AmerisourceBergen does not prescribe drugs, provide them directly to patients or take any action to drive demand for them. We transport medicine from manufacturers to licensed pharmacies, hospitals and other dispensaries. Ensuring the safety and security of this process has always been paramount. To achieve this, we continuously evaluate, enhance, strengthen and expand the proven measures we have implemented to maintain the integrity of every order we ship. These processes include: Performing extensive due diligence on customers who intend to purchase controlled substances from us and vetting discovered information through a best-in-class diversion control team of internal and external experts before granting them permission to purchase. Maintaining an order monitoring program with sophisticated technology that tests every controlled substance order against established governing criteria. Orders exceeding those criteria are redirected to experienced diversion control personnel for further analysis and possible cancellation. Providing daily reports to the United States Drug Enforcement Administration of all opioid-based medication orders, including the quantity, type and recipient of each shipped order. Ensuring that all customers are appropriately licensed by regulatory agencies and continuously monitoring those customers for "red flag" behavior. Discontinue customer relationships where there is an increased potential for diversion by the customer. Support law enforcement efforts to investigate entities that are acting illegally.
For more than a decade, these procedures have enabled us to report and stop tens of thousands of suspicious orders. This does not include countless other orders that were never placed with AmerisourceBergen because of our refusal to provide service.
Cardinal Health is an intermediary in the pharmaceutical supply chain and plays an important but limited and specific role: to provide a secure channel to deliver medications of all kinds from the hundreds of manufacturers that make them to our thousands of hospital and pharmacy customers licensed to dispense them to patients, and to work diligently to spot, stop and report suspicious orders of medications.
Cardinal Health is proud to operate a constantly adaptive and rigorous system to combat controlled substance diversion. We have learned from our experience and the threats the pharmaceutical supply chain faces, and as a result our anti-diversion program today is stronger and more effective as it continues to evolve. We have increased the size of our anti-diversion team, including bringing in personnel with additional regulatory, pharmaceutical, and law enforcement experience. We have developed an analytical model to evaluate our pharmacy customers, assigned threshold ordering limits to them, created a centralized database to store and track data on customers and orders, and enhanced policies and procedures for anti-diversion personnel. Over the years, we have trained thousands of our people on anti-diversion practices. Our people operate in good faith, our goal is to get it right, and we have stopped suspicious orders for the shipment of hundreds of millions of dosage units of controlled substances over the last decade.
As we fulfil our role in the closed supply chain, we are in full compliance with all applicable federal and state laws, which include the requirement to report to state and federal regulators those orders deemed suspicious, despite there being only vague guidance from the Drug Enforcement Administration on what constitutes an unusual, or suspicious, order. We report those suspicious orders to state boards of pharmacy and to the DEA, but we do not know what these government entities do with those reports, if anything. Distributors have no law enforcement power and, unlike the regulators which oversee and regulate the manufacture, distribution, prescribing and dispensing of controlled substances, cannot stop physicians from writing prescriptions for medication nor take unilateral action to block DEA- and state-licensed pharmacies’ ability to dispense medication. Cardinal Health shares the judgment of top policymakers that too many prescriptions have been written for too many opioid pills over the past decade, a trend that began with changes in the medical community’s attitudes toward managing pain. The DEA, the only entity with the ability to limit production of prescription opioids as it sets an annual quota of the amount allowed to be manufactured, also until recently continuously raised these annual production quotas. From 2006 to 2014, the DEA’s authorized quota rose 140%. Thus, the quantity of opioid pills sold is a direct reflection of the number of prescriptions written by healthcare providers and filled by licensed dispensers, neither of which wholesale distributors can influence. Cardinal Health cares deeply about the opioid epidemic and takes seriously our commitment, in cooperation with everyone else in the prescription drug supply chain – state and federal government regulators, pharmaceutical manufacturers, doctors and other healthcare providers, insurers and pharmacies – to find and support solutions to this national challenge.
In addition, Cardinal Health will continue, as we have for over a decade, to make a meaningful difference by raising awareness about the dangers of overprescribing and actively supporting efforts to address it. We also will continue to vigorously defend ourselves in all opioid-related legal matters.”
