American Academy of Emergency Medicine


AAEM Commends Passage of FDA Safety and Innovation Act of 2012

The American Academy of Emergency Medicine (AAEM) commends Congress for passing the Food and Drug Administration (FDA) Safety and Innovation Act of 2012, which reauthorizes the law permitting the FDA to collect user fees from makers of prescription drugs and medical devices, and allows the agency to begin collecting user fees for generic drugs. The bill also includes AAEM-supported provisions that will help ease critical national drug shortages.

According to William T. Durkin, Jr., MD MBA FAAEM, president of AAEM, “The prescription drug scarcities have been affecting medications that play a central role in life-saving emergency care.” Antimicrobials, pain medications, and poison antidotes often requiring highly time-sensitive administration are increasingly in limited supply. In many cases, therapeutic alternatives have not been available or have carried heightened risk of severe side effects and drug-to-drug interactions. “With 123.8 million visits to hospital emergency departments in the United States, the growing number of drug shortages could threaten the safety of patients under our care,” adds Leana S. Wen, MD MSc, president of the AAEM Resident and Student Association (AAEM/RSA).

Recognizing that the current situation is unacceptable, AAEM and AAEM/RSA, in collaboration with key partners including the American Society of Health-System Pharmacists, the American Hospital Association, and the Institute for Safe Medication Practices, engaged with a bipartisan group of legislators in both chambers of Congress to develop the drug shortages provisions in the bill.  “With the passage of the FDA Safety and Innovation Act of 2012 emergency physicians believe that health care is nearer to resolving this troubling public health problem,” states Durkin.

Anticipating swift approval of the bill by President Barack Obama, AAEM and AAEM/RSA look forward to working with the FDA as it administers this law that promises to reinforce patient safety and quality of care in emergency departments nationwide.