Search Results for keywords:"Insys Therapeutics"

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Search Results: keywords:"Insys Therapeutics"

  • Type:Notice
    Citation:86 FR 102
    Reading Time:about 6 minutes

    The Food and Drug Administration (FDA) issued a permanent debarment order against Alec Burlakoff under the Federal Food, Drug, and Cosmetic Act. Burlakoff was convicted of a felony involving illegal activities with a drug called SUBSYS while working at Insys Therapeutics. His actions included bribing doctors to prescribe the drug, often to patients who did not have cancer. As a result, Burlakoff is banned from providing services related to drug product applications, and there are penalties for any approved drug product applications that employ him during this period.

    Simple Explanation

    A man named Alec Burlakoff was caught doing something very bad by tricking doctors into giving out a medicine called SUBSYS when they shouldn't have. Because of this, he is not allowed to work with medicines anymore.

  • Type:Notice
    Citation:86 FR 103
    Reading Time:about 5 minutes

    The Food and Drug Administration (FDA) is issuing a permanent debarment order against Joseph A. Rowan, preventing him from working with any businesses that have drug product applications. This order results from Mr. Rowan's felony conviction related to illegal activities with the drug SUBSYS while at Insys Therapeutics. He was found guilty of racketeering, mail fraud, and wire fraud, including bribing doctors to prescribe SUBSYS to patients without cancer and misleading insurers. Mr. Rowan was notified of this debarment decision and waived his right to contest it by not requesting a hearing.

    Simple Explanation

    The FDA has decided that Joseph A. Rowan can't work with companies making medicine because he broke the law by doing bad things, like lying and giving money to doctors to sell drugs wrongfully, and he didn't ask for a chance to explain why he shouldn't be banned.

  • Type:Notice
    Citation:86 FR 100
    Reading Time:about 5 minutes

    The Food and Drug Administration (FDA) has issued an order under the Federal Food, Drug, and Cosmetic Act to permanently ban Sunrise Lee from working with any person or company that has a drug product application. This decision follows her felony conviction for racketeering related to the regulation of a drug product. Lee, who previously worked in a leadership role at Insys Therapeutics, was found guilty of participating in a conspiracy to bribe medical practitioners to prescribe a fentanyl-based drug called SUBSYS. Despite being notified of the proposed ban and given a chance to contest it, Lee did not respond, resulting in a waiver of her right to a hearing.

    Simple Explanation

    The FDA has decided that Sunrise Lee cannot work with any company that makes medicine because she was involved in a plan to pay doctors to prescribe a strong pain medicine when they shouldn't have, and she did not ask for a chance to explain her side.