McKesson has consistently disclosed controlled substance transactions to the DEA. For decades, DEA has had exclusive access to this data, which can identify the total volumes of controlled substances being ordered, pharmacy-by-pharmacy, across the country.
McKesson distributes prescription opioids and other medications in response to orders placed by state-licensed and DEA-registered pharmacies, and those pharmacies may only dispense these medications to patients with a valid prescription written by a government-licensed health care provider.
The allegations made by the plaintiffs are just that – allegations. They are unproven, untrue and greatly oversimplify the evolution of this health crisis as well as the roles and responsibilities of the many players in the pharmaceutical supply chain. Any suggestion that McKesson influenced the volume of opioids prescribed or consumed in this country would reflect a misunderstanding of our role as a distributor
The Healthcare Distribution Alliance
(Trade group representing drug distribution companies)
Our members operate highly-regulated, diversified businesses and have responsibility for transporting all prescription medicines, including cancer treatments, specialty medicines, vaccines and other health products. Opioids are a small percentage — roughly 1–2 percent — of what our members deliver to licensed healthcare providers and pharmacies. Further, distributors respond to demand in the market for medicines — they don’t create it. Expecting distributors to have unilaterally stemmed the flow of opioids — a flow that increased yearly with the explicit oversight and approval of the DEA — is a transparent attempt by former DEA officials to shift the blame for their own failed approach to regulation during the growth and peak of the epidemic.
Urgent action is needed to address the epidemic in a meaningful and substantial way. Doing so will require us to take an honest and hard look at what changes need to be made. For our part, we’re ready to move forward with practical solutions to improve communication between all entities in the supply chain and with law enforcement to mitigate abuse and misuse before it occurs.
The plaintiffs’ allegations about CVS in this matter have no merit and we are aggressively defending against them. The fact is that we are committed to the highest standards of ethics and business practices, including complying with all federal and state laws governing the dispensing of controlled substance prescriptions. We are also dedicated to helping reduce prescription drug abuse and diversion. We have stringent policies, procedures and tools to help ensure that our pharmacists properly exercise their professional responsibility to evaluate controlled substance prescriptions before filling them.
Over the past several years, we have taken numerous actions to strengthen our existing safeguards to help address the nation’s opioid epidemic. This includes millions of hours training our pharmacy teams about responsibilities and best practices regarding controlled substances.
Pharmacies dispense medication, including controlled substances, to patients who have authorized prescriptions written by doctors, physicians, and other prescribers.
On the Ohio jury verdict:
We strongly disagree with the decision. Pharmacists fill legal prescriptions written by DEA-licensed doctors who prescribe legal, FDA-approved substances to treat actual patients in need. We’re proud of the substantial work we’ve done to support our pharmacists in detecting illegitimate prescribing. But the simple facts are that opioid prescriptions are written by doctors, not pharmacists; opioid medications are made and marketed by manufacturers, not pharmacists; and our health care system depends on pharmacists to fill legitimate prescriptions that doctors deem necessary for their patients. We look forward to the appeals court review of this case, including the misapplication of public nuisance law. As plaintiffs’ own experts testified, many factors have contributed to the opioid abuse issue, and solving this problem will require involvement from all stakeholders in our health care system and all members of our community.
Issued following after the company settled the case against it in the 2021 Ohio pharmacy trial:
Giant Eagle, a regional grocery/pharmacy chain, is proud of the work its pharmacies do in these communities. While Giant Eagle denies it was a cause of the opioid crisis, it recognizes the severity of the crisis, its impact on the public and the hard work of the public officials working to address the harms. This epidemic affects every community in Ohio without regard to race, religion or socioeconomic status. Rather than continue to put resources into litigation, Giant Eagle intends to continue helping the communities in which it operates to address the opioid crisis in a productive way.
Walgreens pharmacists are highly trained professionals committed to dispensing legitimate prescriptions that meet the needs of our patients. Walgreens has not distributed prescription controlled substances since 2014 and before that time only distributed to our chain of pharmacies. Walgreens has been an industry leader in combatting this crisis in the communities where our pharmacists live and work.
