Washington, DC – The United States Health Czar announced in a tweet on July 31 “a new action plan to lay the foundation for the safe importation of certain prescription drugs,” adding, “This is the next important step the Administration is taking to address foreign freeloading and lower the cost of drugs for Americans.” There are, however, warning flags raised by the Northern neighbor as shortages are rising there in supply chains.
In the detailed Action Plan, link cited in his tweet, by the US Health and Human Services Secretary Alex Azar, one of the two pathways to allow safe drug importation from foreign markets mentions Canada.
“Through a notice of proposed rulemaking (NPRM), HHS and FDA would propose to rely on the authority under current federal law (Federal Food, Drug, and Cosmetic Act (“FD&C Act”) Section 804) that would, when the rule is finalized, authorize pilot (or demonstration) projects developed by states, wholesalers or pharmacists and submitted for HHS review, outlining how they would import certain drugs from Canada that are versions of FDA-approved drugs that are manufactured consistent with the FDA approval,” it reads. However, there is no time-frame mentioned nor what is going on about negotiations with the Canadian counterparts to smoothen the process.
Most of the cross-border experts in Canada that IAT reached out to didn’t want to be identified, but wondered if the small Canadian market will be able to not only meet the huge demands of the staggeringly big US drug market, but also manage to keep the Canadians supplied as planned by the Canadian Prime Minister in a recent policy statement.
Canadian Prime Minister Justin Trudeau said in a recent statement, “No Canadian should have to choose between putting food on the table and paying for the prescription drugs they or their family need. Through Budget 2019, we are taking action to make medication more accessible and to lower the cost of prescription drugs for Canadians of all ages. These are important steps toward building a system that helps all Canadians get the medicine they need when they need it.”
There was an alarm sounded by the Canadian Pharmacists Association (CPhA) over the US efforts to import drugs from Canada and thus put the meagre market resources at risk for the Canadians already facing a shortage. The shortfall was recently brought to light by a survey by the CPhA.
Highlighting the drug shortages in Canada as “an unfortunate daily reality for patients and pharmacists,” Barry Power, Senior Director, Digital Content, Canadian Pharmacists Association cautioned, “While we continue to be concerned about the growing number of drug shortages in Canada over the past few years, and the stress they place on patients and pharmacists, we now worry about the potential impact US drug importation legislation could have.”
Without mincing words, Power warned, “With over 20 pieces of legislation at the state and federal levels, the biggest risk for Canadians is exacerbating drug shortages – our drug supply simply is not equipped to supply a country 10 times our size.”