FDA Policy/General

Researchers Find ‘Moderate’ Trust in FDA

University of North Carolina researchers looking at awareness of and trust of FDA and the Centers for Disease Control (CDC) have identified some demographic variables that suggest audiences the agencies may want to target with communications aimed at improving the level of trust. Writing in the open-source journal PLOS One, the researchers say they found high levels of awareness of the existence of FDA and CDC, and moderate levels of trust in the two agencies. Adults were more likely to be aware of the agencies than adolescents, while adolescents were more likely to trust them than were adults.

The authors say that the agencies “could seek to increase their trust among groups who are less likely to trust them. For instance, smokers, individuals of lower education, adults (compared to adolescents), and racial and ethnic minorities might all benefit from communications from FDA or CDC that highlight the significant work these agencies are doing to protect the public health for vulnerable groups. It is feasible (and perhaps likely) that individuals who do not trust FDA or CDC or who are unaware of FDA or CDC may be less likely to engage in preventive services (e.g., cancer screenings or flu shots) or follow recommendations put forth by these agencies.”

Research has shown, they write, that agencies can use several approaches to increasing their levels of trust, including faster responses to public health issues, greater transparency, and collaboration between different public health 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