Drugs

Rep. Slaughter Urges More FDA Antibiotic Resistance Efforts

Rep. Louise Slaughter (D-NY) has urged FDA to take stronger action to preserve the effectiveness of antibiotics and protect public health. The push comes as the agency continues to develop a draft rule (FDA-2017-N-1197) that would impact how antibiotics sold for use in livestock raised for human consumption are measured.

“Eighty percent of all antibiotics used in the United States are used not on humans but on food-animals, most of which are perfectly healthy,” Slaughter said in a letter to FDA. “This is dangerous and unsustainable. As I have been saying for years, publically available data on how antimicrobials are being used on farms is critical to preventing resistance and preserving the effectiveness of these live-saving drugs. I urge you to move forward with meaningful and transparent measures that uphold the FDA’s mandate to protect public health and hold the agricultural and pharmaceutical industries profiting from these irresponsible practices accountable.”

Slaughter is a sponsor of the Preservation of Antibiotics for Medical Treatment Act, which would preserve the effectiveness of medically important antibiotics by ending the use of these drugs in healthy food-producing animals, while allowing their use for treatment of sick animals. It includes a mandatory restriction on unnecessary non-therapeutic uses of medically important antibiotics in healthy animals, which the World Health Organization recently recommended. She has also sponsored the Delivering Antimicrobial Transparency in Animals Act to require the agency to collect and report real-world, on-the-farm usage data including the indication, dose, duration of use, and number of animals treated from large livestock producers.

Slaughter’s letter outlined concrete steps FDA should take immediately, such as disclosing as much antibiotic sales data as possible, using a methodology that allows comparisons with countries like the E.U. and Canada that are ahead of the U.S. in transparent reporting of how antibiotics are used in livestock. She also asked FDA to implement an on-farm data collection program to “fully understand the drivers of antibiotic use and help researchers develop alternative livestock management practices and disease interventions that would benefit both farmers and public health.”

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