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Why is FDA Quiet About the Off-Label Promotion of Ozempic? Ozempic Vs Viagra
(Thursday, April 20, 2023) The media frenzy driven by social media posts describing the off-label use of Ozempic and similar drugs for weight loss has seemingly caught the FDA off-guard. This is a classic case of where off-label promotion of a product by sources independent of the manufacturers has yielded excessive riches for the manufacturers. The hype around weight loss drugs such as Ozempic seems very similar to that around Viagra when it (Viagra) was launched almost 25 years ago. Viagra shifted the conventional paradigm at the time around male sexual health issues bringing an almost taboo topic to the mainstream public discussion. Ozempic and drugs like this are doing the same about obesity. For decades discussion about obesity has yoyoed between that about healthy lifestyle and that about fat-shaming. Now with drugs that can help you lose weight without worrying about what you eat and how you live your life, weight loss could potentially become a purely medical issue that can be addressed with drugs, similar to male sexual health being a purely medical issue treatable with medications like Viagra. The difference is that unlike Viagra where most of the marketing was closely watched by the FDA, Ozempic’s rise has been fueled by off-label social media endorsements primarily by celebrities touting quick weight loss with a monthly treatment with minor side effects. Wegovy and, most recently Mounjaro had added to the market frenzy. Having multiple drugs treat weight loss would increase the social acceptability of these drugs for a condition so far considered sensitive topic lest one get accused of fat shaming. And weight loss is a much bigger market that male sexual health. At its peak, Viagra made about $2 Billion in sales annually; while both Ozempic and Wegovy made about $5 Billion each for their manufacturer, Novo Nordisk, and Mounjaro is projected to fetch about $25 billion per year. The quick rise of these drugs almost entirely driven by social media and news cycles filled with talks about the wonder weight loss drugs, mostly via off-label use, have hyped up the demand so high that all these drugs are currently in short supply. And the FDA was/is unprepared for this event. While the off-label use is rampant, FDA has not even cared to release a public interest announcement telling consumers to let the regulatory processes play out till these drugs are found safe and effective by the Agency for all unlike the currently smaller populations for which these are approved. Or perhaps the FDA’s non-action is its tacit approval of the wider use. This is another example of an Agency that keeps working like a black box contrary to its claims of being transparent. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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