Biologics

Grassley Wants Info on Unproven Procedures in Trials

Reacting to an incident in which a south Florida clinic performed unproven stem cell treatments that left three female patients blind, Sen. Charles Grassley (R-IA) has asked HHS and FDA for additional information. Grassley’s letter to the agencies cited a Washington Post report indicating that the three women believed they were participating in a government-backed clinical trial at U.S. Stem Cell Clinic to reverse the effects of macular degeneration. The newspaper said the stem cell treatment they received was not government approved, but was listed on the National Institutes of Health’s ClinicalTrials.gov comprehensive database of clinical trials. Grassley also noted that an 8/2017 FDA news release said that U.S. Stem Cell Clinic tried to impede the agency’s investigation, which is a violation of federal law.

In his letter, Grassley asked:

whether FDA has completed its investigation into U.S. Stem Cell Clinic and any related entities and if so, to receive a copy of the final report;
how FDA responded to the company when it tried to impede the investigation;
whether FDA referred U.S. Stem Cell and any of its employees to the Justice Department for potential prosecution, and when the referral took place;
for an explanation of how the benefits of clinical trial listings on ClinicalTrials.gov outweigh the risk that patients will incorrectly assume that trials are more credible because they appear on a government Web site;
for an explanation of the process that a clinical trial goes through before being listed at ClinicalTrials.gov;
the steps that have been taken to ensure that trials listed on ClinicalTrials.gov are actually trials and not fee-for-service treatments or advertisements and to advise potential research participants that the listed trials may not be an approved clinical trial; and
for the specific ways in which U.S. Stem Cell Clinic failed to meet federal regulations, the plan it implemented to correct its deviations, and whether they are still permitted to conduct treatments.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome