Drugs

Senators Unveil Legislation to Help with Insulin Costs

U.S. Senators Jeanne Shaheen (D-NH) and Susan Collins (R-ME) have unveiled bipartisan legislation entitled Improving Needed Safeguards for Users of Lifesaving Insulin Now (INSULIN) Act, which is intended to lower insulin costs. The lawmakers note that insulin is one of the most expensive categories of drugs purchased by private and government health care payers. “Out-of-pocket costs increase with list prices, and for people without insurance, the costs are untenable,” they said in a news release. “Between 2012 and 2016, the average list price of insulin nearly doubled. According to the Health Care Cost Institute, the price of an average 40-day supply of insulin rose from $344 in 2012 to $666 in 2016.”

The legislation, if signed into law, would ensure that group, individual market, Medicare Part D and Medicare Advantage health plans waive any deductible and limit cost-sharing to no more than $35 per month or 25% of the list price.

A one-page brief on the legislation is available here, and a section-by-section summary is available here. Text of the legislation is available here.

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