After reviewing thousands of pages of documents requested through the Freedom of Information Act, researchers also found that both the FDA and drug companies became aware of what was happening but took no action to stop it. “The whole purpose of this distribution system was to prevent exactly what we found,” said Caleb Alexander, co-director of the Center for Drug Safety and Effectiveness. In other news on the national opioid crisis: the Oklahoma court case, copycat drugs, marijuana and car crashes.
The Washington Post: FDA, Drug Companies, Doctors Mishandled Use Of Powerful Fentanyl Painkiller
The Food and Drug Administration, drug companies and doctors mishandled distribution of a powerful fentanyl painkiller, allowing widespread prescribing to ineligible patients despite special measures designed to safeguard its use, according to a report released Tuesday. The unusual paper in the medical journal JAMA relies on nearly 5,000 pages of documents that researchers obtained from the government via the Freedom of Information Act, rather than a more typical controlled scientific study. (Bernstein, 2/19)
CNN: ‘Alarming’ Number Of People Received Restricted Fentanyl, Study Says
An “alarming” number of US patients received a highly potent form of opioid that is 100 times more powerful than morphine and that they never should have been prescribed, according to a new study. The research, published Tuesday in JAMA: The Journal of the American Medical Association, found that the US Food and Drug Administration and opioid manufacturers failed at multiple levels to adequately monitor the restricted use of these types of fentanyl as part of a federal program — and that few substantive changes were made even after officials discovered problems. (Drash, 2/19)
The Washington Post: Opioid Crisis: Oklahoma Could Provide Test Of Who Will Pay For The Opioid Epidemic, And How Much
Big pharma is facing a major test in a small courthouse 20 miles south of here: the first trial at which a jury could decide whether drug companies bear responsibility for the nation’s opioid crisis. Thousands of cities, counties, Native American tribes and others have filed lawsuits up and down the opioid supply chain, alleging various claims of culpability for the crisis that began with widespread abuse of powerful painkillers. (Bernstein and Zezima, 2/19)
Reuters: U.S. Top Court Rejects Bid To Block Indivior Opioid Drug Copycat
The U.S. Supreme Court dealt a blow to Indivior Plc on Tuesday, clearing the way for a copycat version of the British pharmaceutical firm’s lucrative opioid addiction treatment Suboxone Film in a victory for India-based generic drug maker Dr. Reddy’s Laboratories. Chief Justice John Roberts, in a brief order, denied Indivior’s request to put on hold a lower court’s ruling that had opened the door to cheaper generic versions of Suboxone while the company prepares an appeal to the high court. (Chung, 2/19)
The New York Times: Legalize Pot? Amid Opioid Crisis, Some New Hampshire Leaders Say No Way
The push to legalize recreational marijuana is sweeping the Northeast: Massachusetts, Vermont and Maine have done it, and the governors of Rhode Island, Connecticut, New York, and New Jersey say they want their states to do it, too. But in New Hampshire, Gov. Chris Sununu and some other state leaders are opposed. The problem, they say, is not just about pot. (Taylor, 2/20)
The Washington Post: Opioid Use Rising In Maryland, But Fatal Car Crashes Involving Drivers With The Drug In Their Systems Have Not Increased
While Maryland is facing a growing epidemic of opioid addiction, there has not been a corresponding increase in traffic fatalities involving drivers who have the drug in their systems, a new report examining data from the state medical examiner found. “The fact that opioid crashes in Maryland over the last 10 years have been more or less steady was a surprise,” said Johnathon P. Ehsani,one of the report’s authors. “That is striking, because Maryland is one of those states that has been quite severely affected by the overall opioid epidemic.” (Halsey, 2/19)
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