WASHINGTON – Sen. Chuck Grassley (R-Iowa) received a letter from the U.S. Food and Drug Administration (FDA) in response to his April 13, 2018 letter to Department of Health and Human Services (HHS) Secretary Alex Azar and then-FDA Commissioner Dr. Scott Gottlieb seeking additional information about an investigation into a South Florida clinic that performed unproven stem cell treatments on patients that left them permanently blind.

“Transparency is not only critical to good government, but also to the health and safety of the public,” Grassley said. “When it comes to people’s health, they deserve to have accurate information from a credible source. The government must take all reasonable steps to ensure that ClinicalTrials.gov is not abused as an accessory to unproven and unregulated trials. When wrongful conduct occurs, the government must aggressively enforce the law to deter that type of conduct from happening again.”

Highlights of the FDA’s response include:

  • The FDA referred the matter to the Department of Justice (DOJ) for a civil enforcement action against U.S. Stem Cell, Inc., U.S. Stem Cell Clinic LLC, and individual defendants including its Chief Scientific Officer. The DOJ then filed for a permanent injunction against the South Florida clinic in May 2018;
  • In June 2019, the federal court granted DOJ’s motion for a summary judgment; and
  • FDA has issued more prominent disclaimers on its website to warn potential patients that the clinical trials listed are not endorsed by the federal government.

Grassley’s letter was in response to a March 15, 2017 Washington Post report that detailed that three women in South Florida participated in what they believed was a government-backed clinical trial to reverse the effects of macular degeneration. The stem-cell treatment they received, though not government approved, was listed on a comprehensive database of clinical trials run by the National Institutes of Health. The episode left them permanently blind. Also, in August 2017, the FDA issued a press release that noted U.S. Stem Cell Clinic tried to impede its investigation, which is a violation of federal law.

Text of the FDA response letter is available here.

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