Drugs

Students Push Califf on Trial Transparency

Members of Universities Allied for Essential Medicines (UAEM), a global alliance of university students urging their universities to register and report clinical trials, are asking to meet with FDA commissioner Robert Califf to discuss ways in which UAEM and FDA could work together to improve clinical trial transparency. In a statement (contains a link to 4/21 letter to Califf), UAEM says a lack of reporting transparency results of clinical trial data can increase bias in studies (due to reduced data), slow the rate of innovation of new medicines, and ultimately may lead to patient harm or death.

In the letter, UAEM says that as public trust in science and FDA declines, “it is more important than ever that the agency embrace transparency and take steps to improve patient, provider, and public access to scientific information.”

The students point out that under the FDA Amendments Act (FDAAA) of 2007, clinical trial sponsors are required to input all eligible trial result information at ClinicalTrials.gov. If trial sponsors don’t comply, FDA can issue fines of more than $10,000 for every late day.

“Although violations of the law have been so frequent and so flagrant that they could have generated over $30 billion in fines to date, FDA has historically neglected its duty to enforce FDAAA….. After significant pressure from the public, including our group of student advocates, FDA has taken limited enforcement action only in the past year, sending, to date, four Notices of Noncompliance to trial sponsors.”

The letter includes past comments from Califf and President Joe Biden supporting transparency and expresses the hope that the statements “are signs that the current leadership of FDA will prioritize clinical trial results reporting requirements at research institutions.”

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