U.S. Government Takes Steps To Combat Antibiotic Resistance

By Lori Clapper

The U.S. government initiated a new strategy last week to track trends in antibiotic resistance, due to reports that it is the cause for at least 23,000 deaths and two million illnesses each year.  The plan lays out specific steps to prevent this epidemic and to accelerate the research and development of new antibiotics by 2020.

Why the growth in antibiotic resistance? People either misuse or overuse these drugs or encounter them more frequently in the nation’s food supply, rendering existing antibiotics virtually ineffective. In addition, there’s been a real lack of new antibiotic candidates in the pipeline in recent years, according to the Center for Disease Dynamics, Economics, and Policy (CDDEP).

In fact, the FDA only approved six antibiotics between 2010 and 2014. Not to mention, issues with safety, efficacy, and shrinking revenue caused a number of antibiotics approved by FDA in the 1980s and 1990s to be taken off the market. Antibiotics have been long believed to be too difficult to develop with little payoff, “especially since resistant bacteria may render a product nearly worthless,” RAPS reported.

In November 2013, the President's Council of Advisors on Science and Technology (PCAST), was tasked by President Barack Obama to make "practical and actionable recommendations" to fight the antibiotic resistance trend. Stemming from that meeting, a new report, Combating Antibiotic Resistance, was released last week, which identifies four problems and the potential solutions to solve the antibiotic problem:

• Half of antibiotics are currently prescribed incorrectly, so significant improvement is necessary in the prescribing of existing antibiotics

• Antibiotics are used to promote growth and prevent infections, which calls for the reduction of the use of antibiotics in food-producing animals
• A dwindling pipeline of new products makes it necessary to improve incentives for companies to develop new products
• Death and illness due to antibiotic resistance is on the rise, so the report calls for increasing surveillance of antibiotic resistance, both in the U.S. and abroad

But these tactics will indeed require regulator and government involvement to reach these goals. For example:

• The FDA needs 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."
• Congress was also asked to support legislation that would allow the FDA to create a full Special Medical Use (SMU) pathway for antibiotics.
• The report asks that Congress establish some economic incentives to encourage more companies to set their sights on antibiotic development.

The FDA is also taking its own measures. In cooperation with other federal agencies, the FDA plans to sponsor a $20 million prize to help create a rapid diagnostic test health care providers can use to identify highly resistant bacterial infections at the point of patient care. In addition, the FDA has asked drug companies to voluntarily cease using antibiotics that promote growth in the animals, specifically antibiotics that are important in human treatment. As of June 2014, all 26 companies that make relevant drugs have agreed to phase them out of animal feed, according to the Wall Street Journal.

The report also challenged the government to invest $900 million to research and track antibiotic resistance, with an additional $800 million a year to encourage drug makers to development new antibiotic drugs – all in hopes of stopping a “brewing problem” from becoming a crisis, according to PCAST.