Hydrocodone shift to Schedule II under consideration
Congress, FDA, DEA reacting to problems of misuse
Sens. Joe Manchin (D-WV) and Mark Kirk (R-IL) and Reps. Vern Buchanan (R-FL) and Ed Markey (D-MA) introduced hydrocodone rescheduling legislation on March 20. The Safe Prescribing Act of 2013 (S. 621) would reclassify hydrocodone products such as Vicodin and Lortab from a Schedule III to a Schedule II controlled substance.
“Under the new restrictions, a written prescription would be required in order to receive hydrocodone painkillers except in cases of emergency,” according to Manchin’s news release. “Pharmacists would require patients to present an original prescription for refills, and traffickers would be subject to harsher fines and penalties.”
As the proposed legislation moves through Congress—by April 3, the Senate bill had drawn 5 cosponsors and the House bill (H.R. 1285) had attracted 44 cosponsors—the same idea is under consideration by regulatory authorities.
FDA’s Drug Safety and Risk Management Advisory Committee voted 19–10 on January 25 to recommend rescheduling of hydrocodone from Schedule III to Schedule II. FDA will now consider its advisory committee’s recommendation in a final recommendation to DEA. Then DEA would have to go through a rulemaking process to propose rescheduling.
Steve Simenson, BSPharm, FAPhA, DPNAP, now APhA President, and Marcie Bough, PharmD, APhA Senior Director of Government Affairs, testified on January 24 of the 2-day advisory committee hearing. APhA did not take a position, but rather provided information on pharmacist and pharmacy issues, including impact on patient access. Bough told pharmacist.com/Pharmacy Today after the hearing that “going through the regulatory process is the appropriate venue to consider rescheduling and allows more time for stakeholder input.”
But Manchin stated in his news release that “the heart-wrenching stories I hear from so many West Virginians underscore the serious need to immediately reschedule hydrocodone.”
Last year, as Congress was considering Prescription Drug User Fee Act reauthorization legislation, Manchin introduced an amendment with language on hydrocodone rescheduling that passed the Senate on May 24, 2012. The House version did not include language on hydrocodone rescheduling. APhA opposed that language in the context of the congressional amendment process, signing onto May 30, 2012, letters from pharmacy groups to House and Senate offices.