This Wednesday, members of the Senate Health, Education, Labor, and Pensions Committee have the opportunity to avert a potential public health crisis when they vote on the Food and Drug Administration (FDA) Revitalization Act by including provisions that address antimicrobial resistance. The Infectious Diseases Society of America has proposed two such provisions that will:
1) expand incentives to spur the development of new, effective antibiotics
2) require FDA to establish and reassess antimicrobial breakpoints so that physicians have the information necessary to use antibiotics wisely and in a way that won’t put patients’ safety or public health at greater risk.
Congress must not miss this opportunity. Why? Because antibiotic-resistant bacterial infections kill tens of thousands of Americans every year and can strike anyone, young or old, healthy or chronically ill. Annually, nearly 2 million U.S. patients acquire infections in the hospital and nearly one in 10 die from them; more than 70 percent of those infections are resistant to at least one of the drugs used to treat them.
Last week the Centers for Disease Control and Prevention (CDC) announced that gonorrhea has become resistant to powerful antibiotics known as fluoroquinolones. This development means that only one class of antibiotics—cephalosporins—can be used to treat gonorrhea, the second most commonly reported infectious disease in the United States.
Gonorrhea has now joined the list of other superbugs for which resistance is rising and treatment options have become dangerously few. Other infections that are becoming difficult to treat include methicillin-resistant Staphylococcus aureus (MRSA), a life-threatening infection that has become increasingly common among young children; Acinetobacter baumannii, a growing cause of hospital-acquired pneumonia and drug-resistant infections among soldiers returning from Iraq and Afghanistan; and vancomycin-resistant Enterococcus faecium (VRE), a major cause of bloodstream infections, infections of the heart, meningitis, and intra-abdominal infections.
Many pharmaceutical companies are abandoning or scaling back antibiotic research and development in favor of more profitable drugs that treat chronic conditions. This is a regrettable, but understandable, development as market forces that would lead companies to consider investing in new antibiotic development are weak. Because antibiotics work so well and so fast, in most cases, they are prescribed for only one or two weeks. That means they don’t have as large a market as drugs that patients take for years.
The FDA Revitalization Act can help to protect patient safety and the public health against antimicrobial resistance. We hope that Congress will take this opportunity to act; otherwise, we may soon return to the pre-antibiotic era, when acquiring a common bacterial infection was often a death sentence.