DEA Missed Deadline for Opioid Production Quotas. Will It Worsen Shortages?

By Pat Anson

In recent years, hundreds of physicians have been prosecuted by the U.S. Justice Department for violations of the Controlled Substances Act (CSA).

In many cases, the doctors were accused of prescribing opioid pain medication without “a legitimate medical purpose” – a vague term in the CSA that was meant to prevent drug abuse, but in practice put the DOJ in charge of deciding whether healthcare decisions involving controlled substances are legal. 

The CSA is rigidly enforced when federal prosecutors believe opioids are prescribed excessively. But when it comes to enforcing another provision in the CSA, the DOJ and Drug Enforcement Administration have routinely ignored deadlines for setting aggregate production quotas (APQs) for opioids and other Schedule I and II controlled substances:

“On or before December 1 of each year, upon application therefor by a registered manufacturer, the Attorney General shall fix a manufacturing quota for the basic classes of controlled substances in schedules I and II.”

The December 1 deadline is important because it gives the pharmaceutical industry a small window to prepare for the coming year by acquiring raw materials for drugs, setting manufacturing schedules, and distributing medications to hospitals and pharmacies – a process that can take as long as six months. . 

But Attorney General Pam Bondi and acting DEA Administrator Terry Cole didn't publish their proposed quotas for 2026 in the Federal Register until November 28, which call for a 6% cut in the supply of oxycodone.

Allowing for a shortened public comment period that ends December 15, and time to review thousands of comments and make changes in the quota allotments, that means the final APQs for next year will likely not be ready until after January 1.

The last time production quotas were that late was in 2024, when the final APQs were not published until January 3. Drug shortages spiked to record levels in the first few months of that year, including many medications that are covered under the quota system. 

Missing the deadline again this year threatens to worsen chronic shortages of oxycodone, hydrocodone, fentanyl, hydromorphone, morphine and amphetamine-based stimulants that are vital to millions of patients who live with pain or attention deficit disorder (ADHD).

The DOJ and DEA did not respond to multiple requests from PNN to explain why the CSA deadline was missed again.

This is not a new problem. Late quotas and drug shortages have persisted for years, as the DOJ and DEA have focused on going after doctors – at times using “flimsy evidence” – rather than ensuring that essential medications are available on time. 

That mindset of being a law enforcement agency first – with maintaining the drug supply an afterthought – may have cost some patients their lives. 

“We talk a lot about opioid misuse, but almost never about the quiet suffering caused when essential pain medicines simply aren't available,” says Lynn Webster, MD, a pain management expert and former president of the American Academy of Pain Medicine. “Chronic delay and rigidity in quota decisions make patients with serious illness feel like collateral damage in a war on drugs that has lost sight of its humanitarian obligations.

“Quotas were meant to curb diversion, not to create a permanent state of scarcity for people in pain. By keeping quotas tight and decisions late, the DEA has turned an already fragile supply chain into a game of musical chairs where patients lose their seats.”

Late Quotas Worsened Drug Shortages

As far back as 2015, the General Accountability Office (GAO) warned in an audit report that the DEA “has not effectively administered the quota process.” Although a decade old, many of the problems cited by the GAO still exist today.

“Each year, manufacturers apply to DEA for quota needed to make their drugs. DEA, however, has not responded to them within the time frames required by its regulations for any year from 2001 through 2014,” the GAO said.

“Manufacturers who reported quota-related shortages cited late quota decisions as causing or exacerbating shortages of their drugs.”

The report found that drugs containing Schedule II controlled substances accounted for over half the shortages between 2001 and 2013. Several manufacturers complained to the FDA the shortages were caused by the DEA’s mishandling of the quota system.

But the DEA denied any responsibility for the shortages, while blaming the missed deadlines on  “inadequate staffing” and an “increasing workload” in its Quota Unit.

“DEA is confident that its administration of the quota process did not affect a shortage during the period of review because drug product shortages are not limited to products that contain Schedule II controlled. substances,” Joseph Rannazzisi, then-DEA Deputy Assistant Administrator, wrote in the agency’s response to the GAO report.

Rannazzisi would later emerge as a “whistleblower” on 60 Minutes, who blamed the opioid crisis on lax policies at the FDA that favored that drug industry.

