In hopes for re-election, the Trump administration announced Wednesday that it would create a way for Americans to legally and safely import prescription drugs from Canada to address public outcry regarding price hikes.
President Donald Trump is feeling the pressure from a 2016 campaign promise, where he said to weaken the import ban on pharmaceutical drugs to provide cheaper alternatives.
If the promise goes through, this would be the first time that Canada will be allowed to import drugs to its neighbor country — reversing years of refusals by health authorities.
Health and Human Services Secretary, Alex Azar, made the announcement and said that the administration recognizes that prescription drug — manufacturing and distribution — is now international.
“The landscape and the opportunities for safe linkage between drug supply chains [have] changed,” Azar said.
“That is part of why, for the first time in HHS’s history, we are open to importation. We want to see proposals from states, distributors, and pharmacies that can help accomplish our shared goal of safe prescription drugs at lower prices,” the secretary added.
Previous administrations had been skeptical with the import of prescription drugs and have sided with the industry on the importation — noting concerns that those drugs could expose patients to risks from counterfeit or substandard medications.
However, this system has allowed U.S. pharmaceutical companies to raise prices without competition. In light of the upcoming 2020 election, health care has been a heated topic of debate, and candidates have made bold promises of changing the system to cater all Americans.
Furthermore, consumer complaints have also made waves, demanding legislation to change to rein in costs for life-sustaining drugs.
“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.
Most patients take affordable generic drugs to manage conditions such as high blood pressure or elevated cholesterol.
The prices for life-sustaining medications such as for cancer or hepatitis C infection annual costs can run up to $100,000 or much more. And long-available drugs like insulin have seen consecutive price increases that forced residents with diabetes to ration their doses.
As a form of protest, two groups have recently visited Canada to buy their much-needed insulin dosages, where a regular $350 to $450 vial in the U.S. can be purchased for only $35 to $45.
The second group was part of Vermont Sen. Bernie Sanders’ campaign to roll back prices on insulin and other drugs and lead an example of how he wants to implement the same healthcare system in Canada to the U.S.
While U.S. regulations cannot keep prices low enough for low-income Americans, the Trump administration’s latest announcement will at least provide a cheaper alternative compared to the overpriced variants available in the country.
Azar, who used to be skeptical of drug importation, and was once quoted dismissing it as a gimmick, said U.S. patients would be able to import medications safely and effectively — with oversight from the Food and Drug Administration. This will also be able to qualm concerns regarding the quality of drugs being introduced in the country.
However, according to Azar, the complex regulations that the government is trying to create could take “weeks and months.” He called on Congress to pass legislation that would lend its muscle to the effort, making it harder to overturn the policy in court.
“The FDA has the resources to do this,” said acting FDA Commissioner Ned Sharpless.
“The agency is interested in considering any reasonable proposal that maintains the bedrock of safety and efficacy for the American consumer,” the commissioner added.
Per usual, the pharmaceutical industry opposed the move and indicated that it would be reckless and jeopardizes patients.
Stephen Ubl, president of the industry group 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,” Ubl said in a statement. “Drugs coming through Canada could have originated from anywhere in the world.”
Other than from the American side, Canadian pharmacists fear changes to medication purchasing regulations in the U.S. will lead to further drug shortages during an already stressful period.
Canadian pharmacies are already experiencing shortages of more than 1,000 medications, amounting to the worst deficit seen in more than 30 years.
Joelle Walker, the vice president of public affairs for the Canadian Pharmacists Association, worries that on top of the potential drug shortages, the change in regulation could also increase the prices of drugs for Canadians.
“Pharmacists are there every day; they want to help patients that walk through their doors,” she said. “Our concern is what policies can be put in place to make sure that we’re not seeing massive amounts of medications that are designed for the Canadian market that end up going to the United States?”
Meanwhile, in response to speculation regarding the reliability and safety of drugs coming from Canada, the office of Health Minister Ginette Petitpas Taylor said in a statement that they are proud of Canada’s health care system and that the U.S.’ interest in Canadian medications is evidence of their “commitment to more affordable prescription drugs.”
Furthermore, addressing fears for Canadian drug supplies, Taylor said:
“Ensuring that Canadians have access to the medicines they need is one of our top priorities,” the statement continues. “We constantly monitor Canada’s drug supply, will be working closely with health experts to understand the implications for Canadians better and will ensure there are no adverse effects to the supply or cost of prescription drugs in Canada.”