- Pfizer will more fully disclose the risk of addiction associated with opioid painkillers, reaching an agreement with the city of Chicago to abide by "strict standards" for marketing and promotion of the drugs.
- The pharma giant also pledged to refrain from promoting opioid drugs for off-label use and will acknowledge the lack of definitive research on the efficacy of opioids past 12 weeks, according to a statement from the Chicago Mayor's office.
- Pfizer currently markets one prescription opioid, a morphine-based drug called Embeda. An FDA panel recently support approval for Pfizer's long-acting painkiller Troxyca ER, although it questioned the drug's abuse-deterrent properties.
The growing crisis of opioid addiction and overdose death has ratcheted up the scrutiny on how prescription painkillers are marketed and sold to consumers.
At the same time, government agencies have scrambled to assemble a more robust response to what Robert Califf, commissioner of the Food and Drug Administration, has termed an "epidemic." Both the FDA and the Centers for Disease Control and Prevention have unveiled new guidance for the labeling and prescribing of opioids, while legislative efforts are underway in the House and Senate.
While Pfizer doesn't market many opioids, the agreement between Chicago and Pfizer marks one of the most high-profile examples of a pharmaceutical company drawing attention to the industry's role in the crisis.
“This landmark agreement is a big step in the right direction to help protect and educate the public about the true risks and benefits of highly potent and highly addictive painkillers,” said Chicago Mayor Rahm Emanuel.
Chicago had filed a lawsuit against five pharmaceutical companies in 2014 for misrepresenting the benefits of opioid painkillers, alleging the companies falsely marketed the drugs as hard to abuse. Pfizer was not named in that suit and has helped Chicago's investigation into the deceptive marketing of opioids.
A Pfizer spokesperson noted the agreement does not implicate the company in any misconduct.
“Pfizer is pleased to work with the City of Chicago to help address the serious problem of prescription opioid abuse. We support efforts that encourage the safe use and appropriate prescribing of opioids," Pfizer said in a statement.
Pfizer also promised to ensure that third party marketing materials disseminated under the Pfizer name accurately describe the risks of addication.
Widespread prescribing of opioids, particularly for use on a long-term basis, have increased costs for Chicago's healthcare system, the mayor's office said. The city's health insurance plan reimbursed $12.3 million in claims related to opioid painkillers between 2008 and 2015, and 84 people died from overdoses in the city last year.
Chicago's corporation counsel, Stephen Patton, indicated the city would continue to push back against what it sees as illegal marketing for the addictive drugs.
"We filed and continue to pursue our legal action against Purdue Pharma and other drug companies to stop these companies from deceptively and unlawfully marketing opioids and to hold these companies responsible for the harm their deception has caused," Patton said.
Separately, the Department of Health and Human Services on Wednesday finalized a rule allowing doctors who have obtained a waiver to prescribe buprenorphine, a drug used to treat opioid misuse, to as many as 275 patients. Previously doctors could only prescribe the drug to 100 patients.
"The opioid epidemic is one of the most pressing public health issues in the United States. More Americans now die from drug overdoses than car crashes, and these overdoses have hit families from every walk of life and across our entire nation,” said HHS Secretary Sylvia Burwell.