Withdrawal of Approved Antibiotic in U.S. Renews Questions About Market Sustainability

Stat and CIDRAP both reported on the withdrawal of the antibiotic Recarbio (imipenem, cilastatin, and relebactam) from the U.S. market.

AMR Action Fund CEO Henry Skinner told Stat that it took a lot of capital” for Merck to win U.S. regulatory approval for three key indications. “It’s striking,” Skinner said. “It’s not a trivial amount of work or money they put into this. To my eye, they did all the right things and still, here we are.”

Skinner told CIDRAP that he was “particularly concerned about the implications for pediatric patients with multidrug-resistant infections. Citing a 2025 study published in the journal Antibiotics, he noted that the small-to-midsize pharmaceutical companies that currently drive antibiotic development completed only 10% of required pediatric post-approval studies, which are needed to expand drug labels for pediatric use, and none received pediatric approvals for their products.

‘Merck did the long, costly work required to fulfill a pediatric postmarketing requirement and expand Recarbrio’s label to children weighing as little as 2 kilograms,’ Skinner said. “If large companies cannot sustain these products on the market, who will generate the evidence needed to bring future antibiotics to children?’”

CIDRAP noted that Skinner was among several experts who expressed that,  "a fix could be provided by the PASTEUR Act, a bill that would establish a new payment model for new antibiotics, under which companies would receive fixed annual payments from the federal government for novel new antibiotics." 

Read the CIDRAP article here.

Read the Stat article here.