The Global Pharmaceutical Supply Chain and Prospects for Safe Drug Importation
Written by Gabriel Levitt with Lucia Mueller
Many consumer products clearly state where those products are made. Not so for prescription medications. Where our drugs are made and where their main ingredients are sourced affects drug safety, affordability, availability, and even national security — concerns that have come to the fore as a result of the global pandemic. Yet there is too little transparency and too much misinformation surrounding the supply chain of the drugs we take. “Not Made in the USA” investigates and details the country of manufacture and the source country for active pharmaceutical ingredients among widely used, brand name prescription drugs. The data shows that the majority of brand name prescription drugs Americans take are not made in the U.S.A., rather they are made in other high-income countries with equally — if not more — stringent pharmaceutical manufacturing capabilities than the United States. As a corollary, it becomes clear that imports of drugs from licensed pharmacies or wholesalers in many countries are no less safe — but much less expensive — than drugs purchased domestically. This is critical information in the debate on whether expansion of drug importation to lower drug prices would be effective and safe for the American consumer. “Not Made in the USA” includes a thorough examination of drug labels as applied by manufacturers (i.e., not repackagers or relabelers) and an analysis of federal drug labeling laws along with the conflicting FDA, FDCA and CBP definitions of a drug’s country of origin. The report identifies countries of manufacture for the top 100 drugs by total expenditures in Medicare Part D in 2018. Looking at wholesale and retail channels, “Not Made in the USA” discusses the vast domestic vs. international price discrepancies of these top 100 drugs. To analyze safety issues relating to drug importation and prices, the report discusses global supply chain issues, including FDA registration and recordkeeping of foreign made drugs; brand versus generic drug supply quality concerns; and issues of national security. Finally, and in depth, the report identifies and analyzes proposed drug importation laws, regulations, and rules that could vastly improve drug affordability for American consumers and government payors.
What I find most interesting in this data-driven report from PharmacyChecker.com is the symbiosis that has evolved between big PhRMA and the FDA. Both the regulator and the regulated benefit from the same lie — that imports of prescription drugs from Canada, the UK and the European Union pose a grave risk to American consumers and that only the FDA can protect Americans from imports, which are inherently dangerous regardless of the country of origin.
The PharmacyChecker.com research is stunning.
JOE GRAEDON, President, The People's Pharmacy
It’s a well-established fact that affordable prescription drugs improve prescription adherence and overall health among Americans. Mostly, in this report, we aim to show how expanding access to lower-cost prescription drugs outside the U.S. could substantively alleviate the crisis of high drug costs in America.
PharmacyChecker’s mission, since its founding in 2002, is to ensure that consumers are properly informed about purchasing safe and affordable medication online to meet their individual health needs.