Just a day after President Obama announced an executive order to create a task force and action plan for confronting antibiotic resistance, the House Energy & Commerce Committee held a hearing on antibiotic resistance and how to foster new drug development.
“Make no mistake: we are losing effective antibiotic treatments because the pace of new and novel drug development has not kept up with these organisms’ ability to build resistance to the treatments available today,” said committee chair and congressman Fred Upton in an opening statement.
Antibiotic resistance is the result of antibiotic overuse, which allows bacteria to mutate and become resistant to the very drug intended to treat it. Estimates show that 2 million infections and 23,000 deaths every year result from antibiotic resistant bacteria.
One of the problems addressed in the meeting by Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, is that developing new antibacterial drugs (to replace ineffective ones and fight bugs) is extremely challenging. “From a scientific standpoint, many patients with bacterial infections are often very sick and need to begin antibiotic therapy immediately. But enrolling a very sick patient in a clinical trial at the same time can be very difficult,” she said, adding that antibiotics are also generally viewed as less profitable due to their low prices and the fact they are taken for short periods of time.
“The judicious use of antibacterial drugs is at odds with the traditional business models and marketing practices used by the pharmaceutical industry for other drug categories, and serves as just one more disincentive to investment in antibiotics,” said Woodcock. She also argued the need for new business models for antibiotic development that disassociate antibiotic drug sales with companies’ returns on investments.
Kenneth Hillan, CEO at biopharma company Achaogen, Inc agreed, and urged support for the DISARM Act (Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms), which would reform reimbursement of antimicrobial products in hospitals by providing value-based pricing instead. Currently, hospitals get paid the same amount regardless of the antibiotic and whether it’s the most effective, so they usually choose the cheapest one.
“This would provide a powerful incentive,” said Hillan. “By providing separate reimbursement for qualifying antibiotics, the DISARM Act would…provide manufacturers with the opportunity to price new antibiotics in a way that is commensurate with the value provided.”
Moving faster than the bugs
As part of the FDA’s Generating Antibiotics Incentives Now Act (GAIN Act), the agency says they are streamlining antibiotic research and have developed a task force to focus on antibiotic drug development. But the FDA also acknowledged that it needs to expedite the process of updating antibiotic “breakpoints.” Breakpoints are found on antibiotic drug labels and show the concentrations at which bacteria are susceptible to successful treatment with antibiotics. Not having the right numbers can lead to over- or under-treatment.
While the committee hearing focused on drug innovation, one speaker, Kevin Outterson, a law professor at Boston University, brought up antibiotic resistance in regards to agriculture, which many argue is a greater problem. Agriculture accounts for more than 80% of antibiotic use in the U.S. and as TIME reported on Thursday, tackling how animals pass resistant strains on to humans is a greater challenge. “Resistance genes have been found throughout the agricultural sector, including dairy cows that did not receive antibiotics,” said Outterson. “We should launch serious research efforts to find and deploy techniques to reduce the need for antibiotics in agriculture and to reduce health risks to humans, including animal husbandry, vaccines, alternative forms of growth promotion, and other innovations.”