1 Antibiotic Resistance: An Update Janice Soreth, M.D. Director Division of Anti-Infective Drug Products February 20, 2002.

Slides:

Advertisements

Similar presentations

Labeling Prescription Drugs for Physicians and Consumers 48 th Annual Conference Preparing for the Next Century of Food and Drug Regulation Food and Drug.

Advertisements

Acute Otitis Media Trials: Evolution of Guidance Janice Soreth, M.D. Division of Anti-Infective Drug Products January 30, 2001.

Regulatory History and Attributes of Consumer Antiseptics Nonprescription Drugs Advisory Committee Meeting Silver Spring, Maryland October 20, 2005 Colleen.

Initiating an Antimicrobial Stewardship Program at BC Children's Hospital Quality Forum 2015 Ashley Roberts, MD, M.Ed, FRCP(C) Karen Ng, BSc.Pharm, ACPR,

Save Antibiotic Strength Health Plans Address the Challenge of Antibiotic Resistance Robert Scalettar, M.D. July 19, 2005.

Challenges in Antibacterial Drug Development Francis P. Tally M.D. Cubist Pharmaceuticals, Inc.

CDC Winnable Battles: Preventing Healthcare-Associated Infections (HAIs) National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare.

Office of Drug Evaluation IV, CDER FDA/IDSA/ISAP Workshop 4/16/04 Overview of PK-PD in Drug Development Programs: FDA Perspective FDA/IDSA/ISAP Workshop.

Surprising Victories Against Old Foes: New Hope for Prevention and Control of Healthcare- Associated MRSA Infections John A. Jernigan, MD, MS Division.

GLOBAL REGULATORY STRATEGY CONSIDERATIONS SCIENTIFIC SARAH POWELL EXECUTIVE DIRECTOR, REGULATORY STRATEGIES SEPTEMBER 14-17, 2008 BOSTON, MA.

April 8, 2005FDLI Annual Conference 1 Labeling Prescription Drugs for Physicians and Consumers (FDA Perspective) Paul J. Seligman, MD, MPH Director, Office.

MONITORING THE VALUE OF TRIAL REGISTER INFORMATION Thomson Pharmaceutical Services LAWRENCE LIBERTI MS, RPh, RAC JULY 16, 2008.

Direct-to-Consumer Advertising of Prescription Drugs: Looking Back, Looking Forward Kathryn J. Aikin, Ph.D. Division of Drug Marketing, Advertising and.

July 2015 PRABHAVATHI FERNANDES, PhD Founder, President and CEO How the PATH Act Can Rejuvenate Antibiotic R & D.

1 FDA Trial Design Requirements for CABP David M. Shlaes MD, PhD Anti-infectives Consulting, LLC Stonington, CT.

IDSA / ISAP / FDA Workshop on Antimicrobial Drug Development Update 2004 Edward Cox, MD MPH ODE IV Center for Drug Evaluation and Research US Food and.

Recommendation on prudent use of antimicrobial agents in human medicine – Slovenian experiences Intersectoral Coordination Mechanism Prof. Milan Čižman,

Introduction There are few public health issues of greater importance than antimicrobial resistance in terms of impact on society. This problem is not.

Antimicrobial Stewardship

Opioid Risk Management Programs Celia Jaffe Winchell, M.D. Acting Deputy Division Director Division of Anesthetic, Critical Care, and Addiction Drug Products.

Summary from the Economics Track With thanks to all track participants, presenters, rapporteurs, moderators and organizers.

Development of Antibiotics for Otitis Media: Past, Present, and Future Janice Soreth, M.D. Director Division of Anti-Infective Drug Products.

1 The Perspective of a Local IRB Challenges related to human subjects research protections in the context of disasters Presented to SCAHRP October 30,

Joint Meeting of Anti-Infective Drugs & Drug Safety and Risk Management Advisory Committees December 14-15, 2006 Ketek  (telithromycin) Regulatory History.

ECDC-EMEA Joint Technical Report Part I: Trends and burden of antimicrobial resistance in the European Union Zsuzsanna Jakab, Director European Centre.

