Zohydro ER hydrocodone bitartrate regulatory update

Reps. Edward Markey (D-Mass.) and Vern Buchanan (R-Fla.) sent a letter to FDA Commissioner Margaret Hamburg asking for adoption of a 19-10 vote by FDA's Drug Safety and Risk Management Advisory Committee on Jan. 25 that the U.S. Drug Enforcement Administration (DEA) reschedule hydrocodone combination products as class II scheduled drugs. Class I indicates the highest potential for abuse and class V the lowest. Currently, hydrocodone combination products are scheduled as class III drugs, while pure hydrocodone is a class II scheduled drug. The change would place greater restrictions on hydrocodone combination products, including requiring written prescriptions that cannot be refilled and limiting prescriptions to a 90-day supply. FDA will provide a final recommendation to the DEA, which would ultimately be responsible for rescheduling hydrocodone products.

The representatives plan to reintroduce the Pill Mill Crackdown Act in the U.S. House of Representatives which also aims to limit how much hydrocodone a patient can receive in between doctor visits and would require written prescriptions, rather than prescriptions that are faxed or called in by phone. ...