OPDP Cites Risk Presentation Issues in YouTube Video, Email in New Enforcement Letters

Oct. 7, 2019 – Promotional materials are false or misleading not only if they make efficacy claims that are unsupported, but also if they fail to bring to light the risks associated with use of the product, the FDA’s Office of Prescription Drug Promotion said in two enforcement letters issued in September to address claims made in a YouTube video and a professional email.

“These latest FDA enforcement letters are especially important and interesting, in that they reflect a focus on information shared through a YouTube video posted on the Internet, as well as an apparent failure to take seriously a prior FDA warning about inappropriate messaging,” stated Jon Bigelow, executive director of the Coalition for Healthcare Communication.

In a Sept. 24 Untitled Letter to Kowa Pharmaceuticals America Inc. OPDP stated that a direct-to-consumer patient testimonial video montage posted on for Livalo® (pitavastatin) tablets – indicated as an adjunct therapy to diet to treat high cholesterol – makes false or misleading claims because it “creates the misleading impression regarding the side effects a patient may experience as a result of Livalo treatment and deemphasizes the risks associated with taking the drug.”

Specifically OPDP states that patient testimonials in the video claim that other statin medications had negative side effects and Livalo did not, and that this presentation “misleadingly suggests that Livalo is safer than its competitors by implying that patients switching to Livalo from other statins will experience a reduction in side effects compared to other statins, or no side effects at all.”

Even though the video included superimposed text (SUPER) saying that “individual results may vary,” OPDP states that this SUPER does “not mitigate the misleading impression. Further, this impression “is especially concerning given that Livalo is associated with serious risks, several of which are the same as those associated with other statins,” according to OPDP.

The agency also takes issue with benefit claims in the YouTube video that are presented prominently when risk information is “presented as scrolling text relegated to the bottom of the video” during patient testimonials, which OPDP states “also compete for the consumers’ attention, making it difficult for them to adequately process and comprehend the risk information.”

In a Sept. 13 Warning Letter to Galt Pharmaceuticals LLC, OPDP asserts that a professional email for Doral® (quazepam) tablets – indicated for the treatment of insomnia characterized by a difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings – makes false or misleading claims and/or representations about the risks associated with and the efficacy of the product, which is a controlled substance and bears a Boxed Warning due to serious, life-threatening risks from concomitant use with opioids.

OPDP notes that it previously expressed concerns regarding Doral promotional materials to the prior application holder (Sciecure Pharma Inc.) in an Oct. 29, 2014, Untitled Letter. “OPDP is concerned that Galt is continuing to promote this product in a similarly violative manner,” according to the recent Warning Letter.

The professional email includes “numerous claims and presentations regarding the benefits of using Doral for the treatment of insomnia,” OPDP states. “However, it completely omits the warning and precaution regarding benzodiazepine withdrawal syndrome,” which is listed in the Warnings and Precautions section of the product labeling, as well as other information from that section.

OPDP acknowledges that the email includes the statement “For a full list of warnings and precautions, please refer to the full prescribing information,” but does not find that statement sufficient “to mitigate the omission of the aforementioned risk information from the email.”  OPDP also asserts that statements made in the email about the abuse potential of the product are misleading “because they minimize the risks of abuse and dependence associated with Doral and suggest that this C-IV scheduled drug is superior in safety to other prescription and over-the-counter products.”

This misleading impression “is compounded by the fact that the email fails to disclose Doral’s potential for abuse and dependence. … This is alarming as it appears that Galt is intentionally attempting to promote Doral as a non-controlled product that is safer than over-the-counter medication,” according to OPDP.

The agency also takes issue with a claim in the email that Doral is “the only” marketed medication for insomnia that helps difficulty falling asleep, difficulty staying asleep and early morning awakening, stating that there are other marketed products that are indicated for all three of these sleep components.

Additionally, the email omits material information from the Indications and Usage section of the product labeling that states that the prolonged administration of Doral is generally not necessary and recommended because insomnia is often transient and intermittent, and that insomnia may be a symptom of several other disorders.

“These omissions are particularly concerning from a public health perspective due to the serious health risks associated with Doral that should be considered when prescribing the product,” the Warning Letter states.

To date in 2019, OPDP has issued two Warning Letters and five Untitled Letters; this total of seven enforcement letters now equals the seven enforcement letters issued by OPDP in 2018.