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After years of delays, the DEA revokes a drug dealer's license due to the opioid crisis
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US. The Drug Enforcement Administration has revoked one of the nation's largest pharmaceutical distributors' license to sell highly addictive painkillers after finding it missed thousands of questionable bulk orders at the height of the opioid crisis.
Pharmaceutical orders fall into boxes as workers ensure they are ready at Morris and Dickson Co. in Shreveport, Wednesday, July 13, 2016. The U.S. Food and Drug Administration has allowed one of the nation's largest wholesale drug distributors to continue supplying opioid painkillers nearly four years after a judge recommended in 2018 that it lose its license for of its "arrogant disregard" for the thousands of questionable orders that fueled the opioid crisis.
- Henrietta Wildsmith - Medlem, The Shreveport Times
FILE - DEA Administrator Anne Milgram, center, flanked by Attorney General Merrick Garland, left, and Assistant Attorney General Lisa Monaco, right, speak during a news conference at the Department of Justice in Washington, Friday, April 14 2023 Prosecutors revealed in a recent indictment that while Sinaloa cartel boss Joaquín "El Chapo" Guzmán is serving a life sentence, his sons have switched the family business to fentanyl and set up a network of labs churning out vast amounts of the cheap and deadly drug smuggled into the United States. .
- Susan Walsh - Personal, AP
In this U.S. video-supplied image, Drug Enforcement Administration Chairman Anne Milgram speaks during a meeting with the commission on Capitol Hill in Washington, Thursday, April 27, 2023. During the session, lawmakers questioned Milgram about millions of dollars. on no-bid contracts that are the subject of a supervisory investigation into whether the agency improperly hired some of its former employees.
- Ukrediteret - hogp, Appropriations Committee of the US House of Representatives
An automated system delivers pharmaceutical orders onto a case conveyor belt at Morris and Dickson Co. in Shreveport, Wednesday, July 13, 2016. The U.S. Food and Drug Administration has allowed one of the distributors of the nation's largest drug wholesaler to continue supplying opioid painkillers nearly four years after a judge in 2018 recommended losing its license for "arrogant disregard "thousands of questionable orders that fueled the opioid crisis.
- Henrietta Wildsmith - Medlem, The Shreveport Times
FILE - U.S. Drug Enforcement Administration Administrator Anne Milgram speaks during a news conference at the Justice Department in Washington, Friday, April 14, 2023. The U.S. Drug Enforcement Administration has revoked the license of one of the nation's largest drug dealers for selling painkillers that cause strong addiction on Friday. on May 26, after finding that it had missed thousands of questionable orders at the height of the opioid crisis.
- Susan Walsh - Personal, AP
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Po JOSHUA GOODMAN i JIM MUSTIAN - Associated Press
The U.S. Drug Enforcement Administration on Friday revoked one of the nation's largest drug distributors' license to sell highly addictive painkillers after finding it missed thousands of questionable orders at the height of the opioid crisis.
The action against Morris & Dickson Co., which threatened to close it, came two days after the Associated Pressinvestigationfound that the DEA allowed the company to continue supplying the drugs for nearly four years after a judge recommended a stiffer penalty for "arrogant disregard" for rules meant to prevent opioid abuse.
The DEA acknowledged that the time it took to issue a final decision was "longer than usual for the agency," but partly blamed Morris & Dickson for delaying the process by seeking delays due to the COVID-19 pandemic and the agency's lengthy search for an agreement. said she had considered it. The order takes effect in 90 days, giving more time to negotiate a solution.
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DEA Administrator Anne Milgram said in the 68-page order that Morris & Dickson did not accept full responsibility for its past actions, which included the delivery of 12,000 unusually large orders of opioids to pharmacies and hospitals between 2014 and 2018. During that time , the company introduced . only three reports of suspicious orders with the DEA.
Milgram specifically cited then-Chairman Paul Dickson Sr.'s 2019 testimony that the company's compliance program was "very good" and that he did not believe "a single person was harmed by (their) drugs."
"These statements by the president of a family business miss the point of the DEA registration request," he wrote. "His acceptance of responsibility did not demonstrate that he or his principals understood the full extent of their misconduct...and the potential harm it caused."
Morris & Dickson, based in Shreveport, Louisiana, traces its roots back to 1840, when its namesake arrived from Wales and placed an ad in the local newspaper for the sale of medicines. Since then, it has become the nation's fourth-largest wholesale drug distributor, with $4 billion in annual revenue and nearly 600 employees serving pharmacies and hospitals in 29 states.
In a statement, the company said it has invested millions of dollars over the past few years to revamp its compliance systems and appears hopeful of finding a solution.
"Morris & Dickson is grateful to the DEA Administrator for delaying the effective date of the order to allow time to resolve these lingering issues," he said. "We remain confident that we can achieve an outcome that secures the supply chain for all of our healthcare partners and the communities they serve... It's business as usual and orders will continue to be shipped on time."
Morris & Dickson's much larger competitors, a trio of pharmaceutical distributors known as the Big Three, have already agreed to pay more than $1 billion in fines and penalties to the federal government to settle similar violations. Cardinal Health, AmerisourceBergen and McKesson also agreed to pay $21 billion over 18 years to settle claims as part of a nationwide settlement.
While Morris & Dickson was not the only drug dealer accused by the DEA of fueling the opioid crisis, it was unique in its willingness to challenge those charges in DEA administrative court.
In a scathing 2019 recommendation, Administrative Law Judge Charles W. Dorman said Morris & Dickson's argument that it changed its ways was too little too late.
Anything less than the harshest sentence, the judge said, "would send a message to DEA registrants that despite their violations, no matter how egregious, they will simply get a slap on the wrist and a second chance as long as they admit their sins and vow no more I'm not wrong."
But as the following years passed, neither Milgram, the Biden nominee, nor her two predecessors took any coercive measures. Former DEA officials told the AP that such decisions generally take no more than two years.
As the pills continued to flow, Morris & Dickson tried to avoid punishment by appealing directly to Milgram to order the case reopened, claiming they would present new evidence showing they had implemented an "ideal" compliance program with the help of a consultant who is now the DEA's deputy commander- and Louis Million. The DEA said Milione has withdrawn from all agency work associated with Morris & Dickson.
Milione retired from the DEA in 2017 after a 21-year career that included two years as head of the division that controls the sale of highly addictive narcotics. Like dozens of colleagues in the DEA's powerful but little-known Office of Diversion Control, he began working as a consultant for some of the companies he was tasked with regulating.
Milione was hired by Morris & Dickson in 2018 as part of a $3 million deal, and later testified that the firm "spared no expense" in auditing its compliance systems, canceling suspicious orders and sending daily emails to the DEA detailing its actions.
A footnote to the DEA's order on Friday said that since Milione returned to the DEA as chief deputy administrator in 2021, he had no contact with Milgram or other agencies related to the Morris & Dickson case because of his prior involvement with the DEA firm.
Goodman reported from Miami, Mustian from New York. Contact the AP Global Investigative Team atInvestigative@ap.org.
Copyright 2023 Associated Press. All rights reserved. This material may not be published, broadcast, copied or redistributed without permission.
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FAQs
Is the FDA at fault for the opioid crisis? ›
The FDA has never been held to account for its improper handling of the opioid crisis. But the FDA's conduct is all the more troubling in light of the close relationship between the agency officials responsible for opioid oversight and opioid manufacturers.
What laws does the DEA enforce? ›The Drug Enforcement Administration (DEA) is the lead Federal agency in enforcing narcotics and controlled substances laws and regulations. DEA also enforces the Federal money laundering and bulk currency smuggling statutes when the funds involved in the transactions or smuggling are derived from the sale of narcotics.
What is the purpose of the DEA and its regulations? ›The mission of the Drug Enforcement Administration (DEA) is to enforce the controlled substances laws and regulations of the United States and bring to the criminal and civil justice system of the United States, or any other competent jurisdiction, those organizations and principal members of organizations, involved in ...
What is a diversion DEA? ›What Is Drug Diversion? Drug diversion is the illegal distribution or abuse of prescription drugs or their use for purposes not intended by the prescriber.
Who is being sued for the opioid crisis? ›In August 2019, the court ordered pharmaceutical giant Johnson & Johnson to pay millions for its role in the state's opioid crisis.
What companies are being sued for opioid crisis? ›The three largest US pharmacy chains have agreed to pay $13bn in a settlement to resolve lawsuits claiming they contributed to the opioid epidemic by dispensing opioid drugs despite obvious red flags. CVS, Walgreens, and Walmart faced more than 3000 lawsuits from states, municipalities, and Native American tribes.
What triggers a DEA investigation? ›Any providers who prescribe or dispense controlled substances may be investigated by the DEA, including in cases where they are suspected of writing or filling prescriptions illegally or where they may have participated in a conspiracy to distribute, dispense, or possess a controlled substance.
What are three types of crimes the DEA handles? ›The DEA collects three types of drug intelligence - tactical, investigative, and strategic. Tactical information is used for arrests, seizures, and interdictions.
What is the DEA rule change for 2023? ›The Drug Enforcement Administration (DEA) issued a temporary rule (Temporary Rule), effective 11 May 2023, extending flexibilities regarding the prescribing of controlled substances via telemedicine that have been in place since the beginning of the COVID-19 public health emergency (PHE).
What is the significance of DEA numbers and why is it important to validate them? ›DEA numbers allow the DEA to monitor who is prescribing controlled substances and the quantities prescribed. DEA numbers follow a specific format — two letters, six numbers, and one check digit — that verifies the number's validity and reveals the prescriber.
Why is the Controlled Substance Act important? ›
The Controlled Substances Act (CSA) establishes a unified legal framework to regulate certain drugs that are deemed to pose a risk of abuse and dependence.
Why is a DEA number important? ›A DEA Registration Number is a unique identifier provided by the Drug Enforcement Agency to medical practitioners like pharmacists, nurse practitioners, doctors, dentists, etc… allowing them to prescribe, dispense and administer drugs defined to be Controlled Dangerous Substances (CDS).
What are the red flags for DEA diversion? ›DEA's Red Flags Enforcement Policy
Red flags can include patients paying in cash, patients driving long distances to obtain their prescriptions, or doctors writing prescriptions for certain combinations of drugs.
This includes chemical analysis of suspected controlled substances, but also encompasses other areas such as digital evidence analysis, crime scene investigations and the disposal of hazardous chemical waste.
What are the duties of a DEA diversion investigator? ›Planning, implementing, and participating in multi-jurisdictional special programs impacting the diversion of pharmaceutical controlled substances and listed chemicals from legitimate distribution; evaluate the results of investigations and the registrant's input and prepare corresponding statements setting forth the ...
What drugs are part of opioid crisis? ›- Hydrocodone (Vicodin)
- Oxycodone (OxyContin)
- Codeine.
- Morphine.
- Methadone.
- Fentanyl.
Funds received from the California Opioid Settlements will be distributed as follows: 15% allocated to the State of California to use for future opioid remediation activities (California State Fund), 70% allocated to Participating Subdivisions to use for opioid remediation activities (Abatement Accounts Fund), and.
How much did Big Pharma pay for opioid settlement? ›Companies Finalize $26 Billion Deal With States and Cities to End Opioid Lawsuits. The first checks could be cut in April. The money — from the nation's three major pharmaceutical distributors and Johnson & Johnson — will be used for addiction treatment and prevention.
Why are opioid companies being sued? ›Opioid lawsuits allege opioid manufacturers caused the opioid crisis through deceptive marketing practices, misrepresenting that opioids had a low risk of addiction and touting benefits without disclosing the medication's risks.
How many opioid lawsuits have been filed? ›In all, more than 3,000 lawsuits have been filed by state and local governments, Native American tribes, unions, hospitals and other entities in state and federal courts over the toll of opioids.
Why is Walmart paying opioid lawsuit? ›
The money would help pay for addiction treatment and drug education programs in communities across the United States.
What are the most cited red flags in DEA audit? ›- The practice is cash only.
- It does not bill insurance.
- The practice has a high number of out-of-state patients.
- It has a high proportion of Schedule II and III narcotics relative to legend drugs.
- Patients travel long distances to fill prescriptions.
DEA is firmly committed to a drug-free society and workplace. Applicants for employment with the DEA, to include paid and unpaid employees; and contractors, who are currently using illegal drugs, or abusing legal drugs or substances at the time of the application process, will not be selected for employment.
How do you know if the DEA is investigating you? ›Usually, you will find out you are under investigation when agents come to your door, or otherwise approach you to ask you questions about a case you are suspected in. You may also hear from others that agents are asking questions about you.
