Regulatory Focus™ > News Articles > US Launches New Antibiotics Strategy, Calls for New Regulatory Efforts and Incentives

US Launches New Antibiotics Strategy, Calls for New Regulatory Efforts and Incentives

Posted 19 September 2014 | By Alexander Gaffney, RAC

US Launches New Antibiotics Strategy, Calls for New Regulatory Efforts and Incentives

A new federal strategy aimed at combatting antibiotic resistance calls for the creation of a "robust pipeline of new antibiotics" and new "comprehensive monitoring" systems to track resistance trends.

Background

The report, authored by the President's Council of Advisors on Science and Technology (PCAST) and released on 18 September 2014, comes just as two troubling trends are intersecting.

New Antibiotics

The first: Antibiotic resistance, which government officials blame for at least 23,000 deaths and 2 million illnesses in the US each year. Officials blame the rise of antibiotic resistance on the misuse and overuse of antibiotics, such as in the nation's food supply, which are causing existing antibiotics to become ineffective.

The second: A sparse pipeline of antibiotics. As noted by the Center for Disease Dynamics, Economics and Policy (CDDEP) last week, FDA approved just six antibiotics between 2010 and 2014—10 fewer than the four-year period between 1983 and 1987. However, many of the drugs approved by FDA in the 1980s and 1990s have since been taken off the market, because of reasons of safety, efficacy or lack of profit.

In light of these two trends, in November 2013 PCAST was tasked by President Barack Obama to make "practical and actionable recommendations" about how antibiotic resistance could be combatted.

Report Overview

The resulting report, Combating Antibiotic Resistance, calls 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

Nearly all of these goals will require involvement from federal regulators, and in particular the US Food and Drug Administration (FDA), the report explains. For example, FDA is asked in the report to "use existing mechanisms to facilitate approval of drugs based on demonstration of safety and efficacy in specific patients infected with antibiotic-resistant bacteria, while discouraging use in other patient populations."

The report also called on Congress to "support the passage of legislation that explicitly authorized FDA to establish a full Special Medical Use (SMU) pathway for antibiotics."

Critically, the report also calls on Congress to "significantly increase economic incentives for developing urgently needed antibiotics." Critics have long contended that antibiotics are too difficult to develop and have too little payoff, especially since resistant bacteria may render a product nearly worthless. However, these incentives will come at considerable cost. The report estimates that it will take approximately $800 million in funding to bring just one new drug to market that would not otherwise exist.

FDA-Centric Proposals

FDA will be called upon to help in other ways as well. FDA will be instrumental in surveillance efforts, which are set to include a national laboratory network for pathogen surveillance, genomic sequencing tools and a publicly available database.

FDA is also asked in the report to "convene industry and other public and private stakeholders to define the requirements for an appropriate clinical trials infrastructure, and NIH and FDA should propose a plan to create such an infrastructure." Common protocols and infrastructure for trials would cost an estimated $25 million per year, the report states.

The agency is also called upon to assess the progress of its voluntary efforts to limit the prescribing of antibiotics in food-producing animals and, if necessary, "take additional measures" to ensure compliance—a potential nod to enforcing bans on the use of antibiotics through regulation instead of voluntary guidance documents.

Executive Order, New $20M Program

The release of the report also coincided with an Executive Order issued by Obama that directs the federal government to "work domestically and internationally to reduce the emergence and spread of antibiotic-resistant bacteria and to help ensure the continued availability of effective treatments for bacterial infections."

The order also establishes two new interagency groups which will develop and implement new policies in support of the new PCAST report.

Also announced is a new FDA-sponsored $20 million prize which, with cooperation from other federal agencies, will help to "facilitate the development of a rapid diagnostic test to be used by health care providers to identify highly resistant bacterial infections at the point of patient care."

 

 

Combating Antibiotic Resistance

President's Statement

FDA Statement


Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe