We Got The Scoop On "One of the Biggest Mistakes in Modern Medicine"
SmartHERNews
Jenna Lee
4.9 • 660 Ratings
🗓️ 10 November 2025
⏱️ 26 minutes
🧾️ Download transcript
Summary
Back in September, we sat down with the head of the FDA, Dr. Marty Makary, to talk about a host of different hot health topics in America.
An area we wanted to focus? Hormone Replacement Therapy or HRT.
One of Dr. Makary's first moves as FDA commissioner was to hold a public panel on what he has now called "one of the biggest mistakes in modern medicine" - black box warnings that the U.S. government placed on hormone replacement therapies, that he believes deterred doctors and women from using these medications to treat life-altering symptoms.
Today, the FDA announced, for the first time in decades, it would initiate removing these warnings from HRTs in the hopes of making the treatments more available and accessible to physicians and patients alike.
Here's the entire portion of our interview that focuses on hormone replacement therapies, so you can hear for yourself why Dr. Makary feels so passionately about making a move on this medicine, at this time, for not only American women, but the country at large.
Listen or watch our complete 1-hour sit-down by clicking on this link.
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Transcript
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| 0:00.0 | Hi, everybody. Welcome to Smarter News. We have a big headline from the FDA and some unique |
| 0:11.5 | insight to this story. So I wanted to make sure to highlight it for you because of the potential |
| 0:16.8 | impact for all of us and all of our families. Today, the FDA announced that they are initiating |
| 0:23.5 | the removal of black box warnings on hormone replacement therapies for women. So what does that |
| 0:30.1 | mean? And why does it matter? Well, black box warnings, similar to warnings that you may see on |
| 0:34.9 | medications, are these stark, you know, very visible |
| 0:38.4 | warnings about potential scary side effects. Now, we've all seen those commercials that list off |
| 0:44.6 | all the different side effects of a medication, but these are very different. You'll see these |
| 0:47.9 | black box warnings when you go and pick up your prescription. And many, including the FDA |
| 0:52.5 | commissioner, Dr. Marty McCarrie, believe that these sort of warning |
| 0:56.2 | labels have deterred both physicians and patients from taking a medication that could really, |
| 1:02.3 | really help them at a specific time in their life. And any medication that could help women |
| 1:07.5 | affects American society overall. So the FDA is initiating the removal of these |
| 1:12.6 | black box warnings. It won't happen overnight, but they're moving in that direction. And the hope is |
| 1:17.4 | that this will open up more access for both physicians and patients to feel more comfortable with |
| 1:25.4 | these treatments. It's not that these treatments weren't available for |
| 1:28.8 | the last several decades. It's just that the concern was so high about side effects that many |
| 1:33.8 | believed that it wasn't worth it. It wasn't worth the chance. This was a big topic of conversation |
| 1:40.8 | that I talked to Dr. Marty McCarrie about, the head of the FDA, back in September. |
| 1:45.7 | And the reason why I talked to him about this topic is it was very clear when he assumed the leadership |
| 1:51.0 | role of the FDA that women's health was going to be a top priority for him. In fact, one of the |
| 1:56.3 | first panels that the FDA broadcast under his leadership was about hormone replacement therapy and |
... |
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