The Food and Drug Administration on Friday cleared the way for Florida’s first-ever plan to import lower-priced prescription drugs from Canada, a long-sought approach to accessing cheaper drugs that follows decades of frustration with US drug prices. .
Republican Gov. Ron DeSantis signed the plan into law in 2019, but it requires federal review and approval by the FDA, which regulates prescription drug imports.
Democratic President Joe Biden has supported such a program as a way to lower prices, signing an executive order in 2021 directing the FDA to work with states on imports.
The policy change represents a seismic shift after decades of lobbying by the pharmaceutical industry, which said imports would expose US patients to the risk of fake or tainted drugs.
The FDA has also previously warned about the difficulty in ensuring the safety of drugs originating outside the US.
But politics has changed in recent years, with both parties — including former President Donald Trump — doubling down on the import approach.
The FDA has previously warned about the difficulty in ensuring the safety of drugs originating outside the US. Reuters
The FDA said the Florida program will be authorized for two years. Under federal requirements, state officials must test drugs to ensure they are authentic and relabel them so they comply with US standards.
Florida’s health department must also provide quarterly reports to the FDA on the types of drugs imported, cost savings, and any potential safety and quality issues.
“The proposal must demonstrate the program will result in significant cost savings to consumers without increasing the risk of exposure to unsafe or ineffective drugs,” FDA Commissioner Dr. Robert Califf said in a statement.
Many people already buy at least some of their medications from pharmacies in Canada or Mexico, even though it is technically illegal to import them.
Republican Gov. Ron DeSantis signed the plan into law in 2019, but it requires federal review and approval by the FDA. Reuters
Efforts to allow state imports began under Trump, a relentless critic of industry prices.
Under current regulations, states can import certain drugs through pharmacies and wholesalers. DeSantis previously estimated taxpayers could save up to $150 million annually under the program.
The state’s recommendations include several classes of drugs, including drugs for asthma; chronic obstructive pulmonary disease, or COPD; diabetes; HIV and AIDS; and mental illness.
The drug is only for certain people, including adoptees, prisoners, certain elderly patients and — eventually — Medicaid recipients.
The policy change represents a seismic shift after decades of lobbying by the pharmaceutical industry. JJAVA – stock.adobe.com
Like many developed countries, Canada sets limits on the prices that drugmakers can charge if they want to enter the market. Health officials there have previously suggested their country’s prescription drug market is too small to have any real impact on US prices.
The US has long had the highest prescription drug prices in the world, with no government limits on the prices companies can charge. Only in 2022 did Congress pass legislation allowing the federal government to negotiate prices for a small number of drugs used by seniors in the Medicare program. The first such negotiations are expected to take place later this year.
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Source: thtrangdai.edu.vn/en/
