FDA Policy/General

FDA Urged to Expand Real-World Data Use

FDA needs to expand its reliance on real-world clinical data to monitor the safety and effectiveness of approved medical products, a move that would augment data from initial clinical trials according to Ethics and Public Policy Center physician and bioethicist Aaron Kheriaty. Writing in an opinion piece in The Hill, he urges the agency to intensify its use of health insurance claims, electronic medical records, and other large-scale clinical databases to detect adverse drug effects that may not be evident during the controlled, pre-approval clinical trial phase.

“Clinical trials are essential, but they are conducted in artificial settings with limited populations,” says Kheriaty. “Once a drug is on the market, we need to see how it performs in the complexity of real-world medicine, where patients have coexisting conditions, take multiple medications, and vary widely in age, race, and other factors.”

Kheriaty points to historical examples where real-world data played a pivotal role in identifying previously undetected risks. Among them is the painkiller Vioxx (rofecoxib), which was withdrawn from the market in 2004 after post-market data revealed increased risks of heart attacks and strokes — signals that were missed in earlier clinical trials involving healthier, lower-risk patients. He also cites FDA’s 2004 decision to add a black box warning about suicidality risks to SSRI antidepressants for adolescents and young adults, a change informed by post-marketing data.

Some critics argue that randomized controlled trials remain the gold standard for assessing drug efficacy and causality, but Kheriaty notes that real-world studies — when conducted with rigorous statistical techniques such as propensity score matching or instrumental variable analysis — can offer complementary insights that are essential for a full drug evaluation. “Every study design has limitations,” he writes. “But by combining data sources and methodologies, we improve our ability to make evidence-based regulatory decisions.”

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