IDSA Urges Congress to Support Hatch Amendment; Provisions Would Counter the Threat of Drug-Resistant Superbugs


The Infectious Diseases Society of America (IDSA) is calling on members of Congress to support the "Antibiotic Safety and Innovation" amendment introduced by Sen. Orrin Hatch (R-UT) to the Food Drug Administration (FDA) Revitalization Act. Without innovative public policy, the practice of medicine may return to the pre-antibiotic era when acquiring a bacterial infection was often a death sentence. 

The FDA Revitalization Act offers an important opportunity to avert the public health crisis that antimicrobial resistance is creating in hospitals and communities across the nation and at the same time to strengthen patient safety.  The Hatch amendment will:

-- expand incentives to spur the development of new, effective antibiotics

-- spur research on new indications or uses for approved antibiotics

-- require FDA to establish and reassess antimicrobial breakpoints so that physicians have the information necessary to use antibiotics wisely and in a way that will not put patients' safety or public health at greater risk

The Centers for Disease Control and Prevention (CDC) reports that more than 63,000 patients in the United States die every year and many more suffer greatly from hospital-acquired bacterial infections that are resistant to at least one common antibioticmore deaths than from AIDS, traffic accidents, or influenza.  The actual number of deaths is likely much higher as many deaths attributed to other causes, particularly those of elderly patients suffering from multiple conditions, may in reality be due to drug resistant infections.

Antibiotic-resistant bacterial infections kill tens of thousands of Americans every year and can strike anyone, young or old, healthy or chronically ill.   It is becoming quite common now for resistant bacterial infections to be acquired in the community-setting rather than in hospitals. Methicillin-resistant Staphylococcus aureus (MRSA) is a good example of this recent phenomenon.  MRSA is an aggressive, difficult to treat form of bacteria that has spread rapidly at an epidemic rate within communities. 

The FDA Revitalization Act can help to protect patient safety and the public health against antimicrobial resistance. IDSA hopes that Congress will take this opportunity to act and the Society applauds Hatch for offering the "Antibiotic Safety and Innovation" amendment.

Source: IDSA

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