IDSA : FDA 10x20

03/14/2013

IDSA Comments on Drug Shortages Task Force and Strategic Plan (PDF)

IDSA, with endorsement from the Pediatric Infectious Diseases Society (PIDS), submitted comments to FDA calling for stronger communication between FDA, CDC, the pharmaceutical industry, and health care practitioners to identify actions that can be taken to prevent drug shortages that impact patient care and public health.

12/21/2012

IDSA Comments on FDA Draft Guidance on Developing Drugs for Complicated Intra-Abdominal Infections (cIAI) (PDF)

IDSA praised FDA for several elements of the guidance, including the acceptability of a single adequate and well controlled study with supportive data as evidence of effectiveness, the use of clinical and microbiological endpoints, the noninferiority margin, and the willingness to accept a greater degree of risk where there is a serious unmet need. IDSA asked FDA to reconsider areas of concern, including allowance of a switch to oral administration of drugs and allowance of 48 hours of prior non-trial antibiotics.

12/18/2012

IDSA Comments on Developing a List of Qualifying Pathogens (PDF)

IDSA submitted comments to the FDA regarding the establishment of a list of pathogens that would qualify for new antibiotic and antifungal incentives, including an additional 5 years of exclusivity.

10/15/2012

Recommendations on the Conduct of Superiority and Organism-Specific Clinical Trials of Antibacterial Agents for the Treatment of Infections Caused by Drug-Resistant Bacterial Pathogens

IDSA white paper on the critical need for new pathways to develop antibacterial agents to treat life-threatening infections caused by highly resistant bacteria.

10/11/2012

CTTI Antibacterial Drug Development Workshop Summary

Workshop summary of the Clinical Trials Transformation Initiative (CTTI) on the topic of Anti-Bacterial Drug Development: Issues in the Design of Trials in Patients with Unmet Need and in Patients with Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia.

08/14/2012

IDSA Comments on Upcoming HHS Antibiotic Incentives Study (PDF)

IDSA sent a letter to Secretary Sebelius providing additional information to help guide the upcoming HHS study on antibiotic incentives and antimicrobial stewardship.

06/19/2012

American Medical Association (AMA) Supports IDSA's Limited Population Antibiotic Drug (LPAD) Proposal (PDF)

The AMA House of Delegates voted to adopt a resolution introduced by IDSA in support of the establishment of the LPAD approval mechanism.

05/24/2012

IDSA Comments on FDA Draft Guidance on Developing Drugs for Complicated Urinary Tract Infections (cUTI) (PDF)

IDSA praised the FDA for its effort to develop the draft guidance and for the inclusion of various elements, including clinical and microbiological endpoints, emphasis on pharmacokinetic data to support phase III trials, and incorporation of rapid diagnostic testing. IDSA raised concerns with precluding prior antimicrobial therapy, the long duration of therapy, the maintenance of IV therapy for the duration of treatment, patient inclusion criteria, and the non-inferiority margin.

12/21/2011

IDSA Comments on FDA Development of Multiplexed Diagnostics (PDF)

FDA sought comments on options being considered for the performance validation of highly multiplexed microbiology/medical countermeasure (MCM) diagnostic devices. In responding to the FDA concept paper, IDSA addressed the clinical and public health need for better infectious diseases diagnostic devices, clinical considerations for device design, and key issues for device validation.

10/26/2011

IDSA/Others Say FDA Must Have Access to Knowledgeable Subject Matter Experts (PDF)

IDSA joined over 75 provider and patient advocacy organizations in urging Senate leaders to eliminate over-the-top conflict of interest requirements that apply only to Food and Drug Administration advisory committees. These requirements tie FDA's hands preventing the agency from hearing opinions from the most knowledgeable experts prior to approving new drugs, vaccines, diagnostics, etc.

10/19/2011

IDSA Comments to FDA on Drug Shortages (PDF)

IDSA submitted comments to FDA regarding drug shortages, highlighting the negative impact anti-infective drug shortages have on public health and patient care.

10/17/2011

IDSA asks FDA to seek IOM's Help to Address Antimicrobial/Influenza Antiviral Regulatory Issues (PDF)

The Society would like FDA to engage the Institute of Medicine to develop a process for reviewing FDA's current approaches to anti-infective clinical trial designs for both antibacterial and influenza antiviral drugs as the current approach has produced infeasible instructions for industry and continues to stymie new drug development in these critical areas.