The relationship between DEA and FDA, at least in 2015, was not one of trust. The FDA advised the DEA about medical demand for Schedule II drugs and any shortages that may exist, but the DEA didn’t always listen.

“DEA and FDA are not able to effectively collaborate due to fundamental disagreement over whether any given shortage exists. DEA has made it clear it does not trust FDA’s information, as it does not consider many of the shortages that FDA verifies to be legitimate,” the GAO said. “They do not believe FDA appropriately validates or investigates the shortages.” 

The GAO concluded that problems in DEA’s Quota Unit run deeper than any petty rivalries with the FDA. 

“Our work shows that DEA’s lack of internal controls, such as controls to ensure data reliability, performance measures, and monitoring of performance, may hinder the agency’s ability to ensure an adequate and uninterrupted supply of controlled substances,” the 2015 report found. “This approach to the management of an important process is untenable and poses a risk to public health.”

New Deadline

The GAO’s critique came at a time when the DEA’s deadline for final APQs was October 1 – a deadline the agency consistently failed to meet. 

To buy itself more time to work on quotas, the DEA lobbied Congress to change the annual deadline to December 1 in the 2018 Support Act, a bill intended to reduce opioid diversion. The DEA also reduced the amount of inventory drug manufacturers are allowed to keep of controlled substances, and agreed to base its quotas on dosages, not the raw supply of drugs.

How has that worked out? Poorly.

The DEA has not only been unable to meet the December 1 deadline, but the smaller inventories have worsened the ability of drug manufacturers to respond to late quotas and emerging drug shortages. 

The pharmaceutical industry warned the DEA that reducing inventories would only worsen shortages and do little to prevent diversion.

“We believe that risks associated with this proposal, including the increased likelihood for drug shortages and market outages, greatly outweigh the negligible benefit this provision will provide,” Larry Cote, an attorney representing a drug manufacturer, wrote to the agency in 2019.

“Given the timing of procurement quota issuance, it will become more imperative to carry increased levels of inventory at year end in order to ensure continued drug supply, as opposed to decreased levels.”

The DEA ignored those warnings and reduced inventories anyway. As a result, analgesic medications needed for surgery and post-op care, such as injectable fentanyl and hydromorphone, have been on the FDA shortage list for years, in part due to low inventories. The two drugs are rarely diverted.

‘Vulnerable to Supply Shocks’

Two pharmacists recently criticized the DEA for its “outdated system” for APQs.

“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. Yet seven years later, the DEA has failed to implement this law, leaving manufacturers constrained, patients underserved, and the nation vulnerable to supply shocks,” Soumi Saha, PharmD, and Justin Schneider, PharmD, wrote in a recent op/ed published in the Pharmacy Times.   

Saha and Schneider believe many of the quota problems could be addressed if the DEA were to hire a Chief Pharmacy Officer who is familiar with the drug supply system and is put in charge of the quota system.

“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,” they said. “A strong CPO would not only modernize quota systems but also bring agility, accountability and patient advocacy to the heart of DEA decision-making.”

To be clear, the DEA is not solely at fault for persistent shortages of opioids and other controlled substances. A 2021 opioid litigation settlement with three drug distributors essentially rationed the supply of opioids at many pharmacies and made pharmacists even more wary of filling new prescriptions. 

In a 2023 PNN survey of over 2,800 patients, 90% said they experienced delays or problems getting their opioid prescriptions filled, mostly because their pharmacy was out of stock. Nearly one in five were unable to get their pain medication, even after contacting multiple pharmacies.

Some generic drug manufacturers have stopped making opioids because of low profit margins and because of concerns they could be targeted by plaintiff law firms in opioid lawsuits that could cost them billions of dollars. 

Bad weather and a heavy reliance on foreign drug manufacturers have also made the supply chain less reliable and contributed to shortages.  

But the DEA’s chronic failure to meet quota deadlines – a problem dating back decades – and its slow-walking of efforts at reforming the quota system, have made a fragile drug supply chain even more vulnerable to disruptions. And it is patients who pay the ultimate price for the DEA’s negligence.

