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U.S. Congress members express concern over timing of Canadian oxycodone rules


July 27, 2015
By Kristy Kirkup The Canadian Press

Some members of the U.S. Congress are concerned Canada is taking too long to force all oxycodone producers to make tamper-resistant forms of the drug.

In a July 22 note to Health Minister Rona Ambrose, obtained by The Canadian Press, 10 congressional members say her department’s intention “to require tamper-resistant properties… is laudable.”

But the group, including Brian Higgins and Kevin Cramer – co-chairs of the Northern Border Caucus – says Canada’s three-year timeline to deliver on the promise is a “source of concern.”

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“The urgency of this request comes because there is evidence that generic versions of oxycodone products continue to be transported or diverted into the United States from Canada, further exacerbating this public health crisis on both sides of the border,” the letter states.

“We respectfully request that Health Canada examine the feasibility of accelerating the timeline and shortening the phase-in period for abuse-deterrent formulations in order to allow for an orderly transition for your regulations to come into force.”

The letter comes after Health Canada issued a consultation notice in the Canada Gazette last month.

It called for feedback on a proposal to require all controlled-release oxycodone products to have tamper-resistant properties before they can be sold in Canada.

In the notice, the department said the three-year phase-in period will “provide sufficient time for product reformulation and the necessary supply chain adjustments.”

Ambrose’s office said it has yet to receive the letter from members of Congress, but the minister’s spokesman, Michael Bolkenius, said Canada is “pursuing strategies on prescribing practices, examining tamper-resistant properties and are already taking action to tighten licensing rules to prevent illegal distribution.”

In 2012, Ambrose’s predecessor Leona Aglukkaq was harshly criticized by members of the medical community, police chiefs and provincial health ministers for giving Health Canada the green light to approve generic versions of the opioid painkiller commonly known as hillbilly heroin on the streets.

The Conservative government was forced to tackle the generics decision when Purdue Pharma, the producer of OxyContin, removed its drug from the market nine months prior to the expiry of its patent.

The pharmaceutical company rolled out OxyNEO at that time, which was designed to be harder to crush and therefore more difficult to abuse, but Health Canada said research on the drug could not support this claim when the drug was approved for market.

Once the Canadian government opened the gate for generics, six major drug companies applied to introduce knockoff versions.

The U.S. Food and Drug Administration did not allow generic versions of oxycodone onto the market, but OxyNEO was introduced south of the border in spring 2010.

– With files from Alexander Panetta


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