Some online compounding pharmacies have stopped marketing GLP-1 drugs in response to the FDA’s announcement, or have pivoted and joined forces with GLP-1 manufacturers, now offering only the brand name anti-obesity medications. Others have continued to supply existing customers with compounded GLP-1 drugs, but have stopped taking on new ones.
But there are still online providers prominently advertising “custom” GLP-1 formulations. At the moment, they appear to be operating entirely within the law.
What happens next is anyone’s guess, says Brunner. The FDA could view the wide-scale manufacturing of custom medications as taking advantage of loopholes that ought to be closed: “I suspect the FDA never contemplated that [its guidance] would be applied the way it’s being applied, given the scale of the compounded GLP-1 phenomenon,” he says.
The FDA has promised to prevent the import of unapproved GLP-1 ingredients, possibly in response to a bipartisan call from congress to reduce the flow of illegal and counterfeit anti-obesity medications into the country. The organization has also singled out ads for compounded GLP-1 drugs as a brazen example of misleading advertising. And the pharmaceutical corporations that have exclusive rights to semaglutide and tirzepatide are trying to stop compounding pharmacies in court.
Despite all the changes, it seems likely that compounding pharmacies will continue to offer GLP-1 drugs, at least for the foreseeable future, says Brunner: “Some patients will be able to maintain these therapies at a price point they can afford in a customized formulation.”
Read the full article here
