Democrats Revive Canada Drug Import Bill as Safety Questions Linger

Regulatory NewsRegulatory News | 28 February 2017 |  By 

Sens. Bernie Sanders (D-VT) and several colleagues who previously opposed such a measure, Cory Booker (D-NJ), Bob Casey (D-PA), Martin Heinrich (D-NM), Angus King (I-ME), alongside Reps. Elijah Cummings (D-MD) and Lloyd Doggett (D-TX) on Tuesday revived legislation lingering for more than a decade to allow the importation of medicines from Canada and other countries to help lower US drug prices.

Sanders called the bill "critical" on Tuesday at a press conference, saying the medicines coming in from Canada is 100% safe and will lower costs. But part of the bill would require companies seeking to bring their drugs into the US to register with the US Food and Drug Administration (FDA) and pay a certification fee.

Also, all companies manufacturing the drugs introduced into Canada and other OECD member countries (most of the EU, Australia, Israel, Japan, Korea, Norway and New Zealand, among others) have to be in compliance with FDA's good manufacturing practice regulations.

All previous legislative efforts, dating back to at least 2003, to allow such imports have failed and run into fierce opposition from the pharmaceutical industry and FDA, with previous commissioners saying such imports cannot be guaranteed as safe.

That opposition appeared again on Tuesday when the Partnership for Safe Medicines and nearly 170 industry-backed groups sent a letter to all members of Congress urging them to “stand against efforts that would allow substandard and even dangerous counterfeit medicines to flow freely across U.S. borders.”

Other experts, however, have said there is no indication that Canadian drugs are less safe or effective than US drugs.

And the bill may have a better shot at passage this year than in the past, particularly as more than a dozen Republicans voted in favor of an amendment in January that would allow such imports, and President Donald Trump has said he supports them.

Earlier this month, Sens. Charles Grassley (R-IA), John McCain (R-AZ) and Amy Klobuchar (D-MN) sent a letter to Tom Price, the newly confirmed secretary of the Department of Health and Human Services, calling on him to fast-track the approval of prescription drugs imported from Canada in four different circumstances, including if the price of a drug increases significantly.

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