Bertko - Novel Technology's Effects 1 Novel Technologies -- A Health Insurance Cost Projection Challenge John Bertko, FSA, MAAA 2008 National Health Policy.

1 Politics of Tobacco Regulation FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (U.S. 2000)

Prudent Health Workshop Clinical Overview Dr Kurt Burkhardt (GP Partner/ Locality Clinical Director)

Antimicrobial Resistance in Streptococcus pneumoniae Implications for Prescription Drug Labeling John H. Powers, MD Lead Medical Officer Antimicrobial.

FDA Office of Orphan Products Development

FDA ICH Public Meeting 5630 Fishers Lane, Rockville, MD May 8, :30 am -- 2:00 pm Implementation of the CTD Update-Issues-Next Steps Justina A. Molzon,

HHS Task Force to Stimulate Medical Innovations David N. Gilbert, M.D. on behalf of the IDSA.

Acute Otitis Media: Lessons Learned Thomas Smith, M.D. Division of Anti-Infective Drug Products.

Research in the Office of Cellular, Tissue and Gene Therapies: Vision and Overview Jesse Goodman, M.D., M.P.H. Director, Center for Biologics Evaluation.

1 Development of Antibacterial Drugs for Infections with Resistant Pathogens Antimicrobial Working Group of the Pharmaceutical Research and Manufacturers.

Center for Drug Evaluation and Research March 6, 2005 Bacteremia and Endocarditis: Products and Guidance Janice Soreth, MD Director Division of Anti-Infective.

NHS Reform Update October Context Health Reform Agenda Significant pace of change Clear focus on supporting the Transition Process At the same time.

1 Future Strategies to Address PPCPs Octavia Conerly Health and Ecological Criteria Division Office of Water Office of Water October 26, 2005 October 26,

In the Best Interests of the Public Health... Janice Soreth, M.D. Acting Director Division of Anti-Infective Drug Products CDER/FDA.

Chapter Legislative Representatives Government Affairs Update April 2014.

Acute Bacterial Otitis Media Summary and Charge to the Committee Renata Albrecht, M.D. Division of Special Pathogen and Immunologic Drug Products ODEIV,

FDA Risk Communication Nancy M. Ostrove, PhD Senior Advisor for Risk Communication Risk Communication Advisory Committee February 28, 2008.

FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology July 22-23, 2008 Introduction and Update Helen N. Winkle Director, Office of.

DEPARTMENT OF HEALTH CENTER FOR BIOLOGICS AND HUMAN SERVICESEVALUATION and RESEARCH AND HUMAN SERVICES EVALUATION and RESEARCH Update on OCTGT Guidance.

1 Developing drugs for resistant pathogens: Problems and possibilities David Ross, M.D., Ph.D. Anti-Infective Drugs Advisory Committee February 20, 2002.

U.S. Strategies to Improve Human Antibiotic Use Lauri A. Hicks, D.O. Director, Office of Antibiotic Stewardship April 13, 2016 National Center for Emerging.

Prepared by: Imon Rahman Lecturer Department of Pharmacy BRAC University.

Fostering Antimicrobial Stewardship in Animals: Overview of FDA Activities William Flynn, DVM, MS Deputy Director for Science Policy Center for Veterinary.

Given the progress that continues to be made in society’s battle against disease, patients are seeking more information about medical problems and potential.

Tools to Support Lasting Change. ABCs for diagnosing UTI in long term care Evidence based guidance for urine testing in the elderly Research conducted.

© Copyright IBM 2007DIA ERS SIAC Presentation, January 2008 The HL7 RPS and SPL Standards - A High Level View Terry Hardin Sr. IT Architect Emerging Software.

Version: 27 May 2007 New Models for Collaboration: Patients as Drivers and Partners in Neurological Research Integrating Patient Input Within the Drug.

All-Payer Model Update

Figure 1. Rate of antimicrobial resistance in S. pneumoniae

AHRQ Safety Program for Improving Antibiotic Use

Balancing Regulation and Innovation: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular.