On the Ohio jury verdict:
We are disappointed with the outcome of this trial. The facts and the law do not support the verdict. We believe the trial court committed significant legal errors in allowing the case to go before a jury on a flawed legal theory that is inconsistent with Ohio law. As we have said throughout this process, we never manufactured or marketed opioids nor did we distribute them to the “pill mills” and internet pharmacies that fueled this crisis. The plaintiffs’ attempt to resolve the opioid crisis with an unprecedented expansion of public nuisance law is misguided and unsustainable. We look forward to the opportunity to address these issues on appeal before the United States Court of Appeals for the Sixth Circuit.
Blaming pharmacists for not second-guessing the very doctors the Drug Enforcement Administration (DEA) approved to prescribe opioids is a transparent attempt to shift blame from DEA’s well-documented failures in keeping bad doctors from prescribing opioids in the first place. In contrast to DEA’s own failures, Walmart always empowered our pharmacists to refuse to fill opioids prescriptions, and they refused to fill hundreds of thousands of such prescriptions. Walmart sent DEA tens of thousands of investigative leads, and we blocked thousands of questionable doctors from having their opioid prescriptions filled at our pharmacies. By demanding pharmacists and pharmacies second-guess doctors, the Justice Department is putting pharmacists and pharmacies between a rock and a hard place with state health regulators who say they are already going too far in refusing to fill opioid prescriptions. Ultimately, patients are caught in the middle.
On the Ohio jury verdict:
We will appeal this flawed verdict, which is a reflection of a trial that was engineered to favor the plaintiffs’ attorneys and was riddled with remarkable legal and factual mistakes. Among the many problems during this trial, the judge allowed it to continue after a juror violated court rules by conducting her own research and sharing it with other jurors. The judge even said that in his 22 years on the bench he had never seen a juror do “anything like” this, and we agree with the plaintiffs’ own lawyer, when he said it was his “ethical obligation” to call for a mistrial because of this juror misconduct. Additionally, this verdict is out of step with courts around the country that have rejected plaintiffs’ novel “public nuisance” liability theories in opioid lawsuits in Connecticut, Delaware, Illinois, California, Oklahoma, North Dakota, and South Dakota, to name a few. Plaintiffs’ attorneys sued Walmart in search of deep pockets while ignoring the real causes of the opioid crisis—such as pill mill doctors, illegal drugs, and regulators asleep at the switch—and they wrongly claimed pharmacists must second-guess doctors in a way the law never intended and many federal and state health regulators say interferes with the doctor-patient relationship. As a pharmacy industry leader in the fight against the opioid crisis, Walmart is proud of our pharmacists, who are dedicated to helping patients in the face of a tangled web of conflicting federal and state opioid guidelines."
The National Association of Chain Drug Stores
(The trade group for chain pharmacies)
NACDS and our members are focusing our energies on real, workable solutions that will address the problem of prescription drug abuse while also ensuring that legitimate patients are able to receive their prescription pain medications. Chain pharmacies engage daily in activities with the goal of preventing drug diversion and abuse. Since chain pharmacies operate in almost every community in the U.S., we support policies and initiatives to combat the prescription drug abuse problem nationwide. We believe that holistic approaches must be implemented at the federal level. Pharmacists take very seriously their role in helping to ensure safe use of medications – but they cannot do it alone. We support a collaborative approach to curb prescription drug abuse and preserve patient access to their medically-necessary pain medications. We believe that there are a variety of ways to help curb prescription drug diversion, and chain pharmacies actively work on many initiatives to reduce this problem.
Since its founding as a family business in 1920, Endo has evolved into a generics and specialty branded pharmaceutical company whose products help millions of patients lead healthier lives. We are deeply concerned about the opioid abuse crisis, a public health challenge unprecedented in scope, severity and complexity. We believe this crisis can only be solved through intensive collaboration among the multiple stakeholders involved in our healthcare system.
The U.S. Food and Drug Administration (FDA) has worked to balance access to pain care medications for appropriate patients while aggressively mitigating the risks of opioid abuse. Endo supports these efforts and has taken parallel actions. Since our new Executive Leadership Team began working together in September 2016, Endo voluntarily stopped promoting opioid products to healthcare professionals and eliminated the Company’s entire pain product salesforce. Endo also voluntarily withdrew Opana ER from the market, discontinued the research and development of new opioid products and implemented additional anti-diversion measures, including product serialization aimed at thwarting counterfeiting and theft to protect patient safety.
