Posted by: Audrey Erbes | August 7, 2011

FDA Commissioner Hamburg Reorganizes the Agency plus Upcoming Meetings


Perhaps you hadn’t noticed that the FDA was reorganized in July. I would have expected more coverage but then the news media has been highly focused on the US debt ceiling and European debt these past weeks.

With the departure of FDA Deputy Commissioner Joshua Sharfstein in January, FDA Commissioner Margaret A. Hamburg, MD took the opportunity to eliminate that position and add a new managerial layer between herself and the four Directorates—some entirely new and one old—identified for the new structure. She created a new Directorate led by a Deputy Commissioner for Medical Products and Tobacco position that will provide high-level coordination and leadership across all four Centers for drug, biologics, medical devices, and tobacco products. Dr. Steven Spielberg, former Dean of Dartmouth Medical School and currently Director of the Center for Personalized Medicine and Therapeutic Innovation at Children’s Mercy Hospital in Kansas City will fill this position. His role will include serving as both an advocate and a support for Center Directors in their important work for FDA.

The other three Directorates and their missions include:

  • A new Directorate will be headed by a Deputy Commissioner for Global Regulatory Operations and Policy, who will oversee the transformation of FDA from being a regulator of only domestic products to one overseeing products from around the world—to essentially handle the global nature of food and drug production and supply. This position will have a specific mandate to make safety of imported products a top priority. Deborah Autor, an attorney who was Director of the Center for Drug Evaluation & Research will fill this new role.
  • The existing Office of Foods, which was created to oversee the FDA’s food and feed program, is the third Directorate. Other responsibilities of this office include the implementation of the Food Safety Modernization Act.
  • There will be a new Office of Operations, which will oversee FDA’s administrative functions, including information technology, human resources, facilities, finance, and other support activities.

See entire announcement by Commissioner Hamburg dated July 13, 2011 in GxP Perspectives blog.

This reorganization effort attempts to overcome shortcomings and challenges facing the FDA, including too much political influence in managing the agency in the past, strengthening management of technical/scientific staff totaling 12,000 with strong managerial skills at the top and better budgetary control to offset criticisms of the Congress. This is the first reorg since 1970 and is intended to address environmental changes but also added responsibilities for heightened food and tobacco surveillance as well as concerns about slowdown in approvals of medical products.

BioCentury has developed a great org chart and analysis of the changes in article written by Washington Editor, Steve Usdin, in their July 18, 2011 issue.

Upcoming events this week include:

  • BioCentury TV Today, Viewable after Sunday Morning, August 7, 2011; Topic: “Biosimilars: Will Pharma Follow FDA’s Pathway?’ Speaker: Dr. Diem Nguyen, General Manager, Biosimilars at Pfizer and Dr. Michael Kamarck, President of Merck BioVentures
  • FountainBlue’s Life Science Entrepreneurs’ Forum, August 8, 2011; Topic: “Software Meets Healthcare,” Facilitator Dipankar Ganguly, CEO, BioTelligent; Panelist Ted Driscoll is a Technology Partner at Claremont Creek, Member, Life Science Angels and Founding Director, Sand Hill Angels; Panelist John Sotir, Senior Manager, Medical & Test Group, Altera; Presenting Entrepreneur Rohan Coelho, CEO, Rexanto; Presenting Entrepreneur Marco Smit, CEO and Founder, Health 2.0 Advisers
  • Bio2Device Group, Tuesday Evening, Aug. 9, 2011; Topic: “Formulating Pricing & Reimbursement Strategies in a Challenging Global Environment;” Speaker: Christian Schuler, Partner, Simon-Kucher & Partners
  • ASQ, Wednesday Evening, Aug. 10, 2011; Topic: “Design Controls, an FDA perspective;” Moderator: George Marcel, Quality Assurance Manager , ArKal Medical; Featured FDA Speaker: Eric W. Anderson,Supervisory Consumer Safety Officer; US FDA San Francisco District
  • FountainBlue’s When She Speaks, Friday Midday, 12 Aug 2011 11:30 AM; Topic: “Politics in the Workplace: The Good, The Bad and The Ugly;” Facilitator Karen Mathews, Real Change Experts; Panelist Erna Arnesen, Head of Global Services Channels and Alliances, Cisco; Panelist Sandy Orlando, VP of Marketing, IP Infusion; Panelist Niamh Pellegrini, Vice President, Rhinology, Acclarent; Panelist Eileen Sullivan, Director of IT, Symantec
  • Stanford Institute for Immunity, Transplantation and Infection (ITI), Saturday Afternoon, Aug 13, 2011; Topic: “Nanotechnology: Point of Care Diagnostics, Imaging and Therapeutics”
I’ll be attending the FountainBlue Life Science Entrepreneurs’ meeting on Monday evening and the Bio2Device Meeting on Tuesday evening where I will introduce Christian Schuler, the speaker. This second meeting provides a rare opportunity to hear about reimbursement and pricing across different sectors of our industry with a worldwide perspective. I look forward to seeing some of you at these events.
See full details for upcoming meetings through September in highlighted title Audrey’s Life Science Meeting Picks.  Right click on highlighted title and open pdf file in new window.

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