A new study reported that Novo Nordisk spent $7.5 million over 2 years on more than 15,000 internet keywords — many focused on weight loss — that drove 2.4 million paid visits to its Ozempic.com website even though Ozempic (semaglutide) isn’t approved by the FDA for weight loss.
In this advertising strategy, companies bid on keywords or phrases related to their businesses that people might use in an internet search. The product or website of the winning company (or companies) appears as the “sponsored” result at the top of the search engine page. The practice — often called “pay-per-click advertising” because the winning company or companies only pay when users click on their sponsored product or website — is a way to drive internet traffic.
The authors of the study — published online in JAMA Network Open — contend that it’s a strategy to prompt patients to “initiate conversations with their clinicians that lead to a prescription.”
A Novo Nordisk spokesperson said that pay-per-click is a way to “to reach consumers interested in exploring treatment options and is rooted in educating consumers on the FDA-approved uses for our products.”
The FDA currently provides guidance on how companies can use social media to market products, but it does not offer such guidance on search engines, noted Daniel Eisenkraft Klein, PhD, at the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital, Boston, and colleagues in the article. The agency could issue new rules or review pay-per-click content “to prevent patients from being misled,” they added.
Novo Nordisk spokesperson Liz Skrbkova took issue with the implication that keyword bidding is unethical or against FDA marketing rules. The company suggested that the practice is common among drug makers.
“A lot of companies do this,” said Dara Katcher Levy, a Washington, DC-based food and drug law attorney who advises manufacturers on promotional issues. The FDA has communicated to industry that paying for keyword search terms is not considered promotional, Levy told Medscape Medical News.
But the agency has cited some companies for not meeting all the requirements for the sponsored ads that result from the searches, she said.
Adriane Fugh-Berman, MD, director of PharmedOut, told Medscape Medical News that the search-word strategy “is a subtle form of off-label marketing.”
The FDA prohibits discussion or promotion of off-label uses of approved medications.
Michael DiStefano, PhD, a bioethicist and assistant professor at the University of Colorado Anschutz Skaggs School of Pharmacy and Pharmaceutical Sciences in Aurora, Colorado, said he is more concerned about “the proliferation of entities not overseen nearly as carefully by the FDA,” such as compounders offering GLP-1s and off-label uses of medications, such as ketamine, for mental health or pain conditions.
Keywords That Drove Traffic
Klein and colleagues used a publicly available database to investigate how internet searchers might end up at Ozempic.com, an official Novo Nordisk website, over the study period, from April 2022 to March 2024.
They reported Novo Nordisk bid on keywords that might be used by people looking for a weight-loss drug or who might be searching “Ozempic” or the names of competing GLP-1s, including Trulicity and Mounjaro, both made by Eli Lilly.
The researchers found that 3500 (23%) of the 15,000 keywords did not mention Ozempic. The keywords that drove the most searchers to Ozempic.com were “Ozempic for weight loss” and “Ozempic weight loss,” and Novo Nordisk spent $302,757 and $188,626 on them, respectively, during the study period. The company also spent $203,578 on “Trulicity” and $113,668 on “Mounjaro.”
Ozempic is only FDA approved for type 2 diabetes. Wegovy, also made by Novo Nordisk, is the only brand of semaglutide approved for weight loss.
The authors wrote that pay-per-click advertising “prioritizes company websites over other sources, an outcome that may not be apparent to users expecting search results to reflect informational relevance or objectivity.”
Manufacturers’ websites “inevitably emphasize medications’ benefits, risks, and alternatives in ways designed to drive prescriptions,” Klein and colleagues wrote.
Clicks Aren’t Guaranteed
A query with the keywords that Novo Nordisk bid on could potentially present a “sponsored” result of Ozempic.com near the top of a search. But not always.
Pay-per-click advertising may bring up different results for different users, based on browsing history and other information collected by the search engine, DiStefano noted. While Ozempic.com might appear first for some users, it could appear lower down on a search page or even on the second page of a search for others.
Levy said “the user has the choice as to whether or not they want to click on [the sponsored ad] to get additional information.” If someone lands on a manufacturer’s website, like Ozempic.com, it is “a website that presumably is clear and balanced and truthful and nonmisleading” because that is what the FDA requires for drug advertising, she said. Many manufacturers seek FDA’s input on an ad before it is published or broadcast, but pre-publication submission is not required.
Novo Nordisk’s keyword strategy is “in compliance with US laws and FDA regulations, and in accordance with our high ethical standards,” Skrbkova said.
DiStefano said that “in a weird way, I might feel better about people who search ‘Ozempic for weight loss’ being sent to the Ozempic.com site, instead of some telehealth site or medspa site that is probably more likely to have false or misleading claims.” The FDA scrutinizes manufacturer advertising more closely than telehealth or medspa sites, he said.
Objectivity Questioned
Although the information on a site like Ozempic.com might be vetted by the FDA, it is not necessarily neutral, said Fugh-Berman, a professor of pharmacology and physiology at Georgetown University Medical Center, Washington, DC.
“The language in the label is negotiated between the drug company and the FDA,” she said. “You don’t go to a drug company website if you want objective information about drugs.”
The strategy described in the JAMA study “is meant to increase prescriptions — that’s the purpose of it,” she said. Like the study authors, she agreed that the FDA should issue clearer guidelines on search engines, including pay-per-click advertising.
The study’s structure as a single-case analysis limits its generalizability, the authors noted. “The relatively modest spending observed may reflect regulatory caution, strategic targeting, or reliance on other digital channels,” they added.
One study author reported receiving research support from Arnold Ventures and declared serving as an expert witness in a case against pharmacy benefit managers and cases against two pharmaceutical manufacturers. DiStefano reported no conflicts. Fugh-Berman reported that she has appeared as an expert witness in pharmaceutical marketing cases, most recently in a trial against Novo Nordisk.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.