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FDA Relinquishes Control to Foreign Drug Regulators

FDA Commissioner, Scott GottliebThis week, FDA Commissioner Scott Gottlieb announced that inspections by drug regulatory authorities of foreign manufacturing plants that export pharmaceuticals to the U.S. are sufficient to ensure the integrity of those products: meaning the FDA doesn’t also need to inspect them. The countries identified are Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom. All are currently members of the European Union (the UK is soon Brexiting).

Although this has made headlines as an unprecedented practice, the FDA relying on inspections from foreign regulators is not an entirely new development. The FDA does not inspect all foreign plants that export medicine to the U.S. even though most pharmaceuticals sold in the U.S. are foreign-made.

So what’s with the big announcement then?

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“American” Prescription Drugs Are Usually Imported

American medications are usually imported. Now you know.

Yesterday, PharmacyChecker released the findings of our new research that shows 70% of brand name medications sold in U.S. pharmacies are not made in America. Those same medications can be purchased at 70% less in Canada – and even less in other countries. As I’ve written before, there’s a troubling aspect of the public policy debate about drug importation: in many news stories, both policy-oriented and those dedicated to consumers, it seems as if drug importation is currently illegal, which is simply not true. Our data indicates that when Americans walk into their local Walgreens or CVS to fill a prescription, the pharmacist will mostly likely dispense an imported drug – that’s if the patient can actually afford it: 45 million did not fill their prescription last year because of cost.

Our findings come in the wake of an announcement from the Congressional Budget Office about The Affordable and Safe Prescription Drug Importation Act of 2017 (S.469), which aims to make it expressly legal to import lower-cost medications from Canada. CBO’s report shows that if S.469 becomes law, it would shave almost $7 billion off the deficit by 2027. We believe the savings would be much greater. The CBO report reflected deficit savings, but did not include the savings that individuals would also realize from buying lower cost medications from Canada. (more…)

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