A bill tabled by senior Democrats would set up a $2 billion prize fund that will try to encourage the development of more effective antibiotics for serious infections.
Tucked away in the wide-ranging Improving Access to Affordable Prescription Drugs Act, the antibiotic research clause calls for "up to three" prizes for products that " provide added benefit for patients over existing therapies in the treatment of serious and life-threatening bacterial infections demonstrating in superiority trials."
The catch? The recipient would waive patent and exclusivity rights to the antibiotic, meaning it could be sold by the developer but also any other company that chose to do so, and would immediately become generic, noted Forbes. In addition, the price that could be charged would have to be "reasonable"—and subject to review by federal agencies—and no more than twice that of comparable established antibiotic products.
Other criteria should give would-be applicants less pause for thought. Any antibiotic program qualifying for a prize has to be based on open-source R&D—in other words the recipient would have to disclose all data from preclinical and clinical trials—and the heads of the NIH, FDA and CDC would have to approve any "marketing, sales and other promotional and educational activities" to help ensure the antibiotic is used responsibly.
The NIH director would set the criteria for awarding the prizes, based on the number of patients that would benefit from the new product, the severity of the infection it treats, and whether there are already approved therapies, among other factors.
The fund would also give smaller "open-source dividend awards" for scientific contributions that advance the field of antibiotic research, although this category would have a ceiling of 5% of the total prize fund.
The proposed prize comes against a backdrop of increasing anxiety about the potency of antimicrobial armamentarium, which has been undermined by decades of underinvestment by the pharma industry.
At the 2017 World Economic Forum in January, Dame Sally Davies—the chief medical officer for England—described antimicrobial resistance as "the biggest threat to global health", adding that it "could halt the progress of over a century of modern medicine."
He comments came against the backdrop of a UK government report issued in 2015 which estimated that antimicrobial resistance could kill 10 million people a year by 2050—more than cancer—at a cost to society of $100 trillion.
In February, the World Health Organization (WHO) tried to focus attention on the problem by publishing a list of the 12 priority pathogens most problematic to human health, particularly resistant strains.