Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Commissioner Eyes New Drugmaker Rules, Including More Doctor Training On Opioids
Food and Drug Administration Commissioner Scott Gottlieb, stepping up the agency's efforts against the nation's opioid epidemic, announced plans Monday to require manufacturers of painkillers to provide more extensive education for physicians and other health-care professionals who prescribe the drugs. In remarks that opened a two-day FDA meeting on painkiller abuse, Gottlieb said the agency will now require makers of immediate-release opioids to provide prescriber training. These formulations, which account for 90 percent of the opioids prescribed in the United States, include hydrocodone as well as oxycodone/acetaminophen combinations. (McGinley, 7/10)
鈥淚t鈥檚 time to take direct action to address the close to 200 million opioid analgesic prescriptions each year that are for the immediate release products,鈥 the commissioner said. 鈥淭he new training will be aimed at making sure providers who write prescriptions for the IR opioids are doing so for properly indicated patients, and under appropriate clinical circumstances.鈥 (Burton, 7/10)
The U.S.鈥檚 top drug regulator said on Monday that more must be done to stem the country鈥檚 tide of opioid addiction, proposing new guidelines and restrictions on some of the most widely used pain pills. Food and Drug Administration Commissioner Scott Gottlieb laid out plans to have drugmakers conduct doctor education programs on immediate-release opioids, which account for 90 percent of the 200 million opioid painkiller prescriptions written in the U.S. each year. The agency is also exploring whether pain-management training should be required for doctors as well as nurses, pharmacists or other health-care providers. (Edney, 7/10)
The FDA on Monday required that all immediate-release opioids come under a special safety regime known as a risk evaluation and mitigation strategy. Manufacturers will be required to make training available for health professionals who prescribe the drugs and patients will get counseling documents on how to safely use the powerful pain medications. (Karlin-Smith, 7/10)
And in other news on the opioid epidemic聽鈥
Last April, after a paramedic helped a colleague's relative get treatment for his addiction, the city launched the Safe Station Program. Now, all 10 of Manchester's firehouses are a safe haven where people struggling with addiction can seek assistance. Paramedics are available 24 hours a day, 7 days a week, to conduct a full medical evaluation before transporting the patient to a local hospital's emergency department or a treatment facility. (Johnson, 7/10)
Amid broad efforts to help people avoid prescription-opioid addiction, some pharmaceutical companies are taking an intriguing approach: making prescription opioids that can鈥檛 be misused. Although the tactic may at first blush seem a miracle cure, it has a decidedly mixed record of success. (Humphreys, 7/10)