as the Office of Inspector General, are also active in enforcing the law in this area. Penalties for noncompliance in this area can be substantial and government enforcement is vigorous. It is clearly in the best interests of pharmaceutical manufacturers to ensure that they are producing advertisements that are fully compliant with FDA regulations.
FDA’s statutory mandate in this area is to oversee that the information manufacturers provide to healthcare professionals about medicines is compliant with the agency’s regulations and the Federal Food Drug and Cosmetic Act – not to not govern the practice of medicine. The information presented in drug advertisements needs to be consistent with and supported by the drug’s FDA approved labeling, and each and every product advertisement that makes representations about the use of the product is required by law to include the medicine’s prescribing information, containing quantified presentations of both the efficacy and safety data from the clinical development program. That is the standard currently applied. While the authors may desire that drug advertising contain complete actionable information pertaining to safe prescribing, in fact drug ads are not sufficient vehicles for physicians to learn about all the aspects of a medicine before prescribing it to a patient. Instead, medical journal advertisements are aimed simply at alerting healthcare professionals about the availability of a new medicine or perhaps the availability of new data about a previously approved medicine. They act to remind the physician of the product but in no way do they purport to present the entire spectrum of data a physician will need to understand in order to properly prescribe them. A reasonable consumer would not purchase a new automobile after watching a 60 second TV ad or reading a two page advertisement in a magazine. Certainly a conscientious healthcare professional would not prescribe a medicine on the basis of an advertisement alone, without acquiring a detailed knowledge of the product’s safety and efficacy.
We note the authors’ recognition that advertising “is a form of free speech and is a constitutionally protected right of industry.” In that spirit, we welcome an active and informed dialogue about whether FDA advertising requirements, in their current form, provide an optimal framework to support informative and accurate communication about medicines and their contribution to public health.
Robert B. Clark, Vice President
Worldwide Regulatory Strategy, Pfizer Inc