Federal laws and Executive Orders have legalized third party importation of prescription drugs with FDA approval, but the concept has not yet been tested in court due to standing. Now that Florida's plan has been approved by FDA, PhRMA will embark on a court test(s):
FDA approves Florida's plan to import cheaper drugs from Canada
By Sydney Lupkin - January 5, 2024Florida is one step closer to being able to import cheaper prescription drugs from Canada.
The Food and Drug Administration says it has authorized Florida's proposed program to import selected drugs.
Under federal law, any state or tribe can submit a proposal for importation, and a few have. The law allows importation of certain prescription drugs in bulk if doing so would save Americans money without adding safety risks. The FDA also has to give its blessing.
Florida's proposal, championed by Republican Gov. Ron DeSantis, is the first to be OK'd by the agency.
The state has to clear a lot more hurdles, however, before imports could begin. Among other things, it has to specify which drugs it wants to import, verify that they meet FDA's standards and relabel them.
While the FDA authorization is a major policy change, experts also say it alone won't solve the United States' problem with high-priced drugs.
Canada's drug supply is too small, and the country has already taken steps to protect it.
The pharmaceutical industry has pushed back and is expected to sue.
"We are deeply concerned with the FDA's reckless decision to approve Florida's state importation plan," says a statement from Stephen Ubl, president and CEO of the drug industry trade group PhRMA. "Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health. ... PhRMA is considering all options for preventing this policy from harming patients."
Health Canada is not enthusiastic about the Florida plan. Florida's population (and hence pharmaceutical demand) is about two-thirds of the entirety of Canada. Exporting Canadian pharmaceuticals to Florida could quickly result in critical drug shortages across Canada:
Statement from Health Canada on FDA decision on Florida bulk drug importation plan
Statement
January 8, 2024 | Ottawa, Ontario | Health Canada
On January 5, the U.S. Food and Drug Administration (FDA) approved the state of Florida's plan to import select Canadian prescription drugs in bulk. The Government of Canada is taking all necessary action to safeguard the drug supply and ensure Canadians have access to the prescription drugs they need and has been clear in its position: bulk importation will not provide an effective solution to the problem of high drug prices in the U.S.
Regulations have been implemented under the Food and Drugs Act to prohibit certain drugs intended for the Canadian market from being sold for consumption outside of Canada if that sale could cause, or worsen, a drug shortage in Canada. This includes all drugs that are eligible for bulk importation to the U.S., including those identified in Florida's bulk importation plan, or any other US state's future importation programs.
Health Canada is actively monitoring the Canadian drug supply and continues to ensure that Canadians have access to the drugs that they need. The Department has informed regulated parties of their obligations under Canadian regulations, including the requirement to not distribute a drug to another person for consumption or use outside Canada unless the person holding the licence has reasonable grounds to believe that the distribution will not cause or worsen a shortage of the drug in Canada and has retained detailed records of the information relied upon to make that determination. The Department will not hesitate to take immediate action to address non-compliance, ranging from requesting a plan for corrective measures, issuing a public advisory or other forms of communication, to taking action on the licenses of regulated parties who contravene the export prohibition if warranted.
Health Canada has listened to Canadians and has consulted with industry stakeholders, pharmacists, provinces and territories, patient groups, and medical associations. All agree that the Canadian government must remain focused on ensuring a stable and adequate supply of prescription drugs for Canadians. Health Canada stands ready to take immediate additional action, if needed, to help safeguard the Canadian drug supply.
Contacts
Media Relations
Health Canada
613-957-2983
media@hc-sc.gc.ca
The Canadian healthcare system is already floundering in its own political morass, and hardly needs the additional issue of chronic drug shortages.
The pharmaceutical industry has pulled out all the stops to maintain their pricing power. The prices of ethical pharmaceuticals increase at rates that far outstrip inflation due to a tiered pricing policy that also encourages black/grey markets:
Dangerous Drug Importation Is Not a Silver Bullet for High Prices
By Mary Bono - January 10, 2024The FDA recently approved Florida’s proposal to import drugs from Canada despite concerns over safety and available supply in Canada. In the middle of a heated presidential campaign, perhaps the political calculations outweigh evidence that importing drugs from Canada, or anywhere else for that matter, is the silver bullet that will immediately bring down the price of prescription drugs.
Federal law states that drug importation can only be allowed if there is “no additional risk” to safety and will “result in a significant reduction” in the cost of drugs. By any reasonable measure, Florida’s plan fails on both counts.
At least 24 U.S. Republican senators and nine conservative organizations have spoken out against importation. These voices understand that importation would drastically undermine patient safety by opening the floodgates to counterfeit drugs, which is estimated to be between a $200 billion and $432 billion a year industry globally.
This isn’t theoretical. The chorus of pro-importation voices are already undermining safety. According to the National Association of Boards of Pharmacy, nearly three-quarters of the online pharmacies that claim to be Canadian actually source their medications from outside of Canada where regulations are even less stringent. All the while some trumpet the benefits of Canadian prescription drugs, criminal enterprises have taken advantage by marketing counterfeit drugs online as “Canadian” to unsuspecting consumers.
Importation would make this trend far worse by potentially legitimizing fake drugs. In our current secure supply chain system, the FDA is able to effectively monitor and track the movement of medicines and root out fraud. Thanks to their supervision, it is far more difficult for counterfeit drugs to infiltrate licensed U.S. pharmacies and existing cases largely take place outside legitimate channels. Importation would put the stamp of approval on less regulated or entirely unregulated sources from all across the world as long as they at one point make their way through Canada. That should be a pretty terrifying thought for consumers.
In recent years, the fentanyl crisis has shown the destructive impact that counterfeit drugs can inflict on communities. As fentanyl overdoses continue to climb at alarming rates, these preventable deaths are increasingly caused by ingestion of counterfeit pills. Stories of accidental overdoses have become far too common as a result of counterfeit drugs. It should go without saying that policymakers shouldn’t do anything to make them more ubiquitous.
To add insult to injury, undermining the safety of our supply chain and trust in our healthcare system would come with little to no cost benefit to patients. Past FDA analyses have found that many American generics are already cheaper than Canadian generic drugs. And, Canada’s existing drug supply is only enough for its much smaller population, representing only 2% of global pharmaceutical consumption as opposed to 44% for the United States. Canadian officials have made it clear that they have no intention of letting this limited supply be shipped to the United States should there be any threat of shortages.
As of now, eight other states have submitted or are pursuing similar plans as Florida. All of them are based on the same false assumptions. As there is no federal law in place, the federal government cannot open the door to a complicated patchwork of 50 different state importation programs. Though these states are right to be concerned about the cost of medicines, importation presents a potentially dangerous and counterproductive approach.
There are ways to address the cost of medicines, particularly for those most vulnerable. However, misleading Americans about the impact on prices and potentially compromising patient safety by importing drugs of untraceable origins shouldn’t be one of them.
The Honorable Mary Bono is a senior vice president at the Washington, D.C.-based federal affairs firm Faegre Baker Daniels Consulting. She is the Chairwoman of Communities United for Smart Policy and was a member of the U.S. House of Representatives from California.
Sign Up for MHF Insights to keep up on the latest in Michigan Health Policy
