Medical industry and patient advocacy groups are calling on lawmakers to pass a bill that would let the Food and Drug Administration approve antibiotics based on smaller clinical trials.
Twenty organizations wrote to lawmakers on the House Energy and Commerce Committee on Tuesday asking that they advance the Antibiotic Development to Advance Patient Treatment (ADAPT) Act.
The bipartisan bill would provide more incentives to drugmakers to develop new antibiotics.
The medical community is concerned about the rise of antibiotic-resistant infections as new antibiotics have been slow to get to the market over the past few decades.
Under the bill, antibiotics may be approved based on one mid-sized clinical trial instead of two large trials that are typically required by the FDA.
“It is often not feasible for [antibiotics] to be developed using traditional, large clinical trials due to the limited numbers of patients in whom these infections currently occur,” wrote the Infectious Diseases Society of America, an advocacy group representing infectious disease specialists. “ADAPT drugs would need to meet FDA standards of evidence for safety and effectiveness for the limited indicated population.”
The bill was sponsored and introduced by Rep. Phil GingreyPhil GingreyBeating the drum on healthcare Former GOP chairman joins K Street Former Rep. Gingrey lands on K Street MORE (R-Ga.) in December. Since then 26 other House lawmakers have signed on to the bill.
In 2012, Congress passed the Generating Antibiotic Incentives Now (GAIN) Act that created a Qualified Infectious Disease Products (QIDP) list.
The act gives certain incentives to drug-makers developing antibiotics for diseases on the list such as faster FDA reviews and longer market exclusivity but the advocacy groups say that’s not enough.
“As IDSA and other key stakeholders have asserted, the GAIN Act was a critical first step, but more work remains to sufficiently stimulate antibiotic R&D,” writes IDSA. “Waiting for the results of another study to once again demonstrate the need for antibiotic incentives will waste valuable time, and patients will continue dying as they wait for desperately needed new antibiotics.”