FDA Releases 18 Years of Isolate-Level Data for Common Gut Bacteria

Posted 20 August 2015 | By Michael Mezher

FDA Releases 18 Years  of Isolate-Level Data for Common Gut Bacteria

In a move to make its data more transparent and promote scientific research, the US Food and Drug Administration (FDA) is releasing 18 years of data on several bacteria, collected as part of the National Antimicrobial Resistance Monitoring System (NARMS).

Background

Health authorities are increasingly citing AMR as one of the most pressing threats to global public health. In its 2014 Antimicrobial Resistance: global report on surveillance, the World Health Organization called AMR "so serious that it threatens the achievements of modern medicine."

The rise of AMR is associated with the overuse and misuse of antimicrobial medicines such as antibiotics. When microbes targeted by a drug are not eliminated, treatment-resistant strains can be spread, which can have deadly consequences.

The problem is compounded by a significant decline in the development of new antimicrobial drugs in recent decades. The danger this can pose can be seen in the case of drug-resistant gonorrhea, where over time strains of the bacteria have developed resistance to many previously effective treatments, leaving health authorities to resort to last-line treatments against resistant strains. Now, strains are emerging that are resistant even to last-line treatment options.

Drug-resistant strains of other diseases, such as tuberculosis, malaria, HIV and E. coli are also on the rise, posing an ever-increasing threat in developed and developing countries alike.

In 2012, to promote the development of new antibiotics, title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA) granted FDA the authority to extend the period of market exclusivity for qualified infectious disease products (QIDP) by an additional five years.

Last year, President Barack Obama issued a report, backed by an executive order, calling for action in four separate areas:

  • improving the prescribing of existing antibiotics, of which the report estimates about half are now incorrectly prescribed
  • reducing the use of antibiotics in food-producing animals, which is now done to promote growth and prevent infections
  • improving incentives for companies to develop new antibiotics
  • increasing surveillance of antibiotic resistance both in the US and abroad

NARMS Data

NARMS is a collaboration between FDA, the Centers for Disease Control and Prevention (CDC) and the US Department of Agriculture (USDA).

FDA says the data it is releasing will contain more than 150,000 isolates of common bacteria, including salmonella, campylobacter, Escherichia coli and enterococcus.

Once the data is released, users will be able to download isolate-level data and analyze it using common database and statistical software.

The agency says it hopes the data, which is collected from "retail meat samples, human clinical samples, and slaughter samples," will be used by researchers to increase their understanding of how antimicrobial resistance develops and spreads.

FDA, NARMS Now, CDC NARMS Now: Human Data


Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe