FDA Policy/General

OPDP Social Science Research Explained

CDER Office of Prescription Drug Promotion senior social science analyst and research team lead Katherine Aikin says her group investigates how healthcare providers and patients perceive medical product information about prescription drugs and make subsequent treatment decisions. Interviewed for an online post, Aikin says her team usually has about 20 studies in various stages of completion at any one time. They initiate four to six studies a year, with each one lasting three to five years.

She reports that a recent project involved patients’ understanding of oncology clinical endpoints that measure a clinical benefit, such as overall survival. Patients can be confused about the purpose of a particular treatment, Aikin says, and the research may be suggesting a need for more patient-friendly definitions of clinical endpoints that may help healthcare providers describe treatment benefits to patients and empower patients to make informed decisions among treatment choices.

In 2022, Aikin reports, the team will be looking at the effects of product endorsements and implied claims. They also will investigate how descriptions of a drug’s mechanism of action affect people’s understanding and impressions of the drug. And another study will explore how consumers and healthcare providers make trade-offs in terms of safety and efficacy.

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