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Issue Brief
Unmet Medical Need in Infectious Diseases
Introduced more than 75 years ago, antibiotics have profoundly transformed health care. Thanks to these drugs and to advances in vaccines and infection control, many formerly devastating bacterial illnesses can be cured or contained. Antibiotics also help make surgery, chemotherapy, and other medical procedures possible by reducing their once prohibitively high risk of infection. However, unlike other drugs, antibiotics gradually lose their effectiveness as bacteria develop resistance.
Nearly a year after the enactment of the Generating Antibiotic Incentives Now Act, the U.S. Food and Drug Administration has released draft guidance for industry on developing antibacterial therapies for patients with unmet medical needs.
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The lack of new antibiotics and the rise in drug resistance have rendered some serious and life-threatening infections untreatable, and the health care community is searching for ways to bring innovative new drugs to patients whose treatment options are limited or nonexistent.
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As multidrug-resistant infections have grown more prevalent, few new antibiotics are reaching the market. This is attributed, in part, to the economic and regulatory challenges associated with their development. Recently, stakeholders have endorsed a novel regulatory pathway to approve these lifesaving drugs for use in limited patient populations — namely those at highest risk and with few or no other options.
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"As a nation, we need to exercise greater care with our use of antibiotics, in both humans and animals, so that these medications remain effective in treating serious bacterial infections."
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This year's celebration of National Public Health Week (NPHW) focuses on the theme, "Public Health is ROI: Save Lives, Save Money." Join us in recognizing the work of Pew's Health Initiatives.
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