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Percent of Imported Pharmaceutical Ingredients Apparently Unchanged in 20 Years

Update FDA information

According to the FDA, in 2017, 80% of the active pharmaceutical ingredients used to make our medicines are imported. I can’t remember how many times I’ve read (and written) that over the past decade or so. Almost every time I read that particular statistic in the news, it’s often a story about drug quality problems, in which foreign APIs are reported as a growing problem. Flashback to the FDA in 1998: as reported by the U.S. Government Accountability Office, the percent of active pharmaceutical ingredients used to make medicines for sale in the U.S. is about 80%.

In March 2019, Anna Edney, from Bloomberg News, wrote an article called: “Tainted Pills Force FDA to Tighten Drug-Safety Regulations.” The main focus of the article is that there are drug quality problems caused by APIs that are not meeting the required standards.

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Florida’s House Drug Importation Bill – HB 19 – Easily Passes

Drug Importation Bill - Drug Prices World

Yesterday, the Florida House Legislature voted 93-22 passing HB 19. The bill creates programs and processes for importing prescription drugs from Canada, as well as from other countries. HB 19 actually calls for the creation of two programs, which I have summarized below. For a deep dive, you should read the Staff Analysis from the Florida House of Representatives.

Canadian Prescription Drug Importation Program (CPDIP)

If HB 19 becomes law, the Florida Agency for Health Care Administration (AHCA) will create processes that meet the safety protocols called for in the bill, which include inspections and testing of drugs, to allow registered wholesale pharmacies to import from Florida-registered Canadian wholesalers. In this program, lower drug prices will save taxpayers money for government funded-entities, such as county health departments, free clinics, and the Department of Corrections.

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Is the FDA Misleading Congress About the Safety of Imported Medicines?

FDA misleads Congress about drug importation

Properly licensed foreign pharmacies help Americans access medicines that they can’t afford here. Counterfeit drug makers and sellers, fentanyl and opioid dealers, and dangerous pharmacy websites are worthy targets of serious regulatory or criminal enforcement actions. There’s no gray there.

An article I wrote that was recently published in The Nation hopefully brings to greater public attention the FDA’s conflation of clearly safe channels for personal prescription imports with counterfeit drugs, the opioid crisis, and rogue online pharmacies. That conflation, one associated with the media relations work of the pharmaceutical industry – is used to justify FDA enforcement actions that exacerbate the crisis of high drug prices by threatening programs that facilitate prescription fulfillment from foreign, licensed pharmacies.

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