Opioid is a kind of drug that has been causing great problems across the world. So many people are getting addicted to it and this does not seem to end soon. Making this drug less addictive will definitely make a lot of difference to everyone. This is also why 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.”
Click here for more information.
“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.