A report published by PharmacyChecker, an independent company that monitors and verifies the credentials of international online pharmacies and compares prices of the prescription drugs available, has released a report, “Not Made in the USA”. The data shows that 68% of the top 100 highest dollar finished drug formulations (FDFs) paid through Medicare Part D in 2018 are imported. Additionally, 78% of the active pharmaceutical ingredients (APIs) of those same 100 drugs are foreign made.
The report states that most FDA-approved brand-name drug formulations are made in high-income countries that have comparable to, if not stronger, systems of pharmaceutical manufacturing than the United States. All except one of the imported medications, were made in either the European Union, Canada, Japan, Singapore, Switzerland, or the United Kingdom. One brand, Neurontin (gabapentin), was imported from India.
The global pandemic has brought important discussions to the forefront about drug quality, healthcare affordability, and U.S. dependence on foreign countries for pharmaceutical supplies, all of which are addressed in the report.
“The public should know that importation is unequivocally the main artery of our drug supply chain,” stated Gabriel Levitt, primary author. “Unfortunately, not only transparency, but accuracy, is lacking about where drugs are made. The FDA does not seem to publish or even have good data for internal purposes...”
For its dataset, “Not Made in the USA” relied on the Medicare Part D Drug Spending Dashboard and Data. The top 100 drugs in terms of total spending were analyzed, which represented 57% of all spending in Medicare Part D for 2018. To determine the countries of origin for both FDFs and APIs, PharmacyChecker reviewed prescription drug labels as found in the U.S. National Library of Medicine. While federal law under the FDA’s jurisdiction does not require drug manufacturers to publish the source country of a medication, other laws, notably the Tariff Act of 1930, do require such disclosures for imported products, including drugs. Where a pill bottle often doesn’t have this information, the actual drug manufacturer’s label usually does.
Of the 100 drugs analyzed that are accessible online, the average international mail-order prices were 75.53% lower than average U.S. pharmacy prices. Average prices available among drugs from Canadian pharmacies, specifically, were 70.18% lower than average U.S. pharmacy retail prices.