R Street Comments on DEA’s Proposed Aggregate Production Quota 2024
November 28, 2023
Drug Enforcement Administration
8701 Morrissette Drive
Springfield, VA 22152
Re: Proposed Aggregate Production Quota 2024 (2023-24282), Docket No. DEA-1228P
Dear Scott A. Brinks,
I am submitting the following comments on behalf of the Integrated Harm Reduction department at the R Street Institute, a nonprofit, nonpartisan public policy think tank. Our team is committed to supporting policy that balances “free market, limited government” ideals with pragmatic policy solutions that prioritize public health and safety.
The Drug Enforcement Administration’s (DEA) Proposed Aggregate Production Quota 2024 comes as the United States finds itself in the midst of two intersecting drug crises. On the one hand, a string of prescription drug shortages is affecting hospital and outpatient care, limiting access to medications.[1] On the other, the nation’s overdose crisis persists, driven not by the diversion of legal pharmaceuticals, but by an increasingly unpredictable and deadly illicit drug supply.[2] Furthermore, history teaches us that when the legal supply of prescription medication is reduced too quickly or by too much—whether through problems in the supply chain or restrictions on provider practices—it harms patients by cutting medication access, potentially sending them to the illicit market in an attempt to manage pain, withdrawal, mental health symptoms and more.[3] As such, we urge the DEA to reconsider its proposed 2024 quotas that would reduce the production of opioid painkillers.
I. There are several ongoing medication shortages in the United States
For nearly a year, the U.S. health care system has been disrupted by a number of medication shortages, caused by both an increase in demand and manufacturing and supply chain problems. By late spring 2023, the country faced 309 shortages of medications commonly used to treat diabetes, cancer and more.[4] One of the most troubling shortages is that of opioid painkillers. Availability of these medications was already stretched thin due to a previous 5 percent production reduction, so current supply chain-related shortages further hampered access.[5]
A. Drug shortages hurt patients
Inadequate access to opioid painkillers is potentially harmful to individual patients and to the health system more broadly. First, restricting the availability of opioid-based painkillers very simply may cause patients to experience unnecessary levels of acute or chronic pain as providers turn to less effective alternatives.[6] For example, research indicates that when faced with a shortage of prescription painkillers, providers adapt by reducing the number of patients who receive opioids, rather than reducing the doses that are prescribed.[7] And drug shortages have been found to lead to significant cost increases.[8] Both cost increases and provider rationing have the potential to affect vulnerable populations disproportionately, thereby widening existing gaps in the quality of treatment received.[9]
B. Reducing prescription drug availability can drive patients to the deadly illicit market
In addition to direct pain-related suffering, chronic pain patients who suddenly find their access to opioid medications cut off may also face unpleasant and sometimes life-threatening withdrawal symptoms.[10] These symptoms, coupled with a desire to mitigate pain, has been shown to drive people to seek opioids on the unregulated illicit market.[11] In fact, research suggests that past restrictions—such as the DEA’s 2014 rescheduling of hydrocodone—have preceded and likely contributed to significant increases in the number of people purchasing opioids on the illicit market.[12]
II. Diverted prescription opioids play little role in today’s overdose crisis
It is noteworthy that the DEA extensively cites the need to minimize diversion as a justification for reducing the 2024 production quotas for opioid painkillers. However, the DEA’s own projected diversion rates are well below 1 percent. Furthermore, the current overdose crisis in the United States is driven not by diverted prescription painkillers, but by illicitly manufactured fentanyl and other synthetic opioids.[13]
III. Conclusion
Given the harms associated with restricting medication availability and the extremely low rates of diversion cited by the DEA, we strongly encourage the reconsideration of proposed 2024 reductions on opioid painkiller manufacturing. Rather, the evidence suggests that in order to protect public health and preserve life, we should ensure people who are experiencing acute and chronic pain can work with their health care providers to make decisions about how best to manage that pain using safe, regulated medications.
