This content material initially appeared on On a regular basis Well being. Republished with permission.
By Lisa Rapaport
Key Takeaways
- Hims & Hers will promote compounded semaglutide, the energetic ingredient in Ozempic and Wegovy, beginning at $199 per thirty days.
- The corporate will join sufferers with medical suppliers to get a prescription, if acceptable.
- The FDA doesn’t overview compounded medicines for security, effectiveness, or high quality.
Direct-to-consumer pharmacy startup Hims & Hers Well being says it’s promoting injectable weight reduction medicines produced from the identical energetic ingredient as Ozempic and Wegovy, at a fraction of the fee for these name-brand medicine.
Hims & Hers will provide compounded GLP-1 medicine containing semaglutide beginning at $199 a month, the corporate stated in a press release.[1] The corporate gained’t take insurance coverage.
With out insurance coverage, Ozempic prices round $1,000 a month and Wegovy prices about $1,300 to $1,500 month-to-month, based on GoodRx.
“We’ve leveraged our dimension and scale to safe entry to one of many highest-quality provides of compounded GLP-1 injections accessible at present,” Andrew Dudum, co-founder and chief government officer of Hims & Hers, stated within the assertion. “We’re passing that entry and worth alongside to our prospects, who deserve the very best commonplace of scientific security and efficacy to fulfill their targets, and we’re doing it in a protected, reasonably priced approach that others can’t ship.”
What Is Compounded Semaglutide?
Typically, compounded medicine combine, mix, or alter substances to make medicines which can be tailor-made to the wants of particular person sufferers — for instance somebody might have a stronger dose than what producers make, or somebody could also be allergic to an inactive ingredient within the ordinary formulation.
As of April 30, there have been shortages of the three smallest doses of the burden loss drug Wegovy that folks want to begin therapy, based on the U.S. Meals and Drug Administration (FDA). Ozempic, the sort 2 diabetes drug with the identical energetic ingredient, is at present accessible, however had beforehand been in brief provide for months on finish. The FDA cited elevated demand for semaglutide as the reason for the Wegovy scarcity, and supplied no indication of when provides is likely to be broadly accessible once more. Provides of Mounjaro and Zepbound, GLP-1 medicine made with the energetic ingredient tirzepatide, are additionally in brief provide and can be not less than till this summer season, based on the FDA.
When there are shortages like this, compounding pharmacies are allowed to make compounded variations so individuals can nonetheless entry wanted therapy. Nevertheless, the FDA doesn’t overview these compounded variations for security, effectiveness, or high quality.
Earlier this yr, the FDA raised issues that folks might expertise unanticipated uncomfortable side effects with compounded semaglutide, which can be made with salt-based types of semaglutide which can be completely different from the energetic ingredient in Wegovy and Ozempic.
“Sufferers ought to be conscious that some merchandise offered as ‘semaglutide’ might not comprise the identical energetic ingredient as FDA-approved semaglutide merchandise and would be the salt formulations,” the FDA stated in a press release.[2] “Merchandise containing these salts, comparable to semaglutide sodium and semaglutide acetate, haven’t been proven to be protected and efficient.”
Amid the continuing shortages and surging demand for Wegovy and Ozempic, many medical spas, wellness clinics, weight reduction clinics, and pharmacies have been promoting compounded semaglutide. Drugmaker Novo Nordisk, which makes Wegovy and Ozempic, has sued many of those firms alleging false promoting, trademark infringement, and illegal gross sales of non-FDA authorised merchandise claiming to be semaglutide, the drugmaker stated in a June 2023 assertion.[3]
Easy methods to Get Compounded Semaglutide On-line
Hims & Hers is considered one of a number of on-line pharmacies that prescribe and promote compounded semaglutide on to shoppers. Others embody Ro, PlushCare, and Henry.
To get compounded semaglutide via Hims & Hers, prospects first should do an internet session with a medical supplier via the corporate’s platform, says Pat Carroll, MD, chief medical officer at Hims & Hers.
“These unbiased suppliers are required to observe evidence-based scientific protocols and use their very own medical judgment to suggest which therapy, if any, is clinically acceptable,” Dr. Carroll says.
Hims & Hers can be partnering with a number one U.S. producer of generic and compounded injectable medicines, Carroll says. The producer is registered with the FDA as what’s often known as a 503B outsourcing facility, which suggests it’s topic to FDA oversight.
“Security and high quality are our highest precedence in the case of compounding, and we carried out in depth analysis for over a yr into discovering a top quality provider who met our rigorous security requirements,” Carroll says.
Easy methods to Know Your Semaglutide Is Secure
FDA spokesperson Amanda Hils stated that the FDA usually doesn’t touch upon particular web sites, firms, or merchandise with out a thorough overview.
“The FDA’s compounding program goals to protect entry to lawfully marketed compounded medicine for sufferers who’ve these wants, whereas defending them from poor high quality compounded medicine,” Hils stated.
“Nevertheless, shoppers ought to be conscious that compounded medicine pose the next danger to sufferers than FDA-approved medicine as a result of compounded medicine are usually not FDA-approved and don’t bear FDA premarket overview for security, effectiveness, or high quality,” Hils stated. “Compounded medicine additionally lack an FDA discovering of producing high quality earlier than such medicine are marketed.”
The one technique to know for certain if compounded semaglutide is protected and efficient is to have it examined to confirm that it truly accommodates the identical energetic ingredient as Wegovy and Ozempic — and no unanticipated or doubtlessly unsafe substances, says Melanie Jay, MD, an affiliate professor of drugs and director of weight problems analysis at New York College.
“I’d wish to see a certificates of authenticity from an outdoor lab that examined the batch of drugs and confirmed that the treatment is genuine,” Dr. Jay says. “I’d additionally wish to be sure that they comprise the bottom type of semaglutide that’s within the FDA-approved medicine, and never semaglutide salts like semaglutide sodium or semaglutide acetate.”
Given these issues, some docs assume individuals are higher off avoiding compounded semaglutide.
“There isn’t any technique to know what you might be getting in compounded semaglutide, regardless of fancy promoting and engaging costs,” says Jody Dushay, MD, MMSc, an endocrinologist and assistant professor at Harvard Medical Faculty. “It could possibly be innocent and ineffective for weight reduction, or it could possibly be frankly harmful.”
The FDA says on-line pharmacies are extra seemingly to offer protected and efficient medicines in the event that they meet the next standards:
- At all times requires a health care provider’s prescription
- Gives a bodily handle and phone quantity in america
- Has a licensed pharmacist on employees to reply your questions
- Is licensed with a state board of pharmacy
The FDA additionally warns that an internet pharmacy could also be unsafe if it:
- Doesn’t require a health care provider’s prescription
- Just isn’t licensed in america and by your state board of pharmacy
- Doesn’t have a licensed pharmacist on employees to reply your questions
- Sends drugs that appears completely different than what you obtain at your native pharmacy, or arrives in packaging that’s damaged, broken, in a overseas language, has no expiration date, or is expired
- Affords deep reductions or costs that appear too good to be true
- Costs you for merchandise you by no means ordered or obtained
- Doesn’t present clear written protections of your private and monetary info, or sells it to different web sites
