Pfizer and the city of Chicago have hammered out an agreement on painkiller marketing, setting out a code of conduct that ensures the powerful drugs are prescribed to the right patients and used with all their serious risks in mind.
The marketing agreement--which publicly codifies Pfizer’s internal rules--could potentially be used as a model for other drugmakers selling the highly addictive opioid drugs. The city of Chicago is set to announce the code on Wednesday.
Like many other cities around the country, Chicago has been struggling with an epidemic of painkiller abuse, but unlike most, has taken that battle to the courts. Last year, the city sued a set of painkiller companies--including the maker of OxyContin, Purdue Pharma--over their marketing practices. The city claims that the companies violated its municipal code and Illinois state law by pushing their opioids for chronic pain, despite the fact that the FDA hadn’t approved the drugs for that use.
Pfizer, which sells one opioid painkiller, was never named in the lawsuit. Its agreement with the city is voluntary and completely separate from that legal fight, a company spokeswoman said. The city did not find that Pfizer had violated any of its ordinances and there’s no admission of wrongdoing.
“For us, it’s a public health issue,” the spokeswoman told FiercePharma Wednesday. Noting Mayor Rahm Emmanuel’s efforts to combat opioid abuse, she added, “Pfizer is happy to stand alongside them to ensure that painkillers are marketed responsibly. We want to make sure that the right people who need it have it.”
The code of conduct essentially reflects Pfizer’s current marketing policies, the spokeswoman said. “Pfizer adheres to all applicable laws and regulations as well as to industry standards, including the PhRMA Code and the ACCME Standards," she said., adding that Pfizer also participates in the FDA's risk-management programs for extended-release and long-acting opioids.
Pfizer’s agreement comes as the FDA and Centers for Disease Control and Prevention are stepping up their own efforts to combat opioid abuse. The FDA has put restrictions on prescribers and added warnings to the drugs’ labels, while the CDC recently issued guidelines calling for drastic reductions in use of the drugs.
Meanwhile, following a Los Angeles Times investigation, last month U.S. Sen. Edward Markey asked the FDA and Federal Trade Commission to investigate Purdue’s OxyContin marketing
Chicago’s original lawsuit against a half-dozen drugmakers was dismissed last year, but the city filed an amended complaint in November, laying out 326 pages of specifics about the companies’ marketing practices and the city’s costs related to painkiller abuse. The LA Times reported that Purdue pushed OxyContin’s long-acting formula even though it knew the drug wore off early in about half of patients in clinical trials.
Purdue pleaded guilty years ago to one felony count of misbranding OxyContin, for suggesting its drug was less addictive and less abused than other painkillers. Purdue’s CEO and two other execs also pleaded guilty to a misdemeanor misbranding charge. The company paid $635 million to settle with the Department of Justice.
Chicago’s complaint leveled allegations against Purdue, Teva Pharmaceutical Industries ($TEVA), Johnson & Johnson's ($JNJ) Janssen unit, Depomed ($DEPO), Endo ($ENDP) and Allergan ($AGN). The lawsuit claims the drugmakers knew "that opioids were addictive and subject to abuse, particularly when used long-term for chronic non-cancer pain" and that products like OxyContin and Percocet should be used only as a last resort.
But, the city says, the companies used sophisticated--and highly deceptive and unfair--marketing to effect a "sea change" in attitudes toward the drugs. The marketing, including a set of awareness campaigns mounted by organizations allegedly funded by the drugmakers, steered patients with chronic pain toward the meds despite the dangers, the lawsuit claims.
The drugmakers have denied the city’s allegations, and they took issue with the city’s decision to sue. “Patients are hurt by litigation that risks creating inconsistent rules governing access to FDA-approved medicines,” Purdue said at the time. Janssen said in a statement that it had acted responsibly in offering a drug to people who suffer chronic pain.
Chicago makes second run at Allergan, J&J, Purdue and others with painkiller lawsuit
Senator wants feds to investigate whether Oxycontin wears off too soon
CDC guidelines call for drastic cuts in opioid painkiller use
J&J, Endo, Teva and Actavis off the hook in Chicago painkiller lawsuit
FDA's Califf calls for 'sweeping re-examination' of policies in effort to fight opioid abuse
Painkiller marketing secrets? Check Chicago's unredacted suit against Endo, Purdue, Cephalon, et al.
Editor's note: This story was updated with a new statement from Pfizer.