August 13, 2026 (Washington DC) – Partnership for Safe Medicines Executive Director Shabbir Imber Safdar released the following statement on the six lawsuits Eli Lilly filed today against businesses it accuses of illegally distributing unapproved copies of its investigational drug, retatrutide.  Lilly is suing these defendants for illegal distribution of retatrutide including, in one case, a licensed 503A compounding pharmacy.

“The activities alleged here would pose a broad and serious danger to patient safety. Federal law here is not ambiguous. Retatrutide is an investigational drug and cannot lawfully be distributed for routine patient use under sections 503A or 503B, a point the Alliance for Pharmacy Compounding has delivered directly to its own members. Today's litigation also follows more than a dozen warning letters FDA has issued over unlawful retatrutide distribution.

"Today's filings raise serious questions about whether existing enforcement mechanisms provide sufficient deterrence when significant profits are at stake.”

"Patients absorb serious risks. Retatrutide remains an investigational drug that has not been approved by FDA for any use and cannot lawfully be distributed for patient use. Products purporting to contain retatrutide have not undergone FDA review for safety, efficacy or quality, leaving patients without the assurance of what they’re receiving.”

Read the complaints:

• Eli Lilly and Company v. Aesthetic Envy
• Eli Lilly and Company v. Astra LLC
• Eli Lilly and Company v. Legendary Peptides
• Eli Lilly and Company v. Lone Star Peptides
• Eli Lilly and Company v. Striker Pharmacy, LLC
• Eli Lilly and Company v. Texas Peptides