Jun 28, 2012 (CIDRAP News) – Some provisions included in a measure that passed Congress this week represent a good first step to spur development of new antibiotics in the face of growing bacterial resistance, says a policy expert with the Infectious Diseases Society of America (IDSA).
Included in the Food and Drug Administration (FDA) Safety and Innovation Act are a measure to extend drug companies' exclusive use of certain data about new antibiotics for 5 years and a requirement for the FDA to provide guidance to help drug companies test pathogen-specific drugs, according to Robert Guidos, JD, the IDSA's vice president for public policy and government relations.
"It's a good first step, but more is needed," Guidos told CIDRAP News.
The main thrust of the legislation is to renew the FDA's authority to charge user fees for its review of prescription drugs and to enable the agency to increase inspections of foreign drug manufacturing facilities, according to an Associated Press (AP) report. Most US drug companies have moved their operations overseas in recent years, the story noted.
The bill is expected to be signed by President Obama.
Guidos explained that under existing law, when a new drug gains FDA approval, there's a 5-year "data exclusivity" period during which other companies seeking to market a generic version of the drug can't use any data that was instrumental in the original drug's approval. The new legislation extends this exclusivity period for another 5 years for new antibiotics, which reduces the chance of a generic version of the drug coming on the market during that time, he said.
But he added, "Unfortunately this protection most likely will run concurrent with existing patent time that's available for antibiotics. On average what we hear from companies is that they have 10 to 12 years of patent time available. This [new law] will provide 10 years of exclusivity, so it provides some assurance that they won't get sued and a new generic won't come on the market, but it's likely that wouldn't happen anyway. . . . [But] some companies said this is a benefit for them and they feel it's some additional incentive."
What's needed to replenish the pipeline of new antibiotics is a combination of "push and pull incentives," Guidos said. "What we're seeing in this legislation is the pull. It's helpful but not enough to raise the net present value of antibiotics so that they are competitive internally to companies versus other products, like oncology and musculoskeletal drugs."
The other antibiotic-related piece of the new legislation is a directive for the FDA to provide industry guidance by the end of 2014 on how to design trials for drugs that target specific pathogens or organisms, Guidos said.
He explained that the idea is to stimulate development of drugs targeting not a disease, such as pneumonia, but a particular resistant pathogen, such as Acinetobacter, that can cause infections at different body sites. For a clinical trial, it's hard to find enough patients who have, for example, a lung infection with Acinetobacter, so it would be necessary to "pool" patients with Acinetobacter-related infections at various body sites, he said.
"A lot of companies are interested in this issue," he added.
Guidos said the law does not include a recent IDSA proposal involving a streamlined approval pathway for antibiotics intended for special classes of patients who lack other treatment options. The idea, which IDSA calls the Limited Population Antibacterial Drug mechanism, envisions smaller clinical trials and a faster regulatory review than those required for drugs with broader uses.
But on the positive side, he said, "We view the measures included in this legislation as a good first step, a recognition from Congress that antibiotics are a unique area of medicine that deserves special protections and incentives. This is the first time Congress has provided a special incentive for one specific type of product."
"One of the benefits it provides is a doorway for additional incentives in the future," he said. "By having something in a statute, it sets a precedent in this space."
The new FDA legislation also calls for a review of antimicrobial stewardship programs "as a critical tool for protecting the antibiotics we currently have against resistance," the IDSA said in a press release this week.
Jun 26 AP story
Jun 26 IDSA press release