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US Attorney For Eastern District of Texas Joseph D. BrownEastern District of Texas U.S. Attorney Joseph D. Brown touted today’s announcement from the Department of Justice and U.S. Drug Enforcement Administration (DEA) proposing a reduction for controlled substances that may be manufactured in the U.S. next year. Consistent with President Trump’s “Safe Prescribing Plan” that seeks to “cut nationwide opioid prescription fills by one-third within three years,” the proposal decreases manufacturing quotas for the most six frequently misused opioids for 2019 by an average ten percent as compared to the 2018 amount. The Notice of Proposed Rulemaking (NPRM) marks the third straight year of proposed reductions, which help reduce the number of drugs potentially diverted for trafficking and used to facilitate addiction.
“To address the opioid crisis in America, we have to attack not only those who illegally distribute drugs, but we also have to address the flood of narcotics from manufacturers and pharmacies that make it so easy for addicted people to get access,” said U.S. Attorney Joseph D. Brown. “I am glad to see some movement on reducing the number of pills that have contributed to so many deaths.”
On July 11, 2018, the Justice Department announced that DEA was issuing a final rule amending its regulations to improve the agency’s ability consider the likelihood of whether a drug can be diverted for abuse when it sets annual opioid production limits. The final rule also promotes greater involvement from state attorneys general, and today’s proposed reduction will be sent to those offices.
In setting the aggregate production quote (APQ), DEA considers data from many sources, including estimates of the legitimate medical need from the Food and Drug Administration; estimates of retail consumption based on prescriptions dispensed; manufacturers’ disposition history and forecasts; data from DEA’s own internal system for tracking controlled substance transactions; and past quota histories.
The DEA has proposed to reduce more commonly prescribed schedule II opioids, including oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine, and fentanyl: