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APUA Highlights: August 2012

Updates on APUA Action

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News and Publications of Note
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New APUA report: Expert advice for antibiotic stewardship programs 

APUA surveyed members from the APUA Scientific Advisory Board about strategies for effective implementation of antibiotic stewardship programs (ASP) in healthcare facilities. They pointed out both technical and perceptual challenges to successful implementation of ASPs and some ways to overcome these obstacles. Contributing experts were: Thomas F. O’Brien, M.D. (Brigham and Women’s Hospital), Shira I. Doron, M.D. (Tufts Medical Center), Philip D. Walson, M.D. (Geörg-August-Universität School of Medicine; Clinical Therapeutics), and Alfred DeMaria, Jr., M.D. (Massachusetts Department of Public Health). Read the results of this survey on the APUA website. Back to top
 

APUA's Leadership Statement advocates strengthening FDA Draft Guidance #213 on antibiotic use in livestock

The FDA Draft Guidance #213 asks drug companies to voluntarily remove "growth promotion" from the lists of FDA-approved uses on their products’ labels and instead list disease treatment, control, or prevention. This guidance was open for public comment until July 12, 2012

APUA, in partnership with PEW Charitable Trusts has been advocating for stricter drafting and enforcement of this guidance. APUA commented on the guidance in the form of an organizational letter urging the FDA to make this change in labeling practices an enforceable rule rather than a recommendation. The letter also encouraged the FDA to remove "disease prevention" from the list of approved uses, because allowing it can, in practice, be identical to allowing the use of antibiotics for "growth promotion".  

In addition, APUA developed a leadership statement addressed to President Obama and FDA Commissioner Hamburg. APUA reached out to colleagues for support and this statement was signed by 21 leaders in science and medicine including 4 Nobel Laureates and 5 ASM Presidents. Back to top

Call for nominations: 2012 APUA Leadership Award for Young Professionals

The annual APUA Leadership Award has traditionally recognized an individual or organization that demonstrates extraordinary leadership in promoting the prudent use of antibiotics in an effort to contain antibiotic resistance. This year, we would like to award a prize of $1,000 to an outstanding young or mid-career professional who has demonstrated these achievements. APUA is accepting nominations until August 31 for the 2012 Award. Consideration will be given to the fields of basic science, public policy, and clinical practice. Find the nomination form and read about past winners of the APUA Leadership Award on our website. Back to top
 

APUA VP Dr. Thomas F. O'Brien leads discussion at Gordon Research Conference

The Gordon Research Conferences (GRC) is a non-profit organization managed by and for the benefit of the scientific community. The Gordon Research Conferences provide an international forum for the presentation and discussion of frontier research in the biological, chemical, and physical sciences, and their related technologies. The GRC's recent conference at Stonehill College in Easton, MA took place July 29 - August 3, 2012 and was titled "A Multidisciplinary Exploration of Similarities in Drug Resistance in Rapidly Evolving Diseases." APUA Vice President, Dr. Thomas F. O'Brien led a discussion at this event on the topic of Drug Resistance Epidemiology. Back to top
 

APUA President Dr.Stuart Levy contributes to WHO Book “The Evolving Threat of Antimicrobial Resistance – Options for Action.” 

In March the WHO released a new book called “The Evolving Threat of Antimicrobial Resistance – Options for Action.” APUA President Dr. Stuart Levy co-authored the chapter entitled "Chapter 3. Measures to ensure better use of antibiotics." This book builds on recommendations from the 2001 WHO Global Strategy for Containment of Antimicrobial Resistance. APUA seeks to collaborate with partners around the world to help implement this strategy. Please contact us if you are interested. Back to top 

US law incentivizing development of novel antibiotics passed on July 9, 2012

Following passage in both houses of congress with broad bipartisan support, President Obama signed into law the fifth reauthorization of the Prescription Drug User Fee Act (PDUFA V) on July 9, 2012. First enacted in 1992, the user fee program allows the FDA to review drug approval applications in a timely manner as salaries for FDA employees are supported by fees charged to the industry. PDUFA is subject to congressional reauthorization every five years, and the reauthorization statutes provide a vehicle for enacting related reforms.

One important reform that passed along with PDUFA V this year is the Generating Antibiotic Incentives Now (GAIN) Act. The GAIN Act extends the following benefits to developers of antibiotics:

  • market protection for 10 years following approval of a new antibiotic
  • eligibility of antibiotics for priority review and fast track review by the FDA
  •  updated clinical trial guidelines to be made available by the FDA within a year of law enactment
  •  FDA guidance on pathogen-focused drug development.


IDSA, with support from APUA, strongly advocated for the passage of a Limited Population Antibacterial Drug (LPAD) approval mechanism along with the GAIN Act. LPAD is intended to expedite the process of approving antibiotics for use in the small population of patients who have serious or life-threatening infections, and have few treatment options left.  Clinical trials of such antibiotics could be faster and less expensive if conducted with a smaller sample size. In the LPAD mechanism, these drugs would only be approved for use in a small, well-defined population of patients, for whom the benefits of treatment outweigh the risks, thus protecting the rest of population from risks or side effects, and hindering the development of resistance. While the LPAD mechanism was not explicitly included in the GAIN Act at this time, there is reason to believe that it will be part of the updated guidelines for clinical trials. For more information on the GAIN Act please see the recent APUA NewsletterBack to top
 

"Sustainable farming: Get pigs off antibiotics"

Sustainable farming: Get pigs off antibiotics” by Frank Aarestrup was published in  Nature in the June 2012 issue. It tells the story of how, since the mid-90s, Denmark has cut by 60% the use of antimicrobial agents per kilogram of livestock produced. In the same time period, the country's pork production has increased by 50%. Denmark is the world's largest exporter of pork, exporting 90% of the pork it produces. Some reasons for the success in Denmark include a widespread public awareness of the problems caused by the overuse of antibiotics, development of a comprehensive surveillance system to track and target overuse, and laws prohibiting veterinarians from profiting from the sale of drugs to farmers.Back to top

Aarestrup, F. (2012) Sustainable farming: Get pigs off antibiotics. Nature 486: 465–466.

"A Matter of Life and Death: The Economics of Antibiotic Resistance"

"A Matter of Life and Death: The Economics of Antibiotic Resistance" by Ramanan Laxminarayan was the cover story in the July issue of Milken Institute Review.  Laxminarayan focuses on the market failures and misaligned economic incentives contributing to antibiotic resistance. He puts forth strategies for correcting these systemic imbalances which address problems in both drug development, and conservation. The article points out that the major challenge in battling antibiotic resistance is incentivizing the development of new antibiotics while concurrently rewarding companies for not overselling these drugs.
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Laxminarayan, R. (2012) A Matter of Life and Death: The Economics of Antibiotic Resistance. Milken Institute Review. 

US FDA position open:  Division Director, Division of Pharmacovigilance

Candidate shall be a medical doctor or pharmacist and have a degree from a U.S. medical school or an equivalent medical education and knowledge with 10 to 15 years of supervisory and/or management experience. A background in drug safety/pharmacoepidemiology is preferred. Experience in post-market drug safety regulations at the Federal level is required. Interested candidates should contact Margaret Gottlieb at Reffett + Associates (mgottlieb at reffettassociates.com). Back to top
 

Upcoming Conferences & Events:

APUA would like to thank APUA-Australia ( Australian Society for Antimicrobials) for their generous donation in support of APUA’s clinical newsletter and global education programs.

 

 

 

 

 
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