November 21, 2016
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD, 20852
Re: Docket No. FDA-2016-N-0001: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices; Draft Guidance for Industry and Food and Drug Administration Staff:
The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments on the Food and Drug Administration (FDA) Draft Guidance entitled, “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test (AST) devices” (“Draft Guidance”).
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but also have reduced healthcare expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.
AST devices are critical in guiding effective treatment selection for patients suffering from infection, informing antimicrobial stewardship, and for supporting epidemiological surveillance of trends in antimicrobial resistance. When a new antimicrobial enters the market, FDA-approved AST devices should ideally also be available to help guide their appropriate use. However, BIO is concerned that a significant delay often occurs before these new AST devices are available. Many factors contribute to this delay, including lengthy development timelines for automated AST devices, regulatory review, complex software updates, drug-specific issues, access to appropriate isolates, and the uncertainty of engaging with competing antimicrobial candidates that may not be ultimately licensed. In the absence of susceptibility guidance, new antimicrobials may be underutilized or inappropriately prescribed, contributing to the emergence and spread of antimicrobial resistance and poor patient outcomes.
BIO applauds FDA’s efforts to encourage coordinated development of antimicrobials and AST devices. Provisions within the Draft Guidance, such as concurrent review by the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), can improve availability of AST devices for newly marketed antimicrobials. BIO also acknowledges that regulatory guidance cannot address all of the factors contributing to...