The federal government is stepping up its regulatory scrutiny of opioid manufacturers and signalling that it will abandon its traditional co-operative approach to addressing any misleading promotional practices in Canada.
As part of a series of new measures, the government says it is creating a compliance and enforcement team to monitor opioid manufacturers, enforce the rules against improper drug promotion and take action where necessary, including recommending criminal charges.
Health Minister Ginette Petitpas Taylor says the industry’s marketing can “unduly influence” doctors, leading to the overprescribing of opioids. The acknowledgment comes as a national epidemic of opioid overdoses worsens. Nearly 4,000 Canadians died of opioid-related overdoses in 2017, up 34 per cent from the previous year.
In addition to the new enforcement team, Ms. Petitpas Taylor has also called on pharmaceutical companies to stop promoting opioids. So far, a dozen opioid manufacturers have suspended activities such as sales representatives’ visits to doctors and ads in medical journals, including Purdue Pharma, whose pain pill triggered the epidemic.
Mathieu Filion, director of communications for Ms. Petitpas Taylor, said the minister’s call for a voluntary ban on marketing opioids does not “close the door” on the government taking legal action against Purdue or any other drug manufacturer for past practices.
“If we uncover evidence of past behaviour sufficient to pursue criminal charges, we will not hesitate to take action,” Mr. Filion said in an e-mail to The Globe and Mail.
Purdue said in a statement to The Globe on Monday that it is “deeply concerned” about the opioid crisis. The company also said it has always marketed its products in compliance with Canada’s rules, including the federal Food and Drugs Act (FDA).
Under the act, companies can be prosecuted for promoting drugs in a manner that is “false, misleading or deceptive.” In the United States, pharmaceutical companies have paid out US$35.7-billion in settlements with federal and state governments over a 25-year period for breaking the rules, according to the national non-profit group Public Citizen.
Health Canada has not referred any matter involving alleged illegal pharmaceutical advertising to the Public Prosecution Service of Canada, which prosecutes criminal offences under federal statutes, since at least 2003, a spokeswoman said.
Joel Lexchin, a Toronto emergency-room doctor and professor emeritus at York University’s faculty of health, said he cannot recall any instance over the past four decades in which a drug company has been prosecuted in Canada for misleading marketing.
“There’s a long history of the government in Canada regarding the pharmaceutical industry as partners and looking for compromises rather than actually confronting the industry,” he said.
Purdue promoted its prescription painkiller OxyContin in North America as safer and less addictive than other opioids, encouraging doctors to prescribe opioids more widely for everything from back pain to fibromyalgia.
The company has acknowledged in the United States that its marketing of OxyContin was misleading and paid US$634.5-million in 2007 to settle criminal and civil charges. Purdue’s Canadian operation has not made a similar admission of wrongdoing.
At the time Purdue was prosecuted in the United States, the maximum penalty that could have been imposed in Canada under the FDA was a fine of $5,000. Revisions to the act in 2014 increased the maximum penalty to $5-million, but it cannot be applied retroactively.
Canada’s opioid epidemic traces its roots to the mid-1990s, with the introduction of OxyContin. Health Canada approved the drug to relieve pain that was moderate to severe in 1996. Until then, opioids had been used primarily for terminal cancer patients. Canada is the world’s second-highest per capita consumer of prescription painkillers after the United States.
OxyContin was the top-selling long-acting opioid for more than a decade. At the same time, reports of addiction and overdose mounted among those who were prescribed it and those who used diverted pills illicitly.
Purdue pulled OxyContin from the market in 2012, shortly before the patent was to expire. A host of other, stronger drugs filled the void, including illicit fentanyl, which began appearing on the streets in Canada in 2012, and which has been largely responsible for the spike in fatal overdoses.
Ottawa has been facing growing pressure to use its powers under the FDA to launch a criminal investigation into the marketing practices of opioid manufacturers in Canada.
“I am encouraged by the tough talk, but after more than 15 years of the crisis and tens of thousands of deaths, we need more than talk,” Nav Persaud, a family physician and researcher at St. Michael’s Hospital in Toronto, told The Globe on the weekend.
Dr. Persaud led a group of seven physicians and academics who sent an open letter to the Prime Minister, the Health Minister and the Justice Minister in April, urging them to probe opioid manufacturers. Others who have called for such an investigation include former Ontario health minister Eric Hoskins and New Democratic MP Don Davies.
In a letter dated July 5 to Dr. Persaud’s group, assistant deputy health ministers Pierre Sabourin and Suzy McDonald say the government cannot apply new, stiffer penalties for misleading marketing to situations that arose before the FDA was amended.
However, “Health Canada will not hesitate to address marketing abuse using the new powers at its disposal,” says the letter, a copy of which was obtained by The Globe. “Our focus remains on rigorous enforcement of the laws as they exist today and ending improper marketing practices for the future.”