Guest Editorial

December 19, 2014
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Understanding the regulation of pharmaceutical drug promotion

Yearly, billions of dollars are funneled into the promotion of pharmaceutical drugs to healthcare professionals (HCPs) and consumers. In 2012, roughly 27 billion U.S. dollars were spent on promotional activity by the pharmaceutical industry, with more than 24 billion dollars spent on marketing to physicians.1 Promotional print items, speaker series, direct-to-consumer advertising (DTCA), detail aids (promotional material left behind by sales reps for physician perusal), and the like are regulated heavily, and it is known that pharmaceutical marketing via DTCA affects both consumer and HCP behavior.2 However, the details of such regulation are not common knowledge, even though pharmaceutical promotion infiltrates daily medical practice and life. Otolaryngologists should be familiar with regulations, the risks associated with pharmaceutical promotion, and opportunities to help ensure dissemination of accurate information.

The established practice at most pharmaceutical companies, although it is different at each organization, has the same goal: to ensure each promotional item developed by marketing teams is in congruence with the U.S. Food and Drug Administration's Office of Prescription Drug Promotion (FDA OPDP) regulations and guidance documents. The team implemented at each company that reviews and critiques promotional materials consists of marketing, legal, and regulatory representation, in addition to two medical liaisons, one of whom is responsible for ensuring the accuracy of the medical facts presented (reference and statistical review), and a medical doctor whose primary focus is on the accuracy, applicability, and medical relevance of the promotional material. The gold standard by which all promotional material is judged is the package insert (PI), which is an FDA-approved document containing indications for use, dosing and administration, safety and risk information, approval study data, and much more.

The OPDP regulations and guidance documents provide a framework within which the pharmaceutical industry can develop commercial material containing claims that are accurate, balanced, and based on the PI (“on-label”) indications. However, this framework is not always black and white. The gray area spreads wide, allowing for differences in interpretation and implementation. When this framework is breached, the OPDP can distribute an “Untitled Letter” instructing the company to which it was sent to cease promotion of the offending material immediately for the reasons outlined within the letter.

More egregious offenses receive a “Warning Letter” instructing companies not only to cease promotion, but also to “right their wrong,” which commonly involves releasing an advertisement containing corrections (a costly endeavor) and/or distributing a “Dear Healthcare Professional” letter.

Both Untitled and Warning letters are available to the public on the FDA's website and are used frequently by pharmaceutical companies to learn from others' errors. They also may prove beneficial to HCPs by bringing light to the common issues involved with pharmaceutical promotion. The most common citations issued in Untitled or Warning Letters are for promotional endeavors containing claims that overstate efficacy, including unsubstantiated efficacy claims, or portray superiority; promotional items that are misleading because of inaccuracies and/or ambiguity; and materials that contain omissions and/or minimization of safety and risk information.

Other common citations address broadening the indication for which the drug is approved or broadening the patient population for which the drug is approved, and inclusion of quality-of-life claims that are often hard to prove with substantial evidence. Promotional materials are often brought under fire for an unbalanced presentation of efficacy and safety information. Essentially, the emphasis on a drug's efficacy outweighs the important safety information, which should be distributed evenly throughout the promotional material or presentation in question.

Pharmaceutical companies are obligated to submit their promotional materials to the FDA's OPDP at the time of promotional distribution, thereby allowing promotional material to be circulating and/or presented for a long while prior to a possible citation by the OPDP. It should be noted, however, that even though submission of promotional materials is required at the time of first use, the FDA does not, in fact, review all distributed promotional materials. This remains a great reason for HCPs to be vigilant regarding pharmaceutical marketing.

There is also an option for industry to submit promotional material for preapproval, before the first use, which may be the route taken for DTCA or new website material, for example. For these materials, a breach of regulation can result in a hefty financial loss for the company because of the required remediation expenditure. The preapproval process involves review by the OPDP and provides an opportunity to receive feedback prior to the distribution of promotional material. This process, however, does not guarantee that the final promotional material will be in accordance with regulations.

Another environment recently accessed by the pharmaceutical industry is social media. This avenue of promotion is relatively new. Being so, clear guidance surrounding the development of promotional material distributed by social media does not exist, and releasing material in this way is by “trial and error,” at best. Applying print regulations to social media promotional material is exceedingly difficult, as multiple elements, such as communication on social media (e.g., consumer commentary), are not contained within print promotion. Therefore, developing social media promotional material imposes a significantly increased risk, resulting in a sector of promotion that may not be fully compliant with the OPDP recommendations.

In addition, the use of technology such as tablets by sales representatives, instead of print material, is a burgeoning development. Originally, it was believed there would be less control over the way the material was presented, and that advancements such as the ability to zoom in on certain portions of the material might leave important safety information minimized and the overall impression unbalanced. However, it was realized that there actually is an ability to obtain more control over what the sales representatives promote. For example, a detail or sales aid can be programmed to display fair balance safety “pop-ups” for a predetermined amount of time, something that a print sales aid cannot offer.

The FDA's “Bad Ad” program is a campaign that includes HCPs in the regulation of promotional activity by the pharmaceutical industry. It is a means by which questionable promotional activity can be reported directly to the FDA for review and, if necessary, for citation. With the continuing technologic advancements and increasing means by which the pharmaceutical industry can promote, HCPs can be increasingly effective in governing pharmaceutical promotion. Otolaryngologists should remain critical in their reading of pharmaceutical materials, vigilant in their search for misleading information to avoid practice errors that might affect patient care adversely, and proactive in participating in federal efforts to ensure accurate and balanced promotion of pharmaceutical products.

Drexel University College of Medicine
Ear, Nose & Throat Journal


  1. Cegedim Strategic Data. 2012 U.S. Pharmaceutical Company Promotion Spending. Updated January 2013. Accessed October 1, 2014.
  2. Kravitz RL, Epstein RM, Feldman MD ,et al. Influence of patients' requests for direct-to-consumer advertised antidepressants: A randomized controlled trial. JAMA 2005; 293 (16): 1995-2002.
Ear Nose Throat J. 2014 December;93(12):486-488