The U.S. Food and Drug Administration announced on Friday that
(Source: FDA)
This matter is not troublesome to explain. Since medicines in the US market are extremely expensive, the cost of importing the same medicines from Canada will naturally be less. Before today’s approval was issued, U.S. residents had long been able to purchase medicines directly from Canadian pharmacies as individuals.
Many state governments have long hoped to import drugs from Canada to lower drug costs for their Medicaid programs, government clinics and prisons. The Florida government had previously expected that by wholesale importing drugs such as diabetes, AIDS, hepatitis C, and mental illness from Canada,
Of course, the FDA's approval does not mean that Florida can import Canadian drugs as it wishes. First of all, this authorization is currently only given for two years; secondly, importers in the state need to submit a list to the FDA in advance and obtain approval before importing drugs. Afterwards, there are clear requirements for ports of entry, drug label correction, and drug efficacy testing. Finally, the state is required to submit quarterly reports to the FDA on the program's effectiveness in saving money and potential safety issues.
Under relevant legislation and FDA approval, Florida, and potentially other state governments that launch similar programs, can only wholesale import prescription drugs from Canada.
U.S. media statistics,
But from the perspective of the Canadian government, bright-eyed U.S. buyers may be closer to trouble in some cases. Although Canada has a place in the field of biopharmaceutical development, it is not a major drug production country like the United States, Germany, and India. After the Trump administration announced in 2020 that state governments could submit drug import applications,
Amir Attaran, a law professor at the University of Ottawa, said bluntly that if the FDA’s decision affects the Canadian market, the Canadian government may further tighten export policies. Amir further stated,
Regarding the FDA's latest move, many pharmaceutical policy experts believe that importing prescription drugs from Canada will not change the fundamental problem of high drug prices in the United States. At the same time, pharmaceutical companies also have corresponding legal weapons to fight against it.
Although many people may not realize it, cutting drug prices is also an important part of Biden's "Inflation Reduction Act." The U.S. government is currently working to launch centralized procurement of dozens of prescription drugs, but the progress is far from smooth. Regarding the approval of Florida’s plan, Nicholas Bagley, a health law expert at the University of Michigan Law School, commented: “
Both Bagley and Harvard Medical School professor Aaron Kesselheim believe that centralized pharmaceutical purchasing will be a more direct way to reduce drug prices. The federal government had expected that the project could save US$98.5 billion over ten years, but pharmaceutical companies are taking legal measures to block the implementation of centralized procurement.
Of course, this policy itself is "popular". According to a survey conducted by the health survey agency KFF in 2019, 80% of the respondents agreed with the importation of drugs from legal Canadian pharmacies. KFF senior policy analyst Meredith Freed explained that people cannot fully understand why they spend more than people in other countries to buy the same drugs.
After obtaining FDA approval, Florida can begin to advance the import of drugs, but there is still huge uncertainty about whether they will finally get the drugs.
PHRMA (Pharmaceutical Research and Manufacturers of America), the largest lobbying organization in the U.S. pharmaceutical industry, said for the first time on Friday that the FDA's approval of the Florida plan was "reckless" and said it was considering "all options to prevent this policy from causing harm to patients."
The Colorado government, which had previously promoted a similar plan, had warned that this drug import plan may not only face prosecution from pharmaceutical companies, but also that some pharmaceutical companies have already signed agreements with drug transportation companies.