The U.S. Food and Drug Administration on Friday gave the nod to a Florida plan to import drugs from Canada at much lower prices than in the United States.

The approval could prove to be a major turning point for the United States’ prescription drug market.

U.S. residents can now buy directly from Canadian pharmacies out of their own pockets, but state Medicaid programs have not been allowed to purchase medications in bulk from Canada.

On average, U.S. drug prices are more than double those found in Canada, according to a Rand Corp. analysis.

Brand-name drugs are even more expensive, with U.S. prices nearly triple those of Canadian prices, the report adds.

Florida says it could save up to $150 million in the first year of the program, by importing medicines that treat HIV, AIDS, diabetes, hepatitis C, mental health disorders and other conditions, the state claimed in a lawsuit filed against the FDA regarding its proposed importation program.

FDA Commissioner Dr. Robert Califf said in a statement issued Friday that his agency is “committed to working with states and Indian tribes” that want to develop similar importation programs.

“These proposals must demonstrate the programs would result in significant cost savings to consumers without adding risk of exposure to unsafe or ineffective drugs,” Califf noted.

However, Florida and other states still face hurdles before cheaper drugs can start shipping across the border.

The Florida program will need to submit separate requests to the FDA for each prescription drug it wants to import, showing that it can maintain the integrity of the supply chain.

The state must show that the drugs brought in from Canada are as effective as U.S.-made meds, and that FDA-approved labels will be slapped onto the medications before they are doled out to patients.

The FDA approval is also expected to draw legal challenges from drugmakers, most likely by the lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA). The group has sued over previous efforts to import cheaper drugs from other countries.

“We are deeply concerned with the FDA’s reckless decision to approve Florida’s state importation plan. 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 President and CEO Stephen Ubl said in a statement Friday.

“Politicians need to stop getting between Americans and their health care,” Ubl added. “PhRMA is considering all options for preventing this policy from harming patients.”

In addition, Canada has expressed reservations about its drug supply being co-opted by the United States.

“Canada’s drug supply is too small to meet the demands of both American and Canadian consumers,” Maryse Durette, a spokeswoman for Health Canada, told the New York Times. “Bulk importation will not provide an effective solution to the problem of high drug prices in the U.S.”

Amir Attaran, a law professor at the University of Ottowa, noted that Canada has nearly 40 million residents, while Florida alone has 22 million residents.

“If all of a sudden Florida is able to extend a vacuum cleaner hose into this country to take what’s in the medicine chest, the supply disruption will be a completely different category,” Attaran told the Times.

The law allowing drug importation passed Congress two decades ago, but implementation has been delayed for years over concerns regarding drug safety, the Times said.

President Donald Trump pushed the law forward in 2020, creating two new pathways for the safe importation of drugs from Canada and other countries, a KFF report says.

The administration of President Joe Biden has continued this effort, fighting a lawsuit from PhRMA and other groups targeting the Trump-era rules.

Eight other states have enacted laws allowing for a state drug importation program, the Times reports — Colorado, Maine, New Hampshire, New Mexico, North Dakota, Texas, Vermont and Wisconsin.

The public strongly favors drug imports. A 2019 KFF poll found that nearly 80% of people supported bringing in drugs from legitimate Canadian drug sellers.

“Importation is an idea that resonates with people,” Meredith Freed, a senior policy analyst with KFF, told the Times. “They don’t fully understand why they pay more for the same drug than people in other countries.”

However, public policy experts said U.S. drug prices could be lowered in a more straightforward way, by allowing the U.S. government to negotiate directly with pharmaceutical companies over prices.

“This whole thing is a jerry-rigged, complicated approach to a problem that’s amenable to a pretty straightforward solution, which is that you empower the government to bargain over the price for drugs,” Nicholas Bagley, a health law expert at the University of Michigan Law School, told the Times. “So instead, we’re sort of trying to exploit the machinery that Canada has created and that we were too timid to create.”

For example, the drug price negotiation provisions contained in the Biden Administration’s Inflation Reduction Act are projected to save the federal government an estimated $98.5 billion over a decade if they’re ever implemented, Bagley noted.

But PhRMA and a host of U.S. drug makers are suing to keep those provisions from taking effect, the Times reported.

More information

KFF has more about prescription drug importation.

SOURCE: U.S. Food and Drug Administration, news release, Jan. 5, 2024; New York Times

Source: HealthDay