November 8, 2024
APC to FDA: Just say no to Lilly
This week APC’s lawyers sent a formal comment to the FDA. The subject: Eli Lilly’s request that tirzepatide be added to the Demonstrably Difficult to Compound (DDC) list. Lilly’s request was, to borrow a phrase, a target-rich environment — one full of misleading assertions and conveniently omitted facts easy for us to call out.
You can read the full letter here, but here are some highlights:
- We pointed out that Lilly’s request was so heavily redacted, it was “impossible for compounders to evaluate and respond to the drugmaker’s complexity claim.”
- Still, we showed how Lilly was deliberately conflating creating the tirzepatide molecule with creating a compounded injection using that molecule.
- We also called out Lilly’s assertion that there were an outsized number of adverse events related to compounded tirzepatide injections. Among other issues was the fact that there have been tens of thousands of adverse events related to branded Mounjaro and Zepbound.
- And, of course, we questioned Lilly’s newfound sense of urgency: “Yet, after nearly two years and millions of doses dispensed, the drugmaker is suddenly urging the FDA to quickly declare that tirzepatide injection is too difficult to compound.”
We think this sentence from our comments sums it up nicely:
“The drugmaker’s nomination of tirzepatide injection to the DDC Lists does not arise out of a sincere concern for patient safety. Rather, it is merely one of several transparent attempts the drugmaker has recently taken to stifle what it improperly perceives as competition.”
