WASHINGTON (AP) — For the primary time, federal well being officers are taking purpose at telehealth firms selling unofficial variations of prescribed drugs — together with standard weight reduction medicines — as a part of the Trump administration’s crackdown on pharmaceutical promoting.
The Meals and Drug Administration on Tuesday posted greater than 100 letters to numerous drug and on-line prescribing firms, together with Hims & Hers, which has constructed a multibillion-dollar enterprise centered round lower-cost variations of blockbuster weight problems injections.
The FDA warned the corporate to take away “false and misleading” promotional statements from its web site, together with language claiming that its personalized merchandise include “the same active ingredient” as FDA-approved medication Wegovy and Ozempic. The formulations cited by regulators are produced by specialty compounding pharmacies and are not reviewed by the FDA.
“Your claims imply that your products are the same as an FDA-approved product when they are not,” states the warning letter, dated Sept. 9.
San Francisco-based Hims mentioned Tuesday that it “looks forward to engaging with the FDA.”
“Our website and our customer-facing materials note that compounded treatments are not approved or evaluated by the FDA,” the corporate mentioned in an announcement.
It’s the primary FDA try to instantly police on-line platforms like Hims, which have lengthy argued they’re not topic to conventional drug promoting guidelines.
A memo signed by President Donald Trump final week directed Well being Secretary Robert F. Kennedy Jr. and the FDA to make sure that pharmaceutical adverts on TV, social media and different web sites are “truthful and non-misleading.” As a part of the initiative, the FDA promised to ship 100 letters to firms with misleading adverts.
The brand new FDA letters every include “cease and desist” language. That’s a special method for the company, which generally drafts its letters in extremely bureaucratic language citing particular FDA laws.
Hims has been below scrutiny from Washington for months.
Earlier this 12 months, a Tremendous Bowl advert from the corporate touted the advantages of its weight-loss medicines however did not record any of their unwanted effects or potential harms. FDA guidelines require commercials to current a balanced image of drug dangers and advantages.
Makary singled out the advert in final week’s Journal of the American Medical Affiliation, calling it a “brazen” instance of how promoting is “contributing to America’s culture of overreliance on pharmaceuticals for health.”
Hims and comparable firms initially bought low-cost generic variations of medication for hair loss, erectile dysfunction and different well being points. However booming demand for weight problems medicines opened the door to promoting cheaper copies.
The FDA permits so-called compounding, or personalized manufacturing, when there’s a scarcity of the official variations of FDA-approved medicines.
FDA not too long ago decided that the GLP-1 medication not met the factors for a scarcity. That ought to have ended the compounding, however there may be an exception: The apply remains to be permitted when a prescription is personalized for the affected person.
Hims and different firms have taken to providing “personalized” dosages and formulations for sure sufferers, arguing they provide additional advantages.
The letters posted Tuesday come from FDA’s drug heart.
A letter posted final week from FDA’s vaccine division took subject with a TV advert for AstraZeneca’s FluMist vaccine, saying the spot’s “background music and visual distractions” detract from details about unwanted effects. The letter was signed by FDA vaccine chief Dr. Vinay Prasad, an ally of Kennedy who not too long ago returned to his job on the company after briefly being compelled to step apart.
Researchers and shopper advocates have lengthy complained that the upbeat TV photos of sufferers having fun with life with household and associates usually overshadow discussions of unwanted effects.
Moreover, research have proven that sufferers uncovered to drug adverts usually tend to ask their docs concerning the medicine, even when they don’t match the prescribing standards. The American Medical Affiliation, the nation’s largest doctor group, got here out in help of a ban in 2015, citing TV promoting’s position in “inflating demand for new and more expensive drugs.”
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The Related Press Well being and Science Division receives help from the Howard Hughes Medical Institute’s Science and Instructional Media Group and the Robert Wooden Johnson Basis. The AP is solely accountable for all content material.
