In DEA’s letter to FDA supporting a petition to restrict the approved labeled use of oxycodone to “severe pain,” DEA said that “abuse of prescription opioids have increased markedly over the past decade.” In the letter DEA also expressed support for the legitimate and beneficial uses of opioid analgesics. These two statements capture the essence of DEA’s uneasy relationship with opioid analgesics, particularly oxycodone and hydrocodone. DEA is both a regulatory agency and a law enforcement agency. DEA must regulate entities that provide opioids for legitimate use and it must investigate those who illegally distribute those same products.
As a regulator, DEA determines the amount of oxycodone and hydrocodone that may be manufactured in the United States through the establishment of annual aggregate quotas. DEA’s quota rule established the amount of oxycodone and certain other controlled substances “to be manufactured in the United States in 2013 to provide for the estimated medical, scientific, research, and industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve stocks.” While DEA correctly observes that abuse of opioids has “increased markedly over the past decade,” the quotas for oxycodone and hydrocodone established by DEA have also increased markedly during that same period.
This demonstrates how difficult it is, even for DEA, to determine how much oxycodone and hydrocodone are needed for legitimate use. It also demonstrates the need for a comprehensive approach to addressing the societal issue of prescription drug abuse. DEA’s current position on oxycodone appears to be “make more, but use less.” Greater supply with less accepted “legitimate” use will likely lead to more enforcement actions but do little to address the problem of prescription drug abuse. I applaud DEA for aggressively pursuing those who illegally distribute opioids, including those who prescribe them without a legitimate purpose. But opening the spigot through quotas and then sounding the alarm about the flood of prescription drug abuse is like responding to a four-alarm fire, sirens blaring, in a loaded fuel tanker.
At a practical level, what should registrants make of DEA’s support for limiting the indication for use of oxycodone to “severe pain?” Is this an indication that DEA believes current prescribing of oxycodone for moderate pain is inappropriate or at least questionable? Is hydrocodone next, particularly if hydrocodone combination products are placed in Schedule II? At a public policy level, should DEA’s quota system be overhauled to address both potential drug shortages and potential over-production of certain products?
It is time for lawmakers, regulators, policy makers, and members of industry to take a comprehensive and collaborative approach to addressing prescription drug abuse while ensuring adequate supply for legitimate use.