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Should Antibiotics Be Given a Separate Regulatory Drug Category?

Posted on: Thursday, 14 December 2006, 18:01 CST

BOSTON, Dec. 14 /PRNewswire/ -- International experts debated whether antibiotics merit a separate regulatory drug category at a World Congress held on December 11 and 12 at the Hyatt Regency Boston Hotel. "We proposed this drastic action because antibiotic resistance is undermining infectious disease treatment worldwide and many large pharmaceutical companies are leaving the antibiotic field," explains Stuart B. Levy, MD, a Tufts Medical School professor and president of APUA, the global public health organization convening the meeting. Pharmaceutical companies spend an estimated $800 million to bring a new antibiotic to market. They face time limits on patent protection before others can manufacture and sell the compound without investing in this expensive research. Also pharmaceutical houses are turning to more profitable lifestyle and chronic disease drugs. The APUA World Congress will explore innovative solutions and partnerships to control antibiotic resistance and promote drug development. "If antibiotics can be given a special category by the U.S. Food and Drug Administration, then unique considerations could be applied to them," says Levy. "By placing antibiotics in a separate regulatory category we could also promote better antibiotic stewardship by patients and doctors and promote responsible industry marketing strategies," according to Kathy Young, executive director of APUA.

Antibiotics are powerful life-saving medicines for use in serious bacterial infections as diagnosed by a physician. However, casual antibiotic use is the norm in many hospitals and community practices in the U.S. As a result, we are experiencing accelerated evolution of resistant bacteria and increased difficulty of treating infections. According to the CDC, half of medically prescribed antibiotics in the U.S. are unnecessary.

APUA's collaboration with the CDC's Get Smart Campaign has resulted in a reduction in antibiotic prescribing for colds -- for which antibiotics are useless. Levy said, "By convening this Congress, we hope to build strong partnerships to both preserve the power of existing antibiotics and accelerate the development of cost effective new treatments and diagnostics."

For more information please visit the APUA website: http://www.tufts.edu/med/apua/

Stuart B. Levy, MD President 617-407-5633 (cell) Kathleen Young Executive Director 617-610-3313 (cell) Christopher Spivey Communications Director 617-636-4048

Alliance for the Prudent Use of Antibiotics

CONTACT: Stuart B. Levy, MD, President, +1-617-407-5633 (cell), orKathleen Young, Executive Director, +1-617-610-3313, or Christopher Spivey,Communications Director, +1-617-636-4048, all of the Alliance for the PrudentUse of Antibiotics

Web site: http://www.apua.org/

Source: PRNewswire

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