Semaglutide shortage resolved

Last Friday, FDA officially, inexplicably indicated on its Drug Shortage List that the semaglutide injection shortage is “resolved.” 

Just as with the tirzepatide shortage ending, the Outsourcing Facilities Association has filed a lawsuit against the FDA, contending the agency declared the shortage over without considering all the real-world evidence that the FDA-approved semaglutide injectables remain out of reach for most pharmacies and many patients, and didn’t conduct notice-and-comment rulemaking to remove the drug from the shortage list. In its brief OFA called it a “reckless and arbitrary decision lacking any semblance of lawful process.”

That argument — that the drug remains hard for patients to find — meshes with our biggest question about FDA’s finding: Did the agency take into account the hundreds of thousands of patients who will suddenly need to be prescribed the FDA-approved version? (It’s a good time to reiterate our mantra: Available doesn’t mean accessible.)

While that OFA lawsuit plays out, it’s time to help your patients transition to the brand name, FDA-approved medications, working with prescribers and counseling those patients. Thankfully, unlike with the tirzepatide shortage resolution, FDA provided an off-ramp for patients to make that transition: 60 days for traditional pharmacies and 90 days for outsourcing facilities. We’re grateful to the agency for hearing us and granting that off-ramp. 

Still, after those 60 days, many patients will be faced with sticker shock at the pharmacy counter, and not all of them will be able to afford the brand-name drugs as we pointed out in our statement. Whether they’ll be able to continue what’s clearly a life-changing therapy — and what that will mean for their health — remains to be seen.