Florida is first US state cleared to import Canadian drugs

The FDA has approved the first request from a US state to import prescription medicines from Canada, giving the green light to Florida for a programme that aims to reduce its spending on drugs.

The authorisation is the “first step” in allowing Florida to import medicines from Canada, said the FDA, setting up a process in which the regulator can approve ‘section 804 importation programme’ (SIP) requests for purchasing drugs directly from Canadian wholesalers. Florida has said it could save $150 million per year by importing drugs for HIV, cancer, diabetes, infectious diseases, and psychiatric conditions.

The go-ahead comes after decades of attempts to use Canada as a source of lower-priced medicines for the US domestic market, which was made legally possible around 20 years ago, but has yet to have a programme come to fruition.

There has been fierce objection to the idea from the pharma industry, which has claimed it could open the door to potentially counterfeit and substandard drugs and put American patients at risk.

FDA said approval will only be given “if the SIP will significantly reduce the cost to the American consumer without imposing additional risk to public health and safety.”

However, Pharmaceutical Research and Manufacturers of America (PhRMA) president and chief executive, Stephen Ubl, insisted that the FDA’s decision to approve the Florida importation scheme was “reckless”, adding: “the importation of unapproved medicines, whether from Canada or elsewhere in the world, poses a serious danger to public health.”

The move comes amid mounting pressure from lawmakers on the cost of accessing medicines in the US, which generally has much higher prices than other countries. It follows other measures, such as the introduction of mandatory Medicare rebates for drugs whose prices rise higher than inflation and allowing the insurance programme to negotiate prices.

PhRMA has sued to block similar Canada import schemes in the past and said it is “considering all options for preventing this policy from harming patients.” There may be opposition from outside the pharma industry as well: the Canadian government has said it may challenge importation on the grounds that it could create domestic shortages and even increase prices for Canadian citizens.

Health Canada told the New York Times that the country’s drug supply “is too small to meet the demands of both American and Canadian consumers” and that “bulk importation will not provide an effective solution to the problem of high drug prices in the US.”

The FDA’s approval of Florida’s programme comes after the state’s Republic governor Ron DeSantis filed a lawsuit accusing the agency and the Department of Health and Human Services (HHS) of “reckless delay” in holding up its approval. The judge in that case had set a deadline of 5th January for the FDA to deliver its verdict on the application.

Information about the drugs that the state wants to import needs to be submitted and reviewed by the FDA before purchase, and it has to be able to show they have been tested for authenticity and compliance with US specifications and standards, and are re-labelled to comply with FDA requirements.

Another condition set by the FDA is that Florida will have to submit a quarterly report to the FDA that includes information about the imported drugs, cost savings, and any potential safety and quality issues. Florida’s SIP is authorised for two years from the date the FDA is notified of the first shipment of drugs to be imported.

Other states, meanwhile, are also going after FDA approval for drug importation schemes, including Colorado, Maine, New Hampshire, New Mexico, North Dakota, Texas, Vermont, and Wisconsin, according to the NYT.

Photo by sebastiaan stam on Unsplash