The FDA is proposing a tougher regulatory process for approving new opioids, the agency announced June 20.
Four things to know:
1. Acting FDA Commissioner Ned Sharpless, MD, withdrew the agency's previous 2014 guidance, laying out new rules that would require opioid manufacturers to divulge not only efficacy and safety, but also the ways the opioid would positively and negatively affect public health.
2. Under the draft guidance, manufacturers would have to disclose whether the drug would mitigate the risks of an overdose, abuse or addiction.
3. "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 nonpatients, including members of the patient’s household, visiting relatives, friends and others," the FDA said in a news release.
4. The FDA plans to hold a meeting Sept. 17 to discuss the draft guidance and solicit feedback.
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