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The Latest on Internet Pharmacies, Supplements, Designer Drugs, and Other High-Risk Merchants

Is Your Prescription Drug Unapproved? Understanding the FDA’s Unapproved Drug Initiative

Last week, LegitScript sent letters to the heads of several large pharmacy chains encouraging them to protect their customers by ensuring that they are only dispensing FDA-approved medications. The letters were sent as a part of a new public education initiative on unapproved drugs that is complementary to our ongoing efforts regarding Internet prescription drug safety.

To put the letters into context, any prescription drug sold in the United States must be, by law, “FDA-approved.” This ensures that it has been subjected to rigorous testing and deemed both safe and effective. If studies show that the medication does not meet the standards needed for approval, then the FDA is bound to deny its application. FDA approval is considered the “gold standard” throughout the world. Americans know that if they fill a prescription at a pharmacy within the United States, they are being provided with drugs that are “FDA-approved” and that provides them with a piece of mind. After all, if you are ill and need medication, you want to know that what you are taking is actually going to work!

Over the last 50 years, there have been a few exceptions to the requirement that prescription drugs be FDA-approved. The FDA drug-review system has evolved over time, and took a leap forward in the 1960s. Drugs that were on the market prior to 1962, and that have not been modified in any way (including their labeling or marketing) since then, can be “grandfathered in” as legal drugs, even if they are not technically “FDA-approved.” If that is, there is no FDA-approved version of the drug currently on the market.

In the 1960s and 1970s, grandfathering those non-FDA approved drugs made sense: the process was new, and the FDA could not have simply ordered all drugs that had been around since the 1950s or before off the market. But now that nearly 50 years have passed, very few unapproved drugs meet the exemption requirements: either there is an approved version of the drug, or something about the drug (chemical makeup, labeling, etc.) has changed. Accordingly, in 2006, the FDA launched the unapproved drugs initiative to identify unapproved drugs that do not or should not meet the exemption requirements and remove them from the market.

Why is this important? In short, it’s a health issue. If you have a medical condition, you want to know that the drug you are taking to treat it will actually work. We’ve learned a lot about medicine since the 1950s, and what may have been the “best available” then is not, in the vast majority of cases, the safest and most effective option now. The FDA has indicated that there are probably extremely few drugs that can legitimately be grandfathered in.

Over the next several weeks, LegitScript will be taking a closer look at some unapproved drugs, and their availability online and offline, as a resource to help inform patients who may be taking an unapproved drug know whether there are better options.

Additionally, in cases where there is now an FDA-approved version of the drug, there are a variety of patient assistance programs to assist individuals without insurance or who otherwise find it difficult to afford their prescription medications. We’ll be looking at ways to help make that information available as well.