Food and Drug Administration Commissioner Scott Gottlieb, M.D., announced Friday his agency was launching a new effort—and a new website—around improved stewardship efforts in the race to protect existing antibiotics as more organisms grow resistant to some of the world's last lines of defense.
That new plan included a more coordinated effort within FDA agencies, including the Center for Veterinary Medicine, to protect the efficacy of existing antibiotics.
“In the long run, the human and economic cost of antimicrobial resistance is enormous including death and disability from sepsis, extended and expensive hospital stays and the need for dialysis and organ transplant in the wake of systemic infections," Gottlieb said, speaking at an event by The Pew Charitable Trusts in Washington, D.C.
But drawing on his own experience in the drug industry, Gottlieb turned his focus toward addressing the dearth of new antibiotics in the pipeline. The market simply has too little financial incentive to convince companies to create new antibiotics, and the reimbursement model has to change.
"The problem is: The ideal drug is one that will be seldom used," Gottlieb said. "Under the current reimbursement stream for drugs, though, profits are driven from the number of prescriptions needed for a drug."
One of the potential solutions he could back? A subscription payment model, he said.
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Gottlieb said the idea of supporting a subscription model would basically allow hospitals to pay flat fees to receive access to a certain number of doses of an antimicrobial. He said it's still in the early process of consideration with the Centers for Medicare & Medicaid Services and that it wouldn't necessarily need to be piloted through Medicare but could be tested through the private sector as well.
"It would provide a sort of foundation of return on investment," he said. "It wouldn’t encompass the whole market but would provide enough of a foundation of a guaranteed market to help more companies get over the hurdle rate of making new investments in drug development in this area."
It's certainly not the first time such an idea has been floated in the public health world. Over the last several years, pharmaceutical companies have considered a number of business models that de-link the number of prescriptions taken from revenue through licensing models or lump sum payments. Gottlieb said he supports the idea of subscriptions because hospitals are already used to that kind of model, paying based on number of beds or admissions, for access to software or durable medical equipment.
Friday's event comes on the heels of a Centers for Disease Control and Prevention report last month about record levels of sexually transmitted diseases which also renewed concerns about the emergence of drug resistance that could eventually garner gonorrhea "untreatable." The CDC estimates in the U.S. annually, at least 2 million people are sickened by antibiotic-resistant pathogens, and 23,000 people die from those infections. It costs the U.S. $20 billion annually.
The World Health Organization warned last year the world is running out of antibiotics that can stop multidrug-resistant organisms. At the time, they pointed to serious lack of new antibiotics under development to address the problem.
See Gottlieb's speech in the video below.