Drugs

Biden Bill Will Hurt Generic Drugs: Analysis

Citizens Against Government Waste health and science policy director Elizabeth Wright says the Biden administration’s Build Back Better Act includes provisions from the Elijah E. Cummings Lower Drug Costs Now Act that will hurt the generic drug industry. In an Inside Sources article reprinted by the American Institute for Economic Research, Wright says the bill says the HHS secretary can negotiate prescription drug prices, “ignoring its use of foreign price controls, excise taxes, and inflationary rebates to determine drug costs.” She writes that advocates for the proposal ignore the harm price controls will have on U.S. leadership in global pharmaceutical research and development and overlook the “severe damage it will cause to generic and biosimilar manufacturing.”

According to Wright, generic drug company CEOs and investors will not know which drugs will ultimately be price-controlled in the future and will be hobbled by the bill’s price controls, “leading to fewer generics reaching the market and patients likely paying more than they otherwise would have.”

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