Congressional action urged to stimulate antibiotic development
As a result, many large drug makers—including AstraZeneca, Sanofi, and Novartis—have abandoned their antibiotic development programs in recent years in favor of more lucrative drugs. Only a handful of large pharmaceutical companies remain in the antibiotic development space.
And while there are many small biopharmaceutical and biotech companies working on new antibiotics, with financial support from government agencies like BARDA (the Biomedical Advanced Research and Development Authority) and public-private partnerships like CARB-X (the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator), these companies lack the financial resources to get drug candidates through late-stage clinical development and Food and Drug Administration (FDA) approval and on to the market.
To address these challenges, many antibiotic development advocates believes new incentives are needed. These incentives, the group writes, could include a mix of tax incentives, novel “pull” incentives that increase the value of new antibiotics, and changes in how pharmaceutical companies are reimbursed for antibiotics.
“We, the undersigned, believe the solution requires a package of incentives that address both the short-term need to stabilize the market and policies to address the broken market that makes antibiotic development economically infeasible for both small and large companies,” the letter states. “The ultimate goal is to create an ecosystem that supports sustainable discovery, development, and commercialization of novel, innovative antibiotics in order to preserve these vital drugs and health care advances they make possible.”
New reimbursement models
One potential idea to delink profits from the volume of antibiotics sold was presented by FDA Commissioner Scott Gottlieb, MD, in September 2018, when he announced the agency’s strategy for fighting antibiotic resistance. Gottlieb suggested the development of a new reimbursement model that would combine milestone payments and subscription fees for new FDA-approved antibiotics that have high clinical and social value—such as drugs that target multidrug-resistant organisms. The subscription fees for access to the new drugs would be priced to create a sufficient return on investment.
Gottlieb said this idea and other potential payment strategies, which would be linked to the promise of effective stewardship efforts by hospital and drug makers, are being discussed with the Centers for Medicare and Medicaid Services.
Other governments are considering similar ideas to spur antibiotic development. Last week, the British government announced that it will launch a pilot program in which the National Health Service will experiment with buying an antibiotic “service” from pharmaceutical companies, paying them up-front for access to effective new antibiotics.
Among the other pull incentives that have been previously suggested are market entry rewards, in which companies would receive a large up-front payment for development and approval of a critical new antibiotic. DRIVE-AB, an international consortium of public health organizations, academic institutions, and pharmaceutical companies, last year proposed a market entry reward of $1 billion for regulatory approval of a new antibiotic, with funding coming from governments and philanthropic organizations.
The letter suggests that any pull incentive package approved by Congress should require that incentives be paid after FDA approval, should aim both to stabilize the current market for new antibiotics and ensure viability of future development, should provide predictability for drug developers, and should be aligned with appropriate antibiotic stewardship and surveillance.