While we are proud of Endo’s actions, neither we nor any other single actor can solve the opioid abuse crisis. Instead, any solution must be multifaceted and consider not only the product supply chain, but also individual risk factors and other factors affecting utilization decisions, together with scientific, legislative and regulatory measures, training, treatment and education. Criminal trafficking of opioids (including heroin and fentanyl), illegal Internet sales and importation must also be addressed. Finally, the legitimate access needs of the millions of patients suffering from acute or chronic pain who rely on opioid medications must be considered. We remain committed to working collaboratively and proactively on a comprehensive solution to the opioid abuse crisis and to continuing Endo’s longstanding mission of improving patients’ lives.
Johnson & Johnson
We recognize the opioid crisis is a tremendously complex public health issue, and we have deep sympathy for everyone affected. The Company’s actions relating to the marketing and promotion of these important prescription opioid medications were appropriate and responsible. The Company no longer sells prescription opioid medications in the United States as part of our ongoing efforts to focus on transformational innovation and serving unmet patient needs.
The Drug Enforcement Administration determines the total quantity of Schedule II opioids needed each year to meet legitimate medical, scientific and research needs in the U.S. Our DEA registrant company, SpecGx LLC, cannot and does not produce more opioids than the annual limit set for the company by the DEA. SpecGx sells only to DEA-approved distributors and other entities, who are themselves registered with and monitored by the DEA. In addition, through its ARCOS database, DEA monitors the flow of these DEA controlled substances from their point of manufacture through commercial distribution channels to point of sale or distribution at the dispensing/retail level.
Mallinckrodt has for years been at the forefront of preventing prescription drug diversion and abuse, and has invested millions of dollars in a multi-pronged program to address opioid abuse. Those efforts include the purchase and donation of nearly two million drug disposal pouches, and working with policymakers, community leaders, law enforcement and industry partners to ensure the responsible use of pain medication and preventing unused medications from ending up in the wrong hands. The company will continue to support these efforts.
Regarding former salesman Victor Borelli:
This is an outrageously callous email from an individual who has not been employed by the company for many years. It is antithetical to everything that Mallinckrodt stands for and has done to combat opioid abuse and misuse.
OxyContin has always had FDA-approved labeling disclosing that the medication has a risk of addiction and abuse and is a Schedule II product with an abuse liability similar to morphing. As required by law, OxyContin promotional materials used during interactions with healthcare professionals were submitted to the FDA for review.
In February 2018, Purdue ceased using a sales force to promote opioids to healthcare professionals.
Purdue Pharma vigorously denies the claims brought forth in the MDL, which are based on mischaracterizations and allegations we believe are without merit. We are confident in the strength of our legal arguments, and will continue to defend ourselves in the litigation.”
Teva Pharmaceutical Industries
Teva has not conspired, failed to report suspicious orders or contributed to the abuse of opioids in the U.S. in any way. We maintain a comprehensive and robust system to prevent suspicious orders from ever entering the market.
Response to jury verdict in the Long Island, New York trial:
In NY, the plaintiffs presented no evidence of medically unnecessary prescriptions, suspicious or diverted orders, no evidence of oversupply by the defendants – or any indication of what volumes were appropriate – and no causal relationship between Teva’s conduct including its marketing and any harm to the public in the state.
Prior to deliberation, Teva sought a mistrial based on, among other issues, the state’s misrepresentation of the amount of opioids sold by Teva in NY by more than 500 times.
Teva continues to focus on increasing access to essential medicines to patients, including opioid medications for approved indications. Most importantly, the Company continues to pursue a national settlement in the best interest of patients.
As recently as last month, a court in California issued a decision finding that Teva did not cause a public nuisance in Orange County, Los Angeles County, Santa Clara County and the City of Oakland and that Teva did not make any false or misleading statements in connection with marketing prescription opioids in California.
Additionally, last month the Oklahoma Supreme Court overturned an earlier judgment against a pharmaceutical manufacturer and ruled that the public nuisance law in Oklahoma does not extend to the manufacturing, marketing and selling of prescription opioids.