7 Questions for HHS and FDA: Grassley Targets Stem Cell Clinic

Regulatory NewsRegulatory News | 17 April 2018 |  By 

Sen. Charles Grassley (R-IA) late last week sent a letter to HHS and FDA leadership, requesting more information about an unproven stem cell treatment that left several patients permanently blind.

Grassley lays out seven questions for FDA Commissioner Scott Gottlieb and HHS Secretary Alex Azar on whether FDA has completed its investigation into US Stem Cell Clinic, the firm that sold the unproven treatment. Last August, FDA warned the company, though Grassley questioned FDA as to whether it had referred US Stem Cell and any of its employees to the Justice Department for potential prosecution.

He also asked for an explanation on and questioned the benefit of listing such trials on ClinicalTrials.gov, which can often be misconstrued as being overseen by the federal government.

“What steps have been taken to ensure that the trials listed on clinicaltrials.gov are actually trials and not fee-for-service treatments or mere advertisements?” Grassley questioned.

Last month, the US Securities and Exchange Commission served a subpoena upon US Stem Cell, Inc., and sought certain documents and communications including, among other things, minutes from the company’s board and audit committee meetings, financial statements and press releases. 

The questions from Grassley follow FDA’s pledge to better crack down on unproven stem cell clinics, though critics have questioned if the agency is acting quickly enough considering how many clinics are now established in the US.


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