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Labeling Changes...What Now?


Just yesterday the FDA sent out a press release announcing a proposal to make some labeling changes to Over-the-Counter (OTC) pain relievers and anti-pyretics taken by mouth (that is, not including topical liniments or rubs). If you're curious and want to read the actual press release you can find it here.

So what does this mean to you the consumer who have probably already ingested more of these medicines than you can recall? Well, first it might help to understand what the FDA's process for approving OTC medications entails. There are actually two ways that a drug gets to the store shelf. One way involves a drug going over-the-counter from behind the pharmacy counter where it was available to consumers by prescription only. The other requires that the manufacturer of said drug product comply with pre-existing marketing standards established in the applicable OTC drug monograph.

In the former, the drug manufacturer submits a New Drug Application (NDA) which should include data that shows that the drug is safe and effective for use by consumers without the assistance of a healthcare professional. Now that's putting a lot of confidence in the hands of the consumers, trusting individuals to follow directions with only the guidance of a label. The drugs themselves must meet established standards for safety and effectiveness. They have to be manufactured according to current good manufacturing practices (cGMP) and must comply with certain labeling content and format requirements. While the FDA does as much as possible to ensure the best possible outcome once these drugs are released to the public, sometimes, as is true with almost anything, hindsight is 20/20. Invariably, when a drug is more accessible to a larger population that's when un-anticipated issues arise. For example the widespread abuse of Pseudoephedrine and other common OTC medications, or in this case, the public needing more information in order to ensure safer use and fewer adverse events.

Personally, I think this is something that should have happened a long time ago because it is just that relevant. Going forward however, the good thing is that anyone who feels strongly enough about this has the opportunity to submit comments to the FDA (deadline May 18th 2007). In the final analysis what this means to you the consumer is that Big Brother is watching over you and watching out for you. Should that make you sleep better at night? Maybe, but that shouldn't absolve anyone of their own responsibility when it comes to their personal health and wellness.

Image courtesy of emagic
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The Healthline Editorial team writes about the latest health news, policy, and research.

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