A pharmacist empties a prescription bottle of opioid painkillers that she filled for a patient at the pharmacy inside the facility in Boston.
John Tlumacki | Boston Globe | Getty Images
The Food and Drug Administration is proposing to tighten the rules for opioid manufacturers by requiring new drugs to be less addictive.
Acting FDA Commissioner Ned Sharpless withdrew the agency’s previous guidance Thursday, laying out a tougher new regulatory framework for evaluating applications for new opioids coming to the U.S. market. Under the proposal, drugmakers would have to say whether their drug has “any characteristics that would mitigate the risks of overdose, abuse or the development of addiction.”
“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,” the FDA said.
The opioid epidemic is a major issue for the Trump administration, which has vowed to crack down on illicit use. 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 U.S. Centers for Disease Control and Prevention.
“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.”
Some 1,600 civil cases against opioid manufacturers, including OxyContin maker Purdue Pharma, are being consolidated and transferred to a judge in the Northern District of Ohio. And in April, a former CEO of Rochester Drug Cooperative, one of the nation’s largest drug distributors, was indicted on what prosecutors say are the first criminal charges against an executive of a drug company to stem from the opioid epidemic.
The FDA on Thursday acknowledged that opioids “present unique challenges” because the drugs help patients in pain but can also “cause enormous harm when misused and abused.”
The FDA is taking public comments on its proposal through Aug. 20 and has scheduled a public meeting Sept. 17 to discuss it.