Drugs

Lilly Opposes Tirzepatide Bulks List Nomination

David McFarland

— 1 min read
Share

Eli Lilly says it opposes the request by the Outsourcing Facilities Association (OFA) that tirzepatide (Lilly’s Mounjaro and Zepbound) be added to the “clinical need” list, otherwise known as the 503 Bulks List. A Lilly comment says that OFA seeks permanent authorization for its members to engage in the mass-manufacturing, mass-marketing, and mass-distribution of unapproved tirzepatide. It says OFA seeks immediate permission for its members to compound tirzepatide without a finding of clinical need, based on an interim enforcement policy established by FDA in 2016 through guidance.

The letter urges rejection of the OFA nomination for three reasons:

  • FDA’s mission is to protect the public health and OFA’s proposal increases the threat of harm to patients;
  • OFA submitted its nomination pursuant to a 2016 interim enforcement policy, but that policy cannot lawfully be applied to an innovative drug substance that was first approved in 2022; and
  • there is no reasonable basis to find a clinical need to compound with bulk tirzepatide.

“In summary,” the letter says, “finding a clinical need to compound with bulk tirzepatide or placing tirzepatide in Category 1 under the interim 2016 policy would be unprecedented, inconsistent with the public health, contrary to law, and in violation of the agency’s own guidance. OFA and its members seek FDA’s permission to engage in the large-scale production of an unapproved, sterile macromolecule. They propose to broadly market their products for unapproved uses and to produce and sell tirzepatide in doses, in combinations, and for routes of administration that have not been shown to be safe or effective. For all of these reasons, …, FDA should not authorize such compounding.”

Read more