02/23/2011

IDSA Comments on FDA HABP and VABP Draft Guidance (PDF)

IDSA Comments on Draft Guidance for Industry on Hospital-Acquired Bacterial Pneumonia (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP)

11/17/2010

IDSA Comments on FDA's Draft Guidance for Industry on Acute Bacterial Skin and Skin Structure Infections (ABSSSI) (PDF)

IDSA calls for extensive revisions to the Food and Drug Administration's draft guidance to industry on clinical trial designs for antibiotics to treat ABSSSIs citing the guidance's potentially negative impact on patients' access to new, life-saving drugs.

08/01/2010

IDSA Position Paper on Clinical Trials of Antibacterials for HABP and VABP (PDF)

Position paper: "Recommended Design Features of Future Clinical Trials of Antibacterial Agents for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia," Spellberg B, Talbot G, et al.

06/21/2010

FDA Approval Process Hinders Development of New Antibiotics (PDF)

This background paper by Brad Spellberg, MD, FIDSA (a member of IDSA's Antimicrobial Availability Task Force) examines the two primary types of clinical trials for new drugs and concludes that non-inferiority trials are the only clear pathway for approval of new antibiotics.

11/17/2009

IDSA Supports FDA’s Preliminary Approach to Breakpoints Updates in a Response to U.S. Rep. DeLauro (PDF)

IDSA notes that FDA Appropriations Chairwoman appears to have received some faulty information when she took FDA to task on its plans to update antibacterial breakpoints on drug labeling (e.g., we disagree that the agency is "outsourcing" this essential function to the Clinical Laboratory Standards Institute).

08/01/2009

Antimicrobial Agents for Complicated Skin and Skin-Structure Infections

Justification of Noninferiority Margins in the Absence of Placebo-Controlled Trials, Spellberg et al.

06/26/2009

IDSA Outlines Priorities for FDA's Incoming Leaders (PDF)

In a letter to FDA Commissioner Peggy Hamburg, IDSA requests a meeting with top agency officials to discuss issues and strategies related to novel H1N1 influenza, impediments to antibacterial drug development, strategies to better address antimicrobial resistance and the use of antimicrobials in animals.

05/21/2009

IDSA Comments on FDA Draft Guidance to Industry on Antivirals for Treatment or Prophylaxis of Influenza (PDF)

In its comments, IDSA raised concerns about FDA's proposal to approve new antivirals for influenza based on superiority or dose-ranging trials vs. non-inferiority trials. IDSA also is concerned about FDA's adherence to Pediatric Research Equity Act requirements, which may act as an impediment to drug development in this critical area.

03/27/2009

IDSA, Others and FDA Co-Sponsor Public Workshop on Clinical Trial Design for HAP and VAP

IDSA, American Thoracic Society, American College of Chest Physicians, Society for Critical Care MEdicine, and the U.S. Food and Drug Administration co-sponsor a March 31-April 1, 2009 public workshop on clinical trial design for hospital-acquired pneumonia and ventilator-associated pneumonia.

12/01/2008

IDSA-FDA Community-Acquired Pneumonia Workshop Supplement

A workshop that brought together the collective expertise of industry, academia, and the regulatory agency to address practical issues in conducting clinical trials of antibacterial agents for the treatment of patients with community-acquired pneumonia.

12/01/2008

IDSA Position Paper on Recommended Design Features of Future Clinical Trials of Antibacterial Agents for Community-Acquired Pneumonia (PDF)

IDSA position paper on recommended design features of future clinical trials of antibacterial agents for Community-Acquired Pneumonia (CAP).

10/15/2008

FDA Response to IDSA's Letters of July 18 and August 28, 2008 (PDF)

FDA response to IDSA's July 18 and August 28, 2008 letters regarding the Orphan Drug Act.

08/28/2008

Second IDSA Letter to FDA Concerning the Orphan Drug Act (PDF)

IDSA met with FDA officials on August 25th to continue its dialogue with FDA on the relevance of the Orphan Drug Act to serious infections caused by resistance organisms. This letter summarizes key points raised during that meeting and seeks FDA's confirmation of these points.

07/18/2008

IDSA Requests FDA to Clarify its Orphan Drug Act and Resistant Infections Policy (PDF)

IDSA seeks clarification on inconsistent statements made by agency officials about the relevance of the Orphan Drug Act to resistant infections and asks whether a parallel regulatory framework with incentives similar to, but not the same as, the Orphan Drug program could stimulate antibacterial drug, and related diagnostic vaccine, research and development.

04/28/2008

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