DEA Keeping Supply of Rx Opioids Unchanged in 2025

By Pat Anson

The Drug Enforcement Administration says it can’t do anything about shortages of opioid pain medication at U.S. pharmacies and will keep the 2025 opioid supply essentially unchanged from this year’s levels.

Under the Controlled Substances Act (CSA), the DEA sets annual aggregate production quotas (APQs) for every drug maker, in effect telling them the amount of opioids and other controlled substances they can make every year.

The APQs for 2025 were recently published in the Federal Register after a public comment period that received nearly 1,900 responses, many from patients and providers worried about further cuts in the opioid supply.  

“DEA received a significant number of comments from pain advocacy groups, hospital associations, health professionals, and others who raised concerns over the proposed APQs for certain opioids in 2025,” DEA said. “After considering all of the relevant factors, DEA has determined… that U.S. manufacturers will need to manufacture approximately the same amount of those opioids in 2025 as in 2024 in order to meet legitimate needs.”

Although the FDA advised the DEA there will be a 6.6% decline in the medical need for opioids in 2025, the DEA adopted only minor reductions for several widely used opioid medications. They are the same amounts proposed by the agency in October.

DEA Opioid Production Quotas for 2025

• Oxycodone:  0.137% decrease

• Hydrocodone: 0.081% decrease

• Morphine: Unchanged

• Codeine: Unchanged

• Hydromorphone: 0.015% decrease

• Fentanyl: 0.0025% decrease

Although the reductions are tiny compared to previous years, 2025 will still be the ninth consecutive year that DEA has cut the supply of opioids. Since 2015, DEA has reduced production quotas for oxycodone by over 68% and hydrocodone by nearly 73%.

DEA acknowledged receiving many comments from pain patients who said their local pharmacies were often out of opioids, forcing them to contact additional pharmacies and travel further to get their prescriptions filled. DEA said those issues were out of its control.

“Drug shortages may occur due to factors outside of DEA's control such as manufacturing and quality problems, processing delays, supply chain disruptions, or discontinuations,” the agency said.  “Currently, FDA has not issued notice of any nationwide shortages of the types of opioid medications mentioned by these commenters.”

The FDA and DEA may not be tracking opioid shortages, but the American Society of Health-System Pharmacists (ASHP) is.

Opioids currently listed in short supply by the ASHP include oxycodone/acetaminophen tablets, oxycodone immediate-release tablets, hydrocodone/acetaminophen tablets, hydromorphone tablets and solution, fentanyl solution, and morphine solution.

Most opioid medications are generic and cheap to make, but they have low profit margins and come with high risks. Teva Pharmaceuticals, a large generic drug maker, recently discontinued production of oxycodone and potent fentanyl lozenges. The medications were entangled in costly litigation that resulted in Teva paying $4.25 billion to settle opioid liability lawsuits.

Opioid shortages at the pharmacy level are also linked to litigation. Under the terms of a 2022 settlement with drug distributors, opioids are tightly rationed at many pharmacies, resulting in patients with opioid prescriptions being unable to get them filled because pharmacies are out of stock.

Here again, the DEA said the shortages are out of its control and claimed its prosecution of doctors for “unlawful” opioid prescribing was a non-issue.

“Patients and medical professionals may notice specific drug products are out of stock in particular areas; however, DEA cannot dictate DEA registrants' distributions of drug products,” the agency said.

“Additionally, DEA's regulations do not impose restrictions on the amount and the type of medication that licensed practitioners can prescribe. DEA has consistently emphasized and supported the authority of individual practitioners under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards.”

Quotas Don’t Prevent Overdoses

For patients reliant on opioids, including those with late-stage cancer, being unable to fill a prescription means withdrawal, uncontrolled pain, and little quality of life.

A palliative care physician recently wrote an op/ed in STAT about “Teresa,” a patient in her mid-60’s with advanced cancer that spread to her abdomen.

“Only her prescription morphine gave her the relief she needed to function and enjoy some small pleasures, like walking her dog in the park,” wrote Dr. Rebecca Rodin, an assistant professor at the Icahn School of Medicine at Mount Sinai.

“But one day, her pharmacy didn’t have her morphine in stock, nor did five other neighborhood pharmacies that she went to. I called another three pharmacies before finding one with a two-week supply available — but it was a 40-minute drive from her home.”   

Rodin says the real culprits in the overdose crisis are illicit fentanyl and other street drugs – not prescription opioids. And no amount of buck passing by the DEA will fix that problem.

“Quotas and resulting shortages of prescription pain medicines are not helping to prevent overdose deaths,” said Rodin. “Quotas are simply turning vulnerable patients with serious illness into collateral damage in a misguided effort to address the opioid epidemic.”   

DEA Plans More Cuts in Opioid Supply, While Raising ADHD Stimulant Production

By Pat Anson

The U.S. Drug Enforcement Administration is planning more cuts in the supply of prescription opioids in 2025, while raising production of amphetamine and other stimulants used to treat attention-deficit/hyperactivity disorder (ADHD).

If the DEA’s plans are finalized after a public comment period, it would be the ninth consecutive year the opioid supply has been reduced.

