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FDA Drafts Guidance to Allow Lower-Cost Foreign Drug Imports From Any Country

The FDA has finished draft guidance on one of two of the Trump administration’s drug importation policy ideas, referred to as Pathway II. The title of this post may seem like a joke for those of you who follow the issue of drug importation in America, but it is real. As a reminder, in August 2019 the administration took its support for drug importation a step further by stating its willingness to support state drug importation programs, Pathway I, and a new idea to give drug companies greater flexibility with their global drug supplies to offer better prices in the U.S, called Pathway II.

Earlier this week, the guidance on Pathway II was sent to the White House Office of Management and Budget (OMB), although I believe it’s not public yet. I found out about the submission to OMB here (BioCentury). It doesn’t relate – at least not directly – to personal drug importation, but it frees the hands of drug companies to sell their own foreign versions of FDA-approved drugs at lower prices in the U.S. market. Its indirect relation to personal drug importation is noted at the end of this post.

Some of this is guesswork. It’s not entirely clear to me what drugs are permissible under Pathway II and it won’t be until the draft guidance is made public.

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Trump’s Campaign Website’s Only Drug Prices Policy Was Importation

If you care about and follow the issue of drug prices, then this week was bizarre on the political scene. In a press conference with Rep. Adam Schiff (D-CA) at her side, Speaker of the House Nancy Pelosi (D-CA) was imploring the media not to focus only on impeachment but on drug prices, noting that she believes Congress and President Trump can continue to work together despite the friction.

Yesterday, Trump was courting seniors in Florida, extolling drug price reductions under his watch that kind of, you know, never really happened and promising to save Medicare from “socialism” (go figure, Medicare is already a huge government program). Bizarrely, he implied that Big Pharma might have something to do with the impeachment inquiry against him. Maybe his Secretary of Health and Human Services, former Eli Lilly Pres. Alex Azar, is in on the “coup”… just joking. 

In the haze of the political circus, something fundamental keeps getting lost. During Trump’s 2016 campaign, the only policy he put forward on his website to bring down drug prices was drug importation. See below screenshot:

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House Ways and Means Report Recommends Looking Abroad for Lower Drug Prices… Kind of…

A report (“A Painful Pill to Swallow: U.S. vs. International Prescription Drug Prices”) was released this week by the Congressional House Ways and Means Committee, showing that brand name drug prices are much lower – by about 75% on average – in other high-income countries. Who knew? Well, our analysis from this past summer showed that the average savings on popular brand drugs filled through online orders with Canadian pharmacies was 75%. When including pharmacies in other countries, the savings jumped to 90%. Those include pharmacies located in middle income countries, such as Turkey. For the record, these are comparisons among PharmacyChecker-accredited online pharmacies.

The committee’s report looked at prices of 79 brand name drugs in the following countries: Australia, Canada (specifically Ontario), Denmark, France, Germany, Japan, Netherlands, Portugal, Sweden, Switzerland, and the United Kingdom. I highly recommend reading this report if you want to learn about international drug price differentials and better understand how Americans are getting ripped off.

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