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- The FDA has mandated that compounding pharmacies cease production of affordable alternatives to popular weight loss drugs such as Ozempic and Zepbound.
- This directive was issued following the resolution of a GLP-1 drug shortage, as determined by federal authorities.
- Users of these compounded drugs express concerns over having to discontinue usage due to the high costs of the original branded versions.
Effective March 19, a prohibition on the so-called imitation versions of weight management drugs containing trizepatide as an active ingredient was implemented.
An upcoming ban on similar versions of weight loss drugs featuring semaglutide is expected to commence no later than April 22.
This series of bans follows the Food and Drug Administration’s revised guidelines for compounding pharmacies that produce inexpensive versions of Eli Lilly’s Zepbound and Mounjaro and Novo Nordisk’s Ozempic and Wegovy.
The FDA revised its guidelines following a legal defeat of the Outsourcing Facilities Association, which had sued on behalf of compounding pharmacies offering trizepatide-based generic medications.
Another lawsuit is presently under consideration on behalf of pharmacies crafting less costly semaglutide medications.
While compounded medications are not FDA-approved, meaning their safety, efficacy, or quality isn’t verified by the FDA, they are permitted to be sold under specific conditions.
Telehealth companies like Eden, Mochi, Ro, and Hims & Hers had been allowed to market alternative versions of these medications since December 2022, driven by a shortage fueled by a surge in demand.
However, by December 2024, FDA officials declared the medication shortage resolved and mandated a phase-out period for compounding pharmacies to cease production of these patented drugs, thereby granting exclusive rights to Eli Lilly and Novo Nordisk.
Individuals dependent on these more affordable medications are faced with the tough choice of either paying much higher prices for branded drugs or discontinuing their GLP-1 treatment, potentially leading to weight gain.
Experts have voiced concerns that the FDA’s decision could strip many of an essential healthcare solution.
“These medications are highly demanded currently because they represent the most effective treatment for weight loss available,” explained Dr. Mir Ali, a general and bariatric surgeon, and medical director at MemorialCare Surgical Weight Loss Center in Fountain Valley, California.
Future of Weight-Loss Drug Availability
A critical inquiry is whether Eli Lilly and Novo Nordisk can scale production to meet the demand for their GLP-1 drugs if compounding pharmacies halt their production.
Additionally, there is speculation about whether the prices for drugs like Ozempic, Zepbound, Wegovy, and Mounjaro will increase in the absence of competition from generic versions.
While Eli Lilly has not commented on this topic, a Novo Nordisk representative emphasized that patient safety is their top priority, stating that unauthorized generic drugs pose significant risks to patient health and safety. The FDA has specifically warned that these knockoffs can be dangerous for patients.
Nevertheless, companies that distribute compounded weight loss medications are committed to continuing support for their clients.
“We are dedicated to ensuring our patients have access to the best treatments suited to their health needs and goals, and we will comply with FDA regulations concerning compounding,” said a spokesperson from Ro.
“GLP-1 medications are significantly improving the health of millions of Americans. It is crucial to maintain access to safe, affordable, and reliable treatment options as we combat obesity, which affects over 40% of the U.S. population,” stated a representative from Hims & Hers.
Despite the FDA’s declaration of an end to the drug shortage, Hims & Hers recently reported that a shortage of GLP-1 medications persists in the U.S.
Dr. Ali is optimistic, however, that Eli Lilly and Novo Nordisk will be able to meet the ongoing demand for their weight loss drugs.
Dependence on Affordable Compounded GLP-1s
Dr. Ali anticipates that the price of brand-name GLP-1 drugs will not significantly increase due to pressure on manufacturers to keep the drugs reasonably priced.
However, he noted that sufficient supply and stable pricing do not necessarily translate to affordability for everyone, as many health insurance plans do not cover these medications.
Dr. Ali also expressed concern about consumers seeking less expensive weight loss drugs from international markets, which may be of questionable quality and potentially hazardous.
“Consumers might not receive the quality they expect,” he noted.
He mentioned that some individuals might qualify for gastric bypass surgery, which could serve as an alternative method for weight loss without the need for medication.
Bailey Fields, a 27-year-old from Minnesota with polycystic ovarian syndrome (PCOS), shared that her current semaglutide prescription from Hims & Hers costs $199 per month, significantly less than the $675 monthly cost of Mounjaro. However, her insurance only covers weight loss drug treatments if she develops type 2 diabetes.
Fields intends to maintain her weight but is worried about the implications if she can no longer purchase the generic semaglutide product.
“I’m concerned about what will happen if I have to stop taking it,” she expressed.
Todd Kennedy, a 45-year-old Tennessee resident, also relies on compounded semaglutide for weight management and hopes to continue losing weight. He is paying $165 per month for the Hims & Hers product, compared to $1,500 for the brand-name drug.
Kennedy described the FDA’s decision to ban compounded versions as “short-sighted,” emphasizing that it removes a valuable and effective tool for many people.
How GLP-1s Like Ozempic and Zepbound Facilitate Weight Loss
Wegovy and Zepbound have received FDA approval as treatments for weight loss.
Ozempic and Mounjaro are officially approved for treating type 2 diabetes, with Ozempic frequently being prescribed off-label for weight loss.
These medications function by targeting the brain or influencing certain hormones to reduce appetite and decrease hunger.
Typically, individuals prescribed these drugs are also advised to follow specific dietary and exercise regimens.
Dr. Ali stated that these drugs are effective because they address the underlying causes of weight gain.
“By focusing on the root causes, these medications are more likely to lead to successful weight loss,” he explained.
He also noted that these drugs represent a new approach in the medical field to managing weight issues.
“There’s a gradual shift towards viewing obesity as a chronic disease that needs ongoing treatment,” he added.
Discover Trusted Online Sources for GLP-1 Medications:
- Guidelines for Acquiring Zepbound: Latest Updates
- How to Purchase Zepbound Online
- Steps to Obtain Mounjaro (Tirzepatide)
- Options for Buying Mounjaro (Tirzepatide) Online
- Where to Buy Ozempic Online
- Online Sources for Ozempic
- Acquiring Wegovy for Weight Loss Both In-Person and Online
- How to Secure a Wegovy Prescription Online