Policy News

ISSCR Comments to FDA Regarding ClinicalTrials.gov

  • 21 November, 2018
In a letter to the U.S. Food and Drug Administration (FDA), the ISSCR commented on proposed industry guidance for "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank." 

Excerpts from the letter:

We are concerned that unscrupulous clinics marketing unproven stem cell-based interventions abuse the ClinicalTrials.gov database to appear legitimate and to promote their treatments to patients. Advertising from these companies often seeks to create the impression of FDA approval, even though they have not been tested for safety or efficacy, and we believe that registering unproven therapies on ClinicalTrials.gov is one step that helps these companies blur the distinction between FDA approved and non-FDA-approved products. We believe this poses a threat to the public’s health; therefore, we encourage the FDA to use the new guidance for ClinicalTrials.gov to prioritize enforcement against unproven stem cell clinics that submit false and misleading promotional information to the database. 

Unscrupulous clinics marketing unproven therapies as legitimate stem cell treatments have a history of abusing the ClinicalTrials.gov database by submitting promotional or false and misleading information. Last year, it was reported in the New England Journal of Medicine that one of the patients blinded by an unproven and scientifically implausible stem cell treatment found the clinic providing the treatment through the ClinicalTrials.gov database. It is common for these clinics to use the database to refer patients to sensational news stories that suggest their treatments can cure serious health conditions. It is also common for these clinics to make spurious claims that their interventions provide a therapeutic benefit for a wide range of serious and incurable conditions. While we understand the challenge of scrubbing the internet of these dubious health claims, we believe that the ClinicalTrials.gov database should be a safe place for patients and physicians searching for accurate information regarding clinical trials. 

The letter is available in its entirety on ISSCR.org.