Thursday, June 14, 2007

The FDA and You

You might be shocked to hear that the Superintendent of the Montgomery County schools has a budget akin to what FDA Commissioner von Eschenbach has to run an agency that regulates a whopping 25% of American consumer spending. Think about how you use FDA-regulated products each day -- when shampooing, brushing our teeth, taking aspirin or prescription drugs, applying makeup, putting on sunscreen, talking on a cell phone, cooking food in a microwave, and even watching TV. It starts to seem like there is little in our daily lives that isn't affected.

In recent weeks, I've been participating in hill visits with the FDA Alliance (I also sit on their Board) to talk to Congressional staff about FDA's resources. We've been making headway to increase awareness about the need for increased appropriations for FDA. We have yet to meet with anyone who disagrees with the argument that the agency needs more money. How much of an increase we'll see remains to be seen, but the next few weeks will be critical.

The FDA budget has been going backwards not forwards because of inflation, increasing costs, expanded missions, and scientific advancement. The current budget levels are far from adequate. We're asking for $2 billion for fiscal year 2008 (plus user fees on top of that).

I think we'd all agree we look to the FDA to be at the ready as scientific innovation flows through the pipeline. Otherwise what's the point of investing in innovation in the first place? We're expecting cures, and we'd like them sooner than later. The agency needs to be a cutting-edge regulator, one that is a "Gold Standard" worldwide. We need to be maximizing the potential of things like large datasets of electronic health records. This will aid in monitoring drug safety.

The list of things that FDA staff are thinking about now is no doubt long, but they can't scratch the surface without adequate funding. We are all either patients now, or will be one at some point. We need a strong and robust FDA. The 111 members of the FDA Alliance representing consumers, patients, professional societies, and industry all uniformly agree on that point. Increasing FDA's budget is a win-win for public health and the economy. Wouldn't you agree?

Margaret Anderson, COO, FasterCures

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