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Telehealth company Hims & Hers announced they will begin selling off-brand GLP-1 drugs similar to Ozempic and Wegovy at a significantly lower price. FreshSplash/Getty Images
  • Hims & Hers is now selling compounded semaglutide for weight loss.
  • They are offering prices that are significantly lower than Wegovy and Ozempic.
  • This could be a boon for consumers since it fills a gap in supply.
  • However, people should be aware that compounded semaglutide is not FDA-approved.
  • Compounded medications undergo less extensive testing than brand-name drugs.

On May 20, 2024, Hims & Hers announced that it will now be selling a compounded version of Novo Nordisk’s popular diabetes and weight loss drugs Ozempic and Wegovy.

Their compounded version of the GLP-1 drug semaglutide will be prescribed by a physician through their own telehealth platform.

With low prices starting at $79 per month for its oral medication kits and $199 per month for injections, these weight-loss medications are significantly less expensive than the brand-name drugs. Ozempic has a list price of $935.77, while Wegovy is available at $1,349.02 per package.

Wegovy, which is the only brand of semaglutide that is currently approved for obesity treatment, has experienced soaring demand. According to The Wall Street Journal, sales more than doubled during the first quarter of this year.

As a result, the U.S. Food & Drug Administration (FDA) reports continuing shortages of Wegovy injections, including the 0.25 mg/0.5 mL, 0.5 mg/0.5 mL, and 1 mg/0.5 mL formulations.

In an interview with CNBC, Andrew Dudum, CEO of Hims & Hers, stated that the company has partnered with one of the largest manufacturers of generics in the U.S. in order to ensure that they would not fall prey to supply issues.

“We have a certain degree of exclusivity with that facility that will guarantee our consumers consistent volume and supply,” he told the news outlet.

According to Dr. Michael O. McKinney, a weight-loss physician at Healthy Outlook in Jacksonville, Florida, the availability of affordable compounded semaglutide through Hims & Hers could be a boon for consumers.

“By adopting this low-priced alternative, the company may open up a market where even more people can afford Ozempic and Wegovy, used in weight loss therapy,” he remarked.

Compounding is a process in which ingredients are combined, mixed, or altered in order to create a medication.

“Unlike commercially manufactured semaglutide products such as Ozempic and Wegovy, compounded semaglutide is made in a compounding pharmacy by a licensed pharmacist,” said McKenny.

“This allows adjustments to be made regarding dosage, form, or ingredients used depending on the individual requirements of the patient,” he added.

One common reason for compounding medications is when a person is allergic to an inactive ingredient in a commercially available medication. The medication can be custom-formulated to contain the active ingredient without any undesirable additives.

In the case of a medication shortage such as with Wegovy, compounding is also a way to increase the available supply of a needed drug.

One other important distinction between compounded medications and those made by large manufacturers is the fact that compounded medications like semaglutide are not approved by the FDA.

“The FDA approval process applies to mass-produced medications and involves rigorous testing to ensure safety, efficacy, and quality,” said McKinney. Compounded drugs do not go through this long approval process.

Dr. Kubanych Takyrbashev, Health & Wellness Advisor at NAO, said there are some concerns when using compounded drugs.

One problem is a lack of recourse if you experience an adverse reaction or an issue with quality.

Normally, you would be able to report any such problems to the FDA, which could then take action to fix them. With compounded medications, you don’t have this same regulatory mechanism to assist you.

“They might have to rely on the compounding pharmacy’s customer service or healthcare provider to address any issues,” said Takyrbashev.

Another potential issue is inconsistent potency and bioavailability, he said.

“Unlike FDA-approved drugs that must meet strict standards for how they are absorbed and utilized by the body, compounded medications can vary significantly,” Takyrbashev said.

“This can mean that one batch of compounded semaglutide might be absorbed differently or have a different potency than another, leading to unpredictable therapeutic outcomes.”

Finally, he addressed safety concerns.

“FDA-approved drugs are tested extensively in clinical trials to identify potential side effects and adverse reactions,” he stated, adding that compounded medications do not go through this same level of testing.

There could be a greater risk for unknown side effects or interactions, said Takyrbashev.

“Additionally, the sterility and cleanliness of the compounding process are critical, and any lapses could introduce harmful contaminants,” he said.

Growing demand for Wegovy and other GLP-1 drugs in the treatment of obesity has created ongoing shortages.

Telehealth provider Hims & Hers has stepped in to fill the gap by providing compounded semaglutide for a price much lower than the brand-name drugs.

However, compounded medications do not go through the same approval process with the FDA.

Consumers need to be aware that they cannot ask the FDA to intervene if they experience quality problems or adverse reactions.

Also, compounded medications do not undergo the same level of testing as brand-name drugs, so they may not have the same potency or bioavailability.

Finally, there are potential safety concerns. Since the same degree of testing is not used, there is a risk of unknown interactions or side effects. It’s also possible that problems with sterility and cleanliness in the facility where the compounding is occurring may exist.