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FDA In Brief: FDA reports on its progress advancing policies for developing next generation antibiotics

For Immediate Release: Feb. 2, 2018

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  Theresa Eisenman
  301-796-2969

"The emergence of antibiotic resistance threatens the advances we’ve made in medicine. Even with better stewardship of our existing antibiotics in both health care and agriculture settings, we continue to see new drug resistance emerge,” said FDA Commissioner Scott Gottlieb, M.D. “There’s an urgent need to develop new antibiotics that are effective against resistant bacteria. But research and development to discover a new antibiotic is scientifically and economically challenging. As one step towards addressing these obstacles, Congress created a program to provide additional incentives for developing new drugs. This program allows the FDA to grant certain drugs a designation as a qualified infectious disease product. At the same time, the FDA has taken steps to make the development process more efficient. Over the last five years, we’ve granted 147 qualified infectious disease product designations, including 74 designations for novel drugs, and we’ve approved 12 drug products with these qualifications. The FDA remains committed to taking new steps to encourage the development of new antibiotics."

Today, the Department of Health and Human Services released a report to Congress on progress made in facilitating the development and approval of new antibacterial and antifungal drugs, implementing stewardship programs to ensure their judicious use and assessing the impact of the Generating Antibiotic Incentives Now (GAIN) provisions on promoting the pipeline of antibacterial and antifungal drugs.

GAIN was signed into law in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) to stimulate development of new antibacterial and antifungal drugs. It created incentives for sponsors to bring to market antibacterial and antifungal drugs intended to treat serious or life-threatening infections. Under the GAIN provisions, applications for certain antibacterial and antifungal drugs that are designated as a qualified infectious disease product (QIDP) can receive fast track designation, priority review designation, and a possible five-year extension of any exclusivity that the application qualifies for upon approval.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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