Sen. Jim Banks (R., Ind.) wants the new leadership of the Food and Drug Administration (FDA) to build off of previous FDA actions that looked into what he called \u201cmisleading advertising by Hims & Hers Health, Inc. and other online pharmacies and telehealth providers.\u201d<\/p>\n
While Hims & Hers made national headlines during the Super Bowl for its advertisements, Banks is concerned that its products don\u2019t live up to their billing. \u201cHims & Hers has heavily promoted compounded GLP-1 products, including a copycat oral \u2018Wegovy pill,\u2019 making claims such as \u2018the same active ingredient as Ozempic and Wegovy,\u2019\u201d Banks wrote to acting Commissioner Kyle Diamantas in a letter obtained exclusively by the Washington Reporter.\u00a0<\/p>\n
\u201cDuring the 2025 and 2026 Super Bowls, Hims & Hers ran ads touting its compounded GLP-1s while denigrating FDA-approved, name-brand drugs,\u201d Banks continued. \u201cThese ads made efficacy claims which may be exaggerated, such as highlighting 20% weight loss when average results are lower, and they may have omitted critical safety information.\u201d<\/p>\n
The FDA, under Acting Commissioner Kyle Diamantas, has been already been praised by many, including by the editorial board<\/a> of the Reporter, for advancing President Donald Trump\u2019s healthcare-related policies, which include massive reshoring of pharmaceuticals.\u00a0<\/p>\n But, Banks wants Diamantas and his agency to double down. The freshman senator is asking the FDA to investigate whether Hims & Hers\u2019s Super Bowl ads, \u201cand similar advertisements comply with FDA advertising regulations,\u201d as well as \u201cwhat scientific evidence did Hims & Hers rely on to support the safety and efficacy of its copycat oral \u2018Wegovy pill\u2019?\u201d<\/p>\n Banks is similarly concerned that \u201cHims & Hers continued marketing compounded GLP-ls using the same language that the FDA had previously warned was false or misleading,\u201d only for it to \u201cpull the \u2018Wegovy pill\u2019 off the market three days after launching it.\u201d<\/p>\n As Americans increasingly turn to GLP-1 products to help with weight loss, Banks noted that Hims & Hers is not the only potential issue. He also wants the FDA to look into \u201cwhether other GLP-1 products currently offered by Hims & Hers and other online pharmacies and telehealth providers are marketed using false or misleading claims.\u201d<\/p>\n But, Banks does single out Hims & Hers for specific criticisms when it comes to the companies \u201cpricing practices [which] raise questions.\u201d For example, he noted, \u201cthe company\u2019s subscription practices deserve scrutiny. Its multi-month medication plans reportedly provide no refunds for unshipped or unused product, even upon cancellation, locking patients into costly commitments.\u201d<\/p>\n Another example is that \u201cpublic reporting and company disclosures show the company has charged patients $1,899 per month for Eli Lilly\u2019s FDA-approved Zepbound (tirzepatide) KwikPen, which is more than 500% higher than the most-favored-nation cash prices now available through TrumpRx and other manufacturer-sanctioned platforms,\u201d Banks wrote. \u201cAt the same time, Hims & Hers has aggressively marketed compounded alternatives at significantly lower prices, even after the FDA declared the GLP-1 shortage resolved and issued the company formal warnings.\u201d\u00a0<\/p>\n This, Banks noted, flies in the face of Trump priorities, including his ever-expanding TrumpRx program. \u201cAdditionally, Hims & Hers previously offered Novo Nordisk\u2019s FDA-approved products Wegovy and Ozempic at prices well above TrumpRx and only reduced these prices to TrumpRx levels following litigation with Novo Nordisk. However, even after this, Hims & Hers did not reduce its price for Zepbound.\u201d<\/p>\n To that end, Banks does have Hims & Hers-specific questions that he wants the FDA to further investigate. He wants to know \u201cwhether Hims & Hers\u2019 pricing strategy may be intentionally steering patients toward more profitable compounded drugs and whether this is clinically appropriate,\u201d as well as \u201cwhether Hims & Hers\u2019 subscription practices are appropriate for a prescription drug and whether patients understand their terms.\u201d<\/p>\n Banks also wants a multi-agency investigation into whether Hims & Hers is undercutting Trump\u2019s goals in TrumpRx, writing that he would like the FDA, \u201cin consultation with the Federal Trade Commission, [to determine] whether these pricing practices are intentionally undermining TrumpRx.\u201d<\/p>\n Banks noted that this follows a pattern of deceptive advertising from Hims & Hers, which he wrote may also violate the Federal Food, Drug, and Cosmetic Act (FFDCA).\u00a0<\/p>\n \u201cThe FDA previously issued a warning letter to the company on September 9, 2025, stating that such claims are false or misleading under the FFDCA,\u201d he wrote. \u201cHims & Hers subsequently pulled its compounded oral pill from the market after Novo Nordisk filed a patent-infringement lawsuit and the Department of Health and Human Services (HHS) referred the matter to the Department of Justice.\u201d\u00a0<\/p>\n Moves by the FDA to enforce the FFDCA are \u201cimportant to inform and protect patients, particularly in light of the large quantities of compounded GLP-1 drugs currently being distributed by such companies,\u201d Banks explained. \u201cI continue to be concerned that many of these companies are ignoring accurate labeling requirements and skirting current good manufacturing practices while misleading the public, and such requirements may not be stringent enough.\u201d<\/p>\n For months, Banks has long been one of TrumpRx\u2019s biggest proponents, which is why his criticisms of Hims & Hers\u2019s practices are expected to carry significant weight.<\/p>\n \u201cI applaud the Trump administration\u2019s efforts to make prescription medicines, including GLP-1s more affordable and accessible,\u201d he concluded. \u201cTrumpRx is an important step forward for greater price transparency. I encourage the FDA to remain vigilant as to whether Hims & Hers and other companies may be misleading the public.\u201d<\/p>\n Hims & Hers is itself no stranger to controversy and to opposing Trump priorities. After the terrorist attacks of October 7, 2023, its CEO said that the company is \u201ceager\u201d to hire anti-Israel students. The company immediately lost<\/a> $210 million in stock value.<\/p>\n","protected":false},"excerpt":{"rendered":"Sen. 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