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Antibiotic Resistance: An Update

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Antibiotic Resistance: An Update Janice Soreth, M.D. Director Division of Anti-Infective Drug Products February 20, 2002 Antibiotic Resistance: Overview FDA/CDER ... – PowerPoint PPT presentation

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Title: Antibiotic Resistance: An Update


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
  • Whats New in 2002

3
(No Transcript)
4
Gram-Positive Resistance - United States,
1980-1999
100
80
MRCNS
Percentage of Pathogens Resistant to Antibiotics
60
MRSA
40
20
VRE
GISA
0
1980
1975
1985
1990
1995
2000
1997
Paladino JA. Am J Health Syst Pharm 200057 Suppl
2S10-2.
5
FDA Meetings on Resistance
  • General
  • July, 1998
  • October, 1998
  • October, 1999
  • Product-specific
  • Synercid February, 1998
  • Levaquin October, 1999
  • Zyvox April, 2000
  • AugmentinES January, 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
Whats 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.
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