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FDA Is Changing The Rules On Drug Labeling For No Good Reason

The opinions expressed by columnists are their own and do not necessarily represent the views of

The Food and Drug Administration is proposing to alter the longstanding rules on drug labels. Who cares? What’s the big deal? They are just labels, right?  We have a lot bigger problems with corruption and cronyism than worrying about something as mundane as labels. True, but labels are where the rubber meets the road for the patient who is the consumer of these drugs.


Pharmacists who fill our prescriptions for the medications we take need to rely on the labels doctors depend on for accurate safety information. So do nurses in hospitals who bring around medications every few hours, and the physician’s assistants and orderlies and home health care aides and workers at senior centers. They’re actually really important to the health of a lot of people.  Labels right now are consistent from the name brand to all of the generics. But with the inconsistent labeling proposed by the FDA, those who prescribe medications and those who take prescription medications will struggle with the information on labels. Drug labels are all important to delivering the meds from the doctor to the patient. Mistakes in that delivery can literally kill people. It is that important.

So what is the FDA doing? Basically, they intend to change the standards that have guided the industry for years to be more fluid and provide more accurate and detailed information to the consumer. That’s not what will really happen of course.

The results will be confused consumers and increased accidents with a direct correlation to the label. That correlation will cause a spike in litigation toward all the drug companies. The larger companies will be able to bear this burden, but the smaller ones and most importantly the generic manufacturers will be hit the hardest.


It’s always the guy on the thin margin who gets hurt the most when our, oh-so-very-helpful, government makes changes. Currently, generic drugs represent more than 88% of the drugs prescribed in America and only 28% of the pharmaceutical cost. That’s a good thing. Why mess with it? I’ll give you one guess. Big money. If people lose confidence in what they are getting from the generic manufacturers or if the docs can’t confidently prescribe generic…it will have a catastrophic effect to the generic market.

These changes will cause market failure for some companies, which will in turn cause a decrease in choices for the patients who already have little choice.

The Generic Pharmaceutical Association (GPhA) issued a brief outlining their concerns. As you can imagine there is no press for this kind of story until someone dies, then only five minutes of air time. The GPhA has several things about the FDA proposed changes that they are not too happy about.

The main two problems with the label changes are that while being under the guise of helping the patient, they will do just the opposite. The key to great labeling from name brand to generic is consistency. If you can read the label on the name brand bottle and read the label on the generic bottle and see that the active ingredients are the same, you have peace of mind in taking the cheaper one.


That already exists in America. The proposed changes will allow companies to alter labels to a point where it will be very difficult for a lay person to figure out what they are taking. The standards will be gone. It will actually make it difficult even for the doctors doing the prescribing to comfortably prescribe the correct meds.

Leave the labels well enough alone. We’d all be better off if the FDA would go play solitaire on their computers. Don’t meddle with something that is already working, especially when it involves the medicines of the American people.

In the end, this will only increase costs and decrease choices for the consumer, while at the same time giving the trial lawyers a whole bunch of new business. Some manufacturers will be forced to close and another link in our medical delivery system will be further weakened by an interfering government. 

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