Several major medical societies are telling Congress to act quickly on a bill that would spur the creation of new antibiotics in the face of antibiotic resistance.
The bill, called the Antibiotic Development to Advance Patient Treatment Act, would enable the US Food and Drug Administration (FDA) to approve antibacterial or antifungal drugs to treat a serious or life-threatening condition in a limited number of patients whose medical options are nil or few. Under the bill, the FDA could base its decision on clinical trials much smaller — and presumably less expensive — than what drug manufacturers are accustomed to.
To avoid inappropriate prescribing, the labels for such antibiotics would caution clinicians that the drug "is indicated for use in a limited and specific population."
Rep. Phil Gingrey, MD (R-GA), introduced the bill November 2013. Twenty-six other House members from both parties have signed on as cosponsors. However, the bill has remained bottled up in the health subcommittee of the House Energy and Commerce Committee.
On Tuesday, a coalition of 22 healthcare organizations sent a letter to the committee, urging it to advance the bill to the House floor sooner rather than later. Medical societies signing the letter included the American College of Physicians, the American College of Cardiology, the American Gastroenterological Association, the Infectious Diseases Society of America (IDSA), and the American Thoracic Society. The Pew Charitable Trusts and the National Association of County and City Health Officials were other signatories.
"Without swift congressional action, we fear that antibiotic research and development will continue to struggle, and that patients will continue dying from infections that are resistant to current antibiotics," the coalition writes. "We see no reason for the Committee to delay consideration of this thoughtful, widely supported proposal."
In a separate letter to the Energy and Commerce Committee this week, 131 members of IDSA spelled out the enormity of the crisis: 23,000 deaths per year because of antibiotic resistant infections, and healthcare costs put at $20 billion per year.
"We don't have a day to waste," the IDSA members write.
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Cite this: Doctors Urge Quick Action on Bill to Develop New Antibiotics - Medscape - Jun 12, 2014.
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