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Lilly seeks to protect interests in compounded drug case

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FDA affirms no shortage of tirzepatide drugs

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Compounded versions cheaper, often not covered by insurers

By Brendan Pierson

Jan 2 (Reuters) - Eli Lilly ( LLY ) has asked to join in

opposing a lawsuit brought by compounding pharmacies against the

U.S. Food and Drug Administration over the agency's decision

that Lilly's blockbuster weight-loss and diabetes drugs are no

longer in short supply.

In a motion filed in Fort Worth, Texas federal court late on

Wednesday, Lilly said it could not rely on the FDA to fully

defend its interests in the case, which will determine whether

compounding pharmacies and facilities can keep selling cheaper

versions of the company's weight-loss drug Zepbound and diabetes

medicine Mounjaro, which have the same active ingredient,

tirzepatide.

The FDA declined to comment. The Outsourcing Facilities

Association, which brought the lawsuit along with a Texas

compounding pharmacy did not immediately respond to requests for

comment.

The compounded drugs at issue, which are essentially copies

of the branded prescription medicines but not approved by the

FDA, can only be made in significant amounts if there is a

shortage.

The FDA decided in October that there was no longer a

shortage of the tirzepatide drugs.

In response to the lawsuit, the agency agreed to reconsider its

decision but on Dec. 19 affirmed that there is no shortage. At

the time, FDA said it would not take any enforcement action for

at least 60 days, and the compounding industry is still seeking

a court order reversing the agency's decision.

Lilly said in Wednesday's motion that it needed to join the

case to defend its own interests because it could not be sure

that the FDA would appeal if the court ruled against it.

Lilly also said it believed compounding pharmacies, as

opposed to larger so-called outsourcing facilities, may not

manufacture compounded drugs even if there is a shortage. It

said that may be at odds with the FDA's view.

Novo Nordisk's rival weight-loss drug Wegovy

remains on the FDA's shortage list. The Alliance for Pharmacy

Compounding, another industry group, in November announced a

survey showing that more than 200,000 prescriptions for

compounded versions of Wegovy were being filled each month.

Insurers generally cover Lilly's and Novo's drugs for

diabetes, but many do not cover the weight-loss medications.

That has led many patients to pay out of pocket for compounded

versions, which are typically cheaper.

Lilly in August began sending cease-and-desist letters to

telehealth companies, wellness centers and medical spas selling

compounded versions of Zepbound and Mounjaro. The company has

also filed lawsuits against those falsely claiming to sell

FDA-approved versions of the drug.