“When DEA repeatedly misses its own deadlines for setting opioid production quotas, that uncertainty reverberates all the way to the bedside,” says Dr. Webster. “Manufacturers pull back, pharmacies ration, and it's the patients – people with cancer, sickle cell disease, or severe chronic pain – who are left wondering if their next prescription will even be filled.” 

Should the DEA hire a Chief Pharmacy Officer? Should deciding what is or isn’t “a legitimate medical purpose” be left to the DEA and DOJ? Only a few days are left to comment on the DEA’s proposed APQs for 2026. You can leave a public comment by clicking here.

Medicare Expands Opioid Monitoring After GAO Report

By Pat Anson, Editor

The General Accounting Office (GAO) – now known as the Government Accountability Office – was established by Congress in 1921 to act as an independent, nonpartisan watchdog of the federal government.  

“We provide Congress with timely information that is objective, fact-based, nonpartisan, nonideological, fair, and balanced. Our core values of accountability, integrity, and reliability are reflected in all of the work we do,” the GAO says in its mission statement. 

Fair and balanced? Not always – at least not when it comes pain patients and their medication.

Two months ago, PNN reported on a GAO audit that recommended the Centers for Medicare and Medicaid Services (CMS) greatly expand its monitoring of Medicare patients who receive high doses of opioid pain medication.  

Over 700,000 Medicare beneficiaries currently receive opioids in excess of 90mg morphine equivalent doses, and the GAO thinks it would be a good idea to have private insurers track these patients and their doctors to look for signs of “inappropriate prescribing.”

Critics say such a policy would have a chilling effect on many doctors, who already fear government sanctions for prescribing opioids.

FOIA Request Rejected

We were struck by a footnote in the GAO report, which indicated the agency had never consulted with pain sufferers, patient advocacy groups or professional organizations that represent prescribers while preparing its audit. But the GAO did reach out to insurers, regulators, law enforcement, addiction treatment specialists, anti-opioid activists, and surgeons who specialize in spinal injections:

"We interviewed officials from the largest six health care plan sponsors: Aetna, Cigna, CVS Health, Express Scripts, Humana, and United Health Group. We also interviewed 12 stakeholders that represent a range of perspectives on opioid use and prescribing patterns in Medicare: AARP, American Health Insurance Plans, American Society of Interventional Pain Physicians, Brandeis Prescription Drug Monitoring Program Training and Technical Assistance Center, Federation of State Medical Boards, National Association of Drug Diversion Investigators, National Association of Medicaid Directors, National Healthcare Antifraud Association, Pew Charitable Trust, Pharmaceutical Care Management Association, Physicians for Responsible Opioid Prescribing (PROP), and one expert on opioid abuse."

The GAO said it did not identify any of the “stakeholders” by name because the interviews were conducted on a not-for-attribution basis to encourage frank discussion. Pain News Network filed a Freedom of Information Act (FOIA) request to get the agency to disclose those names – which was quickly rejected.

“As an agency responsible to the Congress, GAO is not subject to FOIA,” Timothy Bowling, the GAO’s Chief Quality Officer, wrote to PNN. “Please be advised that while conducting the audit engagement above, GAO obligated itself not to disclose any names or identifiable information related to these stakeholder groups.”

This is certainly not the first time pain patients and pain management experts have been denied a seat at the table when federal decisions are made about pain care.

In 2015, the Centers for Disease Control and Prevention failed to consult with patients or practicing pain physicians when it drafted its opioid prescribing guideline. The CDC even refused to disclose who served on its expert advisory panel until it was threatened with a lawsuit.  

Patients and doctors were also excluded from a closed door meeting of the Healthcare Fraud Prevention Partnership -- an obscure federal advisory group – when it met in a 2016 "special session" to discuss Medicare's opioid prescribing policies. More recently, President Trump’s opioid commission released its final report without taking any public testimony from pain sufferers, patient advocates or pain management physicians.

“I find it very disturbing that federal agencies continue to ignore pain care providers and advocacy groups for people with pain when they formulate policies that very clearly will impact those parties. Again and again, they consult with parties that have a vested interest in reducing opioid prescribing regardless of the impact on people with pain," said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

“It’s wrong, and everyone with a stake in pain management should demand that they start allowing us to sit at the table, rather than just to be on the menu.”

Medicare Tracking Opioid Prescriptions  

What became of the GOA report and its recommendations? Many are now being implemented by CMS.

In testimony before a House committee this month, a GAO official said CMS had agreed to start collecting data on all Medicare beneficiaries prescribed high dose opioids, as well as doctors who are “inappropriately and potentially fraudulently overprescribing opioids.”  

“A large number of Medicare Part D beneficiaries use potentially harmful levels of prescription opioids, and reducing the inappropriate prescribing of these drugs is a key part of CMS’s strategy to decrease the risk of opioid use disorder, overdoses, and deaths,” said Elizabeth Curda, Director of Health Care for GAO.

“Access to information on the risks that Medicare patients face from inappropriate or poorly monitored prescriptions, as well as information on providers who may be inappropriately prescribing opioids, could help CMS as it works to improve care.”

CMS is also considering rule changes for Part D prescription drug plans in 2019 that would designate most opioids as “frequently abused drugs,” and would require some Medicare beneficiaries to obtain their opioid prescriptions from prescribers and pharmacies selected by CMS.

GAO Seeks Expanded Tracking of Medicare Rx Opioids

By Pat Anson, Editor

A new report to Congress by the Government Accountability Office (GAO) recommends that the federal government greatly expand the monitoring of Medicare patients who receive high doses of opioid pain medication, as well as the doctors who write their prescriptions.

If adopted, an estimated 727,000 Medicare beneficiaries who receive opioids in excess of 90mg morphine equivalent doses (MED) would have their prescriptions tracked by private insurers and reported to the Centers for Medicare & Medicaid Services (CMS). Critics say such a policy would have a chilling effect on doctors, who increasingly fear government sanctions for prescribing opioids.

In 2016, over 14 million elderly and disabled Medicare patients received an opioid prescription, and CMS spent over $4 billion paying for their opioid medication.

“A large number of Medicare Part D beneficiaries use prescription opioids, and reducing the inappropriate prescribing of these drugs is a key part of CMS’s strategy to decrease the risk of opioid use disorder, overdoses, and deaths,” the GAO report says.

“Despite working to identify and decrease egregious opioid use behavior — such as doctor shopping — among beneficiaries in Medicare Part D, CMS lacks the necessary information to effectively determine the full number of beneficiaries at risk of opioid harm.”

Under current CMS policy, patients are only considered “at risk” if they receive high dose opioid prescriptions from four or more providers and have them filled at four or more pharmacies. Last year, 11,594 Medicare beneficiaries met that criteria, a tiny fraction of those who receive opioids.

The GAO wants to change the criteria so that everyone prescribed a high dose would be monitored, regardless of how many doctors or pharmacies they use.  The principal author of the report said the recommendation is not aimed at taking patients off opioids or lowering their dose, but to improve the data on high dose prescribing.

“We are suggesting that CMS take a close look and monitor and track the numbers of people at risk of harm,” Elizabeth Curda, Director of GAO Health Care, told PNN. “We’re not suggesting CMS investigate 700,000 people who get more than 90mg per day. We want them to focus on how many people are getting these doses and what’s happening to that number. Is it going down? Is it going up?  We have this strategy to reduce harm, so we want to see it coming down.”

“Frankly this is unbelievable.  It is very hard for me to understand how reducing the amount of opioids to people in pain is going to help reduce the amount of smuggled heroin and fentanyl into the United States,” says Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine.  “We need to remember 3 out of 4 drug overdoses do not involve a prescription opioid.  And most of the overdose deaths involving prescription opioids are not in people prescribed the medications.”

Webster is also concerned about a GAO recommendation that Medicare insurers be required to identify and report to CMS all high-dose opioid prescribers. Currently, there’s only a voluntary reporting system when doctors are investigated for fraud, waste or abuse.

“Investigating doctors who prescribe high dose opioids will have a chilling effect.  It will deter all providers from treating people with pain at any dose.  People will suffer.  There will be more suicides because of inadequately treated pain. This is not hyperbole,” said Webster. 

“The whole notion that reducing dose will solve the opioid crisis is misguided.  People who benefit from the high doses will be denied pain relief and those who use any dose for non-medical purposes will just seek illicit and more lethal drugs.”

