Drugs

Support Voiced for PATH Act

Pew senior director for health programs Allan Coukell says that the Promise for Antibiotics and Therapeutics for Health (PATH) act is needed to help speed development of antibiotics for limited populations of patients with serious and life-threatening bacterial infections that are resistant to current treatments. Writing online in Health Affairs, Coukell says that “now, more than ever, there is an urgent need for action to spur the innovation of antibiotics to treat the most serious and life-threatening superbugs.” He says that the limited-population antibacterial drug (LAPD) approach included in the PATH legislation has broad bipartisan support in both the House and Senate. The approach was approved by the House last year as part of the 21^st Century Cures Act.

The Pew Charitable Trusts says there are 39 new antibiotics in clinical development, a number that pales, Coukell says, when one considers that only about 20% of drugs that enter human testing will ultimately receive FDA approval.

“Although no single policy change will address all the myriad challenges facing antibiotic development, the LPAD pathway will help bring drugs to market for the most pressing public health needs and will do so in a way that reduces development costs,” he writes.

He reviews some of the elements in the PATH legislation and responds to criticism or confusion about some of the provisions. “The bipartisan PATH bill is supported by a wide range of stakeholders, including provider associations, public health groups, and pharmaceutical companies, which recognize that now is the time to advance a measure that helps address a public health need and the pressing challenge of antibiotic development,” Coukell concludes.

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