The FDA Early Feasibility Study Pilot and the Innovation Pathway

Professor Alan Johnson Department of HCAI & AMR

Introduction of New Technology: An FDA Division of Cardiovascular Devices Perspective Bram Zuckerman, MD, FACC Director, FDA Division of Cardiovascular.

AHRQ Safety Program for Improving Antibiotic Use

ECDC-EMEA Joint Technical Report Part I: Trends and burden of antimicrobial resistance in the European Union Zsuzsanna Jakab, Director European Centre.

Keeping the Glowing Going: Preview of Upcoming HAI Activities in NM

Amanda Reiff, MPH Epidemiologist Jefferson County Public Health

Call topic identification for 2019 call

Antibiotic Resistance: Strategic Solutions

Chicago Department of Public Health

All-Payer Model Update

Pediatric Clinical investigator training workshop

ANTIMICROBIAL USE AND RESISTANCE SURVEILLANCE PILOT PROJECT – LESSONS FROM THE DURBAN SITE Gray AL, Essack SY, Deedat F, Pillay T, van Maasdyk J, Holloway.

Presentation transcript:

1 Antibiotic Resistance: An Update Janice Soreth, M.D. Director Division of Anti-Infective Drug Products February 20, 2002

2 Antibiotic Resistance: Overview FDA/CDER Meetings Lessons Learned What’s New in 2002

3

GISA VRE MRSA MRCNSPRSP Percentage of Pathogens Resistant to Antibiotics Gram-Positive Resistance - United States, Paladino JA. Am J Health Syst Pharm 2000;57 Suppl 2:S10-2.

5 FDA Meetings on Resistance General July, 1998 October, 1998 October, 1999 Product-specific –SynercidFebruary, 1998 –LevaquinOctober, 1999 –ZyvoxApril, 2000 –AugmentinESJanuary, 2001

6 Lessons Learned Regulatory tools may encourage development. Novel approaches to study design need to be considered (e.g., dose-response trial). Enrichment strategies may help. Data from susceptible isolates are an important component of the overall picture. Using positive culture results to enroll patients in a study (e.g., MRSA) can augment a development program with infection-site specific trial (e.g., pneumonia, skin)

7 Lessons Learned (continued) Regulatory tools have helped, but it is still a challenge to accrue organisms. Great resources are spent to develop a drug for resistant pathogens. Historical controls can be used when there is no approved comparator, but they may be problematic. More data do not necessarily equal better data. Bottom line: New drugs are still needed, as is preservation of the already-marketed ones.

8 What’s New? Resources Surveillance Education Future Approaches

9 Resources We have received resources intended specifically for antimicrobial development and resistance activities. We intend to increase our staff who deal with these issues.

10 Surveillance We will augment our access to surveillance information, in collaboration with CDC and the private sector Goal: To better approach antimicrobial drug development and usage.

11 Education Campaign Target both health care professionals and patients. We plan to address antibiotic resistance and prudent use in product labeling. (Proposed Rule) We anticipate an impact on promotional material.

12 Proposed Rule September 19, 2000: Federal Register publication of proposal to amend regulations to require that all systemic antibacterial products intended for human use contain additional labeling information about the emergence of drug-resistant bacterial strains. Intent is to encourage physicians to –Prescribe antibacterials only when clinically necessary. –Counsel patients about proper use of antibacterials.

13 Education Campaign CDER effort is underway to develop advertisements on the prudent use of antibiotics. We envision a variety of media: –print advertisements in professional journals, patient leaflets, public service announcements.

14 Future Approaches to Anti-Infective Development Require creativity and flexibility on our part. Recognize the limits of resources (patients, time, money) that go into developing an antimicrobial product for resistance.

15 Summary We have made progress in getting antimicrobial products to the market for patients with resistant pathogens, but more are needed. We must preserve the antibiotic treasures we do have, through education, prudent use, etc. We need to strike a balance between available resources for performing clinical trials and level of certainty in determining effectiveness.