Discovery of new superbug gene underscores the need for Congress to act now

As an infectious diseases physician, I was deeply alarmed by recent news of a new superbug gene discovered in China in common bacteria that cause urinary tract infections, pneumonia, and other infections. These bacteria can be dangerous on their own, but this new gene is rendering them resistant to all existing antibiotics.  A similarly worrisome gene was discovered in India in 2010 and is now present throughout the U.S. – it is likely the new superbug gene in China will travel here as well.  Unfortunately, antibiotic research and development (R&D) continues to lag behind existing patient needs and upcoming threats.  Fortunately, Congress can help combat the threat of these deadly infections, but we must act now.

First, Congress can pass funding legislation that provides the increases requested by the President for the Centers for Disease Control and Prevention (CDC), National Institute for Allergy and Infectious Diseases (NIAID), Biomedical Advanced Research and Development Authority (BARDA), Food and Drug Administration (FDA), and US Department of Agriculture (USDA).  Each of these agencies play a critical role in addressing antibiotic resistance, such as outbreak surveillance, promoting appropriate use of antibiotics, and fostering the research necessary to better understand resistance and develop new vaccines, diagnostic tests, and therapies.  Preliminary proposals from House and Senate funding subcommittees included some of the needed new funding, and the recently passed bipartisan budget agreement should allow Congress to fully commit to this priority.

{mosads}Second, Congress can provide urgently needed new incentives to stimulate the development of antibiotics to treat superbugs.  Most companies have abandoned the pursuit of new antibiotics due to high R&D costs and low or non-existent profitability.  Unlike many other types of drugs, antibiotics are typically inexpensive, used for a short duration, and held in reserve to protect their utility from the development of resistance.  Taken together, these factors have created an infeasible business model for most companies to invest in antibiotic R&D.

Reps. Charles Boustany (R-La.) and Mike Thompson (D-Calif.) have introduced the Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act, H.R. 3539.  This bill would address the economic hurdles to antibiotic R&D by providing a tax credit for 50% percent of phase 2 and 3 clinical trial costs for new antibiotics that would address an unmet medical need.  This bill is modeled after the successful Orphan Drug tax credit, which has helped foster needed R&D in disease areas that faced similar obstacles.  Importantly, the READI Act also provides this incentive for new rapid diagnostic tests.  Such tests are urgently needed to guide our use of antibiotics.  Having to treat patients and prescribe antibiotics in the absence of sufficient diagnostic tests is contributing to our overuse of antibiotics which is driving the development of resistance.

Lastly, Congress can address the regulatory barriers to antibiotic R&D.  Currently, it is extremely difficult and in some cases impossible for researchers to find enough patients infected with a particular antibiotic resistant pathogen to fill a traditional, large scale clinical trial, due to the limited number of patients in which these infections presently occur.  A provision (championed by Reps. John Shimkus (R-Ill.) and Gene Green (D-Texas)) in the 21^st Century Cures Act—which was passed by an overwhelming bipartisan majority in the House—would allow companies to study new antibiotics that treat serious or life-threatening infections and address an unmet medical need to be studied in smaller, more rapid clinical trials and approved for the limited number of patients who need them.  Such antibiotics must still be proven safe and effective for the limited indicated population.  These antibiotics would also bear clear “limited population” labeling to alert the health care community that these antibiotics are different from traditional antibiotics and must be used judiciously.  Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) introduced the Promise for Antibiotics and Therapeutics for Health (PATH) Act, S. 185, which would establish this limited population antibiotics approval pathway.  I urge the Senate Health, Education, Labor and Pensions Committee to include this important policy in its upcoming innovations legislation and to swiftly advance this effort.

My colleagues and I already see growing numbers of patients with serious, life-threatening infections that we cannot safely and effectively treat with existing antibiotics.  The threat from China will only worsen our plight, especially if Congress fails to act.  As a physician, there is nothing worse than telling a patient and his or her family that there is nothing I can do.  Luckily, there are many things Congress can do to help save these patients from deadly antibiotic resistant infections.

Bakken is president of the Infectious Diseases Society of America, consultant in infectious diseases at St. Luke’s Hospital and a clinical associate professor at the University of Minnesota Medical School Duluth.