With the resolution, compounding pharmacies are no longer able to produce tirzepatide. And the FDA highlighted the point to the drug makers, writing in bold that the agency “reminds compounders of the legal restrictions on making copies of FDA-approved drugs.”
In an acerbic federal lawsuit filed in Texas this week, an industry group representing large compounding pharmacies—aka outsourcing facilities—blasted the FDA for removing tirzepatide from the shortage list. The group, the Outsourcing Facilities Association, along with a Texas-based compounder, argue that the tirzepatide is still in short supply and that the FDA blindly accepted the word of Lilly—a company that is “self-interested in monopolizing the market.” The compounders back up the claim by noting that the FDA warned in its announcement that “intermittent localized supply disruptions” could continue.
The compounders called the FDA’s announcement “a reckless and arbitrary decision—lacking any semblance of lawful process,” which would “deprive patients of a vital treatment for type 2 diabetes and obesity, two of the most common and harmful medical conditions in existence.”
The compounders also claimed that the FDA broke administrative law by not allowing a public comment or notice period, not providing evidence of sufficient supply, not explaining its decision-making process, and not publishing its decision in the Federal Register.
I don’t like the title, quoting
With the resolution, compounding pharmacies are no longer able to produce tirzepatide. And the FDA highlighted the point to the drug makers, writing in bold that the agency “reminds compounders of the legal restrictions on making copies of FDA-approved drugs.”
In an acerbic federal lawsuit filed in Texas this week, an industry group representing large compounding pharmacies—aka outsourcing facilities—blasted the FDA for removing tirzepatide from the shortage list. The group, the Outsourcing Facilities Association, along with a Texas-based compounder, argue that the tirzepatide is still in short supply and that the FDA blindly accepted the word of Lilly—a company that is “self-interested in monopolizing the market.” The compounders back up the claim by noting that the FDA warned in its announcement that “intermittent localized supply disruptions” could continue.
The compounders called the FDA’s announcement “a reckless and arbitrary decision—lacking any semblance of lawful process,” which would “deprive patients of a vital treatment for type 2 diabetes and obesity, two of the most common and harmful medical conditions in existence.”
The compounders also claimed that the FDA broke administrative law by not allowing a public comment or notice period, not providing evidence of sufficient supply, not explaining its decision-making process, and not publishing its decision in the Federal Register.
Much as it pains me to side with any Texas entity, they seem to have a point. I expect this FDA rule to be overturned quickly.