Purdue Pharma Canada is deeply concerned with today’s statement from the federal Minister of Health that she may not act to delay a decision on generic OxyContin.
The Minister states that she has heard from doctors and patients about OxyContin’s positive impact on the treatment of severe pain and that the issue of prescription drug abuse is larger than one specific product. We agree. But the Minister’s own Scientific Advisory Panel recommended in March 2011 that manufacturers introduce new opioids which are less crushable and less abusable. This is why we introduced OxyNEO®.
The Minister refers to “insufficient proof” to back up claims that OxyNEO, the replacement for OxyContin, is harder to abuse. We disagree. In fact, published data from surveillance studies in the U.S., where OxyNEO has been available for two years, has been submitted on a regular basis and the most recent data submission is still under review by Health Canada.
It shows significant decline in abuse and demand, including a lower street price for the tablets as well as decreases in admissions to addiction treatment and the number of adverse drug reactions reported to poison control centres. There is also evidence of improved safety for patients and their caregivers. We are disappointed that Health Canada has not taken this important evidence into account.
The Minister indicates the law does not permit her to withhold approval. On the contrary, under the Food and Drugs Act, the Minister must be satisfied that any drug, including generics, meets safety and effectiveness standards prior to issuing an approval.
A higher standard has been established with OxyNEO and it is one that should now be applied to all new controlled-release oxycodone products, including generics. As such, we urge the Minister to consider the evidence and require any generic OxyContin to meet those standards in the interest of public and patient safety.
About Purdue Pharma (Canada)
A research-based pharmaceutical company in Pickering, Ontario, Purdue Pharma Canada (www.purdue.ca) is committed to improving patient health and well-being, by developing innovative medicines and supporting quality education for the safe use of its products.