The US agency in charge of setting drug production quotas for substances regulated under the Controlled Substances Act (CSA) is proposing a mid-year adjustment in its production quotas for the active pharmaceutical ingredients contained within many attention deficit hyperactive disorder (ADHD) drugs and painkillers in response to growing drug shortages.
In a 5 July 2012 Federal Register posting, the US Drug Enforcement Administration (DEA) announced it is looking to "adjust the established 2012 aggregate production quotas for some schedule I and II controlled substances." In doing so, DEA cited its authority under 21§1303.13 of the Code of Federal Regulations (CFR) which allows it to adjust the aggregate production quota if it determines there is a sufficient change in demand for a product. Part (c) of 21 CFR 1303.13 requires DEA to publish the proposed change in the Federal Register.
Proposed Changes to the Quota System
The largest proposed change in DEA's quota system would be for amphetamine salts, commonly used in attention deficit hyperactive disorder (ADHD) drugs. DEA is proposing to increase the quota by more than 32% from 25.3 million grams to 33.4 million grams.
The drugs have been in short supply for more than a year, and DEA has received criticism from consumers who complain of having a great degree of difficulty finding the drug. While the agency has previously placed blame for the situation on industry by saying results from manufacturing and distribution problems, its 5 July adjustment seems to indicate it is taking at least implicit responsibility for the problem. (See Regulatory Focus' 3 January story, 'ADHD Drugs Remain in Short Supply')
Opioids and Other Changes
Another notable increase is the quota for hydromorphone, an active pharmaceutical used in certain opioid drugs including Palladone and Dilaudid. DEA said it is proposing to increase the API's quota by 173,000 grams.
Oxycodone, another opioid, will see its quota raised by 700,000 grams per year under the proposal while Oripavine, another opiate, will see a 5.5 million gram increase in its quota.
The majority of the remaining changes would be modest, with most API production quotas only increasing 10 grams for lesser-used drugs and other schedule I drugs only used for research purposes.
The agency is obligated under the CSA to set production quotas for schedule I and II drugs, which are defined as substances having a high probability of abuse. Schedule II drugs, unlike schedule I drugs, are available via a prescription and are seen as having a therapeutic benefit for patients. Access to schedule II drugs are typically restricted through Risk Evaluation and Mitigation Strategy (REMS) plans or other special access restrictions requiring proof of identification, limits on the amount of a drug able to be purchased or special licensing for pharmacists.
Comments on the proposal are due by 6 August 2012.
DEA - Controlled Substances: Proposed Adjustment to the Aggregate Production Quotas for 2012