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How JAMA & Kaiser Family Foundation Studies Have Concluded Millions of U.S. Adults Import Medications

According to a study published in the Journal of the American Medical Association (JAMA), 1.5% of adults in the U.S. who take prescription drugs purchase them from outside the U.S. to save money each year. That’s about 2.3 million people. In 2016, my review of a similar set of data estimated about four million per year. The Kaiser Family Foundation’s 2016 poll data was used to support an estimate showing that 19 million people, 8% of the adult population, have imported lower cost prescription drugs for personal use. What’s going on? 

The JAMA study authors used 2015-2017 government data from the U.S. Centers for Disease Control and Prevention, National Center for Health Statistics, National Health Interview Survey (NHIS), which collected an assortment of health information from 61,238 individuals. As explained in the JAMA study:

“Survey respondents were asked whether they bought prescription drugs from a country other than the US to save money during the past 12 months. We defined respondents as purchasers of medications outside the US if they answered yes to the question.”

Past estimates, including my own, have also used NHIS data but may have extrapolated incorrectly. The percentages should be applied not to the general adult population but to those who take prescription drugs. The adult population is about 256 million. In this study, the sample population of 61,238 represented 152.2 million people who take prescription drugs. The JAMA study found that 1.5% purchased medications outside the U.S. to save money, which comes out to about 2.3 million. My past estimates looked at 1.6%, which was an earlier NHIS estimate of adults who import, of 256 million people, which came out to a little over 4 million people.

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Transatlantic Drug Regulatory Cooperation: Moving Beyond Canada

Canada is a good option for Americans seeking to access their medications at a lower cost through personal drug importation, but even I agree with the pharmaceutical industry when they say that wholesale drug importation on a large scale is not workable with Canada. Why?  Simply because Canada is too small a nation to supply the U.S. market. I have written that there is much more promise if importation is expanded to the European Union. We already rely on the EU to assess U.S. drug safety, and current events have only brought that into greater focus.

Due to the world’s efforts to quell Covid-19, Regulatory Focus reported on increased cooperation between the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These drug regulators have engaged in regular consultations since 2003 in order to share insights and best practices. In 2014, that same cooperation led to the creation of Mutual Recognition Agreements (MRA). Due to an MRA between the FDA and EMA, the U.S. can rely on EU inspections of drug manufacturing establishments in any EU country. That means we have a lot of faith in EU pharmaceutical safety standards.

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Even Drugs Manufactured in America are not “Made in the USA”

PharmacyChecker pays close attention and has performed considerable research related to where drugs are made. Most notably, by researching drug labels and contacting drug companies, we found that 71% of brand name drugs sold in the U.S. are foreign made, a number far higher than the 40% figure regurgitated by the FDA year after year. Americans care a lot about this issue. One of our more popular Ask PharmacyChecker posts is called “How can I determine where a drug is manufactured?” But here’s something different to chew on: Even drugs that our research categorized as manufactured in the U.S.  are often not really very “American.” In fact, many are categorized as imported and considered to be foreign-made pharmaceuticals by U.S. Customs and Border Protection (CBP).

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Canada’s Message to the U.S. on Drug Importation: We care more about our citizens than you.

The pharma-funded and industry opponents of drug importation from Canada just love to talk about how “even the Canadian government opposes importation.” For a quick clarification, Canada has not minded or stopped its pharmacies from safely dispensing medicines by mail to Americans. That’s personal drug importation. When I write that Canada opposes importation, I mean the wholesale drug importation currently proposed by the Trump administration.

Hey, if Canada doesn’t want this new policy, then what the hell can we do? As I see it, Pharma-funded groups, like the Partnership for Safe Medicines and Alliance for Safe Online Pharmacies, have—almost gleefully— pointed out to the U.S. FDA that Canada is opposed to the implementation of Section 804 to allow registered wholesalers in the U.S. to import drugs from Canada. This is mainly due to Canada’s fear of drug shortages. Drug manufacturers supply Canada to meet the needs of its much smaller population. If Canadian wholesale drug exports increase substantially under the new Trump administration policy then it could exacerbate supply problems in Canada.

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Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796”

Below is a copy of Gabriel Levitt’s comments on the FDA Notice of Proposed Rulemaking titled “Importation of Prescription Drugs” that were submitted Monday, March 9th, 2020.

Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796

Docket No. FDA-2019-N-5711

Date: March 9, 2020

Submitter: Gabriel Levitt, Co-founder and President, PharmacyChecker; Founder and President, Prescription Justice

I appreciate the opportunity to comment on this notice of proposed rulemaking (NPRM). Founded in 2002, and launching its website in 2003, PharmacyChecker provides consumers with online pharmacy verification and comparative drug price information to help them make the best decisions for themselves and their families on how to afford prescription drugs.

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The Drug Reimportation Law Curtails Wholesale Not Personal Importation: Who Knew?

On behalf of Prescription Justice, I submitted comments to the FDA in response to its request for public comments on its draft guidance called: “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry.”

I published the comments in their entirety on Prescription Justice here: https://prescriptionjustice.org/resources/blog/opportunities-safe-personal-drug-importation-under-section-801-public-comments-prescription-justice.

I have a different story to tell here about the new, or newish reimportation law.

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