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But it also outlines the implications of the spread of antibiotic resistance and four ways to help avert it. They are: preventing infections from happening in the first place through techniques such as immunization and hand-washing; gathering data on the causes and risk factors of infections that do occur; practicing antibiotic “stewardship,” or ensuring that antibiotics are used safely and appropriately; and developing new antibiotics to keep pace with resistance, along with new diagnostic tests.
On the issue of stewardship, Frieden noted that, nationally, about half of all antibiotic use in people is unnecessary or inappropriate and the prescription rates vary at least twofold between states. The CDC recommends that every hospital in the country have an antibiotic stewardship program, he said. The programs have been shown to lower health care costs and rates of complications and improve patient outcomes, he said.
Development of new drugs has been a focus for some lawmakers who want to find a way to get new antibiotics to market. The Pew Charitable Trusts and the Infectious Diseases Society of America, with the support of other groups, have proposed principles for a new pathway for antibiotics to treat serious or life-threatening infections when there are few or no other treatment options. Some policymakers are considering these principles.
The concern, IDSA President David A. Relman explained at the briefing, is the significant challenge of carrying out traditional, large-scale clinical trials for those infections. A proposed Limited Population Antibacterial Drug pathway would allow the antibiotics to be approved using clinical trials that have fewer patients than trials for more widely used drugs, he said.
“It’s not feasible for antibiotics that treat serious infections due to highly resistant bacterial pathogens to be developed using traditional large clinical trials due to the limited number of patients in whom these infections occur,” Relman said.
Nicole Mahoney, senior officer for Pew’s antibiotics and innovation project, said Pew thinks LPAD legislation would clarify the FDA’s authority to classify antibiotics for limited use in small, well-defined patient populations. A bill would accomplish that, she said, through creating a special designation and label. That would signal to health care providers, insurers and patients that the antibiotics are unique and should only be used in patients who really need them and when the benefits outweigh the risks, she said.
“We think that in the absence of that kind of legislation, FDA is unlikely to approve antibiotics for limited populations,” Mahoney said in an interview. “They could really use the strong congressional support.”Congressional Prospects
Gingrey and Green announced at the Sept. 17 briefing that they are working on legislation, although neither outlined any specific proposals. Green said they “didn’t get everything we wanted under the GAIN Act” and are trying to accomplish more.
“What we need to do is make sure the next generation of those antibiotics have as quick a path to getting from the lab table to the bedside as we can,” Green said. “And that’s what the GAIN Act was about and that’s what our legislation is about: to try and move FDA and put a priority on those type of pharmaceuticals.”