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Ex-FDA Testifies AndroGel Testosterone Gel Sold Off-Label

Ex-FDA Testifies AndroGel Testosterone Gel Sold Off-Label

June 9, 2017 — Dr. David Kessler, former Commissioner of the FDA, testified that he believes AbbVie illegally marketed AndroGel testosterone gel for “off-label” uses, according to Law360..

In the first “bellwether” trial out of more than 4,200 federal lawsuits, attorneys called Dr. Kessler as the first witness on behalf of Jeffrey Konrad, a man who had a heat attack in 2009 after using AndroGel.

AndroGel is only FDA-approved for a rare medical condition known as hypogonadism that causes extremely low testosterone levels. It primarily affects men with genetic disorders or missing testicles.

Even so, AbbVie promoted AndroGel as a treatment for “Low T,” a made-up condition involving age-related symptoms like decreased libido, depressed mood, “falling asleep at the table,” and body fat.

As Dr. Kessler explained to the jury:

“What the companies in essence did was to take those indications of low testosterone in men for specific reasons [and] the company in essence broke that link.”

Dr. Kessler said AbbVie did not advertise AndroGel for the specific disease it was approved to treat. “It was for low testosterone and a broad range of issues,” he said.

Lawyers accuse AbbVie of aggressively promoting AndroGel using illegal marketing tactics, failing to conduct adequate safety studies, and downplaying safety risks when concerning studies emerged.

In March 2015, the FDA ordered AbbVie to update the label on AndroGel to clarify that it was not for the treatment of age-related testosterone loss. Testosterone levels naturally decline after age 40 by about 1-2% per year — and that may be a good thing.

Studies show that testosterone stimulates the formation of red blood cells, which can be a risk-factor for blood clots that cause heart attacks and strokes.

The FDA required warnings about heart attacks and strokes on the label for AndroGel in 2014. By that time, it was already a blockbuster drug for AbbVie. Sales were estimated at $2 billion in 2015 alone, the same year the FDA clarified the label on age-related testosterone loss.

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