Drugs

Congressional Dems Want ‘Drug Deal’ Information

In letters to AstraZeneca, Lilly, Novo Nordisk, and Pfizer, congressional Democratic health leaders are asking for detailed information on the companies’ agreements with the Trump administration to lower prices for some of their drugs in some markets. In a statement (includes links to the letters to the companies) from Democrats on the House Energy and Commerce Committee, three House members and one senator say, “The administration has yet to provide any public information that the announcements [of pricing agreements with the companies] will result in any real savings for consumers. In fact, economists have questioned whether consumers will see any meaningful benefits. The public deserves answers on this and a better understanding of what this means for their everyday costs.”

The statement says the letters ask for more information on the contours of the agreements, including the effects on Medicare, future pricing predictions, the parameters of the TrumpRx platform, and any other benefits the companies are receiving from the administration as a result of the agreements.

“While President Trump has made misleading and false claims to the American public with rhetoric around lowering drug prices, in reality, actions taken by the administration thus far have yielded little, and in some cases have raised prices for consumers,” the legislators wrote in the letters. “Skepticism and scrutiny are warranted as the Trump administration has repeatedly made announcements that fail to meet their stated goals, and instead, only increase costs on the consumer, and yield benefits to the Trump family and administration….Basic details about the agreement have yet to be confirmed by either [party], making it seem that both parties are attempting to shield themselves from oversight accountability, and specifics that could inform consumers whether the agreement will save money.”

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