By Larry K. Houck –
The Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking in the December 19th Federal Register (77 Fed. Reg. 75,075 (Dec. 19, 2012)) to place lorcaserin into schedule IV of the federal Controlled Substances Act (“CSA”). Interested persons must submit electronic comments by January 18, 2012. Written comments must be postmarked by the same date.
Lorcaserin is a new chemical entity with central nervous system hallucinogenic properties that FDA approved on June 27, 2012 as an addition to a reduced-calorie diet and exercise for chronic weight management regimens. Lorcaserin will be marketed under the trade name Belviq® and is approved under NDA No. 022529.
The proposed scheduling is based on a recommendation from the Department of Health and Human Services (“HHS”) and on an eight-factor analysis conducted by DEA. Lorcaserin has not been marketed in the U.S. or any other country so there is no available information about actual abuse. However, HHS found evidence that lorcaserin produces subjective effects in humans and animals similar to those produced by zolpidem, a schedule IV substance, and ketamine, a schedule III substance. HHS concluded that the scope and significance of the lorcaserin’s abuse potential is similar to schedule IV substances and its marketing as a schedule IV substance, rather than as an uncontrolled or schedule V substance, will decrease its potential for abuse. DEA determined that there is substantial evidence of the potential for abuse of lorcaserin and thereby proposes to control it as a schedule IV substance.
This proposed scheduling action illustrates how HHS and the DEA evaluate the abuse potential of a new compound where there is no actual abuse data. In these cases, the agencies review the results of clinical studies to use as a barometer of the potential that drug abusers will seek the drug out once it is marketed. In addition, both agencies compare the drug’s abuse potential to other currently scheduled drugs to determine the best “fit” for which schedule to classify the drug.
DEA’s placement of lorcaserin in schedule IV would subject manufacturers, distributors, dispensers such as pharmacies and physicians, importers, exporters, and anyone in possession of lorcaserin to the applicable provisions of the CSA and its implementing regulations, including administrative, civil and criminal sanctions. DEA registration, recordkeeping and reporting, labeling and packaging, importation and exportation, security and disposal requirements for handlers of schedule IV substances would apply.