FDA Policy/General

Coalition Wants FDA Antibiotic Funding

A coalition representing research and policy organizations, producers, purchasers, and infectious disease doctors and scientists has written to the House and Senate Appropriations Committees calling for funding in the FY 2017 budget to support implementation of the National Action Plan for Combatting Antibiotic-Resistant Bacteria (CARB). The 3/16 letter notes that President Obama’s FY 17 budget request includes level funding of $42 million at FDA for all CARB priorities.

“Since 2012, the agency has worked diligently to advance policies that support judicious use of antibiotics in animal agriculture,” the letter says. “FDA’s industry guidance phasing out production uses of medically important antimicrobials was widely accepted by animal drug sponsors…, while the agency’s new veterinary feed directive will strengthen animal husbandry and promote antibiotic stewardship by ensuring appropriate veterinary oversight of antibiotic use in animal feed.”

The 10 organizations signing the letter say that recent reports that highly mobile resistance genes are emerging to “last resort” antibiotics like colistin raise serious concerns over the future availability of the vital drugs. “Combating this threat and avoiding a world without effective antibiotics will require increased and sustained federal investments in biomedical research, public health infrastructure, and surveillance,” the letter says. The groups also call for $61 million for the Agriculture Department’s antimicrobial resistance priorities.

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