ARTICLE | Regulation
Turning the tide
Why FDA’s plans to combat opioid abuse will create new regulatory precedents
November 18, 2017 1:56 AM UTC
FDA’s plans to blunt the epidemic of opioid abuse, addiction and overdoses will stretch the boundaries of FDA oversight, creating precedents that could be applied in the future to other drug classes and health problems.
Policies FDA may adopt include creating indications based on population effects rather than the effect of a drug on individual patients and using a comparative safety standard to remove drugs from the market if safer alternatives are available (see “Policy Innovations”)...