Hims & Hers Responds To FDA Pressure, Cancels Wegovy Drug Launch After Regulatory Threats

hims-&-hers-responds-to-fda-pressure,-cancels-wegovy-drug-launch-after-regulatory-threats

update from Vidianews

Following threats from the Food and Drug Administration (FDA) that it would take “decisive” measures against companies selling “illegal drugs copied”, telehealth company Hims & Hers announced it would pull the launch of its counterfeit weight-loss drug Wegovy.

“Since launching the semaglutide compound pill on our platform, we have had constructive conversations with industry stakeholders,” Hims & Hers said on Saturday. “As a result, we have decided to stop offering access to this treatment”.

The FDA named Hims & Hers in its Friday announcement, saying, “These actions are intended to protect consumers from drugs that the FDA cannot verify for quality, safety, or effectiveness.” We take any potential violations of the Federal Food, Drug, and Cosmetic Act seriously. »

Hims & Hers’ move also comes as Novo Nordisk has threatened legal action over the cheaper version of its diet pill, which has not been approved by the FDA or undergone clinical trials.

NEW WEGOVY PILL OFFERS NEEDLE-FREE WEIGHT LOSS BUT MAY NOT WORK FOR EVERYONE

Hims & Hers Health, Inc. is shown outside the New York Stock Exchange on January 21, 2021. (Reuters/Carlo Allegri / Reuters)

Hims & Hers announced Thursday that it will begin selling its compound version of Wegovy de Novo at an introductory price of $49 per month, about $100 less than the original, and the lowest price for a GLP-1 weight loss drug in the American market.

Teleprinter Security Last Change Change % HIM HIMS & HERS HEALTH INC. 23.02 -0.46 -1.96% Compounded medications involve pharmacies mixing the ingredients of certain specialty medications in different dosages to make a copied medication. This process has intensified in the United States, because Americans want cheaper drugs.

Shares of Novo initially fell after Hims’ announcement on Thursday, but then recovered and shares of Hims fell after the FDA’s announcement on Friday.

PFIZER CEO ADDRESSES GROWING COMPETITION IN WEIGHT LOSS DRUG

Head office of the pharmaceutical company Novo Nordisk in Bagsvaerd, Copenhagen, Denmark. (Reuters/Tom Little/File photo)

Hims did not say whether it plans to continue selling its compound GLP-1 injection on its website.

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Novo and Hims previously had a partnership that allowed Hims to sell Wegovy, but Novo withdrew after accusing Hims of marketing counterfeit Wegovy medications.

Hims CEO Andrew Dudum accused Novo of trying to control how Hims clinicians make decisions.

Reuters contributed to this report.

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