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BIO Submits Comments on FDA Draft Guidance: Limited Population Pathway for Antibacterial and Antifungal Drugs

August 14, 2018

August 13, 2018

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852


Re: Docket No. FDA-2018-D-2032: Limited Population Pathway for Antibacterial and Antifungal Drugs; Draft Guidance for Industry; Availability


Dear Sir/Madam:

The Biotechnology Innovation Organization (BIO) is pleased to submit the following comments on the Food and Drug Administration (FDA) Draft Guidance, “Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD); Draft Guidance for Industry.”

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 countries.  Our member companies, both established biopharmaceutical companies as well as early-stage biotechnology companies, play a key role in addressing the rise of antimicrobial resistance (AMR) by developing and bringing innovative new medicines to patients.  However, investment in AMR product research and development has declined significantly in recent years, both in early venture capital investment and by companies themselves.  This trend clearly illustrates the economic challenges to traditional market approaches in sustainably incentivizing AMR product development. 

BIO strongly supports incentives that can support a diverse pipeline of antimicrobial products, including the Generating Antibiotic Incentives Now (GAIN) Act, which introduced Qualified Infectious Disease Product (QIDP) designation to stimulate the development of new antimicrobials.  BIO also applauds the leadership of FDA’s Center for Drug Evaluation and Research (CDER) in continuing to examine regulatory approaches that facilitate the development of AMR products to meet unmet medical needs.  This draft guidance provides welcomed clarity for sponsors that are developing antibacterial and antifungal drugs for approval under the Limited Population Development pathway created under the 21st Century Cures Act. Below we offer general comments for your consideration...

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BIO LPAD FINAL Comments 081318
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