FDA Policy/General

2 Prescription Drug Promotion Studies Proposed

The CDER Office of Prescription Drug Promotion (OPDP) is proposing two research studies on different aspects of drug promotion. A Federal Register notice says the first study will examine patient and healthcare provider perceptions about prescription drugs that have medication tracking capabilities. The notice says that to improve adherence to a medication regimen, some companies are developing software that is disseminated by or on behalf of the drug sponsor to track use of the drug. There is little known about patient and provider perceptions of such products, OPDP says, and the study will explore patient and provider perceptions of a fictitious prescription drug product that is accompanied by software that is intended to trace medication use.

A second Federal Register notice says another study will look at the influence of targeted method of action claims, graphics, and disclosures that provide context about a drug’s targeted method of action, using an experimental design with both consumer and healthcare provider samples. Specifically, the proposed study will explore how varied targeted method of action presentations affect consumer and provider understanding of a drug’s method of action, perception of drug benefits and risks, attention to risk information, and interest in the drug.

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