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Source: United States House of Representatives – Congressman Michael C Burgess MD (R-TX)

Washington, D.C. – Energy and Commerce Committee Republican Leader Greg Walden (R-OR), Oversight and Investigations Subcommittee Republican Leader Brett Guthrie (R-KY), Health Subcommittee Republican Leader Dr. Michael Burgess (R-TX), and Representative Morgan Griffith (R-VA) wrote to Drug Enforcement Administration (DEA) Acting Administrator Timothy J. Shea to request a briefing on DEA’s management of the supply of opioids in the United States.

“Each calendar year, the DEA sets the aggregate production quota (APQ) of controlled substances, including opioids, to ensure that patients have the medicines they need while also reducing excess production of controlled prescription drugs that can be diverted and misused,” wrote Walden, Guthrie, Burgess, and Griffith. 

The DEA’s 2019 Drug Threat Assessment report raises questions about how DEA manages the APQ for opioids. In the letter, DEA is asked about the justification of quotas, including why the agency set quotas that were twice the amount of sales the year before.

“According to [a figure of] the 2019 DTA, over 2016, 2017, and 2018 periods, the DEA approved a combined total quota of about 800 million grams of opioids, and drug companies manufactured about 560 million grams of drug and sold, through retail purchases, about 235 million grams. This would indicate that during this 3-year period, drug companies over-manufactured 325 million grams of drug, and had about 235 million grams of finished product in inventory, more than they sold in any year. The DEA quota was 565 million grams over retail purchased, and 475 million grams over manufactured product. In sum, although retail purchases declined, industry increased its manufacturing and inventory year-end levels,” continued Walden, Guthrie, Burgess, and Griffith.

In the letter, the E&C Republican leaders also listed several factors that go into DEA’s decision-making in setting the APQ levels each year. Due to a bipartisan law passed to combat the opioid crisis under then-Chairman Walden’s leadership, the SUPPORT for Patients and Communities Act, the DEA is required to consider opioid abuse, diversion, and overdose deaths in the calculation for quotas. However, DEA has cited issues getting precise overdose death data, so the members ask what needs to be done for the DEA to incorporate the data. The DEA considers estimates provided by the Food and Drug Administration on medical need in the U.S. and in the letter, the DEA is asked why their assessment of opioids medical need consumption is higher than the FDA’s.

This request is in support of a reactivated investigation by Committee Republicans, initiated by the House Energy and Commerce Committee in August 2018, examining how the nation’s opioid epidemic may have been impacted from potential supply chain breakdowns of controlled substances, as well as the role of certain opioid manufacturers in those potential breakdowns.

Click HERE to read the letter to DEA.

MIL OSI USA News