New FDA task force will support innovation in antibacterial drug development

 

Silver Spring, MD, USA (September 24, 2012) – The U.S. Food and Drug Administration today announced the formation of an internal task force that will support the development of new antibacterial drugs, a critical public health care goal and a priority for the agency.

 

As part of its work, the Antibacterial Drug Development Task Force will assist in developing and revising guidance related to antibacterial drug development, as required by the Generating Antibiotic Incentives Now (GAIN) Title of the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012.

 

Research and development for new antibacterial drugs has been in decline in recent decades, and the number of new FDA-approved antibacterial drugs has been falling steadily since the 1980s. During this time, the persistent and sometimes indiscriminate use of existing antibacterial drugs worldwide has resulted in a decrease in the effectiveness of these drugs. This phenomenon, known as antibacterial drug resistance or antibiotic resistance, has become a serious issue of global concern.

 

More than 70 percent of the bacteria that cause hospital-associated infections (HAIs) are resistant to at least one type of antibacterial drug most commonly used to treat these infections. In the United States, nearly 2 million Americans developed HAIs in 2002, resulting in about 99,000 deaths.

 

“The creation of this new task force comes at a critical time,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research (CDER) and co-chair of the task force. “Establishing new ways of developing safe and effective new antibacterial drugs is an enormous challenge and not an effort that can be accomplished alone.”

 

The task force is a multi-disciplinary group of 19 CDER scientists and clinicians who will use existing partnerships and collaborations to work with other experts in the field, including from academia, industry, professional societies, patient advocacy groups, and government agencies, to identify priority areas and develop and implement possible solutions to the challenges of antibacterial drug development.

 

The task force plans to:

 

  • explore novel scientific approaches to facilitate antibacterial drug development, like the broader use of clinical pharmacology data, statistical methods, innovative clinical trial designs, use of additional available data sources, and the advancement of alternative measures to evaluate clinical effectiveness of potential new therapies;
  • identify issues related to unmet medical needs for antibacterial drugs, reasons for the lack of a robust pipeline for antibacterial drug development, and new approaches for weighing the risks, benefits, and uncertainties of potential new antibacterial drugs;
  • evaluate existing FDA guidances related to antibacterial drug development, determine if revision or elaboration is needed, and identify areas where future guidance would be helpful, as set forth in the GAIN Title of FDASIA; and
  • use existing collaborative agreements to work with think tanks and other thought leaders to explore various approaches that could enable antibacterial drug development, including innovative study designs and statistical analytical methods.

 

“By establishing this task force, FDA can help make real progress and change the paradigm,” said Rachel Sherman, M.D., associate director for Medical Policy in CDER, director of CDER’s Office of Medical Policy and co-chair of the task force. “Our hope is that this effort will result in important new breakthroughs in the field of antibacterial drug development and help in the fight against antibiotic resistance.”

 

The task force is part of FDA’s efforts to promote antibacterial drug development and combat antibiotic resistance. Over several years, the agency has provided guidance to industry and hosted public workshops and meetings to address and discuss scientific challenges in the field of antibacterial drug development. The FDA also plays a key role in working with other federal agencies to implement a national plan to address antibiotic resistance.

 

 

For more information

 

 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products

 


 

U.S. Food and Drug Administration, 24.09.2012 (tB).

MEDICAL NEWS

IU School of Medicine researchers develop blood test for anxiety
COVID-19 pandemic increased rates and severity of depression, whether people…
COVID-19: Bacterial co-infection is a major risk factor for death,…
Regenstrief-led study shows enhanced spiritual care improves well-being of ICU…
Hidden bacteria presents a substantial risk of antimicrobial resistance in…

SCHMERZ PAINCARE

Hydromorphon Aristo® long ist das führende Präferenzpräparat bei Tumorschmerz
Sorgen und Versorgen – Schmerzmedizin konkret: „Sorge als identitätsstiftendes Element…
Problem Schmerzmittelkonsum
Post-Covid und Muskelschmerz
Kopfschmerz bei Übergebrauch von Schmerz- oder Migränemitteln

DIABETES

Wie das Dexom G7 abstrakte Zahlen mit Farben greifbar macht…
Diabetes mellitus: eine der großen Volkskrankheiten im Blickpunkt der Schmerzmedizin
Suliqua®: Einfacher hin zu einer guten glykämischen Kontrolle
Menschen mit Diabetes während der Corona-Pandemie unterversorgt? Studie zeigt auffällige…
Suliqua® zur Therapieoptimierung bei unzureichender BOT

ERNÄHRUNG

Positiver Effekt der grünen Mittelmeerdiät auf die Aorta
Natriumaufnahme und Herz-Kreislaufrisiko
Tierwohl-Fleisch aus Deutschland nur mäßig attraktiv in anderen Ländern
Diät: Gehirn verstärkt Signal an Hungersynapsen
Süßigkeiten verändern unser Gehirn

ONKOLOGIE

Strahlentherapie ist oft ebenso effizient wie die OP: Neues vom…
Zanubrutinib bei chronischer lymphatischer Leukämie: Zusatznutzen für bestimmte Betroffene
Eileiter-Entfernung als Vorbeugung gegen Eierstockkrebs akzeptiert
Antibiotika als Störfaktor bei CAR-T-Zell-Therapie
Bauchspeicheldrüsenkrebs: Spezielle Diät kann Erfolg der Chemotherapie beeinflussen

MULTIPLE SKLEROSE

Multiple Sklerose: Aktuelle Immunmodulatoren im Vergleich
Neuer Biomarker für Verlauf von Multipler Sklerose
Multiple Sklerose: Analysen aus Münster erhärten Verdacht gegen das Epstein-Barr-Virus
Aktuelle Daten zu Novartis Ofatumumab und Siponimod bestätigen Vorteil des…
Multiple Sklerose durch das Epstein-Barr-Virus – kommt die MS-Impfung?

PARKINSON

Meilenstein in der Parkinson-Forschung: Neuer Alpha-Synuclein-Test entdeckt die Nervenerkrankung vor…
Neue Erkenntnisse für die Parkinson-Therapie
Cochrane Review: Bewegung hilft, die Schwere von Bewegungssymptomen bei Parkinson…
Technische Innovationen für eine maßgeschneiderte Parkinson-Diagnostik und Therapie
Biomarker und Gene: neue Chancen und Herausforderungen für die Parkinson-Diagnose…