FDA Clears Route for Americans to Get Foreign Meds Cheaply

WASHINGTON (CN) – Americans will soon be able to import lower-cost prescription drugs from foreign countries like Canada as part of a plan unveiled Wednesday by the Trump administration.

Health and Human Services Secretary Alex Azar pauses while speaking during a Cabinet meeting at the White House on July 16, 2019. (AP Photo/Alex Brandon)

The announcement outlines two separate import pathways for pharmacists, wholesalers and states, using authority from sections of the Federal Food, Drug and Cosmetic Act.

Through one pathway, states, pharmacists and wholesalers can apply to the Federal Drug Administration to import specific, FDA-approved drugs authorized for sale in Canada. Applicants also must demonstrate that an imported medicine significantly reduces the cost to consumers.

Infused drugs, intravenously injected drugs and biological drugs are a few versions of prescriptions excluded from this rule.

A second pathway will allow manufacturers of FDA-approved drugs sold in foreign countries generally to import the medicine to the U.S., so long as the drugs have the same effect.

“The administration has reason to believe that manufacturers might use this pathway as an opportunity to offer Americans lower cost versions of their own drugs,” the FDA’s announcement states. “In recent years, multiple manufacturers have stated (either publicly or in statements to the Administration) that they wanted to offer lower cost versions but could not readily do so because they were locked into contracts with other parties in the supply chain.”

Consumers may not see results of this plan for months, as it will first go through stringent regulatory approval.

Christine Simmon, senior vice president for the Association for Assessable Medicines – an advocacy group focused on improving access to generic medicine – said there are more immediate ways to pass savings to patients.

“As the Trump administration considers ways of bringing down drug costs for Americans, there are a number of policies they could implement immediately, like ensuring generic and biosimilar medicines are automatically placed on generic formulary tiers, that would produce billions of dollars of savings for patients and taxpayers,” Simmon said in a statement.

David Mitchell, a cancer patient who founded Patients for Affordable Drugs, also emphasized the early stages of the FDA’s plan.

“We are glad that the administration has opened the door to importation of drugs from Canada and other countries,” Mitchell said. “But this is not the comprehensive answer we need to solve the drug pricing crisis.

“It is a notice of proposed rulemaking that will take time to implement. It will only affect a subset of drugs in limited demonstration projects, potentially providing relief to a relatively small number of Americans,” Mitchell continued. “We stand ready to support the administration as it works to prepare and implement an importation rule. And we look forward to additional actions that will lower list prices of prescription drugs.”

Health and Human Services Secretary Alex Azar noted Wednesday on Twitter that the plan is an important step to address “foreign freeloading,” and to lower the cost of drugs for Americans.

In a separate tweet, Azar thanked Florida Governor Ron DeSantis and other state legislators for bringing attention to the issue. DeSantis signed a bill in June allowing Floridians to import drugs from foreign countries.

President Donald Trump also tweeted this morning about the plan, saying state governors would be happy.

“Lowering drug prices for many Americans – including our great seniors!” the president tweeted, tagging both Desantis and Colorado Governor Jared Polis in the message.

The plan is a vehicle for Trump to fulfill a 2016 campaign promise to lower the cost of prescription drugs. Tackling the issue has provided a common ground between members of both political parties, most notably, when Representative Elijah Cummings, D-Md., agreed to meet with the president to discuss drug prices in 2017.

Cummings, who has endured recent attacks from Trump on Twitter, provided the president with draft legislation allowing Health and Human Services to negotiate drug prices. The administration never communicated with Cummings about the issue after this meeting.

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