Washington (AP) – For the first time, federal health officials are aiming for it Telehealth companies Promoting an informal version of prescription drugs that include popular weight loss drugs – as part of Trump administration crackdown About drug advertising.
On Tuesday, the Food and Drug Administration posted more than 100 letters to various drug and online prescribing companies. Hims & Herswhich built a multi-billion dollar business centered around a low-cost version of BlockBuster. Obesity injection.
The FDA warned the company to remove “falsely misleading” promotional statements from its website, including languages that claim that customized products contain “same active ingredients” as FDA-approved drugs Wegovy and Ozempic. The formulations cited by regulatory authorities are produced by specialized pharmacies and have not been reviewed by the FDA.
“Your claim means your product is the same as an FDA approved product,” the September 9 warning letter stated.
This is the first FDA attempt directly from police Online Platform Like HIMS, for a long time they have argued that they are not subject to drug advertising rules.
Notes signed by the President Donald Trump Last week’s director Health Secretary Robert F. Kennedy Jr. And FDA to ensure that TV drug adssocial media and other websites are “true and unimitation.” As part of the initiative, the FDA has pledged to send 100 letters to companies with deceptive ads.
Each new FDA character contains a “stop, stop” language. This is a different approach for agencies that draft letters in a highly bureaucratic language citing certain FDA regulations.
HIMS has been scrutinized by Washington for several months.
Early this year, Super Bowl Advertisements from the company promoted the benefits of weight loss medications but did not list any side effects or potential harms. FDA rules require that advertisements present images that balance the risks and benefits of drugs.
McCulley picked the ads in last week’s American Medical Association journal, calling them a “brave” example of how ads “contribute to American culture that relies on medicines for health.”
San Francisco-based HIMS did not immediately respond to requests for comment Tuesday morning.
HIMS and similar companies first sold cheap generic versions of drugs for hair loss, erectile dysfunction and other health issues. However, as demand for obesity drugs increased, the door opened to selling cheaper copies.
The FDA allows for so-called composite or customized production if there is a shortage of official versions of FDA-approved drugs.
The FDA recently determined that GLP-1 drugs have not seen them anymore The criteria for shortage. It should end compound interest, but there are exceptions. Practice is still permitted if the prescription is customized for the patient.
HIMS and other companies claim to provide “personalized” doses and formulations to certain patients, providing additional benefits.
The letter posted Tuesday comes from the FDA’s drug center.
A letter posted last week from the FDA’s vaccine division was having problems with TV ads AstraZeneca’s The flamist vaccine says spot’s “background music and visual distraction” will damage information about side effects. The letter was signed by the chief of the FDA vaccine Dr. Vinai PrasadKennedy’s allies recently returned to his job at the agency after being forced to step aside.
Researchers and consumer advocates have long complained that bright TV images of patients enjoying life with family and friends often overshadow discussions of side effects.
Furthermore, studies have shown that patients exposed to drug ads are more likely to ask their physician about drug therapy, even if they do not meet prescription criteria. American Medical Associationthe country’s largest group of doctors came out in 2015 in support of the ban.
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