A recent report from the Centers for Disease Control and Prevention is adding urgency to an issue lawmakers from both parties say they want to address: the rise of bacteria that are resistant to antibiotics.
According to the report, at least 2 million people in the United States are infected each year by bacteria that are resistant to one or more of the antibiotics that are supposed to treat them, directly resulting in at least 23,000 deaths. And that’s “a very conservative estimate of the burden,” CDC Director Thomas Frieden said.
The key message he wants to get across, Frieden told an audience at a Capitol Hill briefing, is that “there’s a big problem and there’s something we can do about it” — a sentiment with which both Republican and Democratic policymakers appear to agree.
Congress last year passed a five-year reauthorization of the Food and Drug Administration’s user fee programs that included a provision designed to provide incentives for the development of new antibiotics to treat drug-resistant infections, known as the Generating Antibiotic Incentives Now Act. The authors of that provision, Reps. Phil Gingrey, R-Ga., and Gene Green, D-Texas, are working on a new bill to help smooth the pathway to get antibiotics to market.
In the Senate, a bipartisan pair has also expressed interest in the issue. And in response to the CDC report, Democratic leaders of the House Energy and Commerce Committee have requested a hearing on antibiotic resistance, a topic that a spokeswoman for committee Republicans said could be a part of expected hearings on issues related to the FDA.
“While all agree that the GAIN Act was a huge step in combating antibiotic resistance, we support the need to identify additional policies that foster and support development of new measures to combat life-threatening infections because the public threat we continue to face is very real,” the spokeswoman said.
“The committee expects to examine FDA-related issues in the coming weeks, which will provide the opportunity to discuss this and other subjects related to the FDA. We look forward to partnering again with our Democratic colleagues on the topic of antibiotic resistance.”
Frieden said the new report represents the first time the CDC has pulled together all of its data on antimicrobial resistance and assembled it in one place. The document categorizes 18 microorganisms as urgent, serious or concerning, based on the level of threat.
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.”
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.”
Gingrey said he thinks Congress will have the most impact by looking for ways to help bring advanced antibiotics to market, which he said has become “a huge problem.” Factors like the high cost of developing drugs and small profit margins have helped drive companies to markets where they have a better return on investment, he said.
“They have a bottom line. They have stockholders. They have employees,” Gingrey said. “It’s just business sense.”
In the Senate, Colorado Democrat Michael Bennet and Utah Republican Orrin G. Hatch have expressed support for the LPAD concept but have not introduced legislation.
Bennet spokesman Adam Bozzi said a bill is being considered, noting that the CDC report underscores the urgency of ensuring the FDA has the tools to address this problem. Matt Harakal, a spokesman for Hatch, said the senator continues to be interested in the proposal.
The Senate Health, Education, Labor and Pensions Committee, on which Hatch and Bennet both serve, is scheduled to hold a hearing on health-care-associated infections on Tuesday.
Frieden, meanwhile, emphasized that prompt action is necessary on all four areas outlined in the report. If the country doesn’t act quickly, he described a bare medicine cabinet with no drug left to combat a life-threatening infection.
“There wouldn’t be much point in sounding an alarm if it was too late. It’s not too late,” Frieden said. “We still have the ability to stop and reverse antimicrobial resistance, or at least to slow it so that we can preserve the antibiotics that we have today for more years, so that we will have them available for our kids and our grandkids.”