The Food and Drug Administration said Friday it wants to help drugmakers produce cheaper, generic versions of prescription opioids that cannot be crushed or otherwise manipulated to produce a fast, dangerous high.
FDA Commissioner Scott Gottlieb said transitioning from conventional opioids to ones that are abuse-deterrent could help rein in the opioids crisis, which is killing tens of thousands of Americans per year.
However, doctors have been reluctant to prescribe the new drugs, because many of them are brand-name products and inherently more expensive than generics.
The FDA released guidance Friday that details its expectations and the types of studies that drugmakers should perform to move their products through the approval process. It was part of a broader dump of regulatory guidance to speed along the development of generic drugs.
“These updated guidances will make the process for developing low-cost, generic versions of these abuse-deterrent products more predictable and practical,” Dr. Gottlieb said.
While abuse-deterrent formulations of opioids make it harder for users to snort, inject or otherwise misuse the drugs, they aren’t “abuse-proof,” the agency warned.
People who don’t use conventional opioids as directed are still at risk of addiction or overdose.
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