FDA issues first

As per the latest updates, FDA (Food and Drug Adminstrations) has authorized Florida to purchase medicines directly from Canada based wholesalers at far less cost than in the US. This approval makes a statement overriding the decades-long objection from pharmaceutical industry.

This indeed is a prominent policy shift for the United States and a step forward in the efforts to rein in drug prices. As per the approval issued in the letter to Florida Friday, now the

Earlier individuals in the US are now allowed to buy directly from Canadian pharmacies but now US can order for mass drug imports from Canada. Florida has estimated that it could save up to $150 million in its first year of the program by importing H.I.V., AIDS, diabetes, and psychiatric medicines.

Several other states have also applied for the similar program to FDA. Inspite of this significant move, there are several other challenges like agreements with Canadian wholesalers not allowing the export of their medicines and the Canadian government taking steps to block the export of prescription drugs that are already in short supply.

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

Although the approval has been passed, Florida is required to send the details on their plans to import. The state has to ensure that the drugs are potent and not counterfeit. It has also been instructed that they put up the FDA approved label on their medications instead of those used in Canada.

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Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.

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