GPhA: 'Up-scheduling' hydrocodone combos will impede patient access, won't curb abuse
This article was originally published in Scrip
Executive Summary
Ahead of a two-day meeting of the FDA's Drug Safety and Risk Management Advisory Committee (DSaRM), in which regulators are seeking advice about whether to "up-schedule" hydrocodone combination medicines, such as Vicodin (acetaminophen-hydrocodone), from Schedule III controlled substance status to the more stringent Schedule II, the Generic Pharmaceutical Association (GPhA) argued that taking such action could prevent patients with acute, sub-acute or chronic pain from accessing the drugs.