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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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.
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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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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