The FDA has finished draft guidance on one of two of the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
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what drugs are permissible under Pathway II and it won’t be until the draft
guidance is made public.
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
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
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.
A lot of media coverage about counterfeit drug threats in the U.S. are spurred by the media relations efforts of organizations funded by pharmaceutical companies, such as the Alliance for Safe Online Pharmacies and Partnership for Safe Medicines. As I see it, their public education efforts conflate safe online sales of medicines imported by consumers in the U.S. with counterfeit drug sales and other forms of drug sales, ones that clearly harm patients. One such article that did not fall prey to the propaganda was published in Kaiser Health News’ California Healthline detailing street market sales of prescription drugs, including cases that involve counterfeit drugs and the dangers they pose. Journalists who are looking closely, checking the funding of organizations disseminating information about prescription drug importation, can help stop the propaganda of the pharmaceutical industry.
The Kaiser story, written by John M. Glionna, focuses on
Latino immigrant communities in which people can’t afford medication or, due to
their immigration status, are fearful of deportation if they go to federally-funded
clinics for medical treatments. Eight people were arrested and charged with
illegal street sales of prescription drugs, including injectables and
controlled drugs. Glionna describes the LA County authorities report:
As I wrote
a few weeks back, PharmacyChecker
filed an antitrust lawsuit against five organizations that we believe are largely
funded or backed by pharmaceutical companies. We allege that these
organizations have conspired to illegally suppress competition in the areas of online
pharmacy verification services and drug price comparisons on the Internet. The
organizations are the National Association of Boards of Pharmacy (NABP),
Alliance for Safe Online Pharmacies (ASOP), Partnership for Safe Medicines
(PSM), LegitScript, and the Center for Safe Internet Pharmacies (CSIP).
As part of that suit, we filed a motion for preliminary
injunction to immediately stop the NABP from including PharmacyChecker.com and
this blogsite on its “Not Recommended Sites” list. That list was created to
ostensibly identify rogue online pharmacies but has included safe international
online pharmacies from its very inception. More recently NABP’s oversight has
been expanded, apparently, to also include sites—such as this blog—that help
consumers avoid rogue online pharmacies and find affordable drug prices!
Stephen Salant, PhD, professor emeritus of economics at the University of Michigan and research professor at the University of Maryland has written a paper that I believe gives voice and pays respect to the millions of Americans who import or are on the verge of importing lower-cost medication using online pharmacies. Let me be clear: this guy is a world-renowned economist. An expert in applied microeconomics, Professor Salant is most famous for his work in the economics of natural resources and industrial organization. Over the past few years, he has turned his attention to the problem of high drug prices in America and how to solve it without decreasing investment in research and development to create new life-saving drugs.
I’ll articulate the basic points of Salant’s paper, as I
understand them, and then give some commentary.