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IDSA calls on Congress to intensify fight against antimicrobial resistance
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The Infectious Diseases Society of America is urging Congress to do more to address the public health crisis of antimicrobial resistance by facilitating research and development of new antibiotics and diagnostics.
On Friday, IDSA President Barbara Murray, MD, testified before the House Energy and Commerce Committee’s Health Subcommittee. She said antibiotics are generally accepted as the greatest medical development of the 20th century, responsible for a 26-year increase in average longevity.
Barbara Murray
“Unfortunately, this tremendous progress is seriously threatened by the rapid rise of antibiotic-resistant bacteria coupled with a persistent market failure to develop new antibiotics. … We are on the very real, very frightening precipice of a post-antibiotic era with mortality rates for infections increasing,” Murray said.
Murray commended the subcommittee, particularly two of its members — US Reps. Phil Gingrey, MD, R-Ga., and Gene Green, D-Texas — for enacting the 2012 Generating Antibiotic Incentives Now (GAIN) Act, which incentivizes antibiotic development by providing a 5-year extension of market exclusivity for new drugs that treat serious or life-threatening infections.
However, pharmaceutical companies are still facing significant economic, scientific and regulatory barriers, she said. Nowhere is this more evident than with carbapenem-resistant Enterobacteriaceae (CRE), which the CDC deemed the “nightmare bacteria” in 2013. With no safe or effective antibiotic treatments available, up to 50% of patients with CRE bloodstream infections die. Meanwhile, there are only a handful of novel antibiotics currently in development for CREs. All of these are unlikely to be approved by the FDA, given that they still face risk of failure in clinical trials.
As pathogens become resistant to more drugs, fewer effective antibiotics are available to compare with those in development — a standard in clinical trials. Additionally, there is a lack of rapid, accurate diagnostic tests to quickly identify patients who may be eligible for these drugs in clinical trials.
According to Helen Boucher, MD, of Tufts Medical Center and a member of the IDSA board of directors, diagnostic tools at the point of care are critical in the fight against antimicrobial resistance.
Helen Boucher
“If we could more accurately diagnose the infection our patient has, we can treat them more appropriately and, importantly, we could avoid giving antibiotics to patients who don’t need them. So, in terms of addressing resistance, this is a huge issue for us,” Boucher told Infectious Disease News.
She said the business model for diagnostic tools poses a significant challenge as well, raising questions about reimbursement and who pays for their use. To make matters more complicated, diagnostics do not follow the same approval process as antibiotics.
The ADAPT Act
To address the growing threat of antimicrobial resistance, Murray asked the subcommittee to markup the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, which would allow antibacterial and antifungal agents to be approved for limited populations based upon smaller, more rapid clinical trials.
“The ADAPT Act would speed patient access to desperately needed, life-saving new drugs for infections for which there are very limited or no therapeutic options, and it includes important provisions to help guide the appropriate use of these drugs,” she said.
The ADAPT Act also would reduce administrative and regulatory costs typically associated with large-scale drug studies. Murray noted that the “21st Century Cures: The President’s Council of Advisors on Science and Technology (PCAST) Report on Drug Innovation,” which was presented in May, also supports a limited population approach to antibiotic development.
Besides the ADAPT Act, Murray called for targeted tax credits, more funding for federal agencies that support antibiotic research and development, and new public–private partnerships similar to the European Union’s “New Drugs for Bad Bugs” initiative. Murray also asked for support of the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act, which would provide Medicare add-on payments for antibiotics used to treat infections associated with high mortality rates.
Meanwhile, the IDSA is asking the House Committee on Ways and Means to fund new diagnostic research through federal agencies such as the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority, and through additional tax credits.
Yesterday, President Barack Obama signed an executive order directing certain federal agencies to take action against antimicrobial resistance. The president’s order was based in part on the PCAST report, which outlined a strategy to strengthen federal leadership on the issue of antimicrobial resistance, improve surveillance of multidrug-resistant pathogens, and increase economic incentives to develop new drugs, among other recommendations.
The 10 x ’20 initiative
In late 2009, the IDSA launched a new campaign aimed at bringing to market 10 new antibiotics by 2020, known as the “10 x ’20 initiative.” Since then, four antibiotics have been approved by the FDA — three of which were approved in 2014 alone. These include dalbavancin (Dalvance, Durata Therapeutics), tedizolid (Sivextro, Cubist) and oritavancin (Orbactiv, The Medicines Company). Although these drugs are active against gram-positive organisms — whereas a large part of the threat remains in gram-negative organisms — Boucher said the fact that they were developed and approved amid so much scientific and regulatory uncertainty is a significant achievement.
“That’s progress compared with where we were 5 years ago,” she said. “We don’t want that to be lost on anyone. Of course, we want the gram-negative drugs, but we’re still encouraged. ... At the end of the day, what we need for our patients and their children is a process that leads to a robust pipeline that is renewable in perpetuity so that we won’t just have 10 by ’20, we’ll have 20 by ’30 and so on.” — John Schoen