Under the Controlled Substances Act, the DEA has broad legal authority to set annual aggregate production quotas (APQs) for drug makers – in effect telling them how much Schedule I and II chemicals and medications they can produce. DEA sets the quotas after consulting with the Food and Drug Administration (FDA) and other federal agencies, as well as individual states about the projected need for controlled substances.

“FDA predicts that levels of medical need for schedule II opioids in the United States in calendar year 2025 will decline on average 6.6 percent from calendar year 2024 levels. These declines are expected to occur across a variety of schedule II opioids. These declines are expected to occur across a variety of schedule II opioids,” the DEA said in a notice recently published in the Federal Register.

There will not be 6.6% cuts across the board for every opioid. Unlike previous years, the agency is proposing only slight reductions in the supply of fentanyl, oxycodone, hydrocodone and hydromorphone, while keeping quotas unchanged for morphine and codeine.

Most of the cuts are very minor – less than a tenth of one percent -- when the proposed APQ’s for 2025 are compared to the ones adopted in 2024.

DEA Opioid Production Quotas for 2025

• Fentanyl: 0.0025% decrease

• Oxycodone:  0.137% decrease

• Hydrocodone: 0.081% decrease

• Hydromorphone: 0.015% decrease

• Morphine: Unchanged

• Codeine: Unchanged

The DEA notice does not address the discrepancy between the FDA’s estimate of a 6.6% decline in medical need for opioids with the quotas it is proposing. The agency says it considered a “potential increase in demand for certain opioids” due to more elective surgeries being performed in 2025. Many of those surgeries were postponed during the COVID-19 pandemic.

The FDA predicted a 3.5% increase in domestic medical use of Schedule II stimulants in 2025. Demand for stimulants to treat ADHD has grown in recent years, but the drugs are also increasingly used to treat brain fog and fatigue caused by Long Covid. The FDA told DEA it was concerned about ongoing shortages of amphetamine, lisdexamfetamine, and methylphenidate, which are used to make stimulants such as Adderall.    

The DEA wants to raise production quotas for amphetamine (+5.9%) and lisdexamfetamine (+23.5%), while leaving the 2025 quota for methylphenidate the same as it was in 2024. The agency said inventories of amphetamine and methylphenidate-based products had increased, while shortages of lisdexamfetamin continue.

“DEA believes that manufacturers will be able to meet the increase in domestic medical need for these three schedule II stimulants with the APQs proposed in this notice,” the agency said.

The Myth of Opioid Diversion

The DEA has been cutting opioid production quotas for nearly a decade, reducing the supply of oxycodone by over 68% and hydrocodone by nearly 73% since 2015. Many of those cuts are due to pressure from Congress, as well as a common belief that prescription opioids are often diverted or sold to people they are not intended for.

That belief is largely a myth.

As required by Congress, DEA estimated the diversion rate of schedule II opioids in 2025, and once again came to the conclusion that diversion is rare – less than half of one percent for oxycodone and hydrocodone. Much of the diversion is a result of theft and losses in the supply chain, before opioids even reach patients.

Estimated 2025 Diversion Rates

• Oxycodone: 0.493%

• Hydrocodone: 0.379%

• Fentanyl:  0.013%

• Hydromorphone: 0.06%

The DEA’s diversion rates are partially based on “red flag” data from prescription drug monitoring programs (PDMP). Potential red flags include patients who see three or more prescribers in a 90-day period; patients who receive a daily opioid dose in excess of 240 morphine milligram equivalents (MME); and patients who pay in cash for a controlled substance.

DEA requested PDMP data from all 50 states, but only 29 states responded to the request by sharing summaries of their red flag data.

“While PDMP data is useful in estimating diversion, it is not conclusive. Further investigation would be required before concluding that any of the subject prescriptions were actually diverted. DEA continues to evaluate its methodologies in estimating diversion in an effort to set quotas more efficiently. State participation is crucial to accurate data analysis, and DEA anticipates working closely with states, as well as other federal and state entities, in future quota determinations,” the agency said.

Public Comments

The DEA quietly published its notice about 2025 production quotas in the Federal Register on September 25, with no fanfare or press release.

Usually the agency receives thousands of comments from the public about its production quotas, but so far there have been only a handful of comments posted. Many are from patients still bitter about the decade of cuts the DEA has imposed on the opioid supply, which have contributed to record shortages of prescription drugs.

“The actions that are being taken by Congress, by the DEA, state legislatures, and state medical boards, have caused THOUSANDS of these patients to lose access to their medications, have resulted in the improper prosecution of pain doctors, resulting in a severe nationwide shortage of pain specialists, and nationwide shortages of medications,” wrote David Smith.  

“The CDC, FDA, and DEA have severely underestimated the needs of chronic pain patients and misjudged the consequences of these cuts. While opioid misuse is a serious issue, penalizing legitimate pain patients is not the solution,” said Gina Harrison.

“Please I'm begging you not to cut opioids meds this year,” said Melissa Guthrie. “I'm on palliative care and there were a couple months last year I didn't get my meds due to shortages. You know it's not the pain meds causing harm. It’s the illicit fentanyl and street drugs killing people.”

You still have time to make your feelings known, as long as you do it by October 25, when the public comment period ends. To make a comment, click here.