What is the highest drug charge? ›Drug Trafficking is the most serious drug offense. It is Delivery of a Controlled Substance (or Possession with the Intent to Deliver a Controlled Substance) plus a minimum weight requirement for the drugs.
Can DEA make arrests? ›Essentially, this means a peace officer or DEA agent can make an arrest if there is good reason to suspect you committed a felony or a gross misdemeanor and/or if a warrant has been issued or charges have been levied.
Which of the following crimes has no statute of limitation? ›Criminal Statute of Limitations in California
No Limitation – There is no time limit for offenses punishable by death or a life sentence, such as first-degree murder and treason. Six-Year Limitation – There's a six-year limit for offenses such as first-degree robbery, arson, and kidnapping.
A limitation of this regulation includes that “not more than one day's medication may be administered to the person or for the person's use at one time. Such emergency treatment may be carried out for not more than three days and may not be renewed or extended.”
What is the DEA limit for Adderall? ›The spokesperson provided some numbers to show how this works: For 2023, the FDA estimated just over 38,000 kilograms of amphetamine would be sufficient to meet the demand for Adderall and its generics – and the DEA set the quota at 42,400 kilograms.
What is the DEA 5 transfer rule? ›Among these conditions is that the amount a practitioner so distributes to other practitioners during a calendar year cannot exceed five percent of the total number of dosage units of all controlled substances that the practitioner dispenses and distributes during that year.
What does F mean in a DEA number? ›
C = Practitioner (i.e., a physician, dentist, veterinarian) D = Teaching Institution. E = Manufacturer. F = Distributor.
What do the first two letters of a DEA number mean? ›The first letter is a code to identify the type of prescriber (i.e., a hospital, a practitioner, a manufacturer, etc.). The second letter is the first letter of the prescriber's last name. The seven numbers follow, and the seventh is the check digit. Let's walk though the steps of how to verify the DEA number.
What would be an example of an invalid DEA number quizlet? ›AD0865936 is not a valid DEA number.
What 3 things are regulated by the controlled substance Act? ›(1) Its actual or relative potential for abuse. (2) Scientific evidence of its pharmacological effect, if known. (3) The state of current scientific knowledge regarding the drug or other substance.
What are the 4 types of controlled substances? ›The control applies to the way the substance is made, used, handled, stored, and distributed. Controlled substances include opioids, stimulants, depressants, hallucinogens, and anabolic steroids.
Which government department withdraws medications from the market? ›The FDA regulates food and drug products to be released in the market and also withdraws substances to protect the public.
Who does the DEA answer to? ›The DEA is headed by an Administrator of Drug Enforcement appointed by the president of the United States and confirmed by the U.S. Senate. The Administrator reports to the Attorney General through the Deputy Attorney General.
Which of the following is required to have a DEA number? ›Who needs a DEA license? A DEA license is necessary for medical practitioners , pharmacists, dentists and other health care roles. Individuals who have a DEA license can prescribe or administer controlled substances.
What are 3 things that the patient must do to get the full benefit from their prescription? ›Sticking to your medication routine (or medication adherence) means taking your medications as prescribed – the right dose, at the right time, in the right way and frequency. Why is doing these things important?
What triggers a DEA audit? ›DEA audits or inspections can be conducted for a variety of reasons, such as: To investigate a tip received by a pharmacy or patient regarding prescribing practices. To investigate deviations in prescribing patterns compared to other prescribers. To inspect at random to ensure compliance.
Which might be considered a red flag on a controlled substance prescription? ›
Pharmacists can look for “red flags”
Altered prescriptions (e.g. multiple ink colors or handwriting styles) Cash payments. Inconsistent or early fills. Multiple prescribers.
Join the DEA and make a difference in the safety and security of your nation and community.
Why would the DEA come to my house? ›If the DEA has reached out to you, it probably means they are suspicious of the distribution, use or prescribing of controlled substances from your practice. Your lawyer should immediately begin to look over patient files and records, looking for anything that the DEA might see as a red flag.
Do DEA agents get drug tested? ›All DEA employees are subject to random urinalysis drug testing throughout their careers.
What are red flags for DEA diversion? ›DEA's Red Flags Enforcement Policy
Red flags can include patients paying in cash, patients driving long distances to obtain their prescriptions, or doctors writing prescriptions for certain combinations of drugs.
