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  5. Connie Ruzicka, Ph.D. - Transcript
  1. Regulatory Science in Action

Connie Ruzicka, Ph.D. - Transcript

Screening dietary supplements to ensure they are safe and effective

Dr. Ruzicka: I realized that helping people doesn’t always mean being a physician. And so I determined that there’s other avenues to help people.

Text Slide:

Connie Ruzicka, Ph.D.

Research Chemist

Division of Pharmaceutical Analysis

Office of Pharmaceutical Quality

Office of Testing and Research

Dr. Ruzicka: The Division of Pharmaceutical Analysis, we do a variety of testing of new and generic drugs to ensure that they’re safe and effective for the public.

One of the areas that we work in for research is utilizing portable technology onsite to screen products being imported into the United States.

It’s changing the paradigm of how FDA does screening. Currently we collect all the samples and send them to the laboratory. Now we have the ability to go onsite and screen products directly at their locations of importation.

One area of interest are dietary supplements. Americans assume that they’re natural, healthy, and safe for them. Sometimes people are actually adding prescription drugs to enhance the claims on the labels.

These prescription drug products aren’t on the label claim. There could be adverse health events. It can have interactions with other medications that they’re on and it can be very harmful.

We’re utilizing portable instrumentation in which we’re able to take them out to import locations or non-laboratory environments. We’re able to do a quick extraction method on the products of interest and then analyze them within 30 seconds with the instrumentation. So we can get a pass/fail result right on site. If multiple prescription drugs are present, we will get an alarm, and the alarm will indicate which drug substances are present.

We’ve had a pilot study. During that six-month study approximately 65 percent of the products that we tested positive utilizing our portable device in the field for the presence of a prescription drug.

So it’s staggering to see that there’s a large number of products being imported that are dietary supplements that have prescription drugs in them.

Coming to the FDA and being able to test drug products and develop this screening program has been extremely rewarding. And I can see that if the American people get this information, that I am making a difference.

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