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Fundamental operational obligations of the DSCSA mean that imported drugs could not be tracked and traced throughout the supply chain. The requirement for unique standardized numerical identifiers means there is no legal or operational way of transforming a drug packaged for the Canadian market into a drug that meets the U.S. requirements of the DSCSA’s track-and-trace system.

“Then there’s the reality that the Canadians don’t sound very excited about this,” Holt said. “They could very easily take legislative action in their country to prohibit the importation of drugs to the U.S. or to give assurance that they won’t have drug shortages. I’m not sure why drug companies would increase their sales if it’s all just being brought back here.”

The bottom line is that all cost savings evaporate when accounting for the cost of quality testing, the medical consequences of treatment failure, & the cost of treating an adverse medical event. I have studied drug importation programs for more than two decades & recently completed an exhaustive analysis of the cost effectiveness of such programs. In an analysis of 24 drugs obtained from Canada, I find that the presumed savings are exhausted in the treatment of only one patient in the case of Nexium for a representative state.

December 17, 2019

Canada's ambassador to the U.S. said last month that importing medicines from north of the border would not significantly lower U.S. prices. Reuters previously reported that Canada had warned U.S. officials it would oppose any import plan that might threaten the Canadian drug supply or raise costs for Canadians.

Earlier this year Canada's acting ambassador to Washington expressed concerns after a meeting with White House officials. "Canada represents only 2% of global pharmaceutical consumption (compared with) America's 44%," Ambassador Kirsten Hillman said in a statement. "Not only are we too small of a market, Canada cannot increase its domestic pharmaceutical drug supply to meet U.S. demand."

“Our government will protect our supply of and access to medication that Canadians rely on,” said Alexander Cohen, a spokesman for Canada’s Minister of Health.

December 18, 2019

Health and Human Services Secretary Alex Azar said the administration also does not have a projection on any cost savings from importing drugs into the U.S.

“While safe and secure, the Canadian market is too small to have a real impact on U.S. drug prices. The U.S. consumes 44% of the global prescription drug supply, compared to Canada’s 2%.”

Canada relies on imported prescription drugs, and cannot readily expand production to meet U.S. demand. Canada imports approximately 70% of its prescription drugs.

"Today's proposal undermines the DSCSA's protections by introducing unsecure foreign prescription drug packages into our drug supply and commingling them with secure FDA-approved products. The lack of clarity around unknown, unproven cost savings does not justify jeopardizing U.S. supply chain integrity and patient safety."

December 18, 2019

December 18, 2019

December 19, 2019

December 19, 2019

December 19, 2019

When the nonpartisan Congressional Budget Office reviewed the prospects of importation in 2004, it concluded that it would lead to few drugs entering the U.S., and small savings. And only drops from that pot of savings will flow to consumers.

American Society of Health-System Pharmacists "has long been opposed to importing drugs from Canada due to safety concerns. 'One of our main concerns with the safety of importation is potentially bypassing safety requirements intended to protect against contaminated or counterfeit medications."”

The NCL's "primary concerns are that this proposed new rule will put the public at greater risk of counterfeit drugs while not clearly passing on any cost savings on to consumer."

“Patients deserve access to the medicines they need with out-of-pocket costs they can afford. Under no circumstance should we risk patient safety to achieve this goal, yet that’s exactly what this dangerous importation scheme will do."

December 20, 2019

December 20, 2019

December 22, 2019

December 23, 2019

December 28, 2019

December 30, 2019

January 2, 2020

January 2, 2020

January 3, 2020