viernes, 31 de marzo de 2017

FDA Law Blog: Interagency Food Safety Analytics Collaboration Issues New Strategic Plan

FDA Law Blog: Interagency Food Safety Analytics Collaboration Issues New Strategic Plan

Posted: 31 Mar 2017 01:12 AM PDT
By Ricardo Carvajal –

The Interagency Food Safety Analytics Collaboration (IFSAC) has issued a strategic plan for the 5-year period beginning in 2017.  This is the second such plan issued by IFSAC, a collaboration between FDA, USDA/FSIS, and CDC that aims “to improve coordination of federal food safety analytic efforts and address cross-cutting priorities for food safety data collection, analysis, and use.”

The first strategic plan focused on foodborne illness source attribution.  The second plan appears geared to not only improve estimates of attribution, but also “develop methods to estimate how sources [of foodborne illness] change over time.”  In furtherance of those objectives, IFSAC intends to:

  • “Incorporate additional sources of data into analyses, such as regulatory sampling data and whole genome sequencing (WGS) information”
  • “Work internally with regulatory partners to identify and evaluate inspectional data and product and environmental sampling data to assess ways it could better inform attribution estimates”
  • “Explore the possibility of incorporating existing sources of laboratory-based, non-human surveillance data into models to generate attribution estimates”
  • “Evaluate existing microbial subtyping data of pathogens isolated from human, food, animal, and environmental samples relevant to foodborne illness”
  • “Explore ways to incorporate genomic data and other novel data sources into models that generate attribution estimates”
  • “Develop methods to assess changes in sources of illness over time”
The potential regulatory impact of these types of activities is obvious.  For example, the plan notes that analyses of “changes in the sources of illness caused by specific pathogens over time... can help in assessing the impact of specific policies, performance standards, regulations, and changes in industry practices.  These analyses could also help identify the emergence of historically uncommon food-pathogen pairs.”  The plan also notes that IFSAC has already contributed to food safety-related rulemaking activities, such as FDA’s 2010 egg safety rule.  It will be worth watching how IFSAC puts to use evidence gathered in the course of inspections, and in turn, how the member agencies draw on IFSAC’s output to refine their approaches to outbreak investigations, and to develop new regulations and guidance documents.
Posted: 30 Mar 2017 12:24 PM PDT
The American Conference Institute’s (“ACI’s”) 11th annual “Paragraph IV Disputes” conference is right around the corner! The conference will take place from April 24-26, 2017 at the Conrad New York in New York, NY.

ACI has put together an excellent program for conference attendees that includes presentations from esteemed Judges and key representatives from the FDA, PTO, and the FTC. In addtion, attendees will get to hear from a virtual “who’s who” of Hatch-Waxman litigators and industry decision makers.  Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst, along with Maryll W. Toufanian, Deputy Director of the Office of Generic Drug Policy, FDA, and Margaret J. Sampson, a Partner at Baker Botts L.L.P., will be speaking at a Q&A session on FDA’s October 2016 final rule implementing certain portions of the December 2003 Medicare Modernization Act (see our previous post here).

FDA Law Blog is a conference media partner. As such, we can offer our readers a special discount off the current price tier.  The discount code is: P10-999-FDAB17.  You can access the conference brochure and sign up for the event here.

 We look forward to seeing you at the conference. 

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