OpEd: The Drug Enforcement Administration Needs a Chief Pharmacy Officer. Here’s Why

Since its inception, the Drug Enforcement Administration (DEA) has played a vital role in protecting public health by enforcing controlled substance laws. But beyond enforcement, the DEA also holds a lesser known yet integral responsibility: ensuring access to critical drugs for medically appropriate use. At times, this clinical function has been overshadowed by enforcement priorities, inadvertently contributing to drug shortages and delays in patient care. It is time to elevate the agency’s clinical responsibility by establishing a Chief Pharmacy Officer (CPO) within the DEA - a role dedicated to ensuring that patient access is not an afterthought, but a core priority.

An Enforcer of Efficient, Accurate Quotas

Today, millions of Americans face unprecedented barriers to accessing essential medications as drug shortages continue to dominate headlines. In the fall of 2023 alone, hundreds of drug shortages impacted over 38 million patients - half of whom delayed or abandoned treatment due to unavailability, nearly 1/3rd reported negative mental health effects, and 1/4 experienced physical health consequences.^1-2

One under-recognized contributor to drug shortages is the DEA’s outdated system for allocating Aggregate Production Quotas (APQs) for controlled substances. The current model, which sets quotas based on active pharmaceutical ingredients (APIs), lacks the flexibility to respond to real-time market disruptions, such as Food and Drug Administration (FDA) shutdowns of manufacturing facilities due to quality issues, sudden spikes in demand from emerging diseases or seasonal surges, and differentiating needs based on strength or dosage form such as tablets versus injectables.

Premier’s data further illustrates the problem. For example, fill rates - a key indicator of supply chain health - have dropped below 80 percent for critical medications such as meperidine, used to treat postoperative shivering. Although the FDA added meperidine to its shortage list in May 2025, the DEA has not yet released additional quota to manufacturers resulting in many strengths and dosage forms of the drug being unavailable for patient care for months.³ Other essential medications, including fentanyl and hydromorphone, have remained on the FDA shortage list for years in part due to quota allocation challenges.^4-5

The current one-size-fits-all system for setting APQs is ineffective and Congress recognized this back in 2018, passing the SUPPORT Act to modernize the APQ setting process and require quota allocations based on dosage form.⁶ Yet seven years later, the DEA has failed to implement this law leaving manufacturers constrained, patients underserved, and the nation vulnerable to supply shocks.

Establishing a CPO at the DEA would mark a transformative shift toward patient-centered policy. A CPO would leverage data insights to issue emergency quota expansions in response to predictable demand surges – such as the annual spike in ADHD medication needs at the start of the school year - ensuring timely access and preventing unnecessary disruptions in care. A CPO would also coordinate with manufacturers and the FDA to reallocate quota in response to quality manufacturing problems, natural disasters or other unforeseen circumstances. In addition, a CPO would finally be able to implement the provisions of the SUPPORT Act and establish quotas based on dosage forms due to their clinical knowledge and expertise of how these drugs are used in patient care, including how drug use may differ based on the care setting such as hospitals versus outpatient. A strong CPO would not only modernize quota systems but also bring agility, accountability and patient advocacy to the heart of DEA decision-making.

A Leader in Enabling and Protecting Telemedicine Prescriptions

COVID-19 accelerated the adoption of telemedicine, with the percentage of patient visits at which physicians used telemedicine technology jumping from 15 percent in 2019 to more than 86 percent in 2021.⁷ While many patients have returned to in-person care, telehealth remains a lifeline—especially for those in underserved areas or facing mental health challenges. Over 150 million Americans live in mental health professional shortage areas and half of U.S. counties lacking a single psychiatrist.^8-9 Yet the DEA’s temporary rule allowing providers to prescribe controlled substances via telemedicine is set to expire at the end of 2025, threatening access to critical medications for millions.¹⁰

The pandemic may be over, but the need for accessible, innovative healthcare is not. A CPO would apply lessons learned from telehealth prescribing during COVID-19, including its documented impact on access and outcomes, while addressing concerns around diversion and opioid misuse, to establish a permanent, balanced, forward-looking framework for prescribing controlled substances via telehealth. A CPO would also monitor ongoing successes and challenges, using emerging data to inform policy recommendations, and lead efforts to modernize DEA prescribing rules to reflect the capabilities of evolving technology and the needs of patients nationwide.

An Advocate for Innovation in Medicine

Oftentimes, new data emerges regarding the clinical benefits of a medication versus its abuse potential and level of physical or psychological dependence warranting its rescheduling. For example, in recent years the DEA rescheduled drugs such as tramadol and hydrocodone to be subject to more restricted controls based on novel data and research regarding their abuse potential.^11-12 In both cases, manufacturers, providers, pharmacists and patients had to navigate more stringent regulatory frameworks that resulted in confusion, frustration and delays in patients receiving their medications. A CPO could have helped alleviate any operational challenges associated with rescheduling by serving as a resource to educate the public about the need for the change, how to navigate the change and how to minimize the impact to patients.

