Why telehealth companies can offer cheaper versions of Ozempic and Wegovy
Millennial-skewed telehealth platform Hims & Hers this week joined several online pharmacies to offer customers a compounded version of semaglutide, the active ingredient in popular weight-loss drugs like Ozempic and Wegovy.
The limited supply of these highly coveted and expensive brand-name drugs has prompted some telehealth platforms to take advantage of a section of the Food, Drug, and Cosmetic Act that allows the sale of compounded versions of drugs that are in short supply.
Hims & Hers announced on Monday that its customers will be able to get a prescription for the drug from a licensed healthcare provider directly on its platform. A monthly supply of Weight loss pills will start at $199 hundreds of dollars cheaper than Ozempics’ list price is nearly $1,000 and Wegovys price $1349.
Other online health platforms that use these unofficial medications include those focused on men Ro AND Henry Meds which also sells a compounded version of tirzepatide, the active ingredient in Zepbound.
Here’s everything you need to know about compounded weight loss pills.
What are compounded drugs?
Composition is the process of customizing a drug approved by a state-licensed pharmacist or physician to meet the specific needs of an individual patient. Changes to these medications may include taking a higher dose, reformulating a medication to not include ingredients to which the patient may be allergic, and changing a pill to a liquid form.
Contract facilities may also compound drugs under the supervision of a licensed pharmacist.
There are approx 7,500 pharmacies in the United States that focus on compounded drugs, according to the American Pharmacists Association.
Why are pharmacies allowed to manufacture and sell compounded weight loss drugs?
Typically, the Food, Drug, and Cosmetic Act prohibits the compounding of drugs that are mere copies of commercially available medications. However, drugs that are in short supply are not considered by the US Food and Drug Administration (FDA) to be commercially available.
Wegovy and Eli Lilly’s weight loss drug Zipbound Both are currently in short supply due to increased demand, according to an FDA database. Because of this, compounders are allowed to purchase semaglutide and tirzepatide from drug ingredient manufacturers to mix them into injectable formulations. These formulations can be mixed with B vitamins or L-carnitine.
Are there any risks?
Compounded formulations are not FDA-approved, so the agency does not review the safety and efficacy of these products.
In January, the FDA said it had received adverse event reports from patients receiving a compounded semaglutide and recommended that patients not use a compounded drug if an approved drug is available. The agency specifically warned about reports of some ingredients using salt forms of semaglutide, which is different from the semaglutide used in approved products like Wegovy in their formulations.
On its website, Ro says its compound semaglutide is made with semaglutide base and not semaglutide salts.
For its part, Hims & Hers said it conducted exhaustive research and verification for more than a year before partnering with a leading US manufacturer of generic and compounded drugs. The company did not disclose the name of the manufacturer.
#telehealth #companies #offer #cheaper #versions #Ozempic #Wegovy
Image Source : qz.com