FRIDAY, Jan. 5, 2024 (HealthDay News) — In what could prove to be a major turning point for the prescription drug market in the United States, the U.S. Food and Drug Administration has approved a Florida plan to import drugs from Canada.
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 Robert Califf, M.D., 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,” he 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 medications, and that FDA-approved labels will be added to the medications before they are made available 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. 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.”
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