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Judge says FDA appropriately weighed supply and demand

information

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Compounding pharmacies barred from making drug copies

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Judge says FDA aware of Novo CEO's comments on drug access

By Diana Novak Jones

June 18 (Reuters) - A federal judge has rejected a bid

by compounding pharmacies to allow them to continue making

copies of Novo Nordisk's blockbuster weight-loss drugs Ozempic

and Wegovy, upholding the U.S. Food and Drug Administration's

decision to remove the drugs' active ingredient from the

shortage list.

In a decision made public late on Tuesday, U.S. District Judge

Mark Pittman, in Fort Worth, Texas, said the FDA had

appropriately weighed information about the supply and demand

for semaglutide and properly removed it from the shortage list.

The ruling is a blow to compounding pharmacies that had been

allowed to produce hundreds of thousands of doses of copies of

obesity drugs while the FDA said there was a shortage of them.

It could also dash patients' hopes of regaining access to

cheaper copies of the popular therapies.

The lawsuit was brought by the Outsourcing Facilities

Association, a compounding pharmacy industry group. The

association believes the FDA's decision was flawed and is

reviewing its options going forward, the group's chairman, Lee

Rosebush, said in a statement.

A spokesperson for the FDA declined to comment.

Pittman had denied the pharmacies' bid for an injunction in

April, blocking them from making copies of the drugs while the

litigation was pending.

Compounders copy brand-name medicines that are in short

supply by combining, mixing or altering drug ingredients to meet

demand.

GROUP SAID FDA ACTED RECKLESSLY

In its lawsuit, filed in February, the association alleged

that the FDA had acted recklessly in removing semaglutide from

the shortage list while there was evidence that the drugs were

still in short supply.

In part, it argued that the agency had failed to consider

statements that Novo Nordisk CEO Lars Fruergaard

Jorgensen had made about limited access to the drugs in a

November 2024 interview with Reuters. The Danish company

announced he would step down as CEO last month over concerns the

company was losing its market advantage in the competitive

weight-loss drug market.

Pittman said the record shows the FDA was aware of the

statements and had confronted Novo with them when it made its

decision.

The regulator gave larger outsourcing facilities, which make

compounded drugs in bulk and are regulated by the agency, until

May 22 to stop making the drugs, according to its website.

Smaller compounding pharmacies, which make drugs to fill

prescriptions for individual patients and are primarily overseen

by U.S. states, were required to stop making copies of

semaglutide in April.

Pittman rejected a separate challenge in May brought by the same

groups over the FDA's removal of Eli Lilly's ( LLY ) weight loss

and diabetes drugs Zepbound and Mounjaro from the shortage list.

The Outsourcing Facilities Association has appealed that ruling.