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Trius Therapeutics, AŞ Message Board

  • slumdawg2011 slumdawg2011 Mar 8, 2012 8:49 PM Flag

    Superbugs as rare disease

    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.

    "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."