Drugs

Bill to Expand Patient Experience in FDA Drug Approvals

U.S. Senators Roger Wicker (R-MS) and Amy Klobuchar (D-MN) have introduced legislation aimed at providing patients and advocates the ability to play a larger role in FDA’s benefit-risk framework for drug approval. The “Better Empowerment Now to Enhance Framework and Improve Treatments (BENEFIT) Act,” is intended to build on the foundation of the Wicker-Klobuchar “Patient-Focused Impact Assessment Act,” which became law in December.

“Specifically, the legislation would address a significant requirement gap by amending the ‘Food, Drug and Cosmetic Act’ to ensure that the patient experience, patient-focused drug development (PFDD), and related data be considered as part of the risk-benefit assessment,” Wicker said in a release. “This would include information developed by a product sponsor or a third party, such as a patient advocacy organization or academic institution. This action would send an important signal to all stakeholders that patient experience and PFDD data will be fully incorporated into the agency’s review process and will encourage such entities to develop scientifically rigorous and meaningful tools and data.”

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