Regulatory Focus™ > News Articles > 2020 > 3 > Drugmakers, Canadians Balk at FDA’s Safe Importation Plan

Drugmakers, Canadians Balk at FDA’s Safe Importation Plan

Posted 16 March 2020 | By Michael Mezher 

Drugmakers, Canadians Balk at FDA’s Safe Importation Plan

Pharmaceutical industry groups and Canadian pharmacists staunchly opposed the US plan to allow states and drug companies to import certain prescription drugs from Canada and other countries in an effort to lower costs.
In comments submitted to the public docket for the US Food and Drug Administration’s (FDA) proposed rule on importation, the two groups pushed back on the plan, citing insignificant cost savings, safety concerns and the capacity of Canada’s drug supply chain to meet US demand.
The comments come as states around the country, including Connecticut, New Mexico, Maine, Oklahoma, Vermont and Wyoming weigh measures to move forward with importing drugs.
In its 81-page comment, the Pharmaceutical Research and Manufacturers of America (PhRMA) calls on the Department of Health and Human Services to abandon the proposal and withdraw the notice of proposed rulemaking.
The pharmaceutical industry group also questions the safety of drugs that would be imported under the proposal and argued that the cost savings it would achieve would not make a significant dent in US health care spending.
Additionally, PhRMA raised a range of legal concerns, including that the proposal is at odds with authorities provided under the Federal Food, Drug, and Cosmetic Act, the First Amendment and the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights.
While its members are somewhat shielded from the proposal, as it does not allow for the importation of biologics, the Biotechnology Innovation Organization (BIO) echoed many of PhRMA’s arguments against importation.
“Even with this exclusion, however, we believe that implementing this rule will still pose considerable risks to public health and safety and will not result in a significant reduction in costs of imported prescription drugs to the American consumer,” BIO writes.
Multiple Canadian pharmacist groups, including the Canadian Pharmacists Association (CPhA), Canadian Society of Hospital Pharmacists and the Alliance for Safe Online Pharmacies Canada also opposed the plan, arguing that it would imperil Canada’s own drug supply and would do little to lower costs across the border.
While the proposal received more than 1,200 comments, some 900 of those appear to be from individual commenters repeating a prompt developed by the Partnership for Safe Medicines.
Public Docket


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