Drugs

PhRMA Ad Cost Info Varies: Analysis

The voluntary plan pushed by Pharmaceutical Research and Manufacturers of America (PhRMA) to give consumers more drug pricing information in direct-to-consumer TV ads is producing mixed results, according to an online analysis by Biopharmadive. The report says the ads generally contain a line of text directing viewers to a company Web site for more cost information. The available information, it says, generally includes the list and average prices, with some companies giving typical averages while others show the highest cost a minority of patients can face.

The trade association’s effort came in response to the Trump administration’s call for companies to be required to cite wholesale acquisition costs in TV ads for drugs and biologics covered through Medicare and Medicaid.

PhRMA said its members would begin to voluntarily point consumers to cost information through their TV ads, without including prices in the actual ads. The report gives examples of how several companies are approaching the voluntary information.

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