On Track: The FDA-TRACK Monthly Newsletter

Learn More: Consumer Representative Positions Open

The Food and Drug Administration (FDA) continually seeks input from consumers on scientific and medical issues. A key method to ensure that FDA obtains the points of views from consumers is by including Consumer Representatives on Agency advisory committees. FDA is currently recruiting to fillvacant Consumer Representative positions. This is a great opportunity for consumer advocates to be part of an important process, and we encourage all those meeting the criteria to apply.

Consumer Representatives provide the perspective of American consumers at large and do not represent their own personal expertise. The role of the Consumer Representative is to:

Represent the consumer perspective on issues and actions before the advisory committee;
Serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and
Facilitate dialogue with the advisory committees on scientific issues that affect consumers.

To fulfill this role, it is essential that those applying for Consumer Representative positions meet these two criteria:

Have an affiliation with and active participation in independent consumer or community based organizations or a history of advocating for the public interest; and
Demonstrate an ability to analyze scientific data and critique research design.

To learn more about FDA Advisory Committees, visit the FDA’s Advisory Committees website. To submit an application for membership, visit the Applying for Membership page or call 301-796-8220 and ask for Kimberly Hamilton. To track advisory committee vacancy rates, visit the Advisory Committees FDA-TRACK Dashboard.

What’s New in September 2016

New performance data are available for the dashboards below.

Cross Agency

FDA Safety and Innovation Act (FDASIA)-TRACK: FDA has completed 124 out of 140 deliverables outlined in FDASIA-TRACK, with the most recent updates focusing on the Best Pharmaceuticals for Children Act, the Pediatric Research Equity Act and FDA Advisory Committees? Check it out to learn more about the Agency’s progress on implementing FDASIA.

Center for Drug Evaluation and Research (CDER)

CDER Dashboard: The number of NDAs and BLAs approved reached a record high of 18 approvals in April 2016. Additionally, the number of NDAs and BLAs approved within the first cycle also reached a record high of 14 approvals, a 100% increase from the overall monthly average since we began tracking the measure in 2012.

Center for Food Safety and Applied Nutrition (CFSAN)

CFSAN Dashboard: In FY16 Q3, the Office of Compliance (OC) found 72 positive findings from their environmental sampling of 55 firms; 29 were Salmonella related, 43 were Listeriarelated, and 0 were E. Coli related.

Center for Veterinary Medicine (CVM)

CVM Dashboard: In FY16 Q3, the Office of Research (OR) received 15 jerky pet treat related complaints, of which 9 required follow-up actions. While this is a new measure that we began tracking in FY16, this represents a 55% decrease in complaints received from FY16 Q2.

Office of the Commissioner (OC)

OC Administrative Offices Dashboard: The Office of External Affairs (OEA) reported that the number of times Consumer Updates were shared via Facebook increased significantly in April 2016 by approximately 1,200% as compared to March 2016. Overall, the most Consumer Updates shared via Facebook in a quarter reached a record high of 6,466 in FY16 Q3 since tracking this measure in 2013. Please visit the FDA Consumer Updates website for the most recent Consumer Updates.