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  5. Karen Mahoney, M.D. - Transcript
  1. Regulatory Science in Action

Karen Mahoney, M.D. - Transcript

Making Naloxone, an opioid overdose reversing drug, available over-the-counter

Dr. Mahoney: I went to a civilian medical school on an Army scholarship and then I was privileged to train at Walter Reed. I always felt the pull of public service. And so I just felt really fortunate when, you know, I was able to start at FDA. And I love my work.

Text Slide:

Karen M. Mahoney, M.D.

Deputy Director

Division of Nonprescription Drug Products

Office of New Drugs

Office of Drug Evaluation IV

Dr. Mahoney: The Division of Nonprescription Drug Products regulates all over-the-counter drug products in the United States, and it’s our job to make sure that consumers understand how to use them safely and effectively without any help from a health care provider. They need to be able to use just the labeling in order to understand how to use it safely and effectively.

We’re always trying to think innovatively about drugs that right now are limited to the prescription world that might benefit people if they could be available without a prescription.

Today 80 Americans will die from an opioid overdose death.

And the number of people who are dying is increasing at a frightening rate.

There is a lifesaving drug called Naloxone that is an opioid overdose reversing drug, and right now it’s only a prescription drug, but we’re working to try to figure out a way to make it be available over-the-counter someday.

Being a prescription drug, a consumer can’t get it easily, but if it could be available over-the-counter, it could be everywhere. And so anyone who knows anyone who may be at risk for opioid overdose death could have it.

Naloxone works by binding to the same receptor that opioids bind to in the body, but Naloxone binds more tidily and so it displaces opioids and prevents them from binding. When it’s administered to someone who has an opioid overdose -- this would be somebody who is unconscious and who’s at risk for dying at any moment, it can be dramatic. Within minutes the person is literally brought back from the brink of death.

Addiction is a disease. And we don’t want people to die from this disease. We want them to live to fight it another day.

The benefits of it so far outweigh the risks that people can really feel comfortable giving it.

One thing that we have heard from manufacturers when we have publicly discussed the possibility of Naloxone being an over-the-counter drug product is that they see having to do the consumer behavior testing, the label comprehension testing as a barrier.

And so we decided to take away that barrier. The FDA has decided on its own to take an unprecedented step. And so what we have done is on our own we have developed a model drug facts label for a potential over-the-counter Naloxone product.

They can use just that label and know what they need to know to in an emergency situation give the drug and save a life. After testing is done, we will release the results publicly and a manufacturer of a prescription Naloxone product could take that label, plug in a little bit of information from their own particular product, do a little bit of retesting and then come into us with an application.

Once that application is submitted, it will be a very high priority for the agency to get it approved as quickly as possible. A lot of lives could be saved.

When I was in private practice, you know, taking care of patients, it’s wonderful, but I help one person at a time. And here if I get it right, I can help thousands or maybe even millions of people. It’s just an extremely satisfying job.

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