Attorney General James Urges CDC to Adopt Stronger Opioid Prescription Guidelines

 

 New York Attorney General Letitia James called on the Centers for Disease Control and Prevention (CDC) to adopt new, common-sense guidelines for prescribing opioids that will help prevent and combat opioid addiction that has claimed hundreds of thousands of lives. In a letter to the CDC, Attorney General James urged the agency to update its guidelines for physicians to help improve pain management and reduce opioid-related harms in communities throughout the country. This is the latest action in Attorney General James’ efforts to fight the opioid epidemic.

“I am proud to lead New York in the fight to hold opioid manufacturers and distributors accountable for the harm they’ve inflicted on our communities, but we must also tackle the root of the issue and where it all begins — with the over-prescription of opioids,” said Attorney General James. “We know that opioids are highly addictive and dangerous, yet some doctors continue to prescribe the medication without reserve, costing us countless lives. We need clear and comprehensive prescribing guidelines for doctors so that our nation can finally decrease its dependence on opioid pain medications.”  

The CDC reported that last year opioid overdose deaths rose by nearly 20,000, marking a record high 75,000 lives lost. In New York alone, more than 4,200 people died from opioid overdoses between October 2020 and October 2021.

To combat these trends, Attorney General James recommends the CDC include the following measures in its official guidelines:

• Develop specific thresholds for assessing the risks of opioids, including;
  • Clearly warning prescribers to exercise caution when increasing an opioid dosage beyond 50 mg;
  • Advising prescribers to offer naloxone, the overdose-reversal drug, to all patients taking at least 50 mg of opiates per day;
  • Directing doctors to review their patients’ prescription drug monitoring program data at least every three months.
• Encourage the use of non-opioid pain therapies and ensure healthcare coverage by insurers.
• Publicly recognize the limited evidence to support the usefulness of opioids for the treatment of chronic pain.
• Publicly acknowledge that pain is undertreated and untreated in women and people of color and encourage prescribers to address potential biases in clinical decision-making.

In March 2019, Attorney General James filed the nation’s most extensive lawsuit to hold accountable the various manufacturers and distributors responsible for the opioid epidemic. The manufacturers named in the complaint included Purdue Pharma and its affiliates, as well as members of the Sackler family (owners of Purdue) and the trusts they control; Janssen Pharmaceuticals and its affiliates (including its parent company Johnson & Johnson); Mallinckrodt LLC and its affiliates; Endo Health Solutions and its affiliates; Teva Pharmaceuticals USA, Inc. and its affiliates; and Allergan Finance, LLC and its affiliates. The distributors named in the complaint were McKesson Corporation, Cardinal Health Inc., Amerisource Bergen Drug Corporation, and Rochester Drug Cooperative Inc. 

In December 2021, a jury found Teva Pharmaceuticals USA, Inc. and its affiliates liable for violating New Yorkers’ rights and responsible for the public nuisance charges made by New York state in its opioid trial in Suffolk County State Supreme Court. A subsequent trial will now be held to determine how much Teva and others will be required to pay, which will be added to the up to $1.5 billion Attorney General James has already secured for the state of New York from different opioid manufacturers and distributors.

In December 2021, an agreement with Allergan was reached that will deliver up to $200 million to New York state and Nassau and Suffolk counties for opioid abatement, as well as make enforceable a bar that stops Allergan and all of its subsidiaries, predecessors, and successors from selling opioids in New York and acknowledge Allergan’s prior exit from the opioid business.

In September 2021, an agreement with Endo was reached that delivered $50 million to New York state and Nassau and Suffolk counties to combat the opioid crisis.

Also, in September 2021, the bankruptcy court in Purdue confirmed a $4.5 billion plan — at least $200 million of which will be earmarked for New York — from the Sackler family and foundations that they control, will end the Sacklers’ ability to manufacture opioids ever again, and will shut down Purdue Pharma. The court’s ruling against Purdue and the Sacklers has since been challenged by dissenting states and is currently in mediation.

In July 2021, a settlement with McKesson, Cardinal Health, and Amerisource Bergen that will deliver up to $1 billion to New York state to combat the opioid epidemic was announced.

In June 2021, a settlement that ended Johnson & Johnson’s sale of opioids nationwide and that will deliver $230 million to New York alone was announced.

The deals with Johnson & Johnson, McKesson, Cardinal Health, and Amerisource Bergen have a global value of approximately $26 billion.

The cases against Mallinckrodt and Rochester Drug Cooperative are now moving separately through U.S. Bankruptcy Court.

Pursuant to the new law establishing the opioid settlement fund, all funds collected by the state from opioid settlements or litigation victories will be allocated specifically for abatement efforts in communities devastated by the opioid epidemic and will not go towards the state’s general fund.

Separately, but related to her work on opioids, in February 2021, Attorney General James co-led a coalition of nearly every attorney general in the nation in delivering more than $573 million — more than $32 million of which was earmarked for New York state — towards opioid treatment and abatement in an agreement and consent judgment with McKinsey & Company.