PharmacyChecker Blog

Helping Americans Get The Truth About Prescription Drug Savings
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Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

Canada believes it is too small to facilitate U.S. wholesale importation of lower-cost drugs. This post will explore a much greater potential for importation from the European Union.

Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. personal importation) often rely on the common belief that the U.S. Food and Drug Administration exemplifies the “gold standard” in drug safety. This “gold standard” importation talking point from the Pharmaceutical and Researchers of America (PhRMA) fuels Americans’ fear of ordering medication internationally despite proof that importation can be very safe and provide financial relief and better adherence to prescriptions:

“The United States is the gold standard when it comes to regulating the safety of our medicine supply. Importing medicines from countries that do not have our same strong standards could taint our medicine supply.”

The first sentence is something you are supposed to take at face value. The second sentence is deceptively broad: as in, yes, importing medicines from countries that do not have our “same” standards could taint our medicine supply. Not necessarily, but it could.

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Hitting Pause on Criticism of the FDA, Just for Today

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is. I’ve also witnessed and participated in its criticism, and with good reason: the agency is not honest or forthcoming about personal drug importation, their regulatory process has been said to be “inherently biased” in terms of which drugs they choose to approve and their coziness with the pharmaceutical industry, among other things. Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration, much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics.  

As my greater advocacy initiatives have worked to implore the FDA to bring more balance, commonsense and fairness to regulating and providing consumer education about personal imports of prescription drugs, I’ve realized that I should practice the same in how I talk about the FDA. So, without further ado, a moment of praise amongst the criticism:

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‘Bottle of Lies’ Author Katherine Eban: Dispense as Written

“Dispense as Written” are the words found on prescriptions in the U.S. when the prescriber wants the patient to take the brand drug, not the generic. Many who read Katherine Eban’s new book – Bottle of Lies: The Inside Story of the Generic Drug Boom – will conclude that they would like to see “DAW” on their prescriptions.

Bottle of Lies teaches its readers that generic drugs are not as good as the FDA claims. It shows that poor manufacturing practices, mostly in India and China, but also in the U.S., are the leading cause of substandard drugs being sold in U.S. pharmacies and throughout the world. More ominously, India and China intentionally ship even lower quality and, in some cases, worthless drugs to poor countries in Africa and Southeast Asia where regulations are weak or non-existent.

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