Emergency Action Adding U4 to the List of Schedule One Controlled Substances

The human mind knows almost no limit to its attraction to opioids and opioid-like substances. They reduce the perception of pain and, for some, induce a euphoric response, as  these drugs affect the brain regions involved in reward. Pharma has long experimented with developing synthetic opioids. Some synthetic opioids are developed in the lab and shelved after development, but their identities as research drugs live on, sometimes accessible through scientific research channels.

Synthetic opioid U-47700, popularly known as U4, comes from the research drug world to the land of street drug via this path.  Widely available, U4 is perhaps  the most recent synthetic opioid to make its mark in drug overdose and drug abuse statistics but it has its peers.  Originally invented by Upjohn in the 1970's, U4 is pharmacologically untested on humans, though widely reported to induce a heroin-like euphoria. Reportedly eight times more potent than morphine, U4 is attracting attention on the street.

U4 is not legally sold as a pharmaceutical.  It lives on as a research chemical sold over the internet under questionable circumstances, often from what is believed to be foreign lab manufacture, specifically labeled as "not for human consumption." Of course, its purchase is often for human consumption. Sadly, U4 is reported to have been part of the deadly drug cocktail implicated in Prince's death. U4's combination with Fentanyl can depress respiration to the point of death.

Both state and local governments can track some estimate of its internet-based purchase and use through drug overdose reports. Ohio, Wyoming, and Georgia were among the earliest states to ban U4's sale and consumption, raising fascinating federalism questions about the push and shove of power in drug control policy. Other countries have already categorized U4 as a controlled substance or as a narcotic.

The DEA has now announced its intent to add U4 to the Schedule One list on a temporary emergency basis after submitting findings of public safety concerns related to an increasing implication of U4 in overdose deaths nationwide. This functions as a two year temporary placement of U4 onto the Schedule One list of controlled substances, those controlled substances considered to be most dangerous to human consumption and deemed to have "no currently acceptable medical use." 

As the Notice of Intent states:

    Section 201 of the CSA, 21 U.S.C. 811, provides the Attorney General with the authority to temporarily place a substance into     schedule I of the CSA for two years without regard to the requirements of 21 U.S.C. 811(b) if she finds that such action is necessary     to avoid imminent hazard to the public safety. 21 U.S.C. 811(h)(1). In addition, if proceedings to control a substance are initiated     under 21 U.S.C. 811(a)(1), the Attorney General may extend the temporary scheduling for up to one year. 21 U.S.C. 811(h)(2).

    Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under     section 202 of the CSA, 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the     Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355. 21 U.S.C. 811(h)(1). The Attorney General has delegated scheduling     authority under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.

Other members of the Schedule One club include: Heroin, LSD, Ecstasy, and Marijuana. Marijuana has been a Schedule One controlled substance since the 1970's.  History tells us that its placement on Schedule One was itself complicated by the understanding that Marijuana's therapeutic potential needed more study before its possible re-classification. The rest, as they say, is history. Marijuana has been continuously listed as a Schedule One controlled substance ever since that time. 

What we know now is that this Schedule One designation has proven remarkably sticky. There are two ways to reschedule or de-schedule a pharmaceutical: administrative action or Congressional action. Both have proven unlikely to accomplish the rescheduling or de-scheduling of Marijuana.   As recently as last month, the DEA declined to re-schedule (or even de-schedule) Marijuana as a Schedule One drug, though it did indicate an intention to  loosen the tight restrictions on scientific research into Marijuana's medical therapeutic potential by making legally grown and supplied Marijuana for medical research purposes somewhat easier to obtain.  The August 2016 decision to maintain Marijuana's status as a Schedule One drug was a surprise to some but not to all. One expert noted, nothing happens fast on Marijuana policy.  It does highlight the risks of substantially constraining medical research into the therapeutic uses of a controlled substance and the significance of loosening the sole approved source requirement.

U4 is a dangerous recreational drug, at least as it is apparently being used on the street by a certain number of Americans.    But, given U4's therapeutic medical lineage, there is fear the temporary serious public risk categorization of it as a Schedule One controlled substance will effectively shut down research into a promising synthetic opioid. We are governed by our fears — in this case, the misuse of opioid medication and opioid research chemicals —  when we take the best science we have, memorialize it in law and regulation in a moment in time, and  then refuse to exercise the leeway built into the system  to revisit our best understandings of years or even decades old science.

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