FDASIA Calls for Public Meeting on Rescheduling Hydrocodone Combination Products and for the Legislative Scheduling of Dozens of Synthetic Drugs in Schedule I of the CSA

By John A. Gilbert, Karla L. Palmer & Larry K. Houck –

The Food and Drug Administration Safety and Innovation Act (“FDASIA”) (S. 3187), which is on its way to the President for enactment after the Senate passed the bill by a 92-4 vote, may impact the scheduling of hydrocodone products, but not by the same means as Senator Joe Manchin’s (D-WV) earlier-introduced bill, S. 2297.

Senator Manchin introduced S.2297 in April of this year to amend the Controlled Substances Act (“CSA”) by legislatively rescheduling hydrocodone combination products from their current schedule III to the more restrictive schedule II.  This rescheduling would affect popular hydrocodone combination products such as Vicodin, Lortab, Lorcet, Norco, Hycodan and Vicoprofen.  (Bulk and single entity hydrocodone products have been classified in schedule II since the passage of the CSA in 1970).

Rescheduling hydrocodone combination products would impact every legitimate controlled substance handler including patients who rely on the products for pain relief.  The rescheduling would subject manufacturers, distributors, dispensers such as pharmacies and physicians, importers and exporters to more stringent regulatory requirements.  For example, schedule II substances can only be transferred between registrants via a triplicate, sequentially-numbered DEA Form 222 Official Order Form or its electronic equivalent while registrants need only document transfers of schedule III-V drugs with invoices, packing slips or other records.  Prescriptions for schedule II substances, with limited exceptions, must be written, and pharmacies must have the original prescriptions in-hand before dispensing.  Prescriptions for schedule III-V may be in a written, oral or faxed format.  Pharmacists cannot refill schedule II prescriptions; but they can, if authorized to do so, refill schedule III-V prescriptions up to five times within a six month period.  Manufacturers and distributors must secure schedule II substances in a safe, steel cabinet or vault while schedule III-V substances may be stored in a less secure controlled substance cage or other enclosure.

The legislative attempt to reschedule hydrocodone combination products quickly ran into significant and vocal opposition from numerous patient advocacy and pharmacy groups.  Several pharmacy groups including the National Association of Chain Drug Stores and the Generic Pharmaceutical Association, and the American Medical Association, have expressed concerns that rescheduling would unduly restrict legitimate patient access to needed medications and impose burdens upon pharmacies.

Thus, instead of legislatively rescheduling hydrocodone combination products from schedule III to schedule II as set forth in S.2297, FDASIA calls for the Secretary of Health and Human Services to hold a public meeting not later than 60 days after the enactment of the Act to assist the FDA with its scheduling recommendation to DEA for hydrocodone products.  If enacted, the law would require FDA to solicit input from stakeholders including patients, healthcare providers and others “regarding the health benefits and risks, including the potential for abuse and the impact of up-scheduling these products.”  Whether by legislative fiat or administrative action, the impact of rescheduling hydrocodone is significant, as noted above.

On a related note, FDA published notice of a public meeting of the Drug Safety and Risk Management Committee to be held at the FDA White Oak Campus on October 29 and 30, 2012.  77 Fed. Reg. 34,051 (June 8, 2012).  The Federal Register Notice states that purpose of the meeting is to discuss “the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive.”  The notice also states that FDA is calling for the meeting because DEA requested the Department of Health and Human Services to conduct a scientific and medical evaluation, and scheduling recommendation, for hydrocodone combination products, “in response to continued reports of misuse, abuse, and addiction related to these products.”  Interested persons can submit data, information and viewpoints orally or in writing.  Electronic and written submissions must be submitted on or before October 15, 2012.

This process may ultimately conclude with the DEA determining to reschedule hydrocodone combination products from schedule III to II pursuant to 21 U.S.C. §§ 811 and 812.  However, unlike the scuttled legislative rescheduling process, the administrative rescheduling process requires notice and public comment, and DEA’s analysis of eight statutory factors prior to rescheduling.  DEA must consider the following eight factors for rescheduling hydrocodone combination products (or any substance):  (1) Actual or relative potential for abuse; (2) scientific evidence of the substance’s pharmacological effects; (3) the state of the current scientific knowledge about the substance; (4) history and current pattern of abuse; (5) scope, duration and significance of abuse; (6) risk to the public health; (7) psychic or physiological dependence liability; and (8) whether the substance is an immediate precursor to an already controlled substance.  21 U.S.C. § 811(c).

Notwithstanding instigating an administrative process to reschedule hydrocodone combination products, FDASIA seeks to legislatively place dozens of synthetic cannabinoids in schedule I of the CSA (without the administrative notice and comment rulemaking, the eight-factor analysis or DEA’s use of emergency scheduling powers).  In a section dubbed the “Synthetic Drug Abuse Prevention Act of 2012,”  FDASIA’s enactment would place certain psychedelic/hallucinogenic dimethoxyphenethylamine drugs and synthetic cannabinoids into schedule I.  Schedule I controlled substances have a high potential for abuse and no recognized medical use in the United States.  In addition, the proposed law if passed would define the term “cannabimimetic agent,” and establish criteria for the control of similar cannabinoid compounds that meet the statutory definition.

FDASIA also seeks to double the term from 18 to 36 months DEA’s emergency authority to temporarily schedule substances in schedule I to avoid imminent hazard to the public health.  DEA exercised its emergency scheduling authority twice in the past two years to temporarily place in schedule I certain substances including some of the cannabinoids now subject to scheduling by FDASIA, in schedule I.  See DEA’s Press Release announcing the addition of 26 synthetic drugs to schedule I.