ASM Issues of Concern Related to FDA

My name is Janet Shoemaker and I am Director of Public Affairs at the American Society for Microbiology. I am accompanied by Dr. Kimberly Walker, Manager of ASM Public Affairs. Thank you for the opportunity to present ASM issues related to the FDA.

The ASM is the largest life science Society composed of over 47, 000 members. Its mission is to promote and advance the microbial sciences.

ASM includes scientists in academia, industry and government and health professionals who direct clinical microbiology, immunology and molecular diagnostic laboratories and who are licensed or accredited to perform diagnostic testing. ASM members include industry professionals who manufacture products for clinical labs and members involved in the development and evaluation of new technologies.

ASM publishes 12 journals which disseminate basic, translational and clinical research knowledge in the microbial sciences, especially related to the diagnosis, prevention and treatment of infectious diseases; ASM hosts educational forums and meetings on diverse topics in the microbial sciences.

ASM is a nonprofit, educational organization and is involved in informing public policy and public awareness related to the microbial sciences and ensuring science based policy decisions.

ASM has expert committees that help formulate evidence based policy recommendations on issues that involve the practice of laboratory microbiology and it is these issues that I will mention today.

The ASM has long supported FDA and the resources needed to fulfill its mission to safeguard public health and safety and each year submits a statement of support to Congress.

Turning to the issues:

The ASM is involved in activities related to Antimicrobial Resistance and has provided expert advice to government agencies, Congress and the public about this growing health threat.

Technology for rapid diagnostic testing to measure microbial susceptibility and guide therapies is essential.

We need to ensure that new and existing antibiotics are used appropriately. Timely, accurate and updated breakpoint data help to ensure the appropriate use of antibiotics. Delays in updating antibiotic labels with new breakpoint information can impact informed treatment decisions. Without updated breakpoint data, antimicrobial susceptibility test devices may misclassify resistant bacteria.

ASM has brought to the attention of FDA concerns about the delay between the availability of new antimicrobials and approved susceptibility methods, which affects the use of new antimicrobial drugs. Availability of accurate susceptibility test methods should be coordinated with new drug applications, without delaying approval of new antimicrobials.

The process of updating breakpoints should be streamlined and FDA should have the flexibility to use external standard setting data to update drug labels and antimicrobial susceptibility test device, and a website for updated breakpoint information.

ASM is also concerned about challenges impacting antibacterial drug development. The pipeline is fragile and a continuing platform of new drugs is needed, which will require an examination of difficulties toward this goal. The new FDA policy to guide use of antibiotics in animals is a step forward.

ASM members are users of next generation sequencing based tests in a clinical setting and are concerned with FDA oversight of infectious disease next generation sequencing based diagnostic devices. NGS technology enables laboratories to explore the genetic contributions of microbes to health and disease. FDA guidelines and regulatory pathways for infectious disease devices that use NGS technology must be carefully considered to ensure a positive impact on patient care. ASM, along with several other organizations, described its concerns and recommendations in a September 11, 2016 letter to FDA in response to its Draft Guidance document on NGS and would be pleased to follow up with FDA about these issues.

ASM has commented to FDA on its 2014 draft guidance for industry and clinical labs Framework for regulatory oversight of laboratory developed tests (LDTs) and possible negative impacts on infectious disease diagnostic tests. Infectious disease LDTs have little known evidence of providing unreliable results. ASM recommends that FDA take into account the benefits of innovation versus risk when considering regulations for infectious disease LDTs. The ASM has coauthored a position paper, “Maintaining Life Saving Testing for Patients with Infectious Diseases, IDSA,ASM and PASV Recommendations on the Regulation of Laboratory Developed Tests” published in Clinical Infectious Diseases. The paper includes recommendations to minimize the disruption of LDTs for infectious diseases and was also summarized in an April 27, 2016 letter to the FDA.

The ASM has provided information on the contamination of medical devices related to medically important bacteria and has had discussions with legislative staff. ASM members have co-authored a paper on CRE following endoscopy. Current US guidelines for duodenoscope/endoscope reprocessing and infection control do not recommend culturing; however, some US healthcare facilities have successfully implemented routine or periodic surveillance sampling and culturing of duodenoscopes to provide early detection of potential problems with a reprocessed instrument. ASM is currently working with the Center for Devices and Radiological Health, Office of Device Evaluation, Division of Reproductive, Gastro-Renal, and Urological Devices to draft sampling and culturing protocols for duodenoscopes.

ASM has commented or participated in FDA public workshops on the classification of microbial devices. Most recently, in November, ASM participated in a workshop on classification of quantitative nucleic acid amplification tests for the measurement of virus DNA levels in transplant-associated infections; in the past, we have commented on reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis complex and influenza virus antigen detection test systems.

Thank you for the opportunity to provide these comments.