The Food and Drug Administration is proposing to tighten the rules for opioid manufacturers by requiring new drugs to be less addictive, according to www.cnbc.com.
Acting FDA Commissioner Ned Sharpless withdrew the agency’s previous guidance June 20, presenting a tougher new regulatory framework for evaluating applications for new opioids coming to the U.S. market. Under the proposal, drug manufacturers would have to say whether their drug has “any characteristics that would mitigate the risks of overdose, abuse or the development of addiction.”
Additionally, the FDA said: “Companies should also indicate whether their drugs have novel or greater risks compared to other opioids on the market and also note the public health implications of their products in terms of risks to non-patients, including members of the patient’s household, visiting relatives, friends and others.”
More than 130 people in the U.S. die every day from opioid overdoses, with about 47,000 people dying in 2017, according to data from the Centers for Disease Control and Prevention. Construction industry workers are particularly susceptible to the opioid crisis—in part because of the industry’s aging workforce and the physically demanding nature of the job, which results in more workplace injuries that require medical intervention.
“Addressing the crisis of opioid addiction is an issue of great concern for our nation and remains a top public health priority for the FDA,” Sharpless said in a statement. “The agency continues to take new steps to confront this crisis, while also paying careful attention to the needs of patients in accessing appropriate pain management.”
The FDA is taking public comments on its proposal through Aug. 20 and has scheduled a public meeting Sept. 17 to discuss it.
