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Top 10 “Things That Hill Staff Need to Know About FDA”

March 6, 2010

ADVOCACY

Next Thursday, March 11 is the Alliance’s Lobby Day. In honor of the event, here is our own Top 10 list of “Things that Hill staff need to know about FDA.”

#10. FDA is a comparatively small agency with an appropriation of jut $2.35B in 2010 to regulate products that represent a quarter of all consumer spending.

# 9. Twenty-five years ago, FDA and CDC were the same size; today, the CDC budget is nearly three times as large.

# 8. A strong FDA is good for the US economy and for our balance of trade.

# 7. FDA is an integral part of our response to public health emergencies, including defense against bioterrorism.

# 6. FDA’s appropriation is almost entirely staff costs (not grants), requiring almost a 6% increase each year to sustain program levels.

# 5.  After three years of good increases (thank you, Congress), FDA staffing levels from the 2010 appropriation have only just been restored to the previous high-level achieved in 1994.

# 4. User fees serve valuable functions, but they are targeted and support only specific activities. They don’t strengthen the FDA in carrying out its overall public health mission.

# 3. All FDA stakeholders support a stronger FDA (consumers, patients, health professionals, research advocates and industry)

# 2. FDA’s responsibilities increase each year — through new mandates, globalization and increased scientific complexity.

And the #1 thing that Hill staff need to know about FDA:

# 1. FDA touches every American multiple times each day. Today’s investment (2 cents per day per American) is a pittance compared to the benefit of a strong FDA and the risk of an underfunded FDA.

Please contact Tony Curry about participating on March 11. The Alliance needs your help in delivering our “Top 10” at Hill meetings

Meeting with FDA Principal Deputy Commissioner Josh Sharfstein The Alliance is set to meet with FDA’s Josh Sharfstein this next week regarding how to measure improvements in the agency’s performance.

Upcoming FDA Hearings

ANALYSIS AND COMMENTARY

As we go into Lobby Day and then beyond, we keep getting asked: why isn’t a 6% increase enough … especially in a year when few agencies will be getting that much?

Our response is that the agency needs to continue to grow beyond the level