Yesterday, I was asked by Ed Silverman of STAT NEWS’ Pharmalot for my thoughts about a report by the Office of Inspector General, Department of Health and Human Services (OIG). The report is an audit of companies in the drug supply chain to test compliance with regulations called for by the Drug Supply Chain Security Act of 2013 (DSCSA). In short, as reported in STAT, OIG found that seven out of 44 drugs audited could not be traced back to the manufacturer in the manner required under the DSCSA. Add to that, the physical locations of 21 drugs could not be determined. Since most drugs subject to DSCSA are made overseas and imported, Mr. Silverman wanted to know if this audit impacted drug importation proposals and plans in the works to lower drug prices. The answer is probably no. The report appears to be a worthwhile effort to test compliance with DSCSA. However, use of the word “legitimate” is found in the DSCSA, and that word is often misused by opponents of drug importation and international online pharmacies – and that got me thinking. I’m sick of that word.

On the subjects of drug importation, online pharmacy verification, drug safety and affordability, the word “legitimate” is thrown around a lot. What is a legitimate online pharmacy? What is a legitimate drug? The word, according to Merriam-Webster Dictionary, can mean “lawfully” and/or “being exactly as intended or presented: neither spurious nor false.” In the DSCSA, an “illegitimate” drug is one that is “is counterfeit, diverted, or stolen.” As we know from the debate on drug importation, the pharmaceutical industry wants to have maximum control over the distribution of its products in a manner maximizing its profits. Let’s say Pfizer sells 10,000 pills of Eliquis to a Canadian wholesale pharmacy for $20,000 but charges a U.S. wholesale pharmacy $80,000. The Canadian wholesale pharmacy might want to sell the 10,000 pills to the U.S. wholesale pharmacy for $30,000. It’s the same drug, but the law prevents the sale. If in fact the sale is made anyway, the Eliquis would be considered “diverted” and therefore “illegitimate” under U.S. law. Does that make the Eliquis unsafe? No way.

The pharmaceutical industry wants the law to reflect as closely as possible its understanding of “drug diversion,” which are any sales that appear to undermine its profit model. So, referring to diverted products as “illegitimate” in the DSCSA gives Big Pharma the public relations and lobbying ability to lump “diverted” products in with “counterfeit” drugs. I’ll let Big Pharma speak for itself. The website of the Pharmaceutical Researchers and Manufacturers of America (PhRMA) states in opposition to drug importation:

“The U.S. Food and Drug Administration (FDA) is the gold standard when it comes to regulating the safety of our medicine supply. Medicines that enter the United States through importation will not be subject to these same strong standards and, as a result, counterfeit, substandard or diverted, repackaged and adulterated drugs could be introduced into our secure drug supply chain.”

Did you notice that string of words: “counterfeit, substandard or diverted, repackaged and adulterated drugs”? Let’s break it down. Counterfeit, substandard, and adulterated drugs are generally unsafe and potentially deadly. That has the ring of illegitimate to me. What about “repackaged”? That came as a shock to me. Drug companies work with drug FDA-registered repackagers all the time. There are good reasons to re-pack pharmaceuticals, in a manner that helps businesses and patients. So, “repackaged” should not mean illegitimate.

You noticed the word “diverted.” In the European Union, pharmaceuticals that are traded among member countries (i.e., Germany to Spain), called “parallel trade,” are often associated with so called “diverted” products by drug companies, per this pharma-funded report in the EU on the evils of parallel trade. Why? When Pfizer sells 10,000 pills of Eliquis to a Spanish wholesale pharmacy for $15,000, it doesn’t want that wholesale pharmacy to sell it to a Germany wholesale pharmacy for $18,000 because Pfizer would prefer to sell Eliquis in Germany for much more. None of that makes the Eliquis unsafe or illegitimate. It’s just not what the drug companies want.

How about a “legitimate” online pharmacy?

To many people, legitimate online pharmacies process drug orders pursuant to a valid prescription that are dispensed by mail order to a patient by a licensed pharmacy. The “many people” I’m referring to are consumers who can’t afford medications locally and buy cheaper medicines from other countries using online pharmacies that meet that definition.

The pharmaceutical industry has invested lots of money in organizations and programs to create its chosen narrative of what “legitimate” online pharmacy means. In fact, we filed an antitrust lawsuit against some of those organizations that contains a wealth of information to show how far they have gone to do so. That narrative holds that any non-U.S. online pharmacy that fills a prescription drug order sent to patient in the U.S. is “illegitimate.”

It’s this framing of online pharmacy legitimacy that has in turn scared people away from websites where legitimate pharmacies sell legitimate drugs at much lower cost than in the U.S. Perhaps what is most egregious is this Pharma-funded effort has actually led to initiatives where patients are more likely to find counterfeit drugs over the Internet. I’m referring to research funded by the American Enterprise Institute showing that the search engine Bing’s use of the National Association of Boards of Pharmacy’s (NABP) “Not Recommended List” as a filter to produce pop-up warnings next to search results linking to those sites. According to that research, since there are some legitimate sites on that list and also many unsafe illegitimate sites that are not on that list, Bing searchers are more likely to buy a counterfeit or other illegitimate drug. I refer to this initiative as “Pharma-funded” because the NABP’s Not Recommended List was launched with a grant from Pfizer.

The NABP’s programs, as I see it, appear to work in tandem with the company LegitScript in propagating a dangerous narrative of legitimacy, one which scares people away from medicines they can afford. That company’s name appropriates the very word “legitimate” when it comes to online pharmacy verification. While LegitScript may not be “pharma-funded,” as it is a business not a non-profit organization, its founder, we have asserted, was a critical player in establishing the narrative of legitimacy wished for by drug companies, including through its funding and leadership of the pharma-funded Alliance for Safe Online Pharmacies, which has focused a good deal of its time lobbying against drug importation.

These types of pharma-funded campaigns, now over a decade old, have worked quite well to brand online pharmacies that safely sell cheaper medicines pursuant to a prescription as “illegitimate.”

And that gets us back to the law, which has been shaped by drug company lobbying. People are dying because they can’t afford their meds in the U.S. While it’s seldom done: the law gives the government the right to seize or destroy a legitimate drug, sold by a legitimate pharmacy, imported for personal use by a consumer with a legitimate prescription who can’t afford it here. What could possibly be legitimate about that?