The preliminary proposal known as the Safe Importation Action Plan would permit states, pharmacies, and drug distributors to import prescription medications from Canada.
Prices of prescription drugs in Canada and other countries can be cheaper than in the United States because their health care systems are controlled by the government and they directly limit the amount they pay for prescription drugs.
“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,” Secretary Alex Azar of the U.S. Department of Health and Human Services said in a statement announcing the plan on July 31.
Opening the door for Canadian drug imports is an idea candidates for the Democratic presidential nomination have been pushing. Days before the Trump administration’s announcement, Sen. Bernie Sanders (I-Vermont) led a group of people with diabetes to Canada to buy lower-priced insulin.
The program won’t go into effect soon, says Sally C. Pipes, president and chief executive officer of the Pacific Research Institute.
“With the pilot program set up as it is now, this wouldn’t become a reality until after the 2020 election,” Pipes said.
The plan must go through regulatory approval, and there are potential court challenges, Washington University law professor and drug policy expert Rachel Sachs told National Public Radio.
“This is a plan to make a plan on importation,” Sachs stated. “This is not happening in the next week, in the next month, or likely even in the next year, because the administration will need to carry out the rulemaking process.”
The Trump administration’s proposed plan would provide two pathways for drug importation. First, it would permit states, wholesalers, and pharmacists to get U.S. Food and Drug Administration (FDA) approval to import from Canada medications that are versions of FDA-approved drugs manufactured consistent with the originals.
Second, the proposal would permit drug manufacturers to request approval for reimportation of drugs they sell in foreign countries. To take advantage of this pathway, the manufacturer would have to show the FDA the foreign version is the same as the U.S. version and appropriately label the drug for sale the United States.
Quality Control Concerns
Although a Kaiser Family Foundation poll from early 2019 found 80 percent of Americans surveyed support Canadian drug imports, the process would not be as simple as the importation of other goods.
A major concern for industry groups is the quality and potential harm of the imported drugs. Drugs approved in the United States are carefully tracked from manufacturing to the pharmacy, whereas those not originally destined for the United States market do not undergo the same thorough scrutiny of the supply chain.
Pharmaceutical Research and Manufacturers of America President Stephen Ubl called the plan “far too dangerous” for American patients.
“There is no way to guarantee the safety of drugs that come into the country from outside the United States’ gold-standard supply chain,” Ubl said in a statement. “Drugs coming through Canada could have originated from anywhere in the world.”
Expecting Too Much?
Canada does not have a sufficient supply of prescription drugs that can be imported into the United States, says Pipes.
“How can Canada supply all these drugs?” said Pipes. “We have a number of states that have signed or are considering drug importation bills. We have over 300 million people in the U.S. versus 37 million in Canada. If 20 percent of U.S. prescriptions were filled in Canada, the supply in Canada could be depleted in 200 days.”
Importing large quantities of drugs from Canada could put pressure on Canada to augment its supply with more imports from other countries, says Pipes.
“That would put Americans at risk,” said Pipes. “Most people can’t tell if a drug is counterfeit or not. Don’t forget the CanadaDrugs.com case. The company was fined $34 million for selling two cancer drugs with no pharmaceutical ingredients.”
Kelsey E. Hackem ([email protected]) is an attorney who writes from Washington.