Skip to main content

Thompson, Boustany Lead Bipartisan Effort to Combat Deadly Infections

September 17, 2015

(Washington, DC) – Congressman Charles W. Boustany, Jr., MD, (R-LA) and Congressman Mike Thompson (D-CA) of the House Ways & Means Committee joined their colleagues Congressman Erik Paulsen (R-MN), Congressman John Shimkus (R-IL), and Congressman Gene Green (D-TX) today in introducing the Reinvigorating Antibiotic and Diagnostic Innovation (READI) Act to address the rising public health challenge of antibiotic resistance.

Boustany said: "We have seen too many cases where families receive the devastating news that their loved one has a bacterial infection that is resistant to antibiotics. We have heard from physicians warning us about the critical shortage of antibiotics and the further need to improve diagnostic tests so they can better diagnose and treat these infections. This is why we are coming together today with legislation to reignite research and development for new antibiotics and diagnostic tests."

Thompson said: "By incentivizing the development of life-saving drugs and diagnostics, we can save money and keep people healthy and safe. In the last quarter-century we've seen antibiotic and antifungal resistance grow while research and development has lagged. This poses a serious threat to public health that must be addressed. Our bipartisan bill tackles this very issue by encouraging the development of new antibiotics and rapid diagnostic tests. The bill will help save lives and money. Congress should quickly pass it."

Antibiotic resistance is increasing and a growing number of patients are suffering from and succumbing to resistant infections that cannot be effectively treated with existing drugs. The pipeline for new antibiotics and antifungals remains disturbingly low leaving patients and physicians few and sometimes no safe and effective treatment options. According to the Centers for Disease Control and Prevention (CDC), at least 23,000 Americans will die this year due to antibiotic resistant infections. The economic cost of antibiotic resistance is high as well, costing the U.S. health care system an estimated $20 billion annually (including 8 million additional days that people spend in the hospital).

Joe Dalovisio, MD, FIDSA, former Infectious Diseases Society of America (IDSA) President and Associate Medical Director, Ochsner Health System, New Orleans said: "My colleagues and I continue to see increasing numbers of patients who we cannot successfully treat with our existing, dwindling arsenal of antibiotics. New infectious diseases threats emerge and grow constantly. For example, in Louisiana, we are beginning to see many more infections caused by the deadly bacteria Acinetobacter baumanni. We had only 11 reported cases in 2001, but 742 in 2010. While the vast majority of the 2001 cases were susceptible to available antibiotics, a whopping two-thirds of the 2010 cases were resistant to Cephalosporins—one of our most powerful classes of antibiotics. These frightening bacteria are becoming a more common cause of health care associated infections, including ventilator associated pneumonia, line sepsis, and burn wound sepsis. We are grateful to have a champion in Congressman Boustany—a fellow physician—who understands the public health crisis of antibiotic resistance and is leading this important congressional effort to help address it."

In an effort to counter the toll antibiotic resistance is taking on public health, the READI Act would amend the Internal Revenue Code by taking a "push" (during development) tax incentive approach for qualifying manufacturers to increase clinical testing of 1) antibiotic and antifugal drugs and 2) rapid infectious disease diagnostic tests. Antibiotic R&D poses unique scientific, regulatory and economic challenges which often make it riskier than R&D for other types of drugs. For example, the drugs become less effective as soon as they are used because bacteria evolve defenses to resist them and then transfer these defenses to other bacteria. Antibiotics also are typically inexpensive and used for short-durations and therefore, can rarely compete for R&D dollars against more profitable drugs like those that treat chronic diseases. In 1990, there were almost 20 pharmaceutical companies with large antibiotic R&D programs. Today, there are roughly three large companies with robust, active programs and a small number of companies with limited programs.

Henry Chambers, MD, FIDSA, Chief of Infectious Diseases, San Francisco General Hospital said: "In California this year, we experienced the antibiotic resistance crisis firsthand, when a deadly outbreak of Carbapenem Resistant Enterobacteriaceae (CRE) occurred in two major California hospitals, underscoring the urgent need to combat antibiotic resistance and develop new treatments for patients who contract these infections. This bill will be an important complement to the Generating Antibiotic Incentives Now (GAIN) Act, which was enacted in 2012 and provides a "pull" incentive for new antibiotics. We need a strong "push" incentive—like the tax credit provided in this bill—to help make antibiotics a feasible investment for companies. Unlike drugs for most other conditions, antibiotics are typically taken for a short period of time, inexpensive, and held in reserve to protect their utility—all contributing to a failure of the market in stimulating development of these important and life-saving drugs."

The following is a list of some of the organizations and companies supporting the READI Act:

AdvaMedDx

Accelerate Diagnostics, Inc.,

Alliance for the Prudent Use of Antibiotics

American Academy of Allergy, Asthma & Immunology

American Congress of Obstetricians and Gynecologists

American Gastroenterological Association

American Society for Microbiology

American Society of Health-System Pharmacists

American Thoracic Society

American Urological Association

Antibiotics Working Group (Cempra, Durata Therapeutics, Optimer Pharmaceuticals, Melinta, The Medicines Company and Theravance)

bioMérieux

Cempra, Inc.

Center for Foodborne Illness Research & Prevention

Da Volterra

HIV Medicine Association

Infectious Diseases Society of America

Making-A-Difference in Infectious Diseases

March of Dimes Foundation

Merck

National Athletic Trainers' Association

National Foundation for Infectious Diseases

Pan American Society for Clinical Virology

Pediatric Infectious Diseases Society

Research!America

Society of Infectious Disease Pharmacists

Issues:Health Care