This article describes a citizen petition filed with the FDA by a physician group that is seeking to increase FDA’s restrictions on prescribing of opioids. FDA recognizes the serious public health problems associated with opioid abuse, and has recently taken steps to curb opioid abuse via a class-wide REMS for certain types of opioids; however, Catalyst President Nancy Bradish Myers comments on the fact that the agency is limited in its ability to impose more drastic measures.
“Congress has made it very clear that they don’t want the FDA dictating the practice of medicine,” she says. “The FDA has a statutory authority that even if they see that there’s a problem in certain areas, they might not have an ability to totally change the paradigm.”
Docs’ Push To Limit Painkiller Prescription Faces Long Odds