DEA Proposes More Cuts in Rx Opioids

By Pat Anson, PNN Editor

For the fourth consecutive year, the U.S. Drug Enforcement Administration is proposing steep cuts in the supply of hydrocodone, oxycodone and three other opioid painkillers classified as Schedule II controlled substances.

In a notice published today in the Federal Register, the DEA proposes to reduce production quotas for hydrocodone by 19 percent and oxycodone by 9 percent in 2020. The supply of hydromorphone, oxymorphone, and fentanyl would also be cut.

“The aggregate production quota set by DEA each calendar year ensures that patients have the medicines they need while also reducing excess production of controlled prescription drugs that can be diverted and misused,” acting DEA Administrator Uttam Dhillon said in a statement.

“DEA takes seriously its obligations to both protect the public from illicit drug trafficking and ensure adequate supplies to meet the legitimate needs of patients and researchers for these substances.”

In setting annual production quotas for controlled substances, DEA considers various factors such as medical need, estimates of retail consumption based on prescriptions, and forecasts from opioid manufacturers. Added to the mix this year is diversion.

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The five opioids being cut are subject to special scrutiny under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, known as the SUPPORT Act, which was signed into law by President Trump on October 24, 2018. The law requires DEA to estimate the amount of diversion of the five opioids and “make appropriate quota reductions.”

The agency estimated that 57 kilograms – about 125 pounds – of oxycodone were diverted or stolen in 2018, along with 24 kilograms (53 pounds) of hydrocodone. There was diversion of relatively small amounts of fentanyl, hydromorphone and oxymorphone last year.   

Cuts Began in 2016

The DEA first began cutting the supply of opioids in 2016 during the Obama administration and the trend has accelerated under President Trump, who pledged to reduce the supply of opioids by a third by 2021.

If approved, the 2020 production quotas would amount to a 60 percent decrease in the supply of hydrocodone since 2016 and a 48 percent cut in the supply of oxycodone.

While overdoses involving prescription opioids have been declining, they’ve been offset by a growing number of deaths attributed to illicit fentanyl, heroin and other street drugs. “Mexican Oxy” – counterfeit oxycodone pills laced with fentanyl – are being trafficked throughout the United States and are blamed for overdoses from New York City to San Diego.

In addition to the five opioids, the DEA is setting production quotas on more than 250 Schedule I and II controlled substances. The agency is proposing to increase the amount of marijuana that can be produced for research by almost a third, from 2,450 kilograms in 2019 to 3,200 kilograms -- almost triple what it was in 2018. The increase reflects growing interest in marijuana research.

Public comments on the DEA proposal will be accepted until October 10. To make a comment online, click here. The agency will publish another notice later in the year on its final decision and begin informing drug manufacturers of their quota allotment.