Activities

FDAAA Annual Dinner Meeting, November 6, 2009

On November 6, FDA Alumni Association members enjoyed their annual dinner at the Lakewood Country Club. President Alan Andersen conveyed the good news that membership reached 850. He recognized Associate Member Liaisons Fredda Valenti and Jim Simpson and thanked Co-chairs of the Activities Committee, Anne Marie Finley and Nancy Myers for arranging the pleasant evening that was highlighted by a presentation by the Acting Associate Commissioner for Regulatory Affairs, Michael Chappell.

Mike joined FDA in 1972 as a Consumer Safety Officer in Nashville, TN, moved to the level of Deputy Associate Commissioner for Field Operations in 2007 and was recently appointed Acting ACRA. He presented a lively talk covering recent changes at FDA and need for FDAAA assistance. Budget increases, from 1.9 billion in FY '07 to 3.2 billion in FY'10 with FTE's increasing from 9500 to 12,000 have led to a remarkable group of New Hires that need training. The Office of the Commissioner has been reorganized to include the return of previous FDA employees Michael Taylor, Special Assistant for Food Safety, William Hubbard, Special Advisor, and John Taylor, III, Counselor overseeing crisis response. Among other changes is the establishment of a Deputy Commissioner for Foods overseeing CFSAN and CVM, and a new Center for Tobacco Products headed by Dr. Lawrence "Bopper" Deyton. An Enforcement Initiative designed to improve effectiveness and timeliness is led by Josh Sharfstein a dynamic, get it done person. The agency seeks to improve its communication under a Transparency Initiative including considering the need for legislative or regulatory changes. Senate action on the Food Safety Enhancement Act, H.R. 2749 passed by the House in July is expected to occur this fall. The "FSEA" supports an integrated national food safety system that calls for building and leveraging state and local inspection capacity, multi-year funding to build infrastructure and information sharing. Mike concluded by outlining FDA needs that could be fulfilled by the FDAAA. If new legislation is passed the agency will need mentors for the management and operational staff, training for new staff, and guidance and assistance for foreign regulatory authorities. Recent changes to the National Defense Authorization Act provide for rehiring of retirees on a part-time basis for mission critical positions, including training or mentoring of employees, without reduction in their annuities. Help and assistance from FDAAA members is needed and valued.