Feds reverse, now ‘open’ to ideas on drug imports
A year after calling proposals allowing Americans to import cheaper drugs from Canada a “gimmick,” Health and Human Services Secretary Alex Azar said the federal government is “open for business” on such a strategy.
Azar announced a preliminary plan Wednesday to allow Americans to import certain lower-cost drugs from Canada.
Insulin and other biological drugs, controlled substances and intravenous drugs would not be included.
The plan relies on states to come up with proposals for safe importation and submit them for federal approval.
Under a second option, manufacturers could import versions of FDA-approved drugs from foreign countries and sell them at a lower cost than the same U.S. versions.
This appears to be a way drugmakers could avoid some of the contracts they have with drug middlemen, known as pharmacy benefit managers.
“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,” according to the plan announced Wednesday. “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.”
The announcement marked the latest shift by the Trump administration on the decades-old debate about formally allowing Americans to buy drugs from Canada, where prices are lower.
Drugmakers were quick to criticize the plan.
Stephen Ubl, president and CEO of the brand-name drug trade group, the Pharmaceutical Research and Manufacturers of America, 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,” he said in a statement. “Drugs coming through Canada could have originated from anywhere in the world and may not have undergone stringent review by the FDA.”
The same medicines often are cheaper in other countries than in the U.S. since most developed countries negotiate with drugmakers to set prices. But opponents of importation say sending drugs over the border will increase the chances Americans get counterfeit medications.
As drug prices have soared, Americans are more open to buying drugs from Canada. Some have for decades been driving over the border; others use online pharmacies or place orders at storefronts that connect buyers to pharmacies in Canada and other countries.
Although these strategies technically are illegal, the government doesn’t prosecute individual offenders. Nor has it moved to stop the dozens of cities, counties and school districts that have programs for employees to buy drugs from Canada and elsewhere.
In May 2018, Azar said the prospect of importing drugs from Canada was just a “gimmick” because that country isn’t large enough to meet all U.S. drug needs.
But lowering drug prices has been a key promise of President Donald Trump, and a few months later, Azar said he was forming a work group that would explore allowing certain drugs that had seen major price boosts to be imported.
The idea got a boost this spring when Trump offered his support, marking the first time drug importation has won a presidential endorsement.
The 2003 Medicare Modernization Act allows states to import cheaper drugs from Canada, but only if the HHS secretary verifies their safety.
Azar, a former top executive at the drugmaker Eli Lilly, said Wednesday that the federal government has changed its “mindset” on the issue.
He acknowledged that HHS and the Food and Drug Administration have consistently said there was no way importing drugs from Canada could be done without putting patients at risk for counterfeit drugs.