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FDA allows Florida to import prescription drugs from Canada

Elise Amendola Associated Press Les médicaments du Canada importés en Floride ne seraient destinés qu’à certaines personnes, notamment les enfants placés en famille d’accueil, les détenus, certains patients âgés et, éventuellement, les bénéficiaires du programme Medicaid.

A major change in U.S. pharmaceutical policy, which allows the importation of drugs from Canada, is raising fears of future drug shortages at home.

The US Food and Drug Administration (FDA) is considering allowing Florida to import millions of dollars' worth of pharmaceuticals from Canadian wholesalers to avoid costs raised in the United States.

Joelle Walker, vice-president of public affairs at the Canadian Pharmacists Association, says the decision does not bode well for Canada, which has more frequently faced severe drug shortages. medications in recent years.

Walker says Canada does not have the capacity to become a pharmacy for the United States.

But she adds that Canadians should not rush to the corner pharmacy to refill their prescriptions, because the threat to Canada is not immediate: the state of Florida still has work to do to do to prove that imports would actually save Americans money.

Ms. Walker also points out that Canada has several safeguards to prevent manufacturers from shipping drugs south and to make the idea less attractive to the United States.

The FDA cleared the way Friday for Florida's first plan to import lower-cost prescription drugs from Canada, an approach long called for in the United States.

Republican Gov. Ron DeSantis signed the initiative into law in 2019, but the plan required federal review and approval from the FDA, which controls all imports of prescription drugs into the United States.

Democratic President Joe Biden has supported such programs as a way to lower prices, signing an executive order in 2021 directing the FDA to work with states on drug imports.

Florida's proposal includes a number of drug classes, including those for asthma, chronic obstructive pulmonary disease, diabetes, HIV AIDS and mental illness.

These imported drugs would be intended only for certain people, including children in foster care, prisoners, certain elderly patients and, possibly, beneficiaries of the Medicaid program.

These new policies represent a major shift in the United States after decades of lobbying by the pharmaceutical industry, which claimed such imports would put American patients at risk from counterfeit or adulterated drugs . The FDA also warned that it could be difficult to ensure the safety of drugs from outside the United States.

But the policy has changed in recent years: both parties — including former President Donald Trump — have pushed to revise the approach on imports.

The FDA said Florida's program would be authorized for two years. Under federal requirements, officials in the state will have to test drugs for authenticity and relabel them so they meet U.S. standards.

The Florida Department of Health will also be required to provide a quarterly report to the FDA on the types of drugs imported, cost savings, and any potential safety and quality issues.

“These initiatives must demonstrate that the programs would result in significant savings for consumers without increasing the risks of exposure to unsafe or ineffective drugs,” said FDA Commissioner Dr. Robert Califf. in a press release.

Many Americans already buy at least some of their medications from pharmacies in Canada or Mexico, even though technically it is illegal to import them into the United States.

Work to allow imports into the states began during the presidency of Donald Trump, a fierce critic of industry pricing.

Under current regulations, states can import certain drugs through pharmacies and wholesalers. Governor DeSantis has already estimated that Florida taxpayers could save up to $150 million per year through this program.

Like most developed countries, Canada sets limits on the prices that drug manufacturers can charge if they wish to enter the market. Health officials have previously suggested that the prescription drug market in their country is too small to have a real impact on prices in the United States.

The United States has long had the highest prescription drug prices in the world, with no government limits on what companies can charge.

It wasn't until 2022 that Congress passed a law allowing the federal government to negotiate prices for a small number of drugs used by seniors under the Medicare program. The first such negotiations are expected to take place later this year.

Teilor Stone

By Teilor Stone

Teilor Stone has been a reporter on the news desk since 2013. Before that she wrote about young adolescence and family dynamics for Styles and was the legal affairs correspondent for the Metro desk. Before joining Thesaxon , Teilor Stone worked as a staff writer at the Village Voice and a freelancer for Newsday, The Wall Street Journal, GQ and Mirabella. To get in touch, contact me through my teilor@nizhtimes.com 1-800-268-7116