FDA advisers support rescheduling of hydrocodone products

Abstract

A multiyear Drug Enforcement Administration (DEA) effort to stem the abuse of hydrocodone-containing combination products received a boost in January when FDA advisers voted 19–10 in favor of reclassifying these products from Schedule III to Schedule II. The vote followed two days of sometimes-emotional testimony, including tearful pleas from parents whose children died after becoming addicted to hydrocodone products and a presentation from DEA about the abuse, misuse, and diversion of these products. “This decision has been very difficult,” said Stephanie Crawford, associate professor and associate head of pharmacy administration at the University of Illinois at Chicago, who voted with the majority. Crawford said she is concerned that rescheduling the drugs will make it more difficult for patients with a legitimate need for hydrocodone-containing products to obtain them. But she said her decision was based on the public health consequences of drug abuse, addiction, and death among patients who use the drug.