Pennsylvania Attorney General Josh Shapiro has disclosed the names of pharmaceutical companies under investigation as part of a multi-state probe into the manufacturing, marketing, sale and distribution of opioids.
The prescription drugs have been linked to an epidemic of abuse. Officials in 41 states, including Pennsylvania, have been ratcheting up legal pressure on pharmaceutical companies that make and market the pills.
“We will change the very system of manufacturing, marketing and distributing these drugs,” Shapiro said Tuesday morning during a press conference in Montgomery County, where he was joined by local law enforcement, addiction survivors and and families of opioid overdose victims.
Shapiro and his fellow attorneys general are seeking documents and information about business practices from companies responsible for distributing nearly 90 percent of the nation’s opioids.
Shapiro said he and the other AGs have served subpoenas for documents and information — called Civil Investigative Demands — on the pharmaceutical manufacturers. Investigators also have sent information demand letters to the distributors under investigation.
Shapiro said that the investigation was based on victims being impacted in Pennsylvania, regardless of where the companies are based.
The companies are:
• Endo International, maker of drugs like Opana and Percocet, whose U.S. headquarters are in Malvern, near Philadelphia.
• Janssen Pharmaceuticals, maker of opioids such as Duragesic, a fentanyl patch, whose headquarters are in Titusville, N.J.
• Teva Pharmaceutical Industries and its U.S. subsidiary Cephalon Inc., which manufactures many generic opioids and drugs such as Actiq, a fentanyl lollipop. Teva is an Israeli multinational, while Cephalon is based in Frazer, also in suburban Philadelphia.
• Allergan Inc., maker of opioids like Kadian, is an Irish company with U.S. headquarters in Parsippany, N.J.
• Purdue Pharma, the maker of OxyContin, which is based in Stamford, Conn.
• AmerisourceBergen, whose headquarters are in Chesterbrook, Chester County.
• Cardinal Health, based in Ohio.
• McKesson, whose headquarters are in San Francisco.
Opioid drugs are the main cause of fatal drug overdoses in Pennsylvania and nationwide, Shapiro’s office said.
Pennsylvania had 4,642 fatal drug overdoses in 2016, a 37 percent increase over 2015, the AG’s office said.
Eighty percent of people suffering from heroin addiction began by abusing prescription drugs, Shapiro pointed out, and 7.3 million opioid prescription drugs were dispensed in Pennsylvania last year — many for common workplace and sports injuries.
“Behind me is a field, where no doubt student athletes have been injured and no doubt, treated with prescription drugs,” Shapiro said from a podium at the Upper Dublin High School athletic complex. “That’s a culture we have to look into and change.”
The press conference included remarks from Joe Lubowitz, an Upper Dublin graduate and three-sport athlete who is in long-term recovery from addiction and has founded Humble Beginnings Recovery Centers.
“It all started with one pill,” said Lubowitz, describing how an addiction to prescription medication that began while he was a student at Penn State escalated into heroin use.
“I didn’t care about anything. I didn’t care if I lived or died,” Lubowitz said.
Shapiro pledged to take the investigation to “the boardrooms of pharmaceutical companies,” likening it to previous multi-state battles against the tobacco industry.
“As we have shown in other cases, broad, bipartisan coalitions of attorneys general can impact national problems through litigation and settlements – more effectively at times than when acting alone,” Shapiro said.
“This epidemic is a national problem requiring a coordinated response to make the citizens of our states safer and to hold the appropriate parties accountable,” he added.
Here is what the companies had to say in response:
• Cardinal released a statement about the investigation on Monday, prior to Shapiro’s press conference, saying it looks forward to working with the AGs on the probe.
“As a pharmaceutical distributor, we operate as part of a multi-faceted and highly regulated healthcare system. We do not manufacture, promote or prescribe prescription medications to members of the public – and believe everyone in that chain, including us, must do their part to address the current crisis,” the statement said.
“To that end, Cardinal Health maintains a sophisticated, state-of-the-art anti-diversion program that includes advanced analytics, technology and on-the-ground deployment of investigators to evaluate pharmacies, scrutinize controlled substance orders, and identify, block and report to regulators those orders of prescription controlled substances medications that do not meet our strict anti-diversion criteria,” Cardinal’s statement added.
• Allergan released a statement saying it is “working cooperatively with state attorneys general.”
“While we work proactively with their offices to provide information, it is important to put into perspective Allergan’s role regarding opioids,” the statement continued.
“Allergan’s two branded opioid products – Norco and Kadian – account for less than 0.08 percent of all opioid products prescribed in 2016 in the U.S. These products came to Allergan through legacy acquisitions and have not been promoted since 2012, in the case of Kadian, and since 2003, in the case of Norco,” Allergan added.
• Janssen spokesman William Foster said the company has “received and plans to address the request from the coalition of state attorney generals, and will continue to work with stakeholders to support solutions.”
“Janssen has acted responsibly and in the best interests of patients and physicians with regard to these medicines, which are FDA-approved and carry FDA-mandated warnings about possible risks on every product label,” Foster added.
• Endo released a statement saying it is the company’s policy not to comment on current litigation or investigations, but added: “At Endo, our top priorities include patient safety and ensuring that patients with chronic pain have access to safe and effective therapeutic options. We share in the FDA’s goal of appropriately supporting the needs of patients with chronic pain while preventing misuse and diversion of opioid products.”
• McKesson released a statement which included a link to information about how it is fighting opioid abuse, noting that in 2015 the firm created a task force of McKesson experts, including clinicians, “to further study the opioid issue and its challenges.”
“As a pharmaceutical distributor, McKesson operates as one component within the pharmaceutical supply chain, which also includes drug manufacturers, regulatory bodies like the U.S. Drug Enforcement Administration and state pharmacy boards, payers, prescribing doctors and dispensing pharmacists,” the statement added.
“McKesson takes seriously its role in helping to protect the safety and integrity of the pharmaceutical supply chain,” the firm said.
• AmeriSource Bergen replied: “We welcome the opportunity to educate the Attorney General coalition on our role in the healthcare supply chain.”
“AmerisourceBergen has taken extensive action to help ensure the safe and secure delivery of these drugs, including reporting suspicious orders to the Drug Enforcement Agency and stopping tens of thousands of suspicious orders from being shipped,” the company added.
“Our goal has been, and continues to be, to do everything we can as a distributor with no visibility into patient information to mitigate the diversion of these drugs in ways that do not interfere with clinical decisions made by licensed healthcare providers,” the statement continued.
“Our hope is that the investigation will be a step forward in driving productive conversation about how we, along with all other parts of the health care supply chain, can work with regulatory, enforcement and legislative leaders to find meaningful solutions to address the opioid epidemic.”
• Purdue wrote: “We share the attorneys’ general concern about the opioid crisis and we are cooperating with their request. This is a multifaceted public health challenge, and we look forward to working collaboratively with government entities to be part of the solution.”