Patients and Prescribers Ignored

Critics of the GAO report are also disturbed that the agency did not consult with any pain sufferers, patient advocacy organizations or professional medical organizations that represent prescribers. Instead, the GAO met primarily with insurance companies, regulators and addiction treatment specialists.

"We interviewed officials from the largest six health care plan sponsors: Aetna, Cigna, CVS Health, Express Scripts, Humana, and United Health Group," the GAO report says in a footnote.

"We also interviewed 12 stakeholders that represent a range of perspectives on opioid use and prescribing patterns in Medicare: AARP, American Health Insurance Plans, American Society of Interventional Pain Physicians, Brandeis Prescription Drug Monitoring Program Training and Technical Assistance Center, Federation of State Medical Boards, National Association of Drug Diversion Investigators, National Association of Medicaid Directors, National Healthcare Antifraud Association, Pew Charitable Trust, Pharmaceutical Care Management Association, Physicians for Responsible Opioid Prescribing (PROP), and one expert on opioid abuse."

The GAO would not identify any of the individuals it met with, saying the interviews were conducted on a “not for attribution” basis to encourage frank discussion. However, it seems likely that Andrew Kolodny, MD, was interviewed, as he is the founder and Executive Director of PROP, works at Brandeis University, and is considered by some to be an expert on opioid abuse.

Kolodny, who is the former chief medical officer of the addiction treatment chain Phoenix House, did not respond to a request for comment. Pain News Network is filing a request under the Freedom of Information Act with the GAO to disclose who they talked to.

ANDREW KOLODNY, MD

“I find it very disturbing that federal agencies continue to ignore pain care providers and advocacy groups for people with pain when they formulate policies that very clearly will impact those parties. Again and again, they consult with parties that have a vested interest in reducing opioid prescribing regardless of the impact on people with pain," said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

“They even go so far as to invite one solo participant who is an ‘expert on opioid abuse.’ It’s as if they were asking representatives from the sugar industry to help develop guidelines on when artificial sweeteners should be used. Clearly, this speaks to a policy that is concerned with driving down opioid prescribing across the board, without considering the needs of the people with pain who actually benefit from opioid analgesics. It’s wrong, and everyone with a stake in pain management should demand that they start allowing us to sit at the table, rather than just to be on the menu.”

“It appears the GAO did not include patients, professional pain organizations and the American Medical Association in their deliberations. I would like to know how they feel their process can be justified,” added Webster. “They only invited groups to comment that appear to benefit financially from reduced prescribing or are opposed philosophically to opioids for non-cancer pain treatment.”

The only professional medical organization the GAO did consult with, the American Society of Interventional Pain Physicians, represents doctors who typically specialize in spinal injections and surgery.

The GAO’s Elizabeth Curda downplayed the role of people who were interviewed, telling PNN they were “not a major part of our methodology” in preparing the report.

Pain patients and pain management experts are often excluded or ignored when federal decisions are made about pain care.

The Centers for Disease Control and Prevention failed to consult with patients or practicing pain physicians while drafting its 2016 opioid prescribing guideline and secretly holding many of its deliberations.  The CDC also ignored a warning from its own consultant that some doctors stopped prescribing opioids after the guideline was issued.

Patients and doctors were also excluded from a closed door meeting of the Healthcare Fraud Prevention Partnership -- an obscure federal advisory group – when it met in "special session" last year to discuss Medicare's opioid prescribing policies. As PNN reported, major insurers like Aetna, Anthem, Cigna and Humana were invited to attend, but no other stakeholders in pain care were asked to appear or to share their insights.

More recently, President Trump’s opioid commission released its final report without taking any public testimony from pain sufferers, patient advocates or pain management physicians.

DEA Opioid Cuts Could Affect Terminally Ill Patients

By Pat Anson, Editor

Steep cuts in the production of opioid pain medication planned by the U.S. Drug Enforcement Administration could worsen drug shortages and affect pain patients receiving end-of-life hospice care.

“Yes, I think that’s absolutely possible. And very, very concerning,” says Judi Lund Person, VP of Regulatory and Compliance for the National Hospice and Palliative Care Organization.

The DEA announced earlier this week that it is reducing production quotas for almost every Schedule II opioid pain medication next year by 25 percent or more. The quota cuts include opioids such as hydrocodone, oxycodone, fentanyl, hydromorphone and morphine – many of which are used to give pain relief to patients in palliative and hospice care.

