Canada Enacts New Regulations Before US Drug Import Rule | United States



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The Trump administration’s new rule that allows U.S. pharmacists and wholesalers to import wholesale prescription drugs from Canada will take effect on Monday.

The Canadian government has announced new measures said to be designed to prevent drug shortages, just days before a new Trump administration rule allows pharmacists and wholesalers in the United States to import drugs from Canada.

In a statement on Saturday, Canada said that as of Friday it has been banned from distributing certain drugs to the Canadian market outside the country “if that sale causes or worsens a drug shortage.”

Companies must also provide the government with information on existing or potential deficiencies when requested. Such requests must be answered within 24 hours in the event of a serious or imminent health risk, the statement said.

“Our healthcare system is a symbol of our national identity and we are committed to defending it. The actions we are taking today will help protect Canadians’ access to the drugs they rely on, ”said Canadian Health Minister Patty Hadju.

U.S. President Donald Trump announced plans late last year to allow U.S. states and indigenous governments to set up programs to import prescription drugs from Canada as part of an effort to reduce what are often costs. exorbitant for American consumers.

That new regulation, known as the prescription drug import rule, will go into effect on Monday.

Under the new regulations, indigenous governments, pharmacists and wholesalers will be able to propose proposals for the import of drugs to the US Food and Drug Administration (FDA).

Importers need to demonstrate how such proposals comply with U.S. health and safety regulations and help cut costs, the rule states.

“The purpose … is to achieve a significant reduction in the cost of covered products to the American consumer without posing any additional risk to the health and safety of the public,” under the new rule.

Ottawa said importing drugs from Canada would not help cope with the high costs in the US as the Canadian prescription drug market accounts for only 2% of global sales.

The cost of prescription drugs in the United States is often exorbitant [File: George Frey/Reuters]

But several states in the United States, including Florida and Vermont, have expressed interest in importing drugs from Canada, the head of the U.S. Department of Health and Human Services (HHS) Alex Azar said last year. , according to the Reuters news agency.

On November 23, Florida Republican Governor Ron DeSantis announced he had submitted a proposal to HHS to import drugs from Canada.

The state will begin by importing drugs to help people with chronic health conditions including asthma, diabetes and HIV / AIDS, DeSantis said in a statement.

“For too long, Floridians have been paying exorbitant prices for prescription drugs,” he said. “Today, we take another step towards lowering these prices.”

US drug companies raised opposition, however, and earlier this week, three industry groups filed a lawsuit against the new regulation, claiming it “ignores key protections … designed to ensure patient safety.”

“It is alarming that the administration has chosen to pursue a policy that threatens public health while we are fighting a global pandemic,” James Stansel, executive vice president of Pharmaceutical Research and Manufacturers of America, said in a statement.

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