By: Matthew Fischer
Iowa Senator Chuck Grassley issued a press release last week indicating that he sent a letter to the leadership of the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) seeking additional information regarding the investigation into U.S. Stem Cell Clinic, LLC based in Sunrise, Florida. The letter poses seven questions with a deadline of April 27th. Last November, the FDA issued new guidance regarding human cell and tissue based treatments and announced its intention to crackdown on unproven treatments. Hence, many in the industry are watching closely to see what actions if any have been taken.
In August 2017, the FDA issued a press release setting forth the details of a warning letter sent to U.S. Stem Cell Clinic, LLC. The warning letter cited manufacturing deviations, efforts to impede an investigation, and issuance of a demand for corrective action. This step was taken as a result of several people experiencing blindness after receiving stem cell injections for treatment of macular degeneration. One of the patients noted that she believed the treatment was part of a clinical trial listed on ClinicalTrials.gov.
In Senator Grassley’s letter, he requested answers to the following questions:
- Has the FDA completed its investigation into U.S. Stem Cell and any related entities? If so, please provide a copy of the final report.
- What was the FDA’s response to U.S. Stem Cell when it tried to impede the investigation?
- Has the FDA referred U.S. Stem Cell and any of its employees to the Justice Department for potential prosecution? If so, when did that referral take place?
- It appears that the listing of a trial on ClinicalTrials.gov has created for some the impression that a trial is government-approved. The website has since posted disclaimers to stress that “[l]isting a study does not mean it has been evaluated by the U.S. Federal Government.” Please explain what benefits are presented by the website that outweigh the risk that patients will still incorrectly assume the trials are more credible because they are listed on a government website.
- Please explain the process by which a clinical trial goes through before placement on the clinicaltrials.gov website.
- 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? What precautions are taken to educate potential research participants that the listed “trials” may not be an approved clinical trial?
- In what specific ways did U.S. Stem Cell Clinic fail to meet federal regulations? What plan did they implement to correct these deviations? Were they permitted to continue conducting treatments in the interim, and are they permitted to conduct treatments still?
It will be interesting to see what concrete actions have been taken. This press release along with the Senator’s letter will likely spur more action on the issue. But how much given the FDA’s current approach of balancing a crackdown while at the same time pledging to ease the path for developing treatments.