Background
Retatrutide is a GLP-1 peptide that has shown promise in clinical trials as a weight loss drug, but the Food and Drug Administration (“FDA”) has not approved retatrutide for any nonexperimental use in humans. Cagrilintide is different from a GLP-1 drug and has also shown promise as a weight loss drug along with semaglutide, the active ingredient in popular weight loss drugs like Ozempic® and Wegovy®, and Novo Nordisk, the maker of Ozempic®, has a clinical trial to determine if cagrilintide can be an effective weight loss drug standing alone.
First Consideration: The FDA Prohibits Providers from Compounding Retatrutide and Cagrilintide
The FDA has recently issued guidance expressing the agency’s concerns about providers prescribing unapproved GLP-1 drugs for weight loss. In this guidance, the FDA explicitly stated that retatrutide and cagrilintide cannot be used in compounding because they “have not been found safe and effective for any condition.” Time will tell if the FDA’s stance on retatrutide and cagrilintide changes if clinical trials show that retatrutide and cagrilintide are safe and effective in humans for weight loss.
Second Consideration: The FDA Is Also Issuing Warning Letters to Drug Manufacturers and Compounding Pharmacies Who Sell Compounded Weight Loss Drugs that Contain Retatrutide and Cagrilintide
The FDA is issuing warning letters to companies that sell to prescribers compounded weight loss drugs that contain retatrutide and cagrilintide. The FDA has also issued a warning letter to a provider who has sold compounded drugs containing retatrutide. These warning letters say that compounded drugs containing retatrutide or cagrilintide are “new drugs” that are required to go through the FDA-approval process, and because these providers are selling the compounded drugs as unapproved drugs, these providers are violating federal law.
The letters also say that selling and marketing these drugs to humans, when they have been labeled “for research use only,” or when they contain directions for intended use when there has been no approved use for such drugs, is considered misbranding and a violation of federal law.
If you need assistance complying with the changing weight loss landscape, would like to prescribe compounded weight loss drugs as part of your practice, or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.