Summary

Pursuant to a congressional request, GAO provided information on how the Drug Enforcement Administration (DEA) establishes aggregate production and manufacturing quotas for methylphenidate and other schedule II controlled substances. GAO noted that: (1) DEA establishes quotas for schedule II controlled substances by analyzing past sales, inventory, anticipated need, and market trend data; (2) although quotas are set on an annual basis, they can be updated and are published for public comment; (3) pharmaceutical companies are notified of their manufacturing quotas and can request quota adjustments by providing DEA with updated medical-use and sales data information; (4) although DEA does not track the extent to which initial and revised quotas match, quotas for many schedule II controlled substances are revised each year; (5) although its 1986 methylphenidate quota failed to provide for legitimate medical needs, DEA recalculated the quota and allowed pharmaceutical companies to produce those amounts; (6) although DEA has no authority to bypass the notice and comment requirements, it can issue interim rules that make quotas effective upon publication; (7) the 2-month delay in publishing the revised 1993 quotas for several controlled substances has caused concern of an impending methylphenidate shortage; and (8) although DEA officials have monitored the possibility of a methylphenidate shortage, they do not believe the matter warrants the use of the interim rule to establish quotas.