Alternatively, the DEA also has the authority to reschedule drugs previously considered to have no accepted medical use due to emerging research regarding their clinical benefits. For example, the Department of Health and Human Services and the DEA have proposed rescheduling cannabis from a Schedule I drug to a Schedule III drug, and the Trump Administration has signaled an interest in rescheduling psychedelics.^13-15 A CPO would serve an integral role in evaluating emerging research to determine if rescheduling is warranted, serving as a liaison to the FDA to evaluate criteria to deem these drugs safe and effective, working with manufacturers to understand supply versus demand and issue appropriate quotas, and monitoring for the long-term impact to public health.

The Path Forward

Improving America’s medication supply is not just a healthcare priority — it is a national security imperative. But the DEA cannot meet that challenge without clinical leadership to help modernize drug policy in a way that works for patients.

The DEA has the authority to institute a CPO today, but it behooves Congress to formally mandate the role and make it permanent. While the annual appropriations process offers the fastest and most immediate path to creating a CPO, any upcoming healthcare package offers Congress a clear opportunity to drive this critical change.

The reality is that a CPO at the DEA would be more than the Chief Pharmacy Officer - it would also be the Chief Patient Officer responsible for championing patient access, safety, and innovation. The time to act is now.

REFERENCES

1. Office of the Assistant Secretary for Planning and Evaluation. Medical product shortages. U.S. Department of Health & Human Services. Accessed October 10, 2025. https://aspe.hhs.gov/reports/medical-product-shortages

2. Office of the Assistant Secretary for Planning and Evaluation. FDA & Medical Product Shortages: Current View, July 2024 [Issue Brief]. U.S. Department of Health & Human Services; 2024. Accessed October 10, 2025. https://aspe.hhs.gov/sites/default/files/documents/1c348191e0660572cfe642e2fbca572c/ASPE_IssueBrief_shortages-2024-07-05_edited_ASPE_508c.pdf

3. U.S. Food and Drug Administration. Meperidine Hydrochloride Injection — Drug Shortages. Accessed October 10, 2025. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Meperidine%20Hydrochloride%20Injection&st=c

4. U.S. Food and Drug Administration. Fentanyl Citrate Injection — Drug Shortages. Accessed October 10, 2025. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Fentanyl%20Citrate%20Injection&st=c

5. U.S. Food and Drug Administration. Hydromorphone Hydrochloride Injection — Drug Shortages. Accessed October 10, 2025. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Hydromorphone%20Hydrochloride%20Injection&st=c

6. U.S. Congress. Substance Use–Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act). Public Law 115-271. Washington, DC: U.S. Government; October 24, 2018. Accessed October 10, 2025. https://www.congress.gov/115/plaws/publ271/PLAW-115publ271.pdf

7. Myrick KL, Mahar M, DeFrances CJ. Telemedicine use among physicians by physician specialty: United States, 2021. NCHS Data Brief. No. 493. Hyattsville, MD: National Center for Health Statistics; 2024. Accessed October 10, 2025. https://www.cdc.gov/nchs/products/databriefs/db493.htm

8. Weiner S. A growing psychiatrist shortage and an enormous demand for mental health services. AAMC News. August 9, 2022. Accessed October 10, 2025. https://www.aamc.org/news/growing-psychiatrist-shortage-enormous-demand-mental-health-services

9. Counts N. Understanding the U.S. Behavioral Health Workforce Shortage (explainer). Commonwealth Fund. Published May 18, 2023. Accessed October 10, 2025. https://www.commonwealthfund.org/publications/explainer/2023/may/understanding-us-behavioral-health-workforce-shortage

10. Drug Enforcement Administration; Health and Human Services Department. Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. 89 FR 91253. Published November 19, 2024. Accessed October 10, 2025. https://www.federalregister.gov/documents/2024/11/19/2024-27018/third-temporary-extension-of-covid-19-telemedicine-flexibilities-for-prescription-of-controlled

11. Drug Enforcement Administration; Department of Justice. Schedules of Controlled Substances: Placement of Tramadol Into Schedule IV. 79 FR 37623 (July 2, 2014). Accessed October 10, 2025. https://www.federalregister.gov/documents/2014/07/02/2014-15548/schedules-of-controlled-substances-placement-of-tramadol-into-schedule-iv

12. Drug Enforcement Administration; Department of Justice. Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products from Schedule III to Schedule II. 79 FR 50371 (August 22, 2014). Accessed October 10, 2025. https://www.federalregister.gov/documents/2014/08/22/2014-19922/schedules-of-controlled-substances-rescheduling-of-hydrocodone-combination-products-from-schedule

13. U.S. Department of Health and Human Services, Office of the Assistant Secretary for Health. Letter to The Honorable Anne Milgram, Administrator, Drug Enforcement Administration. August 29, 2023. Accessed October 10, 2025. https://static01.nyt.com/newsgraphics/documenttools/d1b41750bb7210f6/63765434-full.pdf

14. Drug Enforcement Administration; Department of Justice. Schedules of Controlled Substances: Rescheduling of Marijuana. 89 FR 44597 (May 21, 2024). Accessed October 10, 2025. https://www.federalregister.gov/documents/

15. Schumaker E. RFK, psychedelics, ecstasy, ibogaine & veterans. Politico. June 29, 2025. Accessed October 10, 2025. https://www.politico.com/news/2025/06/29/rfk-psychedelics-ecstasy-ibogaine-veterans-00429997