Drugs

House Subcommittee to Discuss Generics Bill

House Energy and Commerce Committee chairman Greg Walden (R-OR) says a yet-to-be-announced health subcommittee hearing next week will take up a bill being drafted to effect lower drug prices through better generic drug competition. During a 2/2 hearing, Walden said he would push for the drug pricing legislation after attending a meeting Tuesday with several pharmaceutical executives (see story). At the hearing, Walden said, “President Trump made it clear in the White House meeting I attended with him and vice president Pence that he wants competition to bring lower drug prices, and that is precisely what this measure will help accomplish. Patients are tired of waiting for relief, we're going to move forward in a bipartisan way to give them help. It’s an important first step, it needs to happen now.”

According to Walden, the bill would “require FDA to prioritize, expedite and review generic applications of drug products that are currently in shortage, or where there are few manufacturers on the market...” Walden said. “We all remember recent situations where bad actors jacked up the prices of older drugs because there was no competition. We want to make sure that does not happen again.” He also said the bill would increase transparency about the backlog of generic drug applications at the agency, adding that there was an “unacceptably high” number of pending ANDAs.

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