To stem the tide of antibiotic-resistant pathogens, the FDA will provide more incentives and market opportunities in 2019 as part of a five-year plan to get the pharmaceutical industry involved in restoring the dwindling drug pipeline.
This is necessary in addition to antibiotic stewardship because of the historic disincentives in drug development to treat infectious diseases.
“Large pharmaceutical companies have, for the most part, exited from antibiotic research,” FDA Commissioner Scott Gottlieb, MD, said in a recent speech outlining the problem.
“As large companies pare their efforts back, the funding pool available for commercializing innovative projects is shrinking,” he said.
“We’ve recently seen news that some big companies are getting out of this space.”
As infection preventionists are aware, the old adage “use it and lose it” remains in play for antibiotics, which select out resistant organisms and become less and less effective over years of use.
That has prompted some to suggest developing antibiotics, but holding them back in a sort of “break glass in emergency” mode.
“The problem is that the ideal drug is one that will be seldom used,” Gottlieb said.
“In other words, the reimbursement scheme is in direct conflict to our public health goals.”
Indeed, holding a new antibiotic in reserve diminishes revenues early in the drug patent life, when that compensation is at greatest value to manufacturers, he noted.
“It is important to pursue new policies and reimbursement approaches now to shift the investment landscape right away,” Gottlieb said.
“The long-run 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 or organ transplant in the wake of systemic infections,” he said.
With the tremendous burden of deaths, infections, and costs of antibiotic resistance, this pay-it-forward approach could pay for itself over time.
“Reimbursement reforms could include a mix of milestone payments and subscription fees for developers of FDA-approved products with high economic and clinical value, targeted at multidrug-resistant organisms and linked to proven clinical outcomes,” he said.