Testimonials and endorsements made by patients, healthcare professionals (HCPs) and celebrities have long been used in prescription drug advertising and promotional labeling. They are one of the most effective ways to reach and emotionally engage target audiences and drive return on investments and sales. Today, the expansion of social and digital media has made their use even more prevalent. That’s why it is critical for pharmaceutical marketers to understand the regulatory guardrails on the use of testimonials and endorsements, including the recent 2014 FDA draft guidance on interactive promotional media. The result: While endorsements and testimonials are an effective way to communicate with target populations, there are potential pitfalls.
For the purpose of this article, endorsements and testimonials will be considered synonymous, with the word “endorsements” used to describe both. Endorsements are defined by the Federal Trade Commission (FTC) as “any advertising message (including verbal statements, demonstrations, or depictions of the name, signature, likeness or other identifying personal characteristics of an individual or the name or seal of an organization) that consumers are likely to believe reflects the opinions, beliefs, findings or experiences of a party other than the sponsoring advertiser, even if the views expressed by that party are identical to those of the sponsoring advertiser.” Let’s take a look at some real world scenarios.
Risks of Celebrity Endorsements
The recent, publicized travails of Paula Deen, the former celebrity spokesperson for Novo Nordisk’s Victoza, are a good example of how celebrity endorsements may carry public relations risks. However, marketers must be aware that endorsements for prescription drugs also have regulatory risks.
Another example: Years earlier, a spotlight was placed on prescription drug endorsements by Dr. Robert Jarvik, a celebrity/healthcare professional spokesperson for Pfizer’s Lipitor. In the DTC broadcast ads that featured Jarvik, inventor of the Jarvik artificial heart, he appeared to give medical advice. However, Jarvik never had a license to practice medicine or prescribe medications. So in early 2008, the Congressional Committee on Energy and Commerce issued a letter to Pfizer expressing its concern over the Jarvik campaign that ultimately led to the discontinuation of it. The committee explained, “When consumers see and hear a doctor endorsing medication, they expect the doctor is a credible individual with requisite knowledge of the drug.”
PhRMA Guiding Principles
In late 2008, following the Jarvik controversy, Pharmaceutical Research and Manufacturers of America (PhRMA) issued an update to its 2005 Guiding Principles for Direct to Consumer Advertisements. The guidelines advised companies that any ad featuring actors in the roles of HCPs should acknowledge the HCPs are actors, or provide a compensation disclosure if actual HCPs are featured and compensated. Additionally, companies are responsible for verifying that any endorsements made by “real” patients or HCPs accurately reflect the opinions, findings or experience of the endorser.
Around the time the PhRMA principles were issued, the FTC (which has oversight of product advertising exclusive of prescription drugs) issued revisions to its Guides Concerning the Use of Endorsements and Testimonials in Advertising, intended to help advertisers comply with the Federal Trade Commission Act which empowers the FTC to prevent deceptive advertising.
False and Misleading Ads
For instance, in 1997 the FDA’s former Division of Drug Marketing, Advertising and Communications (DDMAC), now the Office of Prescription Drug Promotion (OPDP), issued a Notice of Violation to Merck for DTC materials that used images of baseball player Cal Ripken, Jr. in promotional materials for Prinivil, an anti-hypertensive agent. The ads implied that Ripken was hypertensive and using the drug, when neither was true, a fact later disclosed with less prominence. The DDMAC determined that the ads were misleading.
A review of recent enforcement letters issued by OPDP illustrates how endorsements or testimonials may render an ad false or misleading:
Quality of Life (QOL) Claims: A common citation in OPDP letters concerns statements that represent unsupported QOL claims. A 2005 Warning Letter was issued in response to a testimonial appearing on a website for Quadramet, an analgesic indicated for cancer pain. The patient stated, “Now I have time to enjoy life,” and that it can give you around-the-clock pain relief for up to 16 weeks. These claims were not supported by the pivotal trials.
Onset of Action: A testimonial for the Premarin brand of estrogen claimed, “I went to my doctor and she put me on the lowest dose of Premarin. I noticed the changes immediately.” In contrast, the pivotal trial supporting the drug’s approval did not uphold the claim of immediate symptom relief. In the trial, a statistical difference in menopause symptoms between Premarin and placebo was not demonstrated until after four weeks of treatment.
Duration of Efficacy: A Warning Letter issued for a Magic Johnson testimonial video promoting Kaletra cited the statement, “Well the good thing is, Kaletra is a part of my regimen and for five years I have been undetectable (his viral load), so I just hope that that continues.” Kaletra, indicated for HIV/AIDS, had not demonstrated efficacy in antiretroviral-experienced patients for five years or more, an implication made in the video.
Overstatement of Efficacy: A patient with multiple sclerosis (MS) appeared in a video for Ampyra, a drug indicated to improve walking speed in patients with MS. The patient made claims that with Ampyra, she was able to use her cane less frequently and could walk farther distances. That implication was not supported by the pivotal trial and was considered an overstatement of efficacy.
Minimization of Risk: The most commonly cited violation in all drug ads, including endorsements, is that of omission or minimization of risk. A webcast for Ultram, indicated in chronic pain, featured a celebrity endorsement accompanied by a physician’s discussion about pain treatment. The webcast relegated risk information to the last minute of the video. In comparison to the lively discussion promoting the drug, risk information appeared in a rapidly scrolling text format. The webcast’s net impression undermined the communication of important safety information, resulting in an OPDP Warning Letter.
Substantial Evidence Required
Marketers need to be aware when reviewing prescription drug endorsements that even if all statements are true, they must be supported by substantial evidence and consistent with the labeling. This applies even to claims that appear to constitute “normal” conversation, such as “I felt immediately better after taking Drug X.” To make this claim from a regulatory viewpoint, the sponsor must have substantial evidence, likely in the form of a pre-specified primary endpoint(s) from clinical trials for which a validated patient-reported outcome of onset of pain relief was measured. The appropriate balance of benefits with risk information is required.
Endorsements are among the most effective and enduring promotional tools and using them requires an up-to-date knowledge of all relevant guidelines. But marketers must know the potential pitfalls of using endorsements so they, in turn, can benefit from the rich communication opportunities they provide.
The opinions expressed in the article are Sullivan’s own and do not represent the opinions or policies of Boehringer Ingelheim Pharmaceuticals, Inc.