Drug industry warns importing meds risky

Health and Human Services Secretary Alex Azar pauses while speaking during a Cabinet meeting at the White House in Washington. Azar says he and President Donald Trump are working on a plan to allow Ameri

Trump administration unveils plan to allow drug importation from Canada

"President Trump has been clear: for too long American patients have been paying exorbitantly high prices for prescription drugs that are made available to other countries at lower prices", Azar said in a statement.

"Today's announcement outlines the pathways the administration intends to explore to allow safe importation of certain prescription drugs to lower prices and reduce out-of-pocket costs for American patients".

HHS Secretary Alex Azar claimed the plan was a pathway to ending "foreign freeloading".

The drug industry lobby says the Trump administration's plan to let Americans import cheaper prescription drugs from Canada is "far too unsafe". The plan includes a proposal to import FDA-approved drugs from other countries like Canada. Some states - including Florida and Colorado - have already passed drug import laws, and several others have proposed the idea.

Azar, a former drug industry executive, says USA patients will be able to import medications safely and effectively, with oversight from the Food and Drug Administration.

Drug pricing is an important election issue for Trump and also for Democrats, many of whom have said they would support importing medicines to lower USA drug prices.

"Pharmaceutical distributors support efforts to address the high cost of prescription drugs", a statement by the HDA read. "Drugs coming through Canada could have originated from anywhere in the world". "This pathway would highlight an opportunity for manufacturers to use importation to offer lower-cost versions of their drugs", the FDA stated.

Indeed, most high-income countries have adopted price control strategies, such as centralized price negotiations, national formularies and comparative and cost-effective analysis for setting price ceilings to limit how much drug manufacturers can charge. He and presidential candidate Sen. Azar spoke of a regulatory process lasting "weeks and months" and he also called on Congress to pass legislation that would lend its muscle to the effort, even short-circuit attempts to overturn the changes in court.

The importation idea won praise from a key lawmaker, Sen. Trump is also supporting bipartisan legislation in the Senate that would limit prescription copays for people on Medicare and require drugmakers to pay the government rebates if the cost of their medications goes up faster than inflation. "There is no way to guarantee the safety of drugs that come into the country from outside the United States' gold-standard supply chain".

Current FDA regulations prohibit importation of unapproved drugs, which includes foreign-made versions of drugs that are approved in the USA and "have not been manufactured in accordance with and pursuant to an FDA approval".

"In many advanced industrial countries, there is a national health insurance system that is effectively the dominant purchaser of pharmaceuticals in the country, and that purchaser deliberately uses its monopsony power to try and bargain down global pharmaceutical companies to something close to the lowest price they would accept to be able to sell their drug in that economy", Branstetter told Salon.

"We request that Health Canada provide clarity and assurances to Canadians that USA legislation will not inadvertently disrupt Canada's pharmaceutical supply and negatively impact patient care through greater drug shortages", the group wrote in a July 25 letter to Health Minister Ginette Petitpas Taylor.

But consumer groups have strongly backed the idea, arguing that it will pressure USA drugmakers to reduce their prices.

Lee Branstetter, an economics and public policy professor at Carnegie Mellon University who served on former President Barack Obama's Council of Economic Advisors, explained to Salon that prices are higher in the USA because the country does not employ the same policies approaches to lower drug prices used by many other developed countries, including price controls, reference pricing and cost-effectiveness thresholds.

But it will likely take a while before these lower-priced medications find their way into patients' hands.

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