By way of the craftiest of PR snakes, pharmaceutical companies infest the media, politicians, and consumers with the idea that if we expressly permit people to buy lower-cost medications from other countries, we break the “closed” pharmaceutical distribution system. This concept of a “closed” system is sadly overplayed and misleading.
The U.S. Food and Drug Administration (FDA) is one of the leading drug regulatory authorities, but as the pharmaceutical industry continues its propagandistic efforts against legalizing importation of lower-cost medication, the myth making has got to be called out. You’ll have to forgive me for the lengthy post: I’ve chosen to include long quotes from experts—perhaps to offset my frustrated tone—but mostly to properly inform you what we’re up against.
The fact is, you can trust the safety and efficacy of medications sold in the U.S., but NOT more so than Canada or many other countries. People are not paying attention to the perpetual lies Big Pharma regurgitates on this issue. In a follow-up post, I’m going to discuss myriad ways that the FDA is doing a much better job, but, for the moment, excuse me while I blow off sufficient “What-the-hell-is-going-on?!” steam.
Let’s start with the claim that all medication sold in U.S. pharmacies are made in plants that are inspected by the FDA. People who make that claim are not just misleading but lying (maybe by accident but still). In this case, as in many, the drug companies cite government reports, ones in which foolish lies are rampant. For example: a ubiquitously cited report put out in 2004 by the Department of Health and Human Services, based on the work of the Drug Importation Task Force states that the only types of “legally imported drugs are 1) those that are manufactured in foreign FDA-inspected facilities and adhere to FDA-approval standards, or 2) those that are U.S.-approved and manufactured in the U.S., sent abroad, then re-imported back into the U.S. by the manufacturer under proper controls and in compliance with the FD&C Act”(Source: https://archive.hhs.gov/importtaskforce/Report1220.pdf). This is squarely at odds with what the Government Accountability Office (GAO) wrote in 1998, words of which the drug manufacturers are well-aware:
However, while FDA has recognized that it does not have sufficient resources to routinely inspect all foreign manufacturers of pharmaceutical products imported into the United States, its strategy does not ensure that every foreign manufacturer exporting pharmaceutical products to the United States complies with U.S. quality standards.
It gets worse later in 2007. GAO writes:
FDA’s data indicate that some foreign drug manufacturers have not received an inspection, but the exact number of establishments not inspected was unclear. Of the list of 3,249 foreign establishments, there were 2,133 foreign establishments for which the agency could not identify a previous inspection. Agency officials told us that this count included registered establishments whose drugs are being imported into the United States that have never been inspected but also included other types of establishments, such as those whose products were never imported into the United States or those who have stopped importing drugs into the United States without notifying FDA.
The good news is that, today, the FDA is doing a better job, but there are still about 1,000 plants out there LEGALLY exporting medication to your pharmacy, which have never been inspected by the FDA. By the way, it takes money to do inspections and if the FDA isn’t funded to conduct them, then it can’t. It’s also worth noting that the FDA sometimes relies on the inspections of its counterpart regulators in other countries via Memorandum of Understandings, such as one with Australia.
Pharma-funded groups, such as Partnership for Safe Medicines, state the following in their FAQ section: “Currently, the United States has one of the safest drug supplies in the world because our pharmaceutical supply system is ‘closed’ to importation.” Well, we just learned from the GAO that our drug supply system is, in fact, heavily reliant on importation – often from plants we’ve never inspected. PharmacyChecker.com just researched the pricing and country of manufacture of 20 top brand-name drugs in the United States and found that 70% of them were imported.
While we think the number is higher, the FDA uses the figure 40% to approximate the volume of imported medications sold in U.S. pharmacies. A whopping 80% of the active pharmaceutical ingredients found in American drugs are foreign-made, according to FDA!
If you confront the pharma trolls, they will probably say “well, yeah, but those medications are FDA-regulated.” Uh, not exactly. From the facts presented above, many of “FDA-approved” prescription drugs are neither manufactured in accordance with FDA standards nor in plants visited by the FDA.
Finally, our domestic pharmaceutical distribution system is getting better but remains vulnerable from domestic threats Allan Coukell from Pew Charitable Trust describes the intensely convoluted domestic distribution system:
…numerous entities are involved in drug distribution, and the routes to market are not always simple. Drugs can be bought and sold by one wholesaler or by many before reaching a pharmacy. Drugs may be traded between distributors, and may travel back from distributors and pharmacies in local markets to major wholesalers through sales or returns before ultimately reaching patients. Some drugs travel through repackagers; some are transported by third-party logistics providers who do not actually purchase the drug; that is, the physical movement of drugs does not always conform to transfers of ownership, further complicating drug tracking.
I could go on and on and on… But guess what! Of course, other countries and regions have pharmaceutical safety problems of their own. They are all making improvements as I write (rant). Check out this white paper comparing the U.S. to the EU on new pharmaceutical safety regulations. It’s my hope that more people like Allan Coukell examine the promising work being done in the EU to improve drug safety and distribution. Surely, this will lead to regulatory convergence in helping Americans access affordable prescription medications.
In the meantime, most licensed pharmacies in the aforementioned countries, for all intents and purpose, sell equally safe and effective medication as those in the U.S., which must be a relief to the hundreds of millions of people in the European Union, Australia, New Zealand, UK, Canada, etc. Unlike our safe pharmacies, their drug prices are much lower.Tagged with: closed, coukell, drug distribution, FDA inspections, GAO