Drugs

H.R. 3 Amendments Not Enough: Public Citizen

Public Citizen says that amendments announced 10/16 to H.R. 3, the Lower Drug Costs Now Act, contain several “modest improvements,” but more still needs to be done. In a statement, Public Citizen says the amendments include allowing the government to negotiate prices for some newly launched drugs, eventually increasing the number of drugs required to be negotiated from 25 to 35 annually; establishing transparency requirements; and improving access to Medicare low income subsidies.

“The bill should be strengthened further to cover more Americans and more expensive prescriptions while dealing still more effectively with launch prices, which otherwise will continue to increase, according to independent estimates by the Congressional Budget Office and the Centers for Medicare and Medicaid Services,” the statement says. “The bill should be amended to directly curb year-to-year price spikes in the private market and protect people who are uninsured. It also should consider increasing the public contribution to drug development and innovation.”

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

Read more

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