Weight Loss Drug Shortage Resolved, Compounding Pharmacies Affected
The Food and Drug Administration (FDA) has announced that the active ingredient in Eli Lilly’s weight loss drug Zepbound, tirzepatide, is no longer in shortage. This decision marks the end of a period where certain pharmacies could make and distribute unapproved versions of tirzepatide without facing repercussions.
Impact on Compounding Pharmacies
Compounding pharmacies will have 60 to 90 days to stop making compounded versions of tirzepatide, depending on the type of facility. This transition period will give patients time to switch to the branded version. However, this decision is a blow to some compounding pharmacies, which argue that their copycat drugs help patients who don’t have insurance coverage for Zepbound and can’t afford its hefty price tag of roughly $1,000 a month.
Dispute Between Compounding Pharmacies and FDA
The FDA’s decision is the latest development in a high-stakes dispute between compounding pharmacies and the agency over the shortage of tirzepatide. Eli Lilly has invested billions to expand its manufacturing capacity for tirzepatide as it struggles to keep pace with unprecedented demand. A trade organization representing compounding pharmacies, the Outsourcing Facilities Association, sued the FDA over the agency’s decision to remove tirzepatide from its official drug shortages list.
Compounded Medications and FDA Oversight
Compounded medications are custom-made alternatives to branded drugs designed to meet a specific patient’s needs. When a brand-name medication is in shortage, compounding pharmacies can prepare copies of the drug if they meet certain requirements under federal law. However, the FDA does not review the safety and efficacy of compounded products, and the agency has urged consumers to take the approved, branded GLP-1 medications when they are available.
Patient Impact and Alternative Options
Patients have turned to compounded versions of tirzepatide amid intermittent U.S. shortages of the branded drugs. Many health plans don’t cover tirzepatide for weight loss, making compounded versions a more affordable alternative. The FDA’s decision may affect patients who rely on these compounded versions, and it remains to be seen how this will impact their access to affordable treatment options.
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