GAO CONFIRMS SAFETY OF DRUGS FROM OVERSEAS

Updated: Nov 7


Tens of millions of Americans can’t afford their prescription drugs and the debate over how to ensure access to affordable drugs is hotly contested. One of the biggest strawman arguments propped up by Big Pharma interests, in order to block American patients from accessing prescription drugs at more affordable prices offered in other countries, is to suggest that prescription drugs in other countries aren’t safe. It is a ruse. In fact, most prescription drugs sold in America come from abroad.


Fresh details regarding the safety of international prescription drugs and their prevalence in America came to light in conjunction with a House Agriculture Appropriations Subcommittee Hearing, March 9, 2021. Here are some highlights from a report and testimony given by the Government Accountability Office provided in conjunction with the hearing on the Food and Drug Administration’s Overseas Inspections:


  • “According to FDA, as of May 2020, 74 percent of establishments manufacturing active pharmaceutical ingredients and 54 percent of establishments manufacturing finished drugs for the U.S. market were located overseas. As of March 2019, FDA data showed that India and China had the most manufacturing establishments shipping drugs to the United States, with about 40 percent of all foreign establishments in these two countries.”


  • Inspections conducted by some foreign regulators, when available, can substitute for FDA inspections. In light of the COVID-19 pause in inspections, FDA expanded the use of the mutual recognition agreement it has with the European Union to include inspections conducted outside of Europe by European regulators as a full substitute for FDA inspections. However, this only applies to certain European regulators whose inspections FDA has found to be equivalent to its own.17 Inspections from other select countries (such as Australia and Japan) can be used for oversight purposes, but are not considered by FDA as substitutes for an FDA inspection.”

  • “These tools include relying on inspections conducted by foreign regulators, requesting and reviewing records and other information, and sampling and testing drugs. FDA has determined that inspections conducted by certain European regulators are equivalent to and can be substituted for an FDA inspection”

Prescription drugs from accredited international pharmacies are safe. For example, all of the pharmacies accredited by the Canadian International Pharmacy Association boast a 100% perfect safety record over more than fifteen years serving millions of U.S. online consumers. As of 2020, 2.3 million Americans import medications, and the number of people ordering their medications online is growing according to the Alliance for Safe Online Pharmacies.


There are still some risks as rogues or scams do exist online targeting prescription drug patients. CPPI recommends searching only certified websites for prescription drugs from licensed international pharmacies. Click here, for more information on how to find trusted online pharmacies.

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