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Why Have We Watched “Cures” So Closely?

January 23, 2016

From its beginning 10 years ago, the Alliance has stayed faithful to its original compact: all FDA stakeholders benefit from increased appropriated funding for FDA. Accomplishing that is the Alliance’s mission. In contrast, we do not take positions on policy matters and authorizing legislation because it is not part of our mission to do so. Further, the unanimity that we need (all stakeholders support increased funding) breaks down quickly if we were to become involved in authorizing legislation (where stakeholders frequently disagree with one another).

Nonetheless, the Alliance has tracked the House Cures/Senate Innovations legislative process closely. If we are not going to take a position on the content, why have we kept such careful watch?

First, we need to impress upon authorizers that FDA does not have the resources to take on new mandates unless it is simultaneously given more resources. On the House side, our delivery of this message (along with our members) culminated in the allocation of more than a half billion dollars in mandatory funding for FDA. The committee was clear that the new tasks it envisioned could not be accomplished without more money.

I believe we have created the same consciousness about unfunded mandates in the Senate. However, the road may be more difficult because the Senate seems disinclined to provide mandatory funding. Also, importantly, the process of adopting smaller individual bills may make it seem like the burden placed on FDA is incremental and sustainable even though the intent is to create a more comprehensive set of new responsibilities for FDA.

Second, the Cures/Innovations process stimulates FDA “mission creep” regardless of whether it becomes law. This reflects an important reality: FDA already has broad authority that would allow it to carry out many of the new initiatives contained in Cures. For the most part, FDA will not undertake the Cures activities without specific direction and resources. However, some of this involves programs that FDA would like to do if it had resources, e.g., significant expansion of its efforts to discover and validate new biomarkers.

In sum, Cures — whether adopted or not — has significant implications for FDA funding. That’s why we are watching it so carefully.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.

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