Breakthrough Weight Loss with GLP-1s Threatened: New FDA Rule May Limit Access!

Fields and Kennedy are among those who may lose access to these affordable weight loss options soon.

This is due to the Food and Drug Administration (FDA) banning the sale of these compounded medications.

Previously, a ban on compounded weight loss medications containing tirzepatide was implemented on March 19.

Another ban on compounded semaglutide treatments is set to begin on April 22.

The bans are following the FDA’s updated directives issued to compounding pharmacies that were selling cheaper versions of weight loss medications like Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Zepbound and Mounjaro.

The FDA’s updated guidelines came after a federal judge sided against the Outsourcing Facilities Association, which had filed a lawsuit on behalf of compounding pharmacies producing tirzepatide.

A similar legal challenge is being considered for pharmacies producing semaglutide-based medications.

The FDA does not approve compounded medications, meaning their safety, effectiveness, or quality cannot be guaranteed by the agency. However, they could be sold under specific conditions.

Since December 2022, telehealth providers like Eden, Mochi, Ro, and Hims & Hers were permitted to offer alternative versions of these drugs due to a shortage caused by a surge in demand.

By December 2024, the FDA declared the drug shortage over and began enforcing the prohibition of sales of compounded weight loss drugs.

“The high demand for these drugs stems from their effectiveness in aiding weight loss,” explained Mir Ali, MD, a general and bariatric surgeon at MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in California.

Eli Lilly and Novo Nordisk are making efforts to reduce the costs of their popular weight loss drugs.

In February, Eli Lilly introduced a pricing plan for its Zepbound medication: $499 per month for the initial prescription and for refills ordered within 45 days of the last prescription; otherwise, the monthly cost is $599 for smaller vials and $699 for larger ones.

These reduced rates are available exclusively through LillyDirect, the company’s direct payment website, for patients prescribed Zepbound for obesity or obstructive sleep apnea.

Recently, Novo Nordisk also announced a new price of $499 per month for eligible cash-paying customers purchasing Wegovy at local pharmacies.

However, these discounts may still be prohibitive for some, including Fields and Kennedy.

Both have stated their health insurance does not cover these medications, and they are unsure if they can afford the brand-name drugs.

Their main concern is the potential of regaining weight without these medications, despite maintaining their diet and exercise routines.

“I’m worried I might start gaining weight again,” Kennedy expressed.

“I’m not sure what will happen if I stop the treatment,” said Bailey. “The medication really helps my body utilize the resources I provide it.”

Bailey emphasized that she has attempted every diet and exercise regime, none of which were effective on their own.

“That’s not how my body functions,” she explained.

Bailey and Kennedy argued that the FDA should continue allowing a broad range of options for weight loss medications.

“It provides a valuable tool,” Kennedy stated. “Taking it away doesn’t help anyone.”