Drugs

Comments on Geriatric Info Drug Labeling Guidance

The American Geriatrics Society (AGS) says FDA should consistently use the word “older” in a draft guidance on geriatric information in human prescription drug and biological product labeling rather than “elderly” or any similar term. In an 11/9 comment letter, AGS says that terms like “elderly,” “elders,” “the aged,” or “seniors” should be avoided due to negative connotations that distract from recommendations and research that benefits all people as they age. The letter also recommends more consistency throughout the draft regarding age cutoffs, including three distinct age categories. The society also suggests including a statement that biological age (e.g., frailty) is often more important for treatment decisions than chronological age.

In its letter, the Association for Clinical Oncology (ASCO) says it “applauds the agency’s recent efforts to ensure adequate representation of older adults in cancer clinical trials, and now to ensure that appropriate information on the use of prescription drugs in geriatric patients is clear and accessible to guide their safe and effective use.” ASCO recommends the inclusion of additional information on geriatric patients, including performance status and more comprehensive aspects of older adults’ health status, including geriatric assessment measures.

Pfizer says the draft is unclear which age group the term “younger adult patients” encompasses. It also includes line-by-line specific comments.

Line-by-line comments were provided by Bristol-Myers Squibb and GlaxoSmithKline.

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