Congress must seize the opportunity this year in “must-pass legislation” to head off a growing public health crisis – the inability to treat deadly antibiotic-resistant “super bugs” – by addressing the lack of new antibiotics in development. The Infectious Diseases Society of America (IDSA) and a broad coalition of 50 organizations representing patients, health care providers, health systems, veterans, women’s health, children’s health, seniors, and other stakeholders are reaching out to key congressional leaders to plead that they fix the broken antibiotic research and development (R&D) pipeline by adopting sufficient economic incentives as part of the Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA).
“Many people may not realize how close we are to losing the ability to fight lethal infections,” says Thomas G. Slama, MD, president of IDSA. “The antibiotics we currently have are becoming less effective because bacteria are constantly evolving and outsmarting the drugs used against them.”
Although new antibiotics are desperately needed, the number of these miracle drugs in the development pipeline has plummeted due to scientific, regulatory, and economic challenges. The continual loss of effective antibiotics is reaching a crisis, as each year, antibiotic-resistant infections kill nearly 100,000 U.S. hospital patients and are increasingly affecting healthy people as well. The organizations also are urging Congress to incentivize the development of new diagnostic tests, which can help reduce the costs of antibiotic clinical trials by identifying eligible patients and aid public health officials in recognizing emerging infections and patterns of resistance. Better diagnostic tools also can help physicians prescribe the best drug to treat a particular patient’s infection.
Effective antibiotics and better diagnostic tests could have helped protect 11-year-old Addie Rerecich, of Tucson, Ariz., from the life-threatening strains of Staphylococcus aureus, Escherichia coli (E. coli), and other resistant infections she faced in 2011. “Nothing can describe my feelings as a mother sitting helpless as I watched my little girl go from smiling and healthy to near death in less than a day. Antibiotic-resistant infections have devastated my daughter’s life and our family’s health, wellbeing, and finances,” said her mother, Tonya Rerecich. Addie spent five months in the hospital, needed a lung transplant to save her life, and finally left the hospital in a wheelchair, terribly weakened and with vision loss.
PDUFA is considered one of the few must-pass bills this year in Congress, as without its enactment, FDA will need to lay off personnel by the end of September. Congressional leaders have said they hope to complete work on PDUFA by June. Although the provisions being considered for PDUFA are unlikely to provide the full answer, they are a step in the right direction, said IDSA’s Slama. The incentives are among several that IDSA believes will be helpful and has recommended to Congress. IDSA’s and the other organizations’ end goal is the development of 10 new systemic antibiotics by 2020, also known as “The 10x’20 Initiative."
Two decades ago, 20 large companies had active antibiotic R&D programs; today there are only two or three. Several factors have led to the decline in antibiotic R&D, including extra hurdles companies must clear to bring an antibiotic to market compared to developing drugs to treat chronic conditions, such as high blood pressure and cholesterol. Additionally, because they are used for years, drugs for chronic conditions are more lucrative than antibiotics, which are used for just days or weeks. On top of that, due to antibiotic resistance, antibiotics are at risk of losing their effectiveness as soon as they are approved and used. For this reason, physicians are encouraged not to use the drugs or to hold off using them for as long as possible.
“The simple fact is we haven’t found the right combination of incentives to convince pharmaceutical companies to invest in developing the new antibiotics we desperately need, and PDUFA reauthorization is an opportunity to do so,” says Jeff Levi, PhD, executive director of the Trust for America’s Health (TFAH). “Rich or poor, all of us are dependent on the development of effective new antibiotics.”
The incidence of antibiotic-resistant bacteria, including MRSA, E. coli, Acinetobacter baumannii, Klebsiella, and others has skyrocketed over the past two decades. Treating infections, such as pneumonia, that result from drug-resistant bacteria is extraordinarily expensive, costing $20 billion every year.
“Tuberculosis is an excellent example of a disease we once were able to treat easily but no more,” says Mark Harrington, executive director of the Treatment Action Group (TAG). “TB is making a comeback with a vengeance, particularly among people with HIV. Our efforts to treat increasingly common drug-resistant forms of TB are failing. We need new drugs if we are to have any chance of staying ahead of deadly infections such as TB.”
A total of 50 groups, including IDSA, TFAH and TAG, are urging action. Other groups include: Alliance for Aging Research, American Geriatrics Society, American Public Health Association, Children’s Hospital Association, Department for Professional Employees of AFL-CIO, National Association of County and City Health Officials, National Association of Nurse Practitioners in Women’s Health, National Association of Veterans' Research and Education Foundations, and Premier. To read the full text of the letter and see all of the supporting organizations, visit IDSociety.org.