Beating the street to market painkillers in Chicago? You might need a license for that soon.
City officials are proposing a special license for pharma reps who promote powerful pain meds, a measure that Mayor Rahm Emmanuel touts as a weapon against opioid addiction, the Chicago Tribune reports.
Officials expect to introduce an ordinance next month to require pain reps to earn a license to promote their meds. Then, they’d have to keep records about their contacts with doctors--information to be shared at the city’s request.
The ordinance would also encourage doctors and patients to report any bad behavior to the city. Department of Public Health officials are still working out enforcement plans, the Trib reports; one possibility would be yanking reps’ licenses.
The city of Chicago has aggressively challenged drugmakers’ painkiller marketing practices, most notably with a lawsuit against a half-dozen opioid manufacturers, including OxyContin maker Purdue Pharma. The suit aims to hold the drugmakers accountable for an “epidemic” of painkiller abuse in Chicago and the city’s associated costs.
Separately, in July, Pfizer and the city agreed to a painkiller marketing code. The marketing agreement could potentially be used as a model for other drugmakers selling the highly addictive opioid drugs.
The city’s licensing proposal goes far beyond Pfizer’s code of conduct, which, according to the company, essentially reflects its current marketing rules. Under the Chicago proposal, painkiller reps would have to participate in training on drug abuse, ethics and proper marketing to earn their licenses, and pay a yearly fee of $750.
Licensed reps would be required to record the number of health providers they contact and the drug information they offer, keep track of when and to whom they hand out samples, and note whether doctors are compensated for their time, the Tribune says.
The rules might also require reps to track the names of doctors and other health pros they work with and hand over those names to the city if necessary.
The industry trade group PhRMA wouldn’t comment on Chicago’s specific proposals but did say that local and state regulations in general would hamper pharma’s work with doctors and other health pros.
"Industry interactions with health care professionals … are already extensively regulated” by the FDA, the group said in a statement. “Patchwork local and state initiatives are likely to disrupt the existing federal regulation of important scientific information that benefits both providers and patients.”
Chicago wouldn’t be the only city to require licenses for pharma reps. As the Tribune notes, Washington, DC, requires reps to be licensed, at a fee of $175 per year. Some pharma companies reportedly steer their salespeople away from the District because of the licensing rule, which has been in effect for eight years.
Meanwhile, Chicago’s legal fight against the painkiller companies remains pending. Its original lawsuit against six drugmakers was dismissed last year, but the city filed an amended complaint in November 2015, laying out 326 pages of specifics about the companies’ marketing practices and the city’s costs related to painkiller abuse. The Los Angeles Times reported that Purdue pushed OxyContin’s long-acting formula even though it knew the drug wore off early in about half of patients in clinical trials.
Chicago’s complaint leveled allegations against Purdue, Teva Pharmaceutical Industries ($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.
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.
Related Articles:
Teva, Regeneron won't touch blockbuster pain market with fasinumab, analyst predicts
Pfizer sets painkiller marketing code with Chicago's opioid police
Specialty pharmacy sees 13,381% growth as little-noticed piece of market soars
Painkiller marketing secrets? Check Chicago's unredacted suit against Endo, Purdue, Cephalon, et al.
Insys sued by Illinois AG for off-label marketing of Subsys opioid spray