Under pressure from people impacted by the nation's ongoing opioid crisis, a New York judge has confirmed Gil Kerlikowske, a former national drug czar in the Obama administration, as an outside monitor over Endo International's opioid business. The Chester County drug firm is reorganizing in bankruptcy court.
Endo will pay him as much as $25,000 a month, according to court documents.
"This is straight out of the Purdue playbook," said Temple University law professor Jonathan Lipson.
Purdue Pharma, which manufactures and markets the popular OxyContin pain pill, is monitored by former Montana Gov. Steve Bullock as it reorganizes in bankruptcy.
Restrictions on promoting opioids
Endo faces 3,100 lawsuits over its alleged part in the nation's opioid epidemic that the government estimates has claimed more than 500,000 American lives through prescription and illicit use of opioids. The Malvern firm filed for bankruptcy protection in Manhattan in mid-August. The firm is headquartered in Ireland for tax purposes but effectively run from Chester County.
New York Bankruptcy Judge James L. Garrity Jr. is presiding over the case and signed the court action designating the monitor on Nov. 15.
A bankruptcy committee has said there could be 600,000 potential victims of Endo's opioid pills and pushed for a monitor.
In the preliminary injunction signed by Garrity, Endo agreed to promotions and lobbying restrictions on its opioid business. Among those restrictions are not making false or "unconscionable comments" about opioids, or offering discounts to patients for opioid pills.
The company also won't appoint people to its board from organizations that promote opioids and it won't fund medical societies or advocacy groups that promote opioids.
In its pain pill offerings, Endo said it would not manufacture or distribute an opioid exceeding 30 milligrams of oxycodone. Oxycodone is the active opioid ingredient in time-release OxyContin pill and also sold as a generic drug.
Oregon court documents show that Endo sold branded or generic oxymorphone, hydromorphone, hydrocodone and oxycodone drugs. Endo's operations include Par Pharmaceutical, a generic drug company.
Cap on oxycodone dosage
Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing and medical director for the Opioid Policy Research Collaboration at Brandeis University, said that Endo has the legal right to promote opioids but has agreed not to.
The 30-milligram cap on the oxycodone was too high and could still be abused, Kolodny said. They are the "most popular prescription opioids on the black market," he said.
As monitor, Kerlikowske is expected to make sure that Endo follows through on the restrictions. Kerlikowske had no comment last Friday.
Then-President Obama appointed Kerlikowske director of the Office of the National Drug Control Policyin 2009, a position known as the drug czar. Kerlikowske later served as commissioner of U.S. Customs and Border Protection. During a law-enforcement career, he led the Seattle police department.
In February 2021, Kerlikowske was appointed monitor after the opioid maker and marketer Mallinckrodt filed for bankruptcy protection. A Mallinckrodt monitor is expected to serve five to seven years, regulatory filings show.
With Endo, Kerlikowske is expected to issue two reports on Endo's compliance with the restrictions that it agreed to with the court. Kerlikowske will only serve as monitor while Endo reorganizes in bankruptcy, court documents show.
More potent when injected
In the late 1990s, the Chester County drug firm was a heralded Philadelphia-area drug firm after it was spun out of a partnership between Dupont and Merck. Endo sold oxymorphone as Numorphan, or blues, in the 1960s and '70′s for relieving severe pain, but removed the drug from the market in the 1980s after reports of abuse.
In 2006, as doctors became more comfortable prescribing opioids and OxyContin had become a blockbuster drug, the Food and Drug Administration approved Endo's Opana pain pill with oxymorphone as its active ingredient — a reentry to the market for the opioid.
One of oxymorphone's characteristics is that its potency dramatically increases when it's injected. In 2017, Endo pulled reformulated and crush-resistant Opana ER pills from the U.S. market under pressure from the FDA because it was being abused through injection.
In a 2019 lawsuit, Tennessee Attorney General Herbert H. Slatery III claimed that "Endo likely inflicted more harm on Tennessee than any other state." The suit added that Endo "is substantially responsible for the opioid epidemic in Tennessee."
Before filing for bankruptcy protection this year, Endo agreed with a group of state attorneys general to pay $450 million to settle suits against it. It also agreed to pay an additional $100 million to potentially settle other claims.
Endo's bankruptcy plan is to sell itself to its creditors, who are owed billions of dollars.
As part of the Nov. 15 "voluntary operating injunction," Endo also agreed to make court documents from its lawsuits available in a "public document repository." There are millions of documents that include studies and court discovery. Endo is to pay $2.75 million for costs associated with the repository.
"The fact that Endo's internal documents will be unsealed is a huge win for public health," Kolodny said.
