Drug importation forces choice between price, safety

A little over a year ago, Health and Human Services Secretary Alex Azar joined the ranks of every other HHS Secretary in modern history opposing the idea of drug importation and referred to it as “a gimmick.” Unfortunately, we are now faced with a political gimmick after Secretary

Azar announced an importation action plan that unfortunately will not lower out of pocket costs, and instead create great safety concerns for American patients.

This movement came after Gov. DeSantis and the Florida Legislature searched for innovative ways to help provide quality health care for our older Americans at an affordable price during the 2019 Legislative Session. Unfortunately, one of the revolutionary changes made will allow Floridians to buy their medications from Canada and other international countries, threatening the extraordinary progress made over the last decade.

Drug prices are a major concern for senior citizens, but we cannot jeopardize the life of an older American by taking shortcuts. The American Senior Alliance, a nonprofit organization that brings together our nation’s senior citizens to defend their values and protect the rights and services they have earned, testified in several Florida House and Senate Committee hearings and made several credible recommendations to help save on costs with a focus on lowering the out-of-pocket costs for seniors. However, importing prescription medications and risking counterfeit purchases is definitely not the prudent way to proceed.

Product safety is vital. By importing medicines from countries that do not have our same high-quality standards could easily taint our medicine supply chain. A recent CNN article, “Fake Drugs, The Global Industry Putting Your Life at Risk,” crystallized our message when it said, “The manufacture and distribution of medicines today is a complex, globalized affair that it is often hard to track where fake or substandard medicines come from and where they go.” Meanwhile, the FDA has estimated 99.1% of drug products entering the U.S. through international mail in 2019 is non-compliant with agency standards.

Former FDA Commissioner Scott Gottlieb got our attention early on when he said, “The drug importation scheme contemplated by Florida is ill-advised when considered against the state’s long history of being home to importation ‘front groups’ supplying drugs of troubling origin, quality and legitimacy.” The Wall Street Journal joined in as well, saying the importation plan was “impractical, unsafe, and unlikely to reduce prices at the pharmacy.”

It has only been a few years since America’s most recognizable neurosurgeon, Dr Sanjay Gupta, reported on CBS’ “60 Minutes” that “fake versions of antibiotics, blood pressure drugs, pain-killers and other common medications can be hard to tell from the real things. Sadly, these drugs are made under unsanitary conditions and are typically without the active ingredients necessary, if they have any at all. Once the counterfeits are made, they are sold through websites that offer drugs at a deep discount from their mainstream price.” What was even more alarming, “Thirty-six million Americans are believed to have bought their medicines from these websites, including some sites that pretend to be based in Canada, where legitimate prescription drugs are available for lower prices than in the U.S.” How can importing medications be a good idea for our older Americans who sometimes have cognitive challenges and who often search “high and low” to save on purchases?

Unfortunately, Canadian suppliers will not comply with the U.S. Track and Trace system, which allows a drug to be tracked throughout the supply chain and traced back up the supply chain upon return or recall, and cannot be sanctioned for failing to do so. Canada does not have a closed loop supply chain tracking system to integrate with the U.S. Track and Trace system. Foreign suppliers that supply information to the Track and Trace system will face no legal sanction because the State of Florida has no regulatory authority over them.

Alternatives must be found to address the major concern of out-of-pocket drug prices, but we cannot jeopardize the life of an older American by adopting shortsighted “solutions.”