The FDA is expanding its Risk Evaluation and Mitigation Strategy (REMS) to include manufacturers of immediate-release opioids. The makers of these drugs will soon be required to provide training and education to healthcare professionals on the proper prescription and use of the drugs for pain management…
(Reuters)—The U.S. Food and Drug Administration plans to encourage opioid addicts to use less harmful opioid drugs such as methadone and buprenorphine, a radical shift in policy that could agitate those in the addiction field who believe abstinence is the only effective treatment. Speaking before the House Committee on Energy and Commerce on Wednesday, FDA…
BOSTON (Reuters)—A Rhode Island doctor pleaded guilty on Wednesday to charges he participated in a scheme to obtain kickbacks in exchange for writing prescriptions for an addictive fentanyl-based cancer pain drug produced by Insys Therapeutics Inc. The plea by Jerrold Rosenberg came amid ongoing investigations of Insys related to Subsys, an under-the-tongue spray that contains…
BOSTON (Reuters)—New Jersey on Thursday accused Insys Therapeutics Inc of engaging in a fraudulent scheme to boost sales of a fentanyl-based cancer pain drug, as Massachusetts announced a $500,000 settlement with the drugmaker to resolve similar allegations. The lawsuit by New Jersey Attorney General Christopher Porrino accused Insys of illegally directing its sales force to…
NEW YORK (Reuters)—Makers of fast-acting opioids will have to fund voluntary training for healthcare professionals who prescribe the drugs, including education on safe prescribing practices and non-opioid alternatives, the course said on Thursday. The FDA sent letters to 74 manufacturers of immediate-release opioids, notifying them that they will have to fund the development of courses…
INDIANA, Pa./CHILLICOTHE, Ohio (Reuters)—As deaths mount in America’s opioid crisis, communities on the front lines face a hidden toll: the financial cost. Ross County, a largely rural region of 77,000 people an hour south of Columbus, Ohio, is wrestling with an explosion in opioid-related deaths—44 last year compared with 19 in 2009. The drug addiction…
BOSTON (Reuters)—U.S. prosecutors have identified Insys Therapeutics Inc’s billionaire founder as an unindicted co-conspirator in a case accusing six former executives and managers of participating in a scheme that involved bribing doctors to prescribe a fentanyl-based drug, according to a court document. John Kapoor, who stepped down as chief executive of Insys in January, was…
BOSTON (Reuters)—Insys Therapeutics Inc sought to manipulate insurance payment approval for an opioid cancer pain drug called Subsys even if for inappropriate uses, according to a U.S. Senate report on the opioid crisis released on Wednesday. The report, released by Democratic Senator Claire McCaskill, said those efforts led to an Insys employee making misleading statements…
(Reuters)—Arizona’s attorney general sued Insys Therapeutics Inc on Thursday, accusing the drugmaker of engaging in a fraudulent marketing scheme aimed at increasing sales of a fentanyl-based cancer pain medicine. The lawsuit by Arizona Attorney General Mark Brnovich in Maricopa County Superior Court in Phoenix comes during a series of federal and state investigations centered on…
Nationally, opioid use and addiction are drawing increased scrutiny. An increase in the number of overdoses and addiction to heroin and prescription pain relievers in the past decade has been attributed in part to increased prescribing of opioids for the treatment of pain by physicians. National trends suggest the rate of opioid prescribing plateaued in…