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Tracking the Minibus Toward Conference and Member Input

October 28, 2011

It has been at least two years since anything dealing with budget or appropriations has been completed on (or nearly on) schedule. So I hesitate to say that we have entered the endgame for FDA’s FY 12 appropriations. However, the Senate should pass the agriculture/FDA spending bill next week as part of a “three bills in one” package (the so-called minibus).

The bill then returns to the House where, at a minimum, they will need to align their separate spending bills into a bill that mirrors the Senate minibus. It is being taken for granted that bill consolidation and passage will go smoothly, but problems could arise in the House between factions favoring higher or lower spending levels than that adopted in this summer’s Budget Control Act.

Assuming the House passes a similar minibus, the next step would be for the House and Senate to conference the differences between the two bills. The Alliance is looking for member organizations to send letters to conferees once they are chosen. We will send you materials next week in an Alliance action alert that will include information on key issues to raise. In the meantime, we hope you will prepare your organization for a potential quick turn-around for letters directed at conferees and asking for the highest possible FDA funding levels.

The goal for the House-Senate conferees would be to complete this effort before the current continuing resolution runs out on November 18. In that case, FDA would have year-long funding, but much of the rest of the government would be included in the next CR.

We are also working on the early stages of FY 13 — by monitoring the work of the so-called supercommittee that is charged with recommending at least $1.2 trillion in 10-year deficit reduction. We have also been talking with the Administration to make the case for the President to request additional monies for FDA for FY 13.

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In terms of what an adequately-resourced FDA can accomplish, Dr. Spielberg’s comments at the Alliance annual meeting were exciting to hear. (Dr. Spielberg is the FDA’s recently appointed Deputy Commissioner for Medical Products and Tobacco.) He talked about the opportunities for patients and public health created by accelerating levels of scientific discovery.  Throughout his career as a pediatrician, he has done a lot of work on drug safety issues and, particularly, how to anticipate safety problems early in drug and device development. He spoke of the potential for much greater benefit from therapeutics with much lower risk, a laudable goal that he felt could only be reached by FDA working more closely with collaborators in academia and other government agencies.

In addition to the opportunities, he also spoke of the challenges. He pointed out that everyone involved with FDA is in the information business. Using clinical trials as an example, he talked about how coding and reporting, incompatible computer systems, and the human element all contribute to difficulties in accumulating and interpreting data that ultimately will be shared with FDA.

Dr. Spielberg’s presentation reinforced for me why the Alliance exists. FDA has the capacity to assure Americans the best that medical science and regulatory science can produce. He did not say: and that’s why we need the agency to be well-funded. But I will say it for him.

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

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