The Infectious Diseases Society of America (IDSA) offered a plan on Thursday that would allow the U.S. Food and Drug Administration (FDA) to review certain kinds of antibiotics like it reviews "orphan" drugs for rare diseases, making it easier for companies to gain approval.
These include drug-resistant strains of MRSA and C-difficile, which have wrought havoc in U.S. hospitals, as well as infections common in the developing world, like tuberculosis.
MRSA -- Methicillin-resistant Staphylococcus aureus -- alone is estimated to kill around 19,000 people every year in the United States.
The FDA on Wednesday also highlighted the importance of combating superbugs, as long as there are ways to ensure new antibiotics are not overused, making the problem worse.
But many drugmakers have turned away from what has become an unprofitable area of research, leaving few medicines to fight drug-resistant strains.
Congress passed the Orphan Drug Act in 1983 to deal with a similar problem: too few companies were investing in drugs to treat uncommon diseases, usually ones that affected fewer than 200,000 people in the United States.
Robert Guidos, IDSA's vice president of public policy and government relations, said a similar program could work for antibiotics, where the unmet need is just as great, while investment has plummeted.
"This proposal creates a new mechanism, similar to the orphan drug act (for rare diseases)," he said. "It's a game-changer," Guidos said.
Under IDSA's Special Population Limited Medical Use framework, companies that want to develop new antibiotics can enroll fewer patients in clinical trials and often get a faster response from the FDA.
Janet Woodcock, head of the FDA's drugs center, said the incidence of drug-resistant bacteria has reached "crisis proportions" in the United States, but the FDA was concerned new antibiotics could be overused.
Woodcock said the FDA was exploring creating a special designation for drugs that have the potential for misuse -- such as antibiotics and obesity treatments -- but can also benefit a limited number of patients.
IDSA said it would also work with insurers and doctors to make sure any antibiotics approved through the pathway would go to the right patients. IDSA represents about 10,000 physicians and scientists that focus on infectious diseases.
The group is submitting its proposal on antibiotics to Congress during a hearing on Thursday about a bill to renew FDA user fees, or the funds companies pay to the agency in exchange for faster review of drugs and devices.
Since the fees provide almost half of the FDA's funding, the bill often serves as a vehicle for broader FDA-related changes. The fees must be renewed every five years, with the current bill expiring in September.
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