Drugs

DTC Research Raises Concern on Endpoints in Cancer Ads

New research on drug direct-to-consumer (DTC) television advertising has (XXX INSERT XXX)found that viewers misinterpreted oncology clinical trial endpoint-related claims that referred to overall survival (OS), overall response rate (ORR), and progression-free survival (PFS). “Although participants differentiated between OS, ORR, and PFS, we found evidence that DTC television ads featuring these endpoints resulted in some misinterpretations about the drug’s efficacy,” researchers from CDER’s Office of Prescription Drug Promotion and RTI International wrote in a 4/20 Oncologist article.

The researchers found that “use of a disclosure that explicitly states that improvements in endpoints such as PFS and ORR do not necessarily mean improvements in OS (i.e., living longer) may help people have a better understanding of a drug’s efficacy while not substantially changing their other perceptions of the drug in unintended ways.”

They concluded that disclosures could help reduce the level of misinterpretation ad viewers may experience in trying to understand endpoints like ORR and PFS. “More research is needed to establish best-practice recommendations for using disclosures to improve patient understanding of drug efficacy without changing their perception of the drug in unintended ways,” they said.

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

Read more

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