Infectious-disease doctors have proposed a speedier, easier approval process for drug companies developing antibiotics against untreatable illnesses.
The Infectious Diseases Society of America (IDSA) made the proposal today at a hearing of a subcommittee of the US House of Representatives Committee on Energy and Commerce. The hearing focused on reauthorization of the Prescription Drug User Fee Act, which funds the US Food and Drug Administration (FDA).
According to IDSA, only two or three drug companies are still conducting research on antibiotics in the United States, even as antibiotic-resistant strains of bacteria are becoming an ever more urgent health problem. A bill proposed by Rep. Phil Gingrey (R-GA) called the Generating Antibiotic Incentives Now Act (GAIN), would grant incentives to companies that develop antibiotics against drug-resistant bacteria. IDSA is proposing that lawmakers also create a ‘Special Population Limited Medical Use’ (SPLMU) mechanism that would allow companies to conduct clinical trials in fewer patients and obtain more streamlined approvals for the drugs if they are intended to treat patients for which no other drugs are available.
The new mechanism would also reserve these drugs specifically for use in patients harboring pathogens resistant to all other treatments. That provision is designed to address a major concern among doctors and the FDA that new antibiotics will quickly lose their effectiveness if they are overused.
“We need antibiotics to be used for life-threatening infections that lack medical treatments … and not for your kid’s ear infection,” Janet Woodcock, head of the FDA’s drugs center, told reporters on Wednesday, according to Reuters.