Drugs

Bipartisan Prescription Safety Alert Bill

A bipartisan group of three House members have introduced H.R. 6688 to establish the Prescription Safety Alert System for covered drug products. The legislation, introduced by Reps. Tom Macarthur (R-NJ), Ann Kuster (D-NH), and Barbara Comstock (R-VA), is known as the Analyzing and Leveraging Existing Rx Transactions Act of 2018 or the ALERT Act of 2018.

Under the bill, the safety alert system would:

review patient prescription and dispensing history through pharmaceutical claims data transactions;
collect, maintain, and be capable of providing to dispensers, within a dispenser’s ordinary clinical workflow, information about a patient’s prescription and dispensing history;
deliver information about a patient’s prescription and dispensing history in summary form that allows the dispenser to evaluate the risk of misuse, abuse, addiction, overdose, and drug-drug interactions associated with filling the prescription sought by a patient based upon such patient’s prescription and dispensing history for covered drug products; and
provide the above information to dispensers in real-time.

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