U.S. Proposes Cutting Opioid Manufacturing

What’s one way to cut the number of opioid drugs diverted for abuse?

Cut the quantities being manufacturing — or so the government hopes.

The U.S. Department of Justice and the U.S. Drug Enforcement Administration announced Thursday they will again recommend reducing the amount of more than 250 Schedule I and Schedule II controlled substances manufactured in the United States in 2019, for the third year in a row.

In 2016, the DEA dramatically reduced 2017’s aggregate production quota of Schedule II opioids — grams of those drugs that can be manufactured in the country — by an average of 35 percent. That reduction included commonly prescribed opioids oxycodone, hydrocodone, oxymorphone, hydromorphone, morphine and fentanyl.

Last year’s reduction was less significant, averaging 5 percent total; 2019’s proposal calls for an average 10 percent cut, from a 7 percent cut in morphine (cut by 50 percent over all three years) to a 15 percent cut in oxymorphone (cut by 54 percent over all three years).

DEA sets the quota after looking at “data from many sources,” said a DOJ release, including the FDA’s annual estimate of the legitimate medical need nationally for each drug; estimates of what retailers need to fill prescriptions; the history and forecasts of the drug manufacturers; past quota histories; and DEA’s own system for tracking controlled substance transactions. DEA can revise the quotas it allots to individual manufacturers during the year.

“Cutting opioid production quotas by an average of 10 percent next year will help us continue” reducing prescription rates, which President Donald Trump said he aims to reduce by one-third in three years, “and make it harder to divert these drugs for abuse,” said Attorney General Jeff Sessions in the release.

The DOJ announced last month it would issue a “final rule” amending its regulations to improve its ability to “consider the likelihood of whether a drug can be diverted for abuse” while setting the annual limits. A law last year reduced the DEA’s ability to freeze shipments of prescription drugs; formerly, the DEA had only to argue the drugs posed “imminent danger” to communities, but it now must show a “substantial likelihood” the drugs pose an “immediate threat” before freezing a shipment.

This “final rule” will more heavily involve state attorneys general in the process, the DOJ said.

J. Douglas Overbey, U.S. Attorney for the Eastern District of Tennessee, said his office “fully supports” the cuts.

“Our communities are currently facing the deadliest drug crisis in American history, and Tennessee has already been established as an acute ‘hot spot’ for prescription opioid abuse and opioid overdose deaths,” Overbey said. “Reducing the availability of powerfully addictive prescription opioids will help our efforts to combat this growing opioid addiction crisis and save lives.”

Among the drugs included in the reduction is fentanyl, a powerful opioid slated to be reduced by 12 percent in 2019, 48 percent overall.

In Knox and Anderson counties in 2016, the data used by the Regional Forensic Center in its 2017 report on drugrelated deaths, fentanyl and its analogues topped the list of drugs found in drug-related deaths.

But while diversion of prescribed fentanyl drugs is an issue, much of the U.S.’s illegal fentanyl supply is manufactured in China, arriving through Mexico.

Likewise, heroin — up to No. 10 on the list of drugs found in drug-related deaths in Knox and Anderson County — comes to the U.S. largely from Mexico and South America. Between 20102015, heroin seizures and trafficking arrests at the Mexican border doubled. The number of U.S. adults who reported having used heroin in the past year jumped from 404 in 2002 to 948 in 2016, according to the national Centers for Disease Control and Prevention; the number of heroin overdose deaths between 2010 and 2017 increased more than fivefold, from 3,036 to 15,958. Health officials surmise that as prescription opioids become harder to obtain, addicts are turning to cheaper, more easily available street drugs.


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