Group Asks FDA to Treat Superbugs like Rare Diseases
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.
Misuse of medications and other factors have fueled the evolution of multi-drug resistant bacteria, or "superbugs", for which there are few treatment options.
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 and malaria.
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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.
Today, only two large companies - GlaxoSmithKline Plc and AstraZeneca Plc -- still have strong antibiotic research and development, compared to nearly 20 companies in 1990, according to the IDSA.
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.
The law offered companies tax credits, marketing rights and other incentives, helping to bring 135 "orphan drugs" to market, according to the National Organization for Rare Disorders.
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.
To get approval for the program, companies would have to target their antibiotics at specific strains of disease that have few treatment options.
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.
"We need antibiotics to be used for life-threatening infections that lack medical treatments ... and not for your kid's ear infection," Woodcock said during a briefing with reporters on Wednesday.
The World Health Organization warned last year that misuse of antibiotics was so bad it could bring nations back to the time before major antibiotics were developed.
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.
These drugs would have strict labels on who they are meant for, and pharmacists and doctors would have to know the regulations.
While the FDA has no power to regulate medical practice, Woodcock said she believed this special designation would give doctors enough information to use medicine appropriately.
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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