Drugs

Economic Advisors Praise FDA on Drug Costs

A White House Council of Economic Advisors report praises efforts by HHS and FDA to respond to the problem of high drug costs. “FDA regulations intended to guarantee safety and efficacy can constitute barriers to price competition for drugs,” the report says. “In few other industries do firms spend over $2 billion to enter the market, which is the current state of affairs for new, innovative drugs going through FDA’s safety and efficacy review process.

As part of the Trump administration’s deregulation effort, the report says, HHS and FDA have launched a series of reforms to better facilitate price competition by streamlining the drug application and review process in a way that effectively lowers barriers to entry while ensuring a supply of safe and effective drugs.

The group says it finds that relative annual price growth for prescription drugs has slowed since 1/2017, and estimates of improved health,” the report says, “even though the methods currently being used to estimate changes in drug prices do not reflect this. Implicit price reductions from new, brand name drugs since 1/2017 are providing an estimated $43 billion in annual benefits to consumers.”

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