FDA Budget Asks For $4,030,000,000


FDA has requested $4.03 Billion, a 23% increase, for fiscal year 2011. (I hope I got all the zeros right.) This would be the largest budget in FDA history. Much of the increase is for the new tobacco program. The largest chunk is for food safety and we have an analysis of that by Sid Olufs, the blog’s resident book reviewer and food safety analyst. research informed consent IRB FDA

However, the issue of the FDA budget request has been lost in the light of the deficit and other news. On the Blogroll FiercePharma, but not FierceBiotech, comments as well as Gooznews on Health. Before we get to Sid’s comments I have a few short, but important items to report. First, here is the FDA press release on the budget:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm199516.htm

UPDATE: This Sunday, the 18th of April, the Pew Research Center released a devastating report on the decline in confidence in government over the past 12 years, including a 17% decline for FDA. Pew says, “The declines have been particularly large for the Department of Education, the FDA, the Social Security Administration, as well as the EPA, NASA and the CDC.” Ouch.

(Original Post):

This Sunday, the 7th of February, is the 10th National Black HIV/AIDS Awareness Day and February is Black History Month. Although African-Americans are only 13% of the U.S. population, they have nearly 50% of the newly diagnosed cases of HIV/AIDS. Here is a statement by Dr. Anthony S. Fauci, Director of the National Institute of Allergy and Infectious Disease that conducts AIDS research world wide:

http://www3.niaid.nih.gov/news/newsreleases/2010/BAAID10.htm

Finally there is an interesting “Frequent Flyer” column in the business section of the NY Times. It is written by a retired physics professor, Robert Kolenkow, who is a diabetic. I am a Type 1 diabetic and a very frequent flyer. I have Travel Too Much status with Alaska Airlines (They call it, “MVP Gold”). I have always found it challenging to manage my diabetes on board a packed coach cabin going across the country so I was interested in what Professor Kolenkow had to say. He participates in a diabetes mentoring group called A1C Champions. They are sponsored by Sanofi-Aventis. Since I use Sanofi insulin I am not sure how happy I am about this. However, you can take a look and judge for yourself.

Here is a link to A1C Champions:

http://www.a1cchampions.com/

Here is a link to the article:

http://www.nytimes.com/2010/02/02/business/02flier.html?ref=todayspaper

Guest Commentary by Sid Olufs:

Paying for a Difficult Job

In an earlier post I briefly described the ambitious agenda facing the new Deputy Director for Food, Michael R. Taylor (FDA Has a New Look for Food). It included these lines describing his responsibilities: “inspection and ensuring compliance with rules, coordination with state and local agencies who do much of the work of food safety, responses to “incidents” that hurt people, getting a handle on imported items that find their way into food, sponsoring and organizing the scientific and technical research needed to design a safe food system, including animal feed and veterinary care, and building the information network that helps to knit all of these together.”

Others have looked at the costs of building a food safety system that can do all of this adequately. In the most comprehensive outside analysis of FDA responsibilities and capacity, the authors concluded that the FDA FDA Budgetis critically underfunded in its science-based regulation and decision making, so much so as to put public health at risk. (FDA Science and Mission at Risk, Report of the Subcommittee on Science and Technology, Prepared for FDA Science Board, November 2007.) The Congressional Budget Office estimate of the costs of implementing HR 2749, which falls short of the more complete goals of FDA Science and Mission at Risk, came to almost half a billion dollars a year for the first few years of transition, and about a billion dollars per year thereafter. (CBO Cost Estimate, h.r. 2749, July 24, 2009.)

The Obama administration has now released its budget for FY2011. As described in more detail in the agency budget documents submitted to Congress, FDA requested about $220 million in the form of fee-based inspections, plus additional spending over current spending which brought the total food system upgrade request to about $318 million in additional money for 2011. See the attached link for a brief summary:

http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM199447.pdf

I spent a little time looking at the documents, and only found about $290 million in budget increases in the documents released by OMB. See their detailed HHS budget description, at:


http://www.whitehouse.gov/omb/budget/fy2011/assets/hhs.pdf

The first three pages are the FDA budget summary (the pagination starts at p. 461).) You will see the $220 million on 09.02 Food Registration and Inspection User Fee, on the third page (page # 463) of this document. The fees are “proposed.”

I found no separate discussion of the resources devoted to upgrading the FDA’s information technology, a critical resource in the needed upgrades. It could be that a separate item is included for this, but I searched in vain in the detailed agency appendices and in the Analytical Perspectives that accompany the Budget.

Judging just by the number referred to here, it does appear the Obama administration is taking food seriously, at about two-thirds to three-quarters of the resource level implied by the panel of experts that assembled FDA Science and Mission at Risk. I for one will find it interesting to read how far down that road this new budget authority will take us.

By Sid Olufs

Blogroll Pick: Gooznews on Health– With every post, I am trying to highlight one of the blogs on the Blogroll to your right. This time Gooznews has some interesting comments on the FDA Budget requests.

http://www.gooznews.com/

REMEMBER, YOUR COMMENTS ARE ALWAYS WELCOME !!!

You can read additional posts on FDA Commentaries here:

https://carl1anderson.wordpress.com/category/fda-commentaries/

You can read additional posts on Food Safety here:

https://carl1anderson.wordpress.com/category/food-safety/

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Blogroll: For those of you interested in the financial aspects of our industry – and others – Check out Hedge Hodge at:

http://www.hedgehogs.net/

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