Drugs

von Eschenbach on Reforming Drug Development

In order to speed drug products through the development process, more resources are needed for FDA to advance activities such as the Critical Path Initiative and the use of new methods for clinical trials (e.g., adaptive trial designs and Bayesian statistical methodologies), according to former FDA commissioner Andrew von Eschenbach and Bipartisan Policy Center health innovation director Janet Marchibroda. Writing in a The Hill opinion piece, von Eschenbach and Marchibroda say such efforts have been “inadequately resourced and the process of modernization is falling woefully behind the incredible pace of progress in biomedical research and the emerging demands of precision medicine.”

FDA watchers “rightly compliment the agency for admirable progress in improving review times, due in large part to the provision of resources through industry user fees,” the authors write. “But concurrently the development time however has become longer and more expensive, due to the complexity of science and technology and greater risk of failure in the later stages of development. Larger clinical trials can take as long as seven to ten years and cost on average $1.5 billion.”

Modernizing evidence generation through biomarkers, real-world evidence, adaptive trial designs, and more robust post-market surveillance processes “will have a significant impact on the time and cost of development,” they say. “Increasing regulatory clarity, ensuring adequate scientific capacity, and modernizing regulatory frameworks for advanced therapies, such as regenerative medicine, will also result in vast improvements.

“The president and Congress,” they continue, “can immediately do their part by continuing to advance policies that promote innovation without compromising safety. They should nominate and confirm an FDA commissioner who both knows what needs to be done and has the experience and knowledge of the agency to know how to do it.” They also call on Congress to pass legislation later this year to re-authorize user fees for drugs and devices that will fund some of the drug development reform activities.

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