Drugs

OPDP Study on Accelerated Approval Info DTC Web Sites

CDER’s Office of Prescription Drug Promotion (OPDP) is proposing to conduct a study entitled “Accelerated Approval Disclosures on Direct-to-Consumer (DTC) Prescription Drug Websites.” A recent OPDP analysis of DTC Web sites for accelerated approval products found that 21% contained disclosures about the accelerated approval that used language directly from the approved physician labeling, 79% of the disclosures used at least some medical language, but 27% of the Web sites reviewed did not include any disclosure about accelerated approval.

OPDP says it recently conducted a general-population study testing the disclosure of FDA accelerated approval information on a DTC prescription drug Web site which suggested that consumer-friendly disclosures helped participants understand information related to a drug’s accelerated approval, “but that participants’ understanding was low overall.” It says the proposed study is intended to replicate and extend OPDP’s prior research by: (1) Testing the same experimental conditions with a different study population (cancer survivors and cancer caregivers), and (2) testing additional consumer-friendly disclosures.

A Federal Register notice invites comments on the proposed study design.

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