After neatly wrapping up concerns over a series of Emgality ads last month, Eli Lilly is back in hot water with the FDA's Office of Prescription Drug Promotion.
The FDA gave Lilly a slap on the wrist for an Instagram post about its top-selling diabetes med, Trulicity. This marks the second round of advertising trouble since December for the Indianapolis-based drugmaker. The prior entanglement was over TV spots for Lilly's migraine treatment, Emgality, and was quickly resolved.
Lilly has been quick to take action on Trulicity as well. "The subject ad was immediately removed from the Trulicity Instagram account the same day the letter was received, and we will be providing the FDA a full response to ensure the issue is addressed," an Eli Lilly spokesperson said over email.
In the untitled letter, which the FDA sent on Jan. 19, the regulator said that after reviewing the Instagram ad "10,080 Minutes," and upon receiving a complaint to its Bad Ad Program, it found that the social media post "makes false or misleading claims and representations about the benefits and risks of Trulicity." The letter was first reported by Stat News.
The violations are "especially concerning" because the post elicits "a misleading impression regarding the safety and effectiveness of Trulicity, which is a drug with multiple serious, potentially life-threatening risks including a boxed warning for the risk of thyroid C-cell tumors," the FDA said in its letter.
So, what exactly was the FDA's problem with Lilly's post on the 'Gram? According to the agency, the video portion of the post "prominently communicates" Trulicity's ability to help "lower A1C along with diet and exercise" but fails to thoroughly communicate the drug's indication and limitations of use.
The regulator took umbrage with the "What is Trulicity" section of the medication guide, which sped over details about Trulicity's blood-sugar-lowering potential specifically in adults with Type 2 diabetes as well as the fact that it can't be used as a substitute for insulin or for Type 1 diabetes.
The FDA specifically flagged the "suggestion that Trulicity will help 'lower A1C' in all patients, when this has not been demonstrated."
Furthermore, the indications and limitations were displayed in small, fast-paced scrolling font in a small window below the video, "relegated" to the bottom of the post, the FDA said. There, the agency alleges, the information had to compete for consumers' attention against "several distracting video elements," such as fast-paced visuals, frequent scene changes, busy scenes, large-moving superimposed text and a "strong fast-moving musical beat."
The post also fails to include details about the warning of hypoglycemia in patients using insulin or insulin secretagogues. The ad states that a patient's risk for low blood sugar "may be higher if you use Trulicity with another medicine that can cause low blood sugar, such as sulfonylurea or insulin," the FDA says in its letter.
"The overall effect of this presentation undermines the communication of the important risk information and thereby misleadingly minimizes the risks associated with the use of Trulicity," the FDA said.
The regulator has asked Lilly to respond to its letter within 15 days. The company needs to include Trulicity promotional materials that fall under the concerns laid out in the FDA's letter, alongside a plan for discontinuation of those communications.
"We are conducting a full review of all active Trulicity promotional materials, and any materials that contain representations described in the letter will be revised or discontinued," Lilly's spokesperson said.
"The appropriate use and promotion of our medicines is of the utmost importance at Lilly, and we are committed to complying with all applicable laws and regulations," the spokesperson added.
Meanwhile, this isn't the first time Lilly's run into marketing trouble with Trulicity. The FDA pointed out in its letter that it's reached out five times since 2014 on concerns that Lilly isn't promoting the diabetes med "in a truthful and nonmisleading manner."
Lilly last month received another complaint from the FDA. That case concerned a series of ads for its migraine drug, Emgality, which Lilly did not submit to the agency correctly before airing, according to STAT. Drugmakers usually don't have to win approval from the FDA for their ads but often submit them to the regulator for opinions, often to avoid trouble in the future, the publication notes.
As for the Emgality brouhaha, the FDA was originally concerned that Lilly hadn't included any risk information in the series of Emgality TV spots. Lilly went on to explain, however, that risk information was included in a series of 3 ads, which were meant to run together. The FDA considered the matter resolved in a follow-up letter but reminded Lilly to submit a copy of future promotional material "in its entirety" moving forward.
Editor's note: This story has been updated with comments from Eli Lilly.