Drugs

Bipartisan Drug Pricing Legislation

Sens. Tammy Baldwin (D-WI) and John McCain (R-AZ) and Rep. Jan Schakowsky (R-IL) have introduced the FAIR Drug Pricing Act as “the first step in addressing skyrocketing prescription drug prices by requiring transparency for pharmaceutical corporations that plan to increase drug prices.” A statement issued by Sen. Baldwin (includes links to bill text and fact sheet) says their measure would require drug manufacturers to notify HHS and submit a transparency and justification report 30 days before they increase the price of certain drug products by more than 10%.

“The report will require manufacturers to provide a justification for each price increase, manufacturing, research and development costs for the qualifying drug, marketing and advertising spending on the qualifying drug, and other information as deemed appropriate,” Baldwin says. “The bill will not prohibit manufacturers from increasing prices, but it will, for the first time, give taxpayers notice of price increases and bring basic transparency to the market for prescription drugs.”

The statement says the bill is supported by AARP, Campaign for Sustainable Rx Pricing, Medicare Rights Center, Consumers Union, Doctor for America: Drug Price, Value, and Affordability Campaign, Families USA, Center for Medicare Advocacy, and Public Citizen.

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