FDA to Apply Lean Management Tools to Handling of Combination Products and more
Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.
Please Join Us: Next Wednesday, March 16, for Alliance Capitol Hill Advocacy Day. The Alliance is already deep into meetings with appropriators to help them understand FDA’s growing responsibilities and budgetary needs. Our annual Hill lobbying day is next Wednesday, March 16, and we need your help to communicate with more than 50 offices in one day. If you can participate, either morning or afternoon or both, please e-mail Lynnette Bechtel. To learn more about Hill Day and the Alliance “ask” of Congress, please read this week’s Analysis and Commentary.
House and Senate Budget Process: Still Alive? Even though last year’s budget agreement set funding totals for both FY 16 and FY 17, House and Senate leadership have expressed a desire to have more complete budget resolutions that would touch on a larger number of issues than just top-line funding levels. This process has proved frustrating. At present, the Senate Budget Committee has deferred action until next month, but will continue to discuss the issues this month, as well as consider ways to improve upon the Congressional budget process. Meantime, the House Budget Committee will reportedly vote on a budget resolution on either March 15 or 16. The House leadership and budget chair have been working diligently to placate their more conservative Members, who want to reject last year’s budget agreement.
FDA to Apply Lean Management Tools to Handling of Combination Products. FDA says it is launching a “lean management process mapping approach to build a better system for combination products review -- one that’s more cohesive, more collaborative, and more systematic.” The process begins with an analysis of what’s being done currently, and then it designs a future process state that “eliminates waste and maximizes value,” according to the agency.
Europeans to Emulate FDA Breakthrough Drug Program. The European Medicines Agency (EMA) has announced a new program, called PRIME, to cull out particularly promising drugs for unmet needs and provide them with extra support. The program has its roots in the highly successful FDA Breakthrough Drug program.
Michael Taylor to Leave FDA; Dr. Stephen Ostroff to Succeed Him. FDA Deputy Commissioner for Foods and Veterinary Medicine, Michael Taylor, has announced he will be leaving FDA on June 1. His seven-year tenure has included the entire history of implementing the ground-breaking Food Safety Modernization Act (FSMA). Remarkably, he has made friends and drawn admirers from every segment of the food community, while even-handedly leading the agency through a number of unavoidable controversies created by the FSMA law. He will be succeeded by Stephen Ostroff, currently FDA’s chief science officer and, most recently, acting commissioner, who originally joined the agency in 2013 as the chief medical officer in the Center for Food Safety and Applied Nutrition. We wish Mike the best after a job well done, and look forward to continuing