Health Law News From Arnold & Porter Kaye Scholer

Congress reintroduces legislation to curb antibiotic-resistant organisms

From international law firm Arnold & Porter LLP comes timely views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.

On April 10, 2014, the Infectious Diseases Society of America (IDSA) issued the press release, “Antimicrobial resistant infections affect hundreds of thousands of Americans and cause tens of thousands of deaths each year. The infections are painful, difficult to treat, frequently reoccur and cost tens of billions of dollars to the U.S. health care system annually.”

Indeed, the IDSA’s claims regarding so-called “super bugs” are bolstered by two recent reports issued by the CDC and the World Health Organization (WHO). The CDC report, entitled Antibiotic Resistance Threats in the United States of 2013, estimates that approximately 2 million people are infected with an antibiotic resistant each year and, worse yet, at least 23,000 of those people die from those infections annually.

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Similarly, The Antimicrobial Resistance: Global Report on Surveillance 2014, released by the WHO concluded that “standard [antibiotic] treatments no longer work,” the “risk of the spread of infection to others is increased, “infections are harder or impossible to control,” that “illness and hospital stays are prolonged, with added economic and social costs,” and “the risk of death is greater - in some cases, twice that of patients who have infections caused by non-resistant bacteria.”

The WHO report ominously warns that “[a] post-antibiotic era – in which common infections and minor injuries can kill – far from being an apocalyptic fantasy, is instead a very real possibility for the 21st Century.”

In recognition of this significant, brewing public health crisis, Congress enacted in 2012 the FDA Safety and Innovation Act (FDASIA), a law designed to create incentives to stimulate the development of new antibiotics by granting such drugs an additional five years of patent exclusively. In an attempt to enhance efforts to fight the surge of super bugs, U.S. Senator Sherrod Brown (D-OH) recently reintroduced the Strategies to Address Antimicrobial Resistance (STAAR) Act on April 10, 2014. The legislation aims to curb the rise of antimicrobial resistance organisms by, among other things, promoting prevention, strengthening federal antibiotic use and resistance surveillance and data collection, and encouraging the research and development of new drugs. It has been introduced by virtually every Congress since 2006 but never enacted.  Specifically, the Act proposes to:

  • Promote prevention through public health partnerships at the CDC and regional prevention collaborative;
  • Track anti-bacterial resistance organisms by enhancing data collection and mandatory reporting;
  • Improve the antibiotic drug consumption by educating health care providers on appropriate antibiotic use;
  • Enhance leadership and accountability in antibiotic resistance by reauthorizing the Antimicrobial Resistance Task Force and coordinating agency efforts; and
  • Support research by directing the NIH to work with other agencies and experts to create a strategic plan to address antibiotic resistance.

In reintroducing the legislation, Senator Brown explained that: “Antibiotics and other antimicrobial drugs have been a victim of their own success. We have used these drugs so widely and for so long that the microbes they are designed to kill have adapted to them, making the drugs less effective. We need a comprehensive strategy to address antimicrobial resistance. That is why I am introducing the STAAR Act, which would revitalize efforts to combat super bugs.”

Jennifer Davis-Oliva, JD, can be reached at Arnold & Porter LLP, 555 12th St. NW, Washington, DC 20004-1206; 202.942.6434; email: Jennifer.Davis-Oliva@aporter.com

From international law firm Arnold & Porter LLP comes timely views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.

On April 10, 2014, the Infectious Diseases Society of America (IDSA) issued the press release, “Antimicrobial resistant infections affect hundreds of thousands of Americans and cause tens of thousands of deaths each year. The infections are painful, difficult to treat, frequently reoccur and cost tens of billions of dollars to the U.S. health care system annually.”

Indeed, the IDSA’s claims regarding so-called “super bugs” are bolstered by two recent reports issued by the CDC and the World Health Organization (WHO). The CDC report, entitled Antibiotic Resistance Threats in the United States of 2013, estimates that approximately 2 million people are infected with an antibiotic resistant each year and, worse yet, at least 23,000 of those people die from those infections annually.

LARGE_Arnold_Porter_logo 

Similarly, The Antimicrobial Resistance: Global Report on Surveillance 2014, released by the WHO concluded that “standard [antibiotic] treatments no longer work,” the “risk of the spread of infection to others is increased, “infections are harder or impossible to control,” that “illness and hospital stays are prolonged, with added economic and social costs,” and “the risk of death is greater - in some cases, twice that of patients who have infections caused by non-resistant bacteria.”

The WHO report ominously warns that “[a] post-antibiotic era – in which common infections and minor injuries can kill – far from being an apocalyptic fantasy, is instead a very real possibility for the 21st Century.”

In recognition of this significant, brewing public health crisis, Congress enacted in 2012 the FDA Safety and Innovation Act (FDASIA), a law designed to create incentives to stimulate the development of new antibiotics by granting such drugs an additional five years of patent exclusively. In an attempt to enhance efforts to fight the surge of super bugs, U.S. Senator Sherrod Brown (D-OH) recently reintroduced the Strategies to Address Antimicrobial Resistance (STAAR) Act on April 10, 2014. The legislation aims to curb the rise of antimicrobial resistance organisms by, among other things, promoting prevention, strengthening federal antibiotic use and resistance surveillance and data collection, and encouraging the research and development of new drugs. It has been introduced by virtually every Congress since 2006 but never enacted.  Specifically, the Act proposes to:

  • Promote prevention through public health partnerships at the CDC and regional prevention collaborative;
  • Track anti-bacterial resistance organisms by enhancing data collection and mandatory reporting;
  • Improve the antibiotic drug consumption by educating health care providers on appropriate antibiotic use;
  • Enhance leadership and accountability in antibiotic resistance by reauthorizing the Antimicrobial Resistance Task Force and coordinating agency efforts; and
  • Support research by directing the NIH to work with other agencies and experts to create a strategic plan to address antibiotic resistance.

In reintroducing the legislation, Senator Brown explained that: “Antibiotics and other antimicrobial drugs have been a victim of their own success. We have used these drugs so widely and for so long that the microbes they are designed to kill have adapted to them, making the drugs less effective. We need a comprehensive strategy to address antimicrobial resistance. That is why I am introducing the STAAR Act, which would revitalize efforts to combat super bugs.”

Jennifer Davis-Oliva, JD, can be reached at Arnold & Porter LLP, 555 12th St. NW, Washington, DC 20004-1206; 202.942.6434; email: Jennifer.Davis-Oliva@aporter.com

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