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  5. Kimberly Witzmann, M.D. - Transcript
  1. Regulatory Science in Action

Kimberly Witzmann, M.D. - Transcript

Determining the bioequivalency of generic drugs

Dr. Witzmann: When a drug comes into the FDA, it needs to be approved to make sure it’s safe and to make sure it’s effective. That brand name drug then has a certain amount of time on the market. And then after those patents and exclusivities expire, then generic drugs are able to come into the marketplace with copies of that original drug.

Text Slide:

Kim Witzmann, M.D.

Team Leader

Division of Therapeutic Performance

Office of Generic Drugs

Office of Research and Standards

Dr. Witzmann: The Office of Generic Drugs’ focus is to make sure that the drug products that come in are the same. And the do that by looking at a couple of different aspects of the product that comes in. One is to make sure that the drug is what we call bioequivalent, which means that the drug acts in the same effect at the same location as the reference drug does, that it works exactly the same way. Another thing that we focus on is making sure that the drugs are pharmaceutically equivalent, which means that it’s the same active drug product, it’s the same amount, it’s the same dose, and that all of that is the same as well.

One of the big challenges with some groups of generic drugs are the ones that are not in pills or liquid formulations that people can swallow and take easily.

The ones that I work with particularly are the inhaled and the nasal products. Those are a lot trickier. In those drug products, there’s a drug as well as a device that has to deliver the drug to the place that you’re trying to get it to.

When you think about drugs for the lungs, we think about those inhaler devices. So, that inhaler has to be able to deliver the drug in the same size and shape of particles to the same places in the lung in order for it to really be equivalent to the original product.

Our office is working hard with our research initiatives to try to find better, more efficient, less costly ways to evaluate these products so that we can still have the same integrity and we can make sure that the healthcare providers, the patients and the public feel very confident in the products that we’re putting out, that they are in fact safe, efficacious and equivalent to the original products.

As someone who was a practicing clinician before I came to FDA, I had cases on an almost day-to-day basis where I was on the phone trying to advocate for my patients, to get them medications that they could afford, that were covered under their insurance plans.

I think that all of us share that same goal. We really want to be able to do everything that we can to bring these drugs to market faster.

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