The Opioid Epidemic: Cutting Supply Chains Where They Stand

by Maria Villegas Bravo

In the 1990s, pharmaceutical companies lied about the addictiveness of opioids and fueled an increase in prescriptions that led to an overwhelming growth of addictions.[1] Since then, many opioid users have moved from prescription painkillers to heroin and eventually to synthetic opioids that are up to 100 times more potent than morphine.[2] With the rising accessibility of drugs such as fentanyl, which is available through both legal prescriptions and the black market, the synthetic opioid-related death toll rose to nearly 130 deaths per day in 2018.[3] To combat this, the federal government has taken stringent action by criminalizing more and more synthetic opioids and their analogues so law enforcement can effectively remove these harmful drugs off the streets. However, placing a criminal penalty on possession or importation of these substances is not enough. Demand for these illicit substances will not wane as long as there is a steady supply crossing into America’s borders and slipping through ports of entry. The American federal government needs to switch tracks and put its money toward a more effective solution and empower its enforcement through sufficient funding.


The Controlled Substances Act and the DEA’s Emergency Scheduling Power­


Congress passed the Controlled Substances Act (CSA) in 1971 to battle a deepening drug crisis. The CSA created five categories, or schedules, of drugs defined by the severity of their effects.[4] For substances listed as Schedule I and II, the potential for both types of drugs to be abused is high. They differ in medical use: Schedule I substances are not legal even with a prescription, whereas Schedule II substances have some medical benefit that outweighs the risks. According to the CSA, Schedule I substances are too dangerous to use, even under medical supervision.

Originally, the CSA gave the attorney general the authority to add, remove, and transfer substances to a different schedule. Then in 1973, the attorney general delegated his powers to the DEA,[5] and Touby v. United States later upheld that transfer of power.[6] In order to put a new substance onto a schedule, the Department of Health and Human Services (HHS) must perform scientific and medical evaluations. The DOJ, DEA, FDA, and the National Institute on Drug Abuse also have to evaluate and propose recommendations. This interagency system verifies that the substances being put on the schedules are rigorously evaluated to protect the safety of the American people. HHS evaluates the substance based on eight criteria.[7] After HHS considers these eight factors, the DEA is required to hold a public comment period before the substance can be officially scheduled. This process can take between six to twelve months, such as in the case of Butylone, a powerful opiate that was proposed to be scheduled in March 2016 but was not formally scheduled until March 2017.[8]

Section 813 of the CSA provides for the general regulation of controlled substance analogues to the extent that they are intended for human consumption.[9] It is a vague provision, with most of the text defining the phrase “intended for human consumption,” but it does treat analogues as a Schedule I. This provision was originally proposed in the 115thCongress under H.R. 2851, also known as the Stop the Importation and Trafficking of Synthetic Analogues Act of 2018 (SITSA).[10] However, since SITSA did not pass the Senate, the provision was attached to H.R. 6, the SUPPORT for Patients and Communities Act, which passed both houses and became Public Law 115-271.[11]

Emergency scheduling allows for an expedited processing timeline, where HHS considers only the first three determining factors—history and current pattern of abuse; scope, duration and significance of the abuse; and what risk, if any, there is to public health—as well as the drug’s actual potential for abuse and black market accessibility.[12]Following the expedited evaluations, no public comment period is required, and the substance is temporarily placed in Schedule I for two years. The substance can remain Schedule I for a third year if a full review process is conducted during the two-year period. All substances scheduled with this expedited process must fall under the requirements of Schedule I, as it is assumed that the substance’s effects are severe enough to require the expedited process.[13]

Congress created Emergency Scheduling during the 1980s when drug manufacturers would evade prosecution by designing drugs that were chemically dissimilar enough from a substance under review that it would not qualify as the substance while still having the same effect.[14] Congress added the provision under the assumption that if the process is expedited, the manufacturers of these “designer drugs” would not have time to create these work-arounds.[15] There was also an issue of “imminent hazards” that needed quick and effective action to assess the overwhelming wave of overdoses created by these drugs. For example, when fentanyl first hit the market in the 1980s, there was an immediate uptick in deaths. In the eight months prior to the proposed scheduling of a fentanyl analogue, 26 people died due to overdosing on fentanyl-laced substances.[16] The DEA decided that this surge met the burden of proof for the analogue to be an “imminent hazard” and thus defined more quickly to be illegal.[17]


The Costs of Scheduling Fentanyl Analogues as a Class


In February 2018, the DEA emergency scheduled all fentanyl analogues as a class to stop the flow of designer fentanyl. Since then, Congress has repeatedly proposed legislation to permanently add the whole host of fentanyl analogues to Schedule I.[18] In response to these proposed solutions, a coalition of prominent human rights and drug policy nonprofit organizations wrote a letter to the Senate Judiciary Committee, urging them to not support the bill.[19]

The letter warned that placing a class-wide ban in the CSA allows the DEA to circumvent the rigorous evaluation system put in place to protect the safety of American citizens. Under bills such as S.1622 and H.R. 2851 in the 116th Congress, the DEA would have to consult HHS less than it already does.[20] The DEA is a law enforcement agency, not a public health specialist, yet it would be able to recognize a fentanyl analogue and immediately deem it a Schedule I drug, without any consideration of whether it renders the same psychoactive effect on an individual taking the substance.[21]There is a real and present danger in not consulting scientific experts on scientific matters. For example, a 2015 bill introduced by former Pennsylvania Congressman Charlie Dent on behalf of the DEA would have required Congress to place over 300 substances under Schedule I.[22] Upon review by scientists, however, that number was reduced to 22 in subsequent versions of the bill because the 278 other substances either did not qualify as a Schedule I substance or did not contain any psychoactive properties.[23]

In addition to avoiding oversight from HHS, scheduling fentanyl analogues does not address the problem underlying the opioid crisis: importation. Scheduling the analogues merely increases the amount of criminal sentences on low-level possession offenders rather than targeting those who actually feed the supply of illicit substances into the American market. There will always be customers when a steady supply exists, and the last 50 years of the war on drugs shows that targeting these low-level offenders is futile. There has been a 40-fold increase in the prosecution of fentanyl traffickers under the Trump Administration and this emergency scheduling,[24] but the CDC states synthetic opioid overdoses have still increased.[25]

Possession offenses can already be prosecuted under 21 U.S.C. 813, so the point of scheduling fentanyl analogues as a class is to target importers. However, typical seizures of these substances are low enough on the supply chain (i.e. street dealers and consumers) and are unhelpful compared to seizures at ports of entry. In 2019 alone, Customs and Border Control agents seized over 2,500 kilograms of fentanyl and its analogues at ports of entries.[26] With these seizures, the DEA agents get closer to the source of the drugs and can better investigate the supply chain.


The Path Forward


Despite evidence demonstrating that punishing low-level drug distributors is ineffective in curbing access to these drugs, as seen by the exponential increase in importation levels, Congress passed Public Law 116-114.[27] This law extends the DOJ’s power of emergency scheduling of fentanyl analogues until May 6, 2021, and ordered the Government Accountability Office (GAO) to study the impacts of class-wide scheduling.[28] This GAO report will include research on the specific substances under the current regulations, the law’s effects on enforcement, and reviews of the international regulatory controls of fentanyl-related substances.

A different strategy, though, has been in talks for years now. In 2018, the Senate Homeland Security and Government Affairs Committee’s subcommittee on investigations (HSGAC) released a report detailing the state of opioid importation into the United States. Part of the study found that hundreds of sellers based in China used the internet to import fentanyl and its analogues, and they preferred using the U.S. Postal Service (USPS) to deliver their products.[29]Because of the lack of effective parcel tracking and screening, sellers claimed it was essentially a “guaranteed” delivery.[30] Sellers also had trusted methods to decrease the likelihood of packages being screened, such as diverting their packages through less suspicious countries.[31]Classifying a subject as Schedule I merely worsens the punishment once the importers are caught. There is no incentive or support for law enforcement to do their job more effectively.

Going forward, legislators should focus more on regulations surrounding the delivery mechanisms of these substances and less on their classifications, which have been proven to be ineffective. For example, USPS delivers nearly 20 million packages a day,[32] and most package screening and inspection is done manually.[33] To aid in this monstrous effort of tracking and targeting suspicious parcels, the Universal Postal Union (UPU) instituted a system that tracks advanced electronic data (AED) for international mail items. Both Customs and Border Patrol and the USPS use this data to mark packages as suspicious at ports of entry and consequently investigate supply chains of packages containing fentanyl.[34] As a result, between fiscal years 2016 and 2017 when AED use was implemented, there was an 880 percent increase in parcel seizures relating to synthetic opioids in package screening at international service centers.[35]


Conclusion


While such a huge crisis necessitates more than one plan of attack, the federal government should move toward more effective methods of seizing fentanyl. Providing Customs and Border Patrol and the USPS with the money and resources to better investigate supply chains has yielded concrete returns, whereas the emergency scheduling has less so. Between fiscal years 2018 and 2019, when the emergency scheduling of fentanyl analogues was implemented, seizures of fentanyl related substances only increased 34 percent.[36] When compared to the 215 percent increase in seizures when the UPU instated AED years before,[37] it is clear where our tax dollars are better spent.






[1] What is the U,S, Opioid Epidemic? U.S. Dᴇᴘᴀʀᴛᴍᴇɴᴛ ᴏғ Hᴇᴀʟᴛʜ ᴀɴᴅ Hᴜᴍᴀɴ Sᴇʀᴠɪᴄᴇs, https://www.hhs.gov/opioids/about-the-epidemic/index.html. [2] Tʜᴏᴍᴀs W. Cʟᴀʀᴋ ᴇᴛ ᴀʟ., Pʀᴇsᴄʀɪᴘᴛɪᴏɴ Bᴇʜᴀᴠɪᴏʀ Sᴜʀᴠᴇɪʟʟᴀɴᴄᴇ Sʏsᴛᴇᴍ: Issue Brief, CDC Nᴀᴛɪᴏɴᴀʟ Cᴇɴᴛᴇʀ ғᴏʀ Iɴᴊᴜʀʏ Pʀᴇᴠᴇɴᴛɪᴏɴ ᴀɴᴅ Cᴏɴᴛʀᴏʟ (Brandeis University, 2017), available at https://www.cdc.gov/drugoverdose/pdf/pbss/PBSS-Report-072017.pdf [3] Matthew P. Prekupec et al., Misuse of Novel Synthetic Opioids: A Deadly New Trend, 11 J. Aᴅᴅɪᴄᴛɪon Mᴇᴅ. 256 (2017). [4] Controlled Substances Act, 21 U.S.C. § 812 (1971). [5] 38 Fed. Reg. §§ 18, 380 (1973). [6] See Touby v. United States, 500 U.S. 160 (1991), in which the Supreme Court decided that the CSA allowed the attorney general to delegate authority to other parts of the Department of Justice and that the delegation to the Drug Enforcement Agency was appropriate. [7] See 21 U.S.C. § 811(c), which states that these eight criteria in evaluating a substance are: its actual or relative potential for abuse; scientific evidence of its pharmacological effect, if known; the state of current scientific knowledge regarding the substance; its history and current pattern of abuse; the scope, duration, and significance of abuse; what, if any, risk the drug poses to the public health; its psychic or physiological dependence liability; and whether the substance is an immediate precursor of a substance already controlled under this subchapter. [8] U.S. Dᴇᴘᴛ. ᴏғ Jᴜsᴛɪᴄᴇ, Dʀᴜɢ Eɴғᴏʀᴄᴇᴍᴇɴᴛ Aᴅᴍɪɴɪsᴛʀᴀᴛɪᴏɴ, Oғғɪᴄᴇ ᴏғ Dɪᴠᴇʀsɪᴏɴ Cᴏɴᴛʀᴏʟ, Lɪsᴛs ᴏғ: Sᴄʜᴇᴅᴜʟɪɴɢ Aᴄᴛɪᴏɴs Cᴏɴᴛʀᴏʟʟᴇᴅ Sᴜʙsᴛᴀɴᴄᴇs Rᴇɢᴜʟᴀᴛᴇᴅ Cʜᴇᴍɪᴄᴀʟs 8 (2020). [9] 21 U.S.C. § 813. [10] H.R. 2851, 115th Cong. (2018). [11] H.R. 6, 115th Cong. (2018). [12] See 21 U.S.C. § 811(h); See also Olivia Castillo, Kratom Crackdown: How the DEA Abused Its Emergency Scheduling Authority Under the Controlled Substances Act, 72 U. Mɪᴀᴍɪ L. Rᴇᴠ. 972, 992-4 (2018). [13] Castillo, supra note 12 at 992. [14] Id. at 994. [15] Id. [16] Id. at 998. [17] Id. [18] H.R. 2851. [19] Letter from A New PATH (Parents for Addiction Treatment and Healing) & AIDS United et al. to Lindsey Graham, Chairman, & Diane Feinstein, Ranking Member (July 1, 2019), available at https://www.hrw.org/news/2019/07/03/coalition-opposes-s1622-stopping-overdoses-fentanyl-analogues-act-sofa#. [20] Stopping Overdoses of Fentanyl Analogues Act, S.1622, 116th Cong. § 2 (2019); see also the Fairness and Accuracy in Employment Background Checks Act of 2019, H.R. 2851, 116th Cong. (2019). [21] Id. [22] Dangerous Synthetic Drug Control Act of 2016, H.R. 3537, 114th Cong. (2015). [23] Letter from A New PATH & AIDS United et al., supra note 19. [24] Exᴇᴄᴜᴛɪᴠᴇ Oғғɪᴄᴇ ᴏғ ᴛʜᴇ Pʀᴇsɪᴅᴇɴᴛ ᴏғ ᴛʜᴇ Uɴɪᴛᴇᴅ Sᴛᴀᴛᴇs, Oғғɪᴄᴇ ᴏғ Nᴀᴛɪᴏɴᴀʟ Dʀᴜɢ Cᴏɴᴛʀᴏʟ Pᴏʟɪᴄʏ, Aɴ Uᴘᴅᴀᴛᴇ Oɴ ᴛʜᴇ Pʀᴇsɪᴅᴇɴᴛ's Cᴏᴍᴍɪssɪᴏɴ ᴏɴ Cᴏᴍʙᴀᴛᴛɪɴɢ ᴀɴᴅ ᴛʜᴇ Oᴘɪᴏɪᴅ Cʀɪsɪs: Oɴᴇ Yᴇᴀʀ Lᴀᴛᴇʀ 1 (2017). [25] Synthetic Opioid Overdose Data, Cᴇɴᴛᴇʀ ғᴏʀ Dɪsᴇᴀsᴇ Cᴏɴᴛʀᴏʟ ᴀɴᴅ Pʀᴇᴠᴇɴᴛɪᴏɴ (last updated March 19, 2020), https://www.cdc.gov/drugoverdose/data/fentanyl.html. [26] U.S. Dᴇᴘᴀʀᴛᴍᴇɴᴛ ᴏғ Hᴏᴍᴇʟᴀɴᴅ Sᴇᴄᴜʀɪᴛʏ, U.S. Cᴜsᴛᴏᴍs ᴀɴᴅ Bᴏʀᴅᴇʀ Pʀᴏᴛᴇᴄᴛɪᴏɴ, CBP Eɴғᴏʀᴄᴇᴍᴇɴᴛ Sᴛᴀᴛɪsᴛɪᴄs Fɪsᴄᴀʟ Yᴇᴀʀ 2020 (2020). [27] Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act, Public Law 116-114, 116th Cong. (2020). [28] Child Nicotine Poisoning Prevention Act of 2015, Pub. L. No. 116-114, 130 Stat. 1. [29] Uɴɪᴛᴇᴅ Sᴛᴀᴛᴇs Sᴇɴᴀᴛᴇ Pᴇʀᴍᴀɴᴇɴᴛ Sᴜʙᴄᴏᴍᴍɪᴛᴛᴇᴇ ᴏɴ Iɴᴠᴇsᴛɪɢᴀᴛɪᴏɴs Cᴏᴍᴍɪᴛᴛᴇᴇ ᴏɴ Hᴏᴍᴇʟᴀɴᴅ Sᴇᴄᴜʀɪᴛʏ ᴀɴᴅ Gᴏᴠᴇʀɴᴍᴇɴᴛᴀʟ Aғғᴀɪʀs, Cᴏᴍʙᴀᴛᴛɪɴɢ ᴛʜᴇ Oᴘɪᴏɪᴅ Cʀɪsɪs: Exᴘʟᴏɪᴛɪɴɢ Vᴜʟɴᴇʀᴀʙɪʟɪᴛɪᴇs ɪɴ Iɴᴛᴇʀɴᴀᴛɪᴏɴᴀʟ Mᴀɪʟ (2018) [30] Id at 37. [31] Id. at 40. [32] United States Postal Service, Hundreds of Millions of Holiday Packages Expected Between Thanksgiving and New Year’s Day, Uɴɪᴛᴇᴅ Sᴛᴀᴛᴇs Pᴏsᴛᴀʟ Sᴇʀᴠɪᴄᴇ (Nov. 7, 2019), https://about.usps.com/newsroom/national-releases/2019/1107-20-million-packages-to-be-delivered-daily-this-holiday-season.htm [33] Combatting the Opioid Crisis: Exploiting Vulnerabilities in International Mail: Hearing before the Permanent Subcommittee on Investigations Committee on Homeland Security and Governmental Affairs United States Senate, 115th Cong. (2018) (statement of William Siemer, Acting Deputy Inspector General, United States Postal Service). [34] Combatting the Opioid Crisis: Exploiting Vulnerabilities in International Mail: Hearing before the Permanent Subcommittee on Investigations Committee on Homeland Security and Governmental Affairs United States Senate, 115th Cong. (2018) (statement of Joseph Murphy, International Postal Policy Unit Chief, Department of State, Bureau of International Organizations). [35] Combatting the Opioid Crisis: Exploiting Vulnerabilities in International Mail: Hearing before the Permanent Subcommittee on Investigations Committee on Homeland Security and Governmental Affairs United States Senate, 115th Cong. (2018) (statement of Robert Cintron, Vice President, Network Operations, United States Postal Service). [36] U.S. Dᴇᴘᴀʀᴛᴍᴇɴᴛ ᴏғ Hᴏᴍᴇʟᴀɴᴅ Sᴇᴄᴜʀɪᴛʏ, supra note 26. [37] Id.

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