FDA Head Califf Lays Out Efforts To Battle Opioid Abuse
The newly confirmed Food and Drug Administration Commissioner Robert Califf says his agency can't alone solve the problem, but he pledges to support the development of harder-to-abuse painkillers, as well as encourage the safe disposal of such drugs. In other FDA news, the agency is asking the maker of Essure to conduct a new study on risks following reports of adverse effects from the sterilization device.
The Associated Press:
New FDA Chief Cites Promise Of Harder-To-Abuse Pain Drugs
The Food and Drug Administration's new commissioner is pledging to fully back efforts to develop harder-to-abuse painkillers, part of a sweeping government effort to reduce deadly overdoses tied to prescription pain medications. Dr. Robert Califf told a panel of FDA advisers on Tuesday that his agency alone cannot solve the crisis of prescription drug abuse. But he pledged to do "everything possible under our authority to prevent abuse, save lives and treat dependence." (Perrone, 3/2)
FDA Orders Study On Sterilization Device
In response to thousands of reports of adverse events related to Essure, an implantable sterilization device for women, the Food and Drug Administration on Monday announced that it asked the maker of the device to conduct a new clinical study on its risks. The FDA also issued new labeling guidance for the device, and released a checklist that doctors can use to discuss its risks with patients. (Siddons, 2/29)