Romney Might Win, Obama Might Win, but Will FDA Win?

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Patrick Stone, President, TradeStone QA

Will the upcoming election affect FDA funding? There’s a lot of money and public health issues riding on the answer.

The FDA fiscal year (FY) 2012 will draw to a close September 30th operating on continuing resolutions and budget short falls. How will FY 2013 stack up for the FDA and will it receive the much needed funds to operate?

The good news is the FDA recently secured more revenue through the approved user fee act. The bad news is that this money does not come for a few more years. How will FDA train enough field investigators to get this extra clinical trial inspection work done domestically and internationally?

Will politics from the presidential race and the gridlock in both the House & Senate get in the way of public safety? The budget appropriation crystal ball forecast from congress is more of a stay at the same level or less for FY 2013. FDA must meet congressional mandates for food safety work and now squeeze in many more bioresearch monitoring inspections for clinical trials with basically less money to do it with.

I can see a case for building fewer bombs in a tight fiscal year but not cutting back on public health or patient safety dollars. The FDA may have to come up with new ways of doing business and tidy up the current workforce for serious workloads.

Right now it appears that congressional approval ratings are at an all time low in part for NOT getting a basic budget for the country passed in many years and the multitude of other issues of the people that have not been addressed. In the swamp of Washington, appearance of doing something seems to be more important than actually getting to work. In the end it should not matter if you are a donkey or elephant, the public health should come first. Fiscally responsible government, red or blue, should be priority one.

Politics aside, FDA should be a science-based decision making organization not a political football to be tinkered with. FDA’s 2012 metrics tell the full story of how much work is really getting accomplished. In 2011 a total of 551 clinical investigator audits were conducted by FDA.

The new user fee acts for generic drugs and biosimilars will require substantially higher numbers of domestic inspections. One possible solution is to migrate the EU model of third party quality assurance audit mandates. The FDA may have to contract some of this extra work to private industry. The FDA is also softly pushing industry into the all electronic systems model for a reason and for future application review models. FDA investigators may in the future be able to conduct a partial review from their desk.

Only time will really tell what FY 2013 will bring for our public safety but we should always remain optimistic. It beats the alternative, right?

Patrick Stone is the author of Bubble Gum Badge – An FDA His-Story. You can also follow him on Twitter.

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Romney Might Win, Obama Might Win, but Will FDA Win?
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Romney Might Win, Obama Might Win, but Will FDA Win?
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Will the upcoming election affect FDA funding? There’s a lot of money and public health issues riding on the answer. The FDA fiscal year (FY) 2012 will draw to a close September 30th operating on continuing resolutions and budget short falls. How will FY 2013 stack up for the FDA and will it receive the much needed funds to operate?
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