Drugs

FDA Getting Ahead of Drug Abuse Changes

FDA commissioner Scott Gottlieb and two top CDER officials say the agency is investing in a multifaceted system of pharmacovigilance, using various tools to mine traditional and new sources of epidemiologic data, assess products’ pharmacologic properties, and evaluate the social contexts in which substances are being used. Writing in the New England Journal of Medicine, the officials say the goal is to identify emerging trends earlier and intervene more quickly. The Perspective article discusses three recent examples illustrating the necessary elements of a new system:

FDA has been tracking changes in prescribing and use patterns for gabapentinoids through a social media “listening platform” and exploring healthcare databases to assess the consequences of using gabapentinoids in combination with opioids;
investigating use of the unapproved botanical kratom as an alleged treatment for opioid use disorder and pain; and
exploring a dramatic increase in misuse and abuse of loperamide, a common OTC opioid product.

“FDA faces challenges as we confront the opioid crisis and monitor changing patterns of use, abuse, and misuse of other products,” the article concludes. “Going forward we will need to understand and be ready to respond to such challenges.”

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