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NCSD Testifies at FDA Hearing on Drug Resistant Gonorrhea

As part of NCSD's continued leadership sounding the alarm on the rise of multi-drug resistant gonorrhea and to highlight the importance of STD programs, Bill Smith, NCSD's Executive Director, testified earlier today in front of a panel of experts at the Food and Drug Administration (FDA) on the issue of the growing antibiotic resistance of the bacteria Neisseria gonorrhoeae.  NCSD's final comments, which Bill delivered at the hearing, can be found here on NCSD's website.  This hearing, titled "Establishing a List of Qualifying Pathogens That Have the Potential to Pose a Serious Threat to Public Health," focused on which pathogens should be deemed eligible for newly-created incentives to encourage the development of products to treat antibiotic-resistant infections.

Should members be interested and able, FDA is still accepting written and electronic comments on this hearing until January 25, 2013.  Submit written comments to the Division of Docket Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD, 20852.  Electronic comments can be submitted here: http://www.regulations.gov/#!submitComment;D=FDA-2012-N-1037-0001.  Please feel free to use NCSD's comments as a template.

As has been discussed in past NCSD Weekly Updates, as well as at the NCSD Annual Meeting in October 2012, the Generating Antibiotic Incentives Now (GAIN) Act was signed into law earlier this year.  The GAIN Act  creates incentives to encourage the development of products to treat, prevent, detect and diagnose antibiotic-resistant infections, which could help address the growing resistance of gonorrhea to antimicrobials.  To be eligible for these incentives, a drug must be used to treat diseases caused by antibiotic- or antifungal-resistant pathogens (including new or emerging pathogens), or  be part of a "qualifying pathogens" list maintained by the FDA.  Today's public hearing was held in order to solicit public comments on which pathogens should be included  as a "qualifying pathogen" and what issues should be considered when developing this list.  In discussing the importance of adding gonorrhea to this pathogen list, Bill focused on gonorrhea's impact on public health due to drug-resistance, growth in drug-resistance of gonorrhea, and the morbidity of gonorrhea in humans.

More information on this hearing, including a full list of speakers, can be found on the FDA's website.

If you have any questions or concerns, please contact NCSD's Manager, Policy and Communications, Stephanie Arnold Pang at sarnold@ncsddc.org or 202-715-3865.

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