Federal health officials are now targeting telehealth companies that promote unofficial versions of prescription drugs, including popular weight loss medications. The FDA issued over 100 letters to various drugmakers and online prescribing companies, like Hims & Hers, warning them to remove “false and misleading” promotional statements from their websites. Specifically, the agency took issue with claims that compounded products contain “the same active ingredient” as FDA-approved drugs. Furthermore, the FDA also addressed misleading advertising from manufacturers of GLP-1 drugs, including an infomercial featuring Oprah Winfrey.
Read the original article here
FDA takes aim at Hims and other telehealth services in drug advertising blitz. It seems the FDA is cracking down on telehealth companies like Hims, specifically targeting their drug advertising practices. It’s not about stopping the sales of anything outright, but rather focusing on the promotional language used on these companies’ websites. The core issue is the implication that their products are the same as FDA-approved drugs, which, according to the FDA, isn’t accurate and is likely misleading.
The FDA’s approach appears to be evolving. Instead of using the usual, highly technical language, they’re issuing “cease and desist” letters. This is a more direct approach, indicating a shift in how the agency is handling these types of issues. The concern is not so much the medicines themselves, but the way they’re being marketed and presented to potential customers.
The consensus is that the ads for Hims and similar services are often over the top and even sexist. The content feels designed to prey on insecurities, be it about erectile dysfunction, weight, or hair loss. These ads, with their brash and sometimes vulgar nature, have clearly struck a nerve. Some people even stopped using streaming services because of the frequency and tone of these ads. The focus of this blitz isn’t just on the advertising, but also on the implication of equating the product with FDA-approved drugs.
Big Pharma may be behind this, with the FDA helping to protect their market share, potentially by going after the companies that make getting prescription drugs easier and cheaper. Others speculate that this could be the start of something bigger, potentially targeting telehealth services in other areas like transgender healthcare, after they’ve achieved success in restricting brick and mortar places. The feeling is that these companies are making it easier to get access to medications, but are skirting around transparency regarding the side effects of said medications.
The ads are clearly designed to make consumers feel inadequate, prompting them to seek a quick fix. This practice is considered shady and misleading. While this has created some strong opinions, the situation has to be closely examined. The core concern is around the language these telehealth companies use to promote their products. The implication that they are essentially the same as FDA-approved drugs is what’s drawing the FDA’s attention.
The FDA’s involvement is often seen as a warning letter. The FDA’s is following its standard enforcement process, and it’s not “just a letter.” The agency is involved with enforcement actions and the goal of the letters is to compel the companies to comply. It is the last step before an Injunction if the firm doesn’t quit their shit.
It’s also worth noting that the FDA is not the same as it used to be. This creates an unsettling question regarding the agency’s ability to hold the companies in question to meet its own standards. As a result, these companies might have more room to operate than they should.
The crux of the matter is that the way these telehealth companies have found a loophole is by having customized and tailored medication. A “tailored to you” prescription, for example, allows them to bypass laws. If the FDA goes after the “asterisk this product does not treat any disease and has not been approved by the FDA” clause, it could severely impact the entire supplement industry.
The consensus is that the companies are selling non-evaluated medicine. Some feel that it is a shakedown and nothing but a means of extracting money. There is a feeling that these companies are not trustworthy when it comes to medical advice and treatment.
The use of compounded medications is an important factor here, too. Telehealth companies can provide custom medication if the patient doesn’t tolerate the name brand. Compounding of identical medications was supposed to have ended late last year, but the FDA decided that tirzepatide was no longer in shortage. The availability and cost of the medication may be an important driver in this scenario.
The impact of these ads should also be addressed. They can prompt consumers to ask doctors about drugs. This strategy has worked for drugs in the past, and the goal is to get the patient asking for their trademarked drugs over alternatives and generics. The key is to get you to ask your doctor about their drug.
