The Trump administration released Wednesday a proposed rule that would allow states to import certain prescription drugs from Canada in an attempt to lower drug costs in the U.S.
Federal health officials also announced the release of a draft guidance that explains how manufacturers could import drugs and biological products originally intended for sale in other countries.
“Today’s announcement outlines two pathways for the safe importation of certain prescription drugs to help provide safe, effective, more affordable drugs to American patients,” said Health and Human Services Secretary Alex M. Azar II, describing safe importation as a “commonsense approach” to lowering drug costs.
Although it is unclear if drug importation will affect health care costs before the 2020 election, the Trump administration has gone beyond its predecessors in trying to establish a regulated system for drug importation.
Due to price controls, other advanced countries pay less for medicines than the U.S.
A government report shows that U.S. prescription drugs prices decreased by 1% last year — a first in 45 years. The slight decrease is attributed to declines for generics and slow growth in the cost of brand-name medications.
The proposed rules for drug importation follow an announcement the Trump administration made in July.
“I’ve been a longtime advocate of allowing prescription medicine from Canada to be imported to the United States,” said Senate Finance Committee Chairman Chuck Grassley, who is pushing for broader pricing legislation in Congress that President Trump has endorsed. “This proposal would ensure that any drugs imported for sale to Americans abides by strict FDA health and safety standards.”
The U.S. government has no estimates on the amount of money consumers might save from the drug importation plan since it is unknown how many states will want to participate. The governors of Florida, Maine, Colorado, Vermont and New Hampshire already have expressed interest in importing drugs from Canada, according to Reuters.
However, pharmaceutical companies and Canada have criticized the drug importation plan.
Pharmaceutical companies have successfully opposed drug importation for years. The industry has argued that drug importation won’t lower costs and also doesn’t guarantee the safety of medicines purchased from other countries.
“At a time when there are pragmatic policy solutions being considered to lower costs for seniors at the pharmacy counter and increase competition in the market, it is disappointing the administration once again put politics over patients,” said Stephen Ubl, president and CEO of PhRMA. “The administration chose to proceed with an importation scheme that could endanger American lives, could worsen the opioid crisis and has been called unworkable by Canadian officials.”
Health experts have expressed concern that the U.S. government’s plan could exacerbate drug shortages in Canada.
“The Canadian market does not have enough drugs to meet U.S. needs,” said Jason Shafrin, senior director of policy and economics for Precision Xtract. “The U.S. population is more than nine times as large as Canada’s, and total U.S. pharmaceutical market is 20 times as large as Canada’s. Even if only 40% of U.S. prescriptions were filled by imports from Canada, the Canadian drug supply would be exhausted in 118 days.”
“Further, drug companies are likely to respond to drug importation by either raising prices for their drugs in Canada or deciding not to enter the Canadian market at all,” Mr. Shafrin said. “While many politicians claim that importing drugs from Canada has the potential to bring down drug costs, in practice it is not a long-run workable solution.”
Canada has warned U.S. officials that it would oppose any import plan that might raise drug costs for its citizens or threaten the country’s drug supply.
The proposed rule issued Wednesday mainly would cover pills and would exclude insulin, biologic drugs, narcotics and certain other medications.
Capitol Hill is taking other actions to cut drug costs. Both the House and the Senate are working on legislation to lower prices.
A bipartisan bill in the Senate, which passed the House, from Speaker Nancy Pelosi would limit out-of-pocket costs for medicines for Medicare recipients and penalize drug companies that set their prices above the inflation rate. Mrs. Pelosi also would give Medicare the authority to negotiate drug prices.
The White House has threatened to veto Mrs. Pelosi’s bill due to Republican opposition to Medicare negotiations.
• Tom Howell Jr. contributed to this article, which is based in part on wire service reports.
• Shen Wu Tan can be reached at stan@washingtontimes.com.
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