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The Friday Update — September 4, 2009

November 27, 2009


Metrics Project Update — Comments Requested.  We are requesting written comments from the subgroup members by September 11th, and the in-person half-day working groups are planned for the week of September 14.


Congress returns next week and President Obama will address Congress on  health care reform. For those of us who need some public drama in our lives, salvation is coming.

FDA resources are in good shape for now.  The House, Senate and President have all agreed upon a $295M increase for FY 10.  FDA has known the likely amount since at least June, well in advance of the start of the fiscal year on October 1. This might not seem such a big deal, but FY 09 was finalized 5 months into the fiscal year and FY 08 was set about 3 months into the fiscal year.  We expect FDA to plan and spend money wisely. Having the final numbers early should make the job easier.

The FY 11 appropriations process has already begun.  Over the summer, FDA has been finalizing its request and started discussions with HHS.  In turn, HHS is already talking with OMB on a very preliminary basis. It will take until December for the process to conclude. In January, the budget will form an important basis for the President’s State of the Union address. Usually the entire President’s budget request is released the following week.  For FDA, three years are in play during the summer. They are spending this year’s monies, making plans to spend next year’s monies and formulating their request for the following year.

Over the next few months, the Alliance will be talking frequently with the Executive Branch, while staying connected to the FDA’s advocates on the Hill.  This is also our time to be preparing  for the Congressional appropriations cycle. This is taking two forms: developing new presentation materials and moving forward on our metrics project.

The latter is designed to give us, Congress and FDA a fuller picture of where new dollars are going and whether they are having an impact.  For this fiscal year, Congress has accepted that progress is largely reflected in people power: how many new positions have been created, how many of these slots have been posted for job-seekers, how many have been filled with new employees, and how many have been hired and now in training.  Questions from Congress will get tougher next year and the expectations will be substantially higher.

After we started the metrics project early this year, several Alliance members mentioned their own roles in the five-year doubling of the NIH’s budget. In retrospect, they wish more attention had been paid in years 2 and 3 to the question: what will we say when the doubling is completed. History tells us what happened: NIH suffered a drought of new funds because Congress felt the job was completed. The Alliance does not want that to happen to FDA and the metrics project is our effort to provide support for continued increases over many years.

For those who have not signed up for the metrics project, please let Tony Curry know you want to participate. Please indicate, as well, whether  you want to participate in the drug task force, the device task force or the food task force. You may be a member of more than one group.

A week from now, Congressional theatre will have returned to DC. There will be a lot more to report next Friday.

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


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