New FDA Rule Threatens Access to Compounded Weight Loss Drugs Amid Rising Demand

New FDA Rule Threatens Access to Compounded Weight Loss Drugs Amid Rising Demand

Since December 2022, telehealth providers have taken much of the weight loss market by storm, providing cheaper, alternative versions of the market’s darling drugs. Startups such as Eden, Mochi, Ro, and Hims & Hers have stepped up to the plate. They’re taking action to make up for the enormous shortfall in available weight loss medications. The increasing demand for safe and effective weight loss solutions has driven these healthcare providers to act. They now have compounded drugs with active ingredients like semaglutide. Unfortunately, a troublesome FDA rule threatens to cut off access to these compounded alternatives in the near future.

Fields, an ICU nurse and patient living with polycystic ovarian syndrome (PCOS), found relief. She was able to do this by using a compounded weight loss drug from Hims & Hers. The drug, which contains semaglutide, costs Fields roughly $199 per month. In fact, one of the most common side effects of PCOS is unexpected weight gain. This compounds their risk of developing type 2 diabetes, underscoring the need for effective weight loss solutions for those impacted.

Surge in Demand Amid Shortages

The rising demand for weight loss drugs is due to their success. Dr. Mir Ali, a general and bariatric surgeon, tells us that these drugs are undeniably amazing at managing weight. He’s used to the misconceptions as the medical director at the MemorialCare Surgical Weight Loss Center in California.

“The reason there is so much demand is because, at this time, these drugs are the most effective medications for weight loss,” – Mir Ali, MD.

As adoption of these treatments increases, conventional pharmaceutical manufacturers are jumping to the challenge, creating competitive pricing pressure by decreasing prices of their proprietary products. Eli Lilly is already making moves to reduce prices for its weight loss drug, Zepbound. At the same time, Novo Nordisk is employing similar tactics to protect its product Wegovy. Together, these new efforts start to chip away at the shortage and help fill the gap on improving patients’ access to effective, long-term weight management solutions.

Impact of New Regulations

Despite the advancements and availability of compounded weight loss medications, an FDA regulation set to take effect in about a month poses a significant challenge. Under this new rule, the sale of compounded drugs that are made with semaglutide will be limited. As a result, patients who depend on these therapies are increasingly left with no access. This regulation could be monumental. This is particularly important to people suffering from conditions such as PCOS, because they depend on successful strategies for weight loss.

Telehealth providers—including many like Eden, Mochi, Ro, and Hims & Hers that we’ve highlighted—have been leading the charge through this crisis. They’ve provided the necessary alternative, legitimate medications to patients who need them. For this reason, their ability to provide compounded versions of popular weight-loss drugs has doubly filled an essential market niche. The new upcoming rules may require these providers to reconsider their service offerings and reduce choice for consumers.

The Future of Weight Loss Medications

As the healthcare landscape continues to change, access to these proven, effective weight loss medications is an important consideration. These new restrictions would limit access to compounded drugs, pushing patients back into the arms of brand-name products. Given the continued efforts by Eli Lilly and Novo Nordisk to address affordability, this is a very confusing move. If access to compounded alternatives disappears, thousands of patients could be left without a viable option.

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