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A Late Night on the Hill … But No Resolution

October 21, 2011

The Senate stayed up late last night — determined to finish the appropriations “minibus” legislation that includes three separate bills including Agriculture/FDA appropriations. They didn’t get it done.

As predicted last week, the FDA portion of the legislation was largely unaffected by floor action. FDA would still receive a $50 million increase (over FY 11) in the Senate bill. What little attention FDA received was in the form of policy amendments or riders. In fact, very little money shifted accounts anywhere in the legislation, reflecting the challenge of achieving consensus on cuts that would offset any proposed increases.

One amendment that still may be pending would add $10 million to the budget for the Office of the FDA Commissioner to work on resolving drug shortages. Tellingly, the text of the amendment had an offset, which the bill sponsors have crossed off. We know that FDA needs additional resources to work on the drug shortage issue — this is an issue that the House and the Senate may work on in Conference, even if no monies are added during consideration of the Senate bill.

Deliberations on the “minibus” resume on November 1. While it is still possible that the legislation will be completed, conferenced with the House and become law before November 18 … the slow pace on this bill suggests that the problem of moving appropriations legislation has not been solved with the 3-in-1 minibus approach. This means another fight over a continuing resolution is likely in mid-November. The only question is whether FDA will be in or out of that fight.

One commentator has also suggested that when the Senate passes the minibus, it might add an extension of the CR for the rest of the government. Perversely, that might kill the minibus when it goes back to the House, forcing the entire government’s funding into discussion of extending the CR that ends November 18.

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On a completely different track, the Alliance is urging its members to attend this coming Alliance member meeting on Wednesday, October 26th at 2 p.m. Our guest speaker will be Stephen P. Spielberg, MD, PhD, who is the new Deputy Commissioner for Medical Products and Tobacco. He is a distinguished physician and researcher and former dean of Dartmouth Medical School. He also spent 11 years in industry, working for Merck and then J&J.

In his new role, Dr. Spielberg will oversee the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health and the Center for Tobacco Products. His appointment was made as part of a reorganization announced this past summer by Commissioner Hamburg. In addition to appointing Dr. Spielberg, she appointed Deborah Autor to oversee the Office of Regulatory Affairs and the Office of International Programs. Michael Taylor already holds a comparable position overseeing CFSAN and CVM. At the same time, the Commissioner announced the creation of a new Chief Financial Officer for FDA, although the position has not yet been filled.

In addition to the stature Dr. Spielberg brings to FDA, his bio describes his research interests as: mechanisms of idiosyncratic adverse drug reactions, human pharmacogenetics and personalized medicine, and pediatric clinical pharmacology. This background is germane to the areas of patient and industry concerns about pre- and post-market review of medical products and also positions him to be one of the agency’s chief advocates for improvements in regulatory science.

Come join us to hear Dr. Spielberg. We’ll be looking for you.

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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