Washington – For the first time, federal health officials aim Health care companies Enhancing informal versions of prescribed drugs – including popular weight loss drugs – as part of Trump administration campaign On pharmaceutical ads.
On Tuesday, the Food and Drug Administration published more than 100 messages to various companies describing online, including Shake & she hasWhich were built with billions of dollars centered on low -cost versions of unpleasant scent films Obesity.
The Food and Drug Administration (FDA) has warned the company against removing “wrong and misleading” promotional data from its website, including the language that claims that allocated products contain the “same active ingredient” as the drugs approved by FDA Wegovy and OzemPIC. The preparations mentioned by the organizers are produced through specialized pharmacies and are not reviewed by the FDA.
“Your allegations indicate that your products are the same as a certified product from the FDA (FDA) when they are not,” says the warning letter, on September 9.
“He is looking to engage with the FDA.”
“Our website has not been approved on the Internet and our materials facing customers that complex treatments were not approved or evaluated by the Food and Drug Administration,” the company said in a statement.
It is the first attempt to manage the food and drugs directly Online platforms Like a shake, who has long argued that they are not subject to the rules of advertising traditional drugs.
A memorandum signed by the president Donald Trump Exit last week Health Minister Robert F. Kennedy Junior. And FDA to ensure this Pharmaceutical ads on TVSocial media and other websites “honest and unaccounted”. As part of the initiative, the Food and Drug Administration promised to send 100 messages to the deceptive ads companies.
The new FDA letters contain a “stop and stop” language. This is a different approach to the agency, which usually affects its messages in a very bureaucratic language indicating specific regulations from the Department of Food and Drugs.
HIMS was under check -up from Washington for several months.
Earlier this year, a Super Ball The company described the benefits of weight loss medications, but none of its side effects or possible damage was included. FDA rules require advertisements to provide a balanced image of drug risk and benefits.
Makary dedicated the announcement in the American Medical Association magazine last week, describing it as an “rude” for how “advertising” in a culture of dependence on medicines in America. “
HIMS and similar companies initially sold cheap public versions of hair loss, an erection dysfunction and other health issues. But the prosperous demand for obesity medications has opened the door to sell cheaper copies.
FDA allows the so -called compound or dedicated production, when there is a shortage of official versions of the drugs approved by the FDA.
FDA recently decided that the GLP-1 drugs no longer meet Discussion standards. That boat should have ended, but there is an exception: the practice is still permitted when allocating a prescription for the patient.
HIMS and other companies have taken “dedicated” doses and installments to some patients, on the pretext that they provide additional benefits.
The messages published on Tuesday come from the Drug Center in the Food and Drug Administration.
A message published last week from the Food and Drug Administration Department (FDA). Astrazeneca’s Flumist vaccine, saying that “background music and visual deviations” detract from information about side effects. The message was signed by the head of the FDA vaccine Dr. Vina BrasadKennedy’s ally, who recently returned to his job at the agency after he was briefly forced to step down.
The researchers and consumer advocates have complained that optimistic TV images of patients who enjoy life with family and friends often overwhelm discussions about side effects.
In addition, studies have shown that patients exposed to drug ads are likely to ask their doctors about the drug, even if they are not commensurate with the description criteria. the American Medical AssociationThe largest group of doctors in the country appeared to support a ban in 2015, noting the role of the TV advertisement in “amplifying the demand for new and most expensive drugs.”
___
The Ministry of Health and Science at Associated Press receives support from the Houard Hughes Institute. AP is the only responsible for all content.