Drugs

Senators Introduce Prescription Information Modernization Act

Senators Jim Banks (R-IN) ) and Cory Booker (D-NJ) have introduced the bipartisan Prescription Information Modernization Act to allow drug makers to distribute prescribing information electronically while retaining the option to receive paper copies.

Current laws require prescribing information — including dosing instructions, drug interactions, precautions for pregnant women, pediatric information, and other critical safety information — to be printed and included in paper form with every medication. The bill would allow physicians, pharmacists, and pharmacies to access this information digitally while continuing to provide paper copies to those who prefer them, according to the lawmakers.

Key provisions of the bill include:

Allowing drug manufacturers to provide prescribing information electronically to health care providers and pharmacies.
Preserving the option for providers and pharmacies to receive paper prescribing information if they choose.
Modernizing access to prescribing information while reducing unnecessary printing, packaging, and paper waste.

Full bill text can be found 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