Category Archives: Quota

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Senate Committee Questions DEA on Quota Process

On May 5, 2015, the United States Senate, Caucus on International Narcotics Control held a hearing exploring the findings and recommendations of a Government Accountability Office investigation into the Drug Enforcement Administration’s management of its quota process.  The hearing, called by Senators Grassley and Feinstein, sought to explore the connection between DEA’s quota process and … Continue Reading

GAO Report Criticizes DEA Quota Process

On March 4, 2015, the Government Accountability Office (GAO) released a report titled, Drug Shortages: Better Management of the Quota Process for Controlled Substances Needed; Coordination between DEA and FDA Should Be Improved.  GAO’s report examined, (1) the trends in such shortages, (2) the effect on patients and providers, (3) DEA’s administration of the quota … Continue Reading

Don’t Squeeze the Balloon: An International Perspective on Preventing Prescription Drug Overdoses

Last year the United Nations Office on Drugs and Crime (UNODC) and the World Health Organization (WHO) published a paper on reducing opioid overdose mortality.  The paper addressed opioid overdoses related to heroin use and concluded that reduction in supply is an effective measure governments can take to reduce heroin overdoses.  The UNODC and WHO … Continue Reading

Sometimes Numbers Lie: Decline in Opioid Prescriptions is Hollow

According to the Milwaukee Journal Sentinel, IMS has reported that the number of prescriptions for opioids declined 5% in 2013 compared to 2012.  Although this could signal a positive step in combating opioid abuse, data suggest otherwise.  The decline in the number of prescriptions for opioids signals one thing only — a decline in the number of prescriptions.  … Continue Reading

DEA Finalizes 2014 Quota

Sometimes consistency is a bad thing… On September 9, 2013, the DEA published the 2014 Aggregate Production Quota (APQ) and Annual Assessment of Needs (AAN).  This is noteworthy because it continues the DEA’s streak of failing to meet the deadline for establishing the APQ going back at least to 1998 and the AAN since the … Continue Reading

Upcoming DEA Conferences

The DEA has announced an upcoming Manufacturer/Importer/Exporter Conference to be held in June 2013 at the National Harbor, Gaylord National Resort & Convention Center. “The purpose of this conference is to provide a forum to present federal laws and regulations that affect the pharmaceutical and chemical manufacturing, importing, and exporting industry and to discuss practices … Continue Reading

Obtaining DEA Quota to Manufacture Controlled Substances

DEA Quota Season is Upon Us This is the first of several discussions we will have regarding the DEA quota process and the adverse impact DEA’s handling of the quota process can have on the availability of controlled substances for the legitimate medical needs of the United States.  Some context and background is required to … Continue Reading

DEA’s Uneasy Relationship with Oxycodone

DEA’s position on oxycodone is clear — more or less. In DEA’s letter to FDA supporting a petition to restrict the approved labeled use of oxycodone to “severe pain,” DEA said that “abuse of prescription opioids have increased markedly over the past decade.”  In the letter DEA also expressed support for the legitimate and beneficial uses of … Continue Reading
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