The DEA said the cuts are needed to prevent the diversion and abuse of opioids, and because opioid prescribing has been in decline for several years.

But Person says some patients in palliative care – who are generally disabled and chronically ill, but still living at home  – are already having trouble getting their opioid prescriptions filled.

“We’ve had patients who’ve had a lot of trouble finding a pharmacy that carries certain opioids,” she said

Person is worried that the DEA’s production cuts will also make it difficult for hospices to obtain opioids for terminally ill patients. Her organization, which represents about 4,000 hospice facilities in the United States, is still examining the possible impact of the opioid cuts.

“What does that do for patients at the end of life who need these drugs? That, I think, is one of our biggest questions,” Person told PNN.

“Living and working in the Washington area, the pressure is on so much around the opioid addiction crisis, and looking for any and all opportunities to see if we can correct that. It doesn’t surprise me in any way that this is happening. Now, what we’ll do about it and how we switch over to other drugs that will be available is a completely different question. I don’t know what we’ll do.”

Person says there are 1.4 million Medicare patients in hospice care and several million more receiving palliative care.

Many chronic pain patients who are not in palliative or hospice care say opioids are already hard to get, because many doctors are reluctant to prescribe them and some pharmacies claim they’re out of stock.

“I am really, really scared about my future and others. So many others are already suffering needlessly. How many more are going to be thrown under the bus?” asks Rich Martin, a Nevada pharmacist who was forced into early retirement by chronic back pain. “I take hydrocodone for my rescue doses, 5 times a day, and I almost always use them unless I am totally sedentary. I think hydrocodone is being reduced by 36 percent. 

“Opioids across the country have already been reduced or stopped parabolically downward. This whole quota thing could collapse to where there is indeed inadequate opioids for treatment of legitimate pain patients.  Then pharmacies may actually be telling the truth when they say they are out of opioids.”

The DEA says its opioid quotas are sufficient to provide “adequate and uninterrupted supply for legitimate medical need,” and could be adjusted if problems develop.

“DEA may revise a company’s quota at any time during the year if change is warranted due to increased sales or exports; new manufacturers entering the market; new product development; or product recalls,” the DEA said in a press release.

“This is a step in the right direction,” Sen. Dick Durbin (D-Illinois) said in an interview with WGN Radio. Durbin was among a group of senators that urged the DEA to lower the quota for opioids.

“Clearly there is more (opioids) than is necessary to alleviate pain. I’m the glad the DEA stepped up. It’s the first time.”

GAO Questions DEA’s Competency

Many Americans may not be aware of the significant role DEA plays in regulating the nation’s drug supplies. Drug manufacturers apply to the DEA every year to produce opioids and other controlled substances, and the agency determines how many – the quota – each drug maker can produce.

But in a recent series of highly critical reports, a congressional watchdog agency questioned the DEA’s competency in regulating pharmaceutical drugs.

In March 2015, the DEA was criticized in a lengthy report by the Government Accountability Office (GAO) for its inability to deal with drug shortages, a problem so serious it was called “a risk to public health.”

The GAO said that between 2001 and 2013, there were 87 “critical” shortages of controlled substances, over half of them pain relievers. There were also shortages of anti-anxiety medications, sedatives, and stimulants. 

“The shortcomings we have identified prevent DEA from having reasonable assurance that it is prepared to help ensure an adequate and uninterrupted supply of these drugs for legitimate medical need, and to avert or address future shortages. This approach to the management of an important process is untenable and poses a risk to public health,” the GAO report states.

A second GAO report in July 2015 faulted the DEA for heavy-handed tactics during pharmacy investigations. Many pharmacists said they were worried about being fined or having their licenses revoked, and blamed the DEA for poor communication and unclear rules. 

“In the absence of clear guidance from DEA some pharmacies may be inappropriately delaying or denying filling prescriptions for patients with legitimate medical needs,” the GAO report said. 

What has the DEA done in the last year to correct these problems? 

Of the 11 recommendations made by the GAO to improve the quota system and prevent drug shortages, the DEA has fully implemented only two of them.

