Task force seeks breakthrough in developing antibacterial drugs
■ Twenty-nine such medications were licensed between 1980 and 1989. The number fell to nine between 2000 and 2009.
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Infectious diseases specialist Helen W. Boucher, MD, and her colleagues at Tufts Medical Center in Boston treat patients with antibiotic-resistant infections every day. The infections occur not just in critically ill individuals but also in healthy outpatients who develop urinary tract infections or skin infections.
Due to drug shortages and a lack of new antibiotics, Dr. Boucher and other physicians increasingly go back to drugs that were shelved decades ago because of high levels of toxicity. As resistance develops to those medications, the last resort often is combining antibiotics.
“The need is so great that people need to buckle down and come up with creative ways to develop effective antibiotics for the serious problems we have,” Dr. Boucher said. “The old cookie-cutter approach isn’t going to work.”
Among the latest efforts to remedy the antibiotic problem is the Food and Drug Administration’s Antibacterial Drug Development Task Force. On Sept. 24, the FDA announced the creation of the panel, which will consist of 19 clinicians and scientists who are part of the FDA Center for Drug Evaluation and Research.
The intention is to end years of stalled antibiotic research and fuel the development of much-needed new antibacterial drugs.
To accomplish that goal, the task force plans to take the following steps:
- Identify reasons for the lack of a robust pipeline for antibacterial drug development.
- Explore novel scientific approaches to facilitate the creation of antibacterial medications.
- Determine new approaches for weighing the risks, benefits and uncertainties of potential new antibacterial drugs.
- Evaluate FDA guidances related to antibacterial drug development, see if revisions are needed and identify areas where future guidance would be helpful.
- Work with think tanks and others to explore approaches to antibacterial drug development, including innovative study designs and statistical analytical methods.
“By establishing this task force, [the] FDA can help make real progress and change the paradigm,” said Rachel Sherman, MD, MPH, co-chair of the task force. She is director of the Office of Medical Policy in the FDA Center for Drug Evaluation and Research. “Our hope is that this effort will result in breakthroughs in the field of antibacterial drug development and help in the fight against antibiotic resistance.”
The creation of the task force follows the July enactment of the Prescription Drug User Fee Act. The legislation includes the Generating Antibiotic Incentives Now Act, which offers pharmaceutical companies economic incentives to develop antibiotics. For instance, the measure extends the exclusivity period by five years for a new prescription drug that is a qualified infectious diseases product. Such a product is defined as an antibiotic drug for treating, detecting, preventing or identifying a qualifying pathogen.
A slowdown in drug development
In the United States, hospital-acquired infections kill about 90,000 people a year, according to the National Institute of Allergy and Infectious Diseases. That figure is up from about 13,300 deaths in 1992. More than 70% of the bacteria that cause these infections are resistant to at least one of the antibiotics used to treat them.
Contributing to resistance problems are patients who do not take antibiotics as prescribed and the misuse of the medications by health professionals. Such misuse is due, in part, to a lack of training on conserving antimicrobials, infectious diseases experts say.
Complicating matters is the significant slowdown in the development of new antibacterial drugs. Twenty-nine such medications were licensed between 1980 and 1989, according to the FDA. The number fell to 23 in the 1990s and dropped to nine between 2000 and 2009.
Just as concerning, experts say, are the limited number of potentially new antibiotics in research and development.
Contributing to the slowdown is the fact that antibiotics aren’t as profitable as other drugs, such as those for chronic diseases, because antibiotics are prescribed sparingly to prolong their use. There also are regulatory disincentives to developing the medications, including outdated strategies for evaluating the effectiveness of new antibacterials once they’re in development, said Robert Guidos, vice president of public policy and government relations at the Infectious Diseases Society of America.
“The IDSA views [the task force] as an extremely positive development,” he said. “The task force is charged with coming up with new ideas to bring clarity to the regulatory pipeline and to create a feasible pathway” for approval of antibacterial drugs.
On the heels of the FDA’s announcement, a White House advisory body issued a report on Sept. 25 detailing a plan to double during the next decade the production of new drugs, including antibiotics, that go on the market each year for patients with serious diseases.
The report, developed by the President’s Council of Advisors on Science and Technology, identifies two needs related to drug discovery and development that must be addressed to advance innovation. One need is the creation of better methodologies and tools for scientists to translate basic biological insights into validated therapeutic targets. The other area to be addressed is inefficiency in clinical trials, the report said. The White House advisory body also recommends creating a public-private partnership to identify and plan actions to speed drug developments.
“The past quarter-century has seen tremendous progress in biomedical research. Still, the pace of new therapeutic development has not kept up with the explosion in scientific knowledge,” the advisory body wrote in a letter to President Obama. “The recommended actions [in the report] will advance the health of Americans, as well as economic growth for the nation.”