The DEA investigates drug cases through a multifaceted approach, utilizing three primary types of intelligence – tactical, investigative, and strategic. Tactical intelligence focuses on real-time information that supports arrests, seizures, and interdictions, enabling agents to respond effectively to immediate threats.
What are the duties and responsibilities of special investigator? ›Prepares investigative reports, subpoenas, sworn statements, case tracking documents, and related documentation. Develops and utilizes sources of criminal intelligence and other sources, including confidential contacts. Conducts covert investigations and surveillance.
How did the FDA cause the opioid crisis? ›It started in the mid-1990s when the powerful agent OxyContin, promoted by Purdue Pharma and approved by the Food and Drug Administration (FDA), triggered the first wave of deaths linked to use of legal prescription opioids.
What role did FDA play in opioid crisis? ›Since 2009, FDA has worked with DEA and other organizations to help educate the public on safe disposal of opioids when they are no longer needed for pain.
Why are pharmacies being sued for opioid epidemic? ›Lawsuits by numerous states accused CVS and other pharmacy chains of fueling the opioid crisis by filling prescriptions that should have been flagged as inappropriate.
Has the FDA made mistakes? ›
Unfortunately, their decision-making process has proven to be not as much of an exact science it should be. In fact, the FDA has made some pretty huge blunders that have ended in irreparable damage and even death. Here are just a few disastrous FDA mistakes that unleashed harmful drugs into the market.
What was the effect of the opioid crisis? ›Opioid misuse can compromise labor supply in a variety of ways, including absenteeism, increased workplace accidents, and withdrawal from the labor force due to disability, incarceration, or death.
When did opioids become a crisis? ›Opioid addiction is not a new phenomenon in the United States, but in the past, it did not have such a marked impact on the nation as a whole. The groundwork for the crisis was laid in the 1980s, when pain increasingly became recognized as a problem that required adequate treatment.
When was the opioid crisis declared a crisis? ›In 2017 HHS declared the opioid crisis a public health emergency. HHS is deeply committed to improving the physical and mental health and well-being of every American as we work to address the evolving crisis. HHS continues to support science- and community-based efforts to combat the opioid crisis.
What has Biden done to help the opioid crisis? ›WASHINGTON, D.C. – To advance the Administration's plan to beat the opioid epidemic as part of his Unity Agenda, President Biden released his FY 2024 budget request to Congress, which calls for a historic investment of $46.1 billion for National Drug Control Program agencies.
What is the new FDA approved opioid? ›FDA Approves New Buprenorphine Treatment Option for Opioid Use Disorder. Today, the U.S. Food and Drug Administration approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (under the skin) to treat moderate to severe opioid use disorder (OUD).
What are the 3 FDA approved medications for opioid use disorder? ›There are three drugs approved by the FDA for the treatment of opioid dependence: buprenorphine, methadone, and naltrexone.
Why is Walmart paying for opioid? ›Walmart believes these settlements are in the best interest of all parties and will provide significant aid to communities across the country in the fight against the opioid crisis, with aid reaching state and local governments faster than any other nationwide opioid settlement to date, subject to satisfying all ...
Why are doctors refusing to prescribe pain medication? ›Speak directly with your doctor about why they've prescribed you certain medications and why they won't prescribe you others. Some additional reasons why your doctor might not prescribe pain medications include: Drug-seeking or disruptive behaviors from patients. Personal beliefs and values.
Does Walmart fill opioids? ›Walmart does not manufacture, market, or distribute opioids. The following report summarizes important components of Walmart's response to the opioid crisis and the Board's oversight of Walmart's activities related to the dispensing of prescription opioid medications in the United States, as of September 14, 2020.
What is the strongest warning of FDA? ›
A contraindication is FDA's strongest warning and is only added when a medicine should not be used because the risk clearly outweighs any possible benefit.
How many drugs fail FDA approval? ›Why does 90% of clinical drug development fail? Only 1 out of 10 drug candidates successfully passes clinical trial testing and regulatory approval.
Which FDA recall is the most serious? ›Class I Recalls by the US Food and Drug Administration (FDA) are the most severe type of FDA recall. In a Class-I recall there is a potential for serious injury or death.