Policy and Regulation
IDSA proposes a fast-track FDA approval path including a new Special Population Limited Medical Use (SPLMU) Drugs category for new treatments where few or no therapeutic options exist.
The SPLMU designation would allow drugs to be tested in smaller and thus faster clinical trials. FDA appears warm to the idea. Dr. Woodcock noted that the agency could set up general criteria and then make more specific agreements with companies about drug designation when they come in to talk to the FDA about their development programs.
IDSA said that its proposal should be added to a bill pending in Congress, the Generating Antibiotic Incentives Now (GAIN) Act of 2011 (HR 2182). GAIN would extend the exclusivity period for new qualified infectious disease products by five years, on top of any extension for pediatric exclusivity. The extension would not apply to supplemental applications for new indications or modifications to the structure of presently approved drugs. The bill would also give qualified infectious disease products six more months of exclusivity if the sponsor or manufacturer identifies a companion diagnostic test.
IDSA believes GAIN Act is helpful but may not offer enough incentive. The measure should include some exclusivity at the end of existing patent periods plus incentives to defray research R&D such as tax breaks, Jezek said.
Congress should also encourage public-private research collaborations, she added. This is the goal of a program being developed by the Innovative Medicines Initiative (IMI), a joint effort of EU and European pharmaceutical industry group EFPIA. IMI is preparing a call for proposals to be issued later this year for entities interested in running its “NewDrugs4BadBugs” program, spokeswoman Kim De Rijck told GEN.
The GAIN Act has been in committee since its introduction last June by by Rep. Phil Gingrey, M.D. (R-GA). The companion bill in the Senate (S.1734) was introduced by Sen. Richard Blumenthal (D-CT) last October. “Rep. Gingrey anticipates its passage this year,” spokeswoman Jen Talaber told GEN. “He has been working with other members to build consensus for some time and is urging Congress to move forward on this legislation.” The Senate bill has 10 co-sponsors, while Gingrey’s bill has 39.
Instituting Change More Quickly
“The GAIN Act is squarely focused on serious bacterial pathogens, with equally serious unmet medical need, including Gram-negative bacteria,” Rep. Gingrey said. Of particular interest, he said, is Acinetobacter baumannii or “Iraqibacter,” which infected numerous U.S. troops fighting in Iraq.
The GAIN Act would boost federal involvement in supporting antibiotic drug development, overseen for more than a decade by the Interagency Task Force on Antimicrobial Resistance. NIH, CDC, and FDA co-chair the task force, which last year published an updated Public Health Action Plan to Combat Microbial Resistance.
Jezek said IDSA supported many of the updated plan’s ideas but laments that the task force needed four years to publish the update and that no single point person has been named to ensure the task force’s work moves forward. “While there are a lot of really great ideas in there, there aren’t a lot of deadlines and benchmarks for holding the agencies accountable for taking on all of these new ideas and actions.”
NIH/NIAID also belongs to the Trans-Atlantic Task Force on Antimicrobial Resistance (TATFAR). Last year, TATFAR released a report outlining 17 recommendations for future EU-U.S. cooperation, Dennis M. Dixon, chief of the bacteriology and mycology branch of the NIAID, told GEN. TATFAR suggested that policymakers need to consider the establishment of incentives to stimulate antibacterial drug development.
It also noted that FDA and EMA should use the same clinical development program and facilitate vaccine development for healthcare-associated infections as well as consultation and collaboration on a survey of point-prevalence for such infections.
The task force’s work highlights the need for continued coordination of antibiotic research and drug development efforts now scattered among several agencies. But coordination should not be a reason to slow down the urgent work of developing drugs and vaccines.
Given the consensus in Congress, some form of GAIN Act will likely pass, either as a standalone bill or an amendment to the proposed fifth authorization of the Prescription Drug User Fees Act pending before Congress. The GAIN Act poses an opportunity to evaluate various initiatives, with an eye to bringing under a single umbrella all federally funded efforts to understand both how the pathogens function and how to eradicate them with drugs and preventive efforts.