Senator Bernie Sanders introduced the Affordable and Safe Prescription Drug Importation Act in late February in an effort to provide US-based pharmacies with a legal route of importing less expensive branded pharmaceuticals from Canada. While not a new idea, Sanders and other proponents of the bill hope that it could provide patients with a more affordable way of getting their medications while encouraging drug pricing competition in the country.
If approved, the bill could save the US federal government up to $7 billion in healthcare costs over the next 10 years, according to the Congressional Budget Office. Not surprisingly, pharmaceutical companies and others are opposed to bill, saying it unnecessarily introduces drug safety issues.
“Allowing the importation of drugs from other countries into the United States would be unsafe and lead to potentially dangerous outcomes for patients,” said Allyson Funk, former senior director of public affairs at pharmaceutical industry trade group PhRMA, in a blog post on the website. “Importation exposes Americans to the risk of counterfeit, diverted, adulterated, improperly stored or repackaged medicines. Importation also lacks proper oversight and enforcement and increases the potential to compromise the safety of the US drug supply system.”
Four former US Food and Drug Administration (FDA) Commissioners have also publicly denounced the idea of importing drugs in a letter to Congress. In their letter, Robert Califf, Mark McClellan, Margaret Hamburg and Andrew Von Eschenbach all highlight potential safety issues of drug importation, including a lack of tracking and oversight.
“Allowing importation of drugs purported to be manufactured overseas in FDA-inspected facilities and drugs purported to be manufactured domestically for export to other countries and reimported from those countries to the United States cannot meet the requirements under the existing closed drug manufacturing and distribution system because the drugs could not be tracked and certified by the manufacturer,” said the letter written by the former FDA Commissioners. “It could lead to a host of unintended consequences and undesirable effects, including serious harm stemming from the use of adulterated, substandard, or counterfeit drugs.”
Current FDA Commissioner Scott Gottlieb appears to agree with his predecessors. In an article written for Forbes in March of 2016, he commented on then-presidential candidate Donald Trump’s healthcare plan to lower the cost of prescription drugs.
“The problem is that drug importation doesn’t address any of these core challenges,” said Gottlieb. “In fact, the imported drugs may end up being quite expensive.”
If passed, Sanders’ bill would only allow wholesalers, pharmacies and individual patients to import drugs from FDA-inspected manufacturing facilities in Canada. A Kaiser Family Foundation poll found that about eight percent of US patients already buy their prescription drugs from other countries, including Canada, due to cost differences.
“While five major drug manufacturers made more than $50 billion in profits in 2015, nearly 1 in 5 American adults could not afford the medicine they were prescribed,” said a statement released by Sanders. “Allowing the importation of safe and affordable prescription drugs is overwhelmingly supported by the American people with 71 percent in favor of allowing Americans to buy prescription drugs from Canada.”