Biologics

Questions on FDA Response to Antibody Scams

The four leading Democrats on the House Energy and Commerce Committee are asking FDA for information on its response to fraudulent Covid-19 antibody test scams occurring in the marketplace. In a 7/22 letter, the lawmakers say that last month the FBI warned that scammers are marketing fraudulent and/or unapproved antibody tests to consumers. “The reported goal of such scams is to obtain sensitive personal information, such as Social Security numbers, dates of birth, and insurance information, which can then later be used in identity theft or insurance theft schemes,” the letter says.

The representatives ask FDA to answer these questions:

whether FDA has determined the extent to which fraudulent antibody test scams are occurring in the marketplace and what it has found;
what resources the agency is employing to monitor the marketplace to determine whether such scams are occurring and the frequency of such monitoring;
if FDA receives indications of a scam, what criteria it uses to determine whether to investigate;
whether FDA has already taken action against any entities engaged in fraudulent antibody test scams; and
the status of any information sharing and other coordination efforts between FDA and other federal and state agencies.

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