Last month the Drug Enforcement Administration, tasked with setting quotas for opioid production in the U.S, announced a proposal to reduce production levels another 10 percent, having already reduced production by 25 percent in 2017 and an additional 20 percent in 2018. This would bring down production levels to 53 percent of 2016 levels. Yesterday the DEA released a proposal to develop “use-specific” quotas. The DEA press release explains this as follows:
Today’s proposal amends the manner in which DEA grants quotas to manufacturers for maintaining inventories…The proposal also introduces several new types of quotas that DEA would grant to certain DEA-registered manufacturers. These use-specific quotas include quantities of controlled substances for use in commercial sales, product development, packaging/repackaging and labeling/relabeling, or replacement for quantities destroyed.
The rationale behind the production quotas is to reduce the amount of prescription opioids that can be diverted into the black market for non-medical use. But last month’s DEA quota proposal stated (Federal Register page 48172):
As a result of considering the extent of diversion, DEA notes that the quantity of FDA-approved drug products that correlate to controlled substances in 2018 represents less than one percent of the total quantity of controlled substances distributed to retail purchasers.
Therefore, it appears that diversion of prescription opioids into the black market is now a rare event. An obvious question then is why tighten quotas even further? Is the DEA on a mission to reduce or eliminate the use of opioids based upon this law enforcement agency's belief that it knows best how health care practitioners should engage in pain management?
As I have pointed out many times, there is no correlation between per capita prescription opioid volume and misuse or opioid use disorder in persons age 12 and up. And opioid-related overdose rates soared while prescription volume plunged. In 2017, illicit fentanyl and heroin were involved in 75 percent of opioid-related overdose deaths, and 68 percent of all opioid-related overdoses were “polydrug,” i.e., involved multiple other drugs, including alcohol, cocaine, heroin, fentanyl, benzodiazepines, and barbiturates. In fact, less than 10 percent of opioid-related overdose deaths in 2017 were from prescription opioids that didn’t involve other drugs.
The DEA’s presumption to know just how many prescription opioids of all classifications and in all situations will be needed in the coming year for a nation of 325 million people is a great example of what FA Hayek called the “fatal conceit.” DEA prescription opioid quotas have already been tied to an acute shortage of injectable opioids that afflicted hospitals across the country in 2018.
Aside from that, these additional quotas will do nothing to stem the deaths from illicit fentanyl and heroin that comprise the overwhelming majority of opioid-related overdose fatalities.