One of the problems the DEA failed to address is the timeliness of its release of production quotas. Under guidelines set in 2006, the DEA is supposed to set quotas for controlled substances on or before May 1 of each year, to give drug manufacturers enough time to adjust their production schedules for the following year.

“DEA officials attributed this lack of compliance to inadequate staffing and noted that the agency’s workload with respect to quotas had increased substantially,” the GAO said in a report this summer.

“We could not confirm whether DEA’s lack of timeliness in establishing quotas had caused or exacerbated shortages because of concerns about the reliability of DEA’s data, among other things. However, by not promptly responding to manufacturers’ quota applications, we concluded that DEA may have hindered manufacturers’ ability to manufacture drugs that contain schedule II controlled substances that may help prevent or resolve a shortage.”

The quotas for 2017 were released on October 5 -- the 10th straight year that DEA has missed the quota deadline.

Fear of DEA Causing Drug Shortages

By Pat Anson, Editor

Millions of dollars in fines and thousands of investigations by the U.S. Drug Enforcement Agency have had a chilling effect on the nation’s drug supply chain, leading to quotas, shortages and legitimate prescriptions going unfilled, according to a new government report.

Pain patients have complained for years that it was becoming difficult to get opioid prescriptions filled, but the DEA called the evidence of that “anecdotal” and said it was not responsibility for any shortages.

In a survey of hundreds of pharmacies, drug wholesalers and physicians by the General Accounting Office (GAO), over half said DEA enforcement actions had limited their ability to supply drugs to patients. Many said they were fearful of being fined or having their licenses revoked by the DEA. Others blamed the agency for poor communication and unclear rules.

“In the absence of clear guidance from DEA some pharmacies may be inappropriately delaying or denying filling prescriptions for patients with legitimate medical needs,” the GAO report states.  

In recent years the DEA has fined distributors, pharmacies and practitioners over $94 million for violations of the Controlled Substances Act. Over 4,500 criminal investigations were also launched.

The crackdown helped lead to a reduction in prescription drug abuse and diversion, but it has also disrupted the drug supply chain. The GOA estimates that over half the distributors have placed a strict quota system on the amount of controlled substances that pharmacists and physicians can order.

“A distributor reported it refuses to distribute large volumes of controlled substances to prescribers or pharmacies that specialize in pain management, even if it has no evidence that the prescribers or pharmacies are engaged in diversion,” the GAO said.

One pharmacy chain told the GAO they were “afraid of being the target of DEA enforcement action even if they fill a prescription in good faith.”

Another small pharmacy chain said “we take things to the extreme to the point where we have received complaints from providers for turning away legitimate patients.”

“The DEA has NO communication out to pharmacies at all. The DEA is not preventative, it is all reactive,” one pharmacist complained. “The only experience we get with the DEA is hearing when they investigate and levy fines against a pharmacy for common pharmacy practices.”

The GAO recommended that the DEA improve its communication with distributors, pharmacists and practitioners so they would have a better understanding of what’s expected of them.

In response to the GAO report, a top DEA administrator wrote a letter stating there was only “anecdotal data that patient care is being compromised.”  

“The DEA would like to emphasize that it has no authority to control otherwise legitimate business decisions of registrants,” wrote Joseph Rannazzisi, deputy assistant administrator of the DEA’s Office of Diversion Control. “DEA and state partners have repeatedly and emphatically informed distributors that arbitrary thresholds are inappropriate, negatively impact legitimate patients, and are an inadequate substitute for fulfilling their obligations under the CSA (Controlled Substances ACT).”

The GAO report is the second this year to criticize the DEA for its management and policies. In March, we reported the GAO had faulted the DEA for "weak internal controls" and poor management of the system under which controlled substances are produced and distributed. The GAO said there were 87 “critical” shortages of drugs containing controlled substances, over half of them pain relievers.

The shortages have grown worse in recent years, according to many pain patients, who say controlled substances such as hydrocodone are increasingly difficult to obtain in some parts of the country.

Under federal rules, the manufacture and distribution of controlled substances is regulated by the DEA, while the Food and Drug Administration regulates what conditions the medications can be taken for. The two agencies are supposed to work together when shortages develop, but according to the GAO they do not have a “sufficiently collaborative relationship” and even “disagree about what constitutes a shortage.”