How compounders plan to continue making GLP-1s
Add Axios as your preferred source to
see more of our stories on Google.
Illustration: Shoshana Gordon/Axios
Drug compounders and telemedicine companies may be ready to defy a Food and Drug Administration ban on copycat GLP-1 weight-loss drugs that takes effect on Thursday, arguing the law still allows customized versions tailored to patients' needs.
Why it matters: It would be the latest chapter in a battle with brand-name GLP-1 giants Novo Nordisk and Eli Lilly as millions try to get their hands on versions of the blockbuster drugs.
Driving the news: Noom, a digital health company that prescribes compound semaglutide, the active ingredient in some of Novo's GLP-1s, said it will continue to offer compounded versions of the drug beyond the May 22 enforcement deadline.
- "The compounding law is clear," said CEO Geoff Cook. "There must be an individual patient benefit to the personalization. And so Noom works with [compounding] pharmacies to provide personalized medication when it's clinically indicated."
When prescribing a compounded GLP-1, Noom has been following a "low and slow" approach to titrating up dosages in patients in a way that is not available in commercial versions of GLP-1s.
- Noom said it also prescribes brand name versions of GLP-1 products in a partnership announced earlier this year with Lilly Direct, as well as prescribing non-GLP-1 alternatives.
- "I think we are looking to be on very firm ground on when it's clinically indicated," Cook said.
Yes, but: Pharma companies will likely challenge that interpretation.
- "Compounders should have already transitioned patients to approved medicine, and anyone continuing to sell mass compounded tirzepatide, including by referring to it as 'personalized,' 'tailored' or something similar, is breaking the law and putting patients at risk," Eli Lilly said in a statement to Axios.
Catch up quick: The FDA allowed compounders to make cheaper copies of the drugs while they were in shortage.
- When the agency declared Novo and Lilly's drugs were in sufficient supply earlier this year, compounders were put on notice that most versions of GLP-1s copies would not longer be allowed.
- The compounding labs filed a challenge to put tirzepatide, the active ingredient in Lilly's GLP-1s, back in shortage. Earlier this month, a judge ruled against them.
The FDA also allows compounding for prescriptions specific to particular patients.
- In those cases, the drugs cannot be produced in large batches that might allow for cheaper production costs.
- One focal point could be if providers write "tailored" prescriptions for their entire patient population and the drug isn't individualized, Arielle Miliambro, a partner at Frier Levitt, told Axios in an email. "Providers should expect this to be challenged, especially if they are advertising it."
- This has happened before when telehealth companies moved patients to compounded version with additives en masse, she said.
