Makers of immediate-release opioids must fund training on their use, FDA says
pharmafile | September 29, 2017 | News story | Medical Communications | FDA, OxyContin, opioids, pharma, pharmaceuticals, vicodin
As part of its ongoing response to the opioid crisis in the US which is claiming the lives of over 100 citizens a day, the FDA has announced that it plans to mandate manufacturers of such drugs to fund voluntary training for healthcare professionals who prescribe them, in order to build knowledge of the dangers of the drugs, safe prescribing practices and alternative forms of treatment.
As part of the action, the agency notified 74 manufacturers of immediate-release painkillers like Vicodin that their products would be affected by this new move, though medical practitioners are not actually obligated to take part in the training.
Manufacturers of these varieties of opioid now join the makers of long-acting versions such as OxyContin, who have been subject to these requirements since 2012.
It is estimated that around two million Americans are currently addicted to prescription opioids, with over 15,000 deaths occurring as a result of overdoses from these drugs.
Commissioner Scott Gottlieb stated that the FDA also plans to expedite the availability of generic versions abuse-deterrent formulations of opioid drugs in the future: “Most of the currently approved opioids with labelling describing abuse-deterrent properties are extended release/long-acting (ER/LA) formulations of opioids. These drugs are generally formulated to be more resistant to the sort of manipulation that would otherwise make them amenable to snorting and/or injecting. Addicted patients who start by using the IR drugs will sometimes migrate onto the ER/LA formulations, and then try to manipulate those higher-dose formulations in ways that can provide a more immediate ‘high’ through injection or snorting. But there are currently only brand name ADF formulations. These steps that FDA is taking are aimed at addressing each end of the spectrum of abuse and addiction.”
Matt Fellows
Related Content
MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …
Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation
Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …
Johnson & Johnson submits robotic surgical system for De Novo classification
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …
