Last week, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) released their “Safe Importation Action Plan”. The action plan would allow importation of certain prescription drugs from Canada and other countries. Importing drugs, whether from Canada or elsewhere in the world, poses a big safety risk with a large portion of stakeholders expressing their concern about the plan.
Drug importation schemes increase the potential for counterfeit products entering the U.S. pharmaceutical supply chain which puts Americans in harms way.
The CEO of PhRMA, Stephen J. Ubl explained, “There is no way to guarantee the safety of drugs that come into the country from outside the United States’ gold-standard supply chain. Drugs coming through Canada could have originated from anywhere in the world and may not have undergone stringent review by the FDA.”
In Canada, there have also been concerns raised with a lot of people pointing out how the proposal is unworkable. As Joelle Walker, who is part of the Canadian Pharmacists Association explained to The Washington Post, “This is going to exacerbate some of the drug shortages that we’re already seeing in Canada …. We aren’t equipped to deal with a country that is ten times our size.”
When it comes to regulating the safety of the U.S. medicine supply, the FDA is the gold standard. The importation of drugs from other countries outside the FDA’s regulated, closed supply chain could adulterate U.S. medicines and have life-threatening consequences for American patients.
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