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Antibiotic development lagging despite desperate need
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With only one new antibiotic approved by the FDA since 2010, time is running out to develop 10 new antibiotics by 2020, a goal established in the Infectious Diseases Society of America’s “10 x ’20 Initiative.”
There is a need for new antibiotics to combat drug-resistant bacteria, which are becoming more common. According to an IDSA report published in Clinical Infectious Diseases, there are only seven new drugs in development for the treatment of multidrug-resistant gram-negative bacteria. There is no guarantee that any of these drugs will receive FDA approval.
The IDSA has voiced concern about the lack of progress in antibiotic development since 2002. The number of antibiotics approved in the United States has continued to decline, but the number of infections caused by resistant bacteria continues to increase. According to the report, however, several large pharmaceutical companies have withdrawn from research and discovery of new antimicrobials.
“Right now, companies don’t find it financially beneficial to invest in antibiotics,” Barbara Murray, MD, president-elect of the IDSA and an author of the report, told Infectious Disease News. “Antibiotics are taken for a short period of time. Developing drugs that need to be taken for a lifetime, such as those for diabetes or heart disease, is more profitable.”
Barbara Murray
In the report, the IDSA recommends a multi-pronged approach that includes new economic incentives for antibiotic research, clarification of FDA’s requirement for antibiotic approval, increased research funding, improved infection prevention, new public health efforts and antibiotic stewardship. IDSA leaders are working with other stakeholders for solutions to the problem, including the creation of a faster approval pathway. In addition, Republican leaders in the US House of Representatives intend to make antibiotic research and development a priority for the 113th Congress.
“There are legislation efforts to increase the incentives for pharmaceutical companies to develop antibiotics,” Murray said. “Part of IDSA’s efforts is to find out from the companies what they would consider a good enough financial incentive to get back into the antibiotic development industry.”
Murray said that the Generate Antibiotic Incentives Now (GAIN) Act of the FDA gives companies a longer patent time on antibiotics that are considered new and important. Other suggestions include giving companies a tax benefit when they conduct large clinical trials on antibiotics. Another necessary component is stimulating research funding through NIH or other agencies for investigators at universities or pharmaceutical companies to conduct basic science research.
David A. Relman
“IDSA is committed to ensuring proper use of currently available antibiotics to make certain we can continue to count of them,” IDSA President David A. Relman, MD, said in a press release. “But that is not enough. Simply put, the antibiotic pipeline is on life support and novel solutions are required to resuscitate it — now. The lack of new antibiotics to treat these potentially life-threatening infections signals the end of modern medicine as we know it.”
Disclosure: Murray and Relman report no relevant disclosures.
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