White Plains, New York – January 4th, 2022 – A new report published by PharmacyChecker entitled “Not Made in the USA” shows that 68% of the top 100 highest dollar finished drug formulations (FDFs) paid through Medicare Part D in 2018 were imported. Additionally, 78% of the active pharmaceutical ingredients (APIs) of those same 100 drugs are foreign made. Contrary to most imported generic medications, these 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. Sixty-seven, all except one of the imported medications, were made in either the European Union, Canada, Japan, Singapore, Switzerland, or the United Kingdom. Brand Neurontin (gabapentin), was imported from India.
For reasons of drug affordability, safety, and national security, there is cause for concern among American consumers and policymakers about where prescription drugs are made. Over the last 20 years, the U.S. Government Accountability Office, academic and public policy researchers, and the media have relied on FDA data to inform the public that 80% of APIs and, for over a decade, that 40% of FDFs sold in U.S. pharmacies are imported. Those figures were never backed up with supporting data and had gone unquestioned in Congressional reports. 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 “Not Made in the USA.”
“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. The industry, while simultaneously fearmongering about drug importation, relies on drug importation to sell medications at much higher prices than available in all other high-income countries. Common sense, facts, and public health need to be at the forefront of how we approach importation and prescription drug affordability moving forward.”
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 carefully 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.
Because the pharmaceutical industry was able to stave off larger policy lifts in the Build Back Better Act, importation could become far more important in realizing a future where U.S. drug prices are comparable to the lower prices available in other high-income countries. Despite current regulatory restrictions, according to a survey by the Kaiser Family Foundation, about eight percent (20 million) of Americans have imported prescription drugs for personal use.
“Americans should have full access to wholesale and personal importation of brand name drugs and the regulatory hurdle is worth the resulting savings,” said Levitt.
About PharmacyChecker
PharmacyChecker, based in New York, is the only independent company that verifies the credentials of and accredits international online pharmacies, publishing a list of accredited online pharmacies and drug price comparisons based on those pharmacies. PharmacyChecker insight and accreditation have been recommended and/or referenced by AARP Magazine, the New York Times, the People’s Pharmacy, Yahoo Finance, and others. For more information, visit www.pharmacychecker.com.
Press Contact: Lucia Mueller, Director of Communications for PharmacyChecker.com | lucia.mueller@pharmacychecker.com | (718) 554-306
