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The Friday Update — October 16, 2009

November 27, 2009

UPCOMING MEETINGS

 Principal Deputy Commissioner Joshua Sharfstein to Address Alliance Members/Notice of Annual Member Meeting Change to Thursday, October 29

Dr. Sharfstein will address Alliance Membership at 2:00 pm and the Annual Member Meeting will take place immediately following Dr. Sharfstein’s remarks.  Location:  1333 New Hampshire Avenue, NW, 10th Floor.

Please note that the Alliance Annual Member Meeting which was initially scheduled for October 27th has been changed to the 29th to coincide with Dr. Sharfstein’s address to Alliance Membership.

Other Meetings:

  • Meeting with HHS Secretary Sebelius: Monday, October 19.
  • Meeting with Director of FDA Center for Veterinarian Medicine Bernadette Dunham: October 28. 

Recent Meetings:

  • Meeting with FDA Director  of Office of Regulatory (ORA) Affairs Mike Chappell: Tuesday, October 13.
  • Meeting with FDA Director of National Center for Toxicological Research Dr. Slikker: Wednesday, October 14.

THE GROSSMAN ANALYSIS

With a successful FY 10 appropriation signed into law, the Alliance looks forward to even better results for FDA in the FY 11 cycle.  In future weeks, we will discuss the FY11 cycles in greater detail.  

Over the last several months, the Alliance has been meeting with FDA leaders to get a better sense of how new monies are being spent and to gain additional insight about their needs.  Among others, we had excellent meetings with Dr. Sundlof (CFSAN) and Janet Woodcock (CDER). We are looking forward to next week’s meeting with Secretary Sebelius and to Dr. Sharfstein’s presentation at the Alliance member meeting at 2 p.m. on October 29.

Some of the most valuable meetings have been with FDA leaders who are less well known and whose offices sometimes seem invisible. One of the things I have learned: there are no unimportant parts of FDA

This past week provided excellent examples. On Tuesday, the Alliance met with Michael Chappell, Acting Associate Commissioner for Regulatory Affairs and Director of the Office of Regulatory Affairs (ORA).  On Wednesday, we met with William Slikker, Director of the National Center for Toxicological Research (NCTR).  Neither are well-known, either as individuals or as organizations. Whether or not we are paying attention, they  are important to FDA and America’s consumers and patients.

ORA is responsible for the inspections and enforcement activities of FDA.  The office is a budgetary powerhouse, accounting for 1/3 of FDA’s appropriation  and over 40% of the agency’s staff. Commissioner Hamburg has indicated that strengthening their activities is a priority. They are definitely an important part of FDA. Yet, they can be hard to find. FDA’s  homepage does not acknowledge ORA as an organization. The  monies that go to ORA are tucked into each Center’s budget under the rubric of “Field Activities.”  It was a great meeting and an opportunity for the Alliance to learn more and understand better.  

The mission of NCTR is to develop a scientifically sound basis for regulatory decisions and reduce risks associated with FDA-regulated products.. They are  a research organization, not unlike the NIH intramural program. They belong at FDA because they support the development of regulatory science and provide practical scientific support for all of the Centers. When FDA needs to have its own scientists resolve an issue, most often they turn to NCTR. This is important in its own right, as well as supporting Commissioner Hamburg’s public remarks about advancing regulatory science. Within the FDA budget, they are the smallest entity with a line item, amounting to nearly $60M in FY 10. We had yet another great meeting that helps the Alliance  understand FDA better.

The Alliance exists to support the resource needs of the entire FDA. Nonetheless, we each tend to look at FDA through the perspective of our own stakeholder group, sometimes (inadvertently) marginalizing other parts of the agency. As we have meetings similar to this past week, I hope to illuminate why there  are no unimportant parts of FDA.

For more information on ORA: just click here.

For more information on NCTR: just click here.

One of my recent blogs on ORA was entitled The Uncrowned Prince of FDA.

Note: This analysis and commentary is written by Steven Grossman, the Deputy Executive Director of the Alliance.

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