Respectfully submitted,
____________________________
Stacey McKenna, PhD
Senior Fellow
Integrated Harm Reduction
R Street Institute
1411 K Street NW
Suite 900
Washington, D.C. 20005
970-443-8063
[1] John Yang and Ali Rogin, “What’s causing the unusually high number of drug shortages in the U.S.?” PBS News Weekend, Nov. 5, 2023. https://www.pbs.org/newshour/show/whats-causing-the-unusually-high-number-of-drug-shortages-in-the-u-s; Taylor Bryan and Mason Watkins, “Prescription pain medication shortages affecting local doctors and pharmacies as well as patients,” WPSD Local 6, July 12, 2023. https://www.wpsdlocal6.com/news/prescription-pain-medication-shortages-affecting-local-doctors-and-pharmacies-as-well-as-patients/article_4cf5caca-210d-11ee-9076-cbef41a46f3d.html.
[2] Daniel Ciccarone, “The triple wave epidemic: Supply and demand drivers of the US opioid overdose crisis,” International Journal of Drug Policy 71 (September 2019), pp. 183-188. https://www.sciencedirect.com/science/article/pii/S0955395919300180.
[3] Amanda J. Deutsch et al., “The Impact of the Parenteral Opioid Medication Shortages on Opioid Utilization Practices in the Emergency Department of Two University Hospitals,” Journal of Medical Toxicology 17 (April 27, 2021), pp. 372-377. https://link.springer.com/article/10.1007/s13181-021-00842-7; Office of the Assistant Secretary for Planning and Evaluation, ASPE Report to Congress: Impact of Drug Shortages on Consumer Costs, U.S. Department of Health and Human Services, May 22, 2023. https://aspe.hhs.gov/reports/drug-shortages-impacts-consumer-costs.
[4] Yang and Rogin. https://www.pbs.org/newshour/show/whats-causing-the-unusually-high-number-of-drug-shortages-in-the-u-s.
[5] Bryan and Watkins. https://www.wpsdlocal6.com/news/prescription-pain-medication-shortages-affecting-local-doctors-and-pharmacies-as-well-as-patients/article_4cf5caca-210d-11ee-9076-cbef41a46f3d.html.
[6] “Opioid Drug Shortages Affect Patients, Health Systems,” Pharmacy Times, Sept. 28, 2023. https://www.pharmacytimes.com/view/opioid-drug-shortages-affect-patients-health-systems.
[7] Deutsch et al. https://link.springer.com/article/10.1007/s13181-021-00842-7.
[8] Office of the Assistant Secretary for Planning and Evaluation. https://aspe.hhs.gov/reports/drug-shortages-impacts-consumer-costs.
[9] Mary E. Morales and R. Jason Yong, “Racial and Ethnic Disparities in the Treatment of Chronic Pain,” Pain Medicine 22:1 (January 2021), pp. 75-90. https://academic.oup.com/painmedicine/article/22/1/75/6046167; Kristin Drogell et al., “Race and Sex Are Associated With Variations in Pain Management in Patients Presenting to the Emergency Department With Undifferentiated Abdominal Pain,” The Journal of Emergency Medicine 63:5 (November 2022), pp. 629-635. https://www.sciencedirect.com/science/article/abs/pii/S0736467922005261.
[10] Kim Burrows, “Nevada pain patients left in distress due to prescription opioid shortage,” News 4, July 24, 2023. https://mynews4.com/news/local/opioid-shortage-leaves-nevada-patients-doctors-in-a-lerch-hydrocodone-oxycodone-drugs-pain-management-doctor-pharmacy.
[11] Geoff Bardwell et al., “’People need them or else they’re going to take fentanyl and die’: A qualitative study examining the ‘problem’ of prescription opioid diversion during an overdose epidemic,” Social Science and Medicine 279 (June 2021). https://pubmed.ncbi.nlm.nih.gov/33971445; Phillip O. Coffin et al., “Illicit opioid use following changes in opioids prescribed for chronic non-cancer pain,” PLoS ONE 15:5 (May 4, 2020). https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0232538.
[12] James Martin et al., “Effect of restricting the legal supply of prescription opioids on buying through online illicit marketplaces: interrupted time series analysis,” The British Medical Journal 361 (June 13, 2018). https://www.bmj.com/content/361/bmj.k2270.
[13] Ciccarone. https://www.sciencedirect.com/science/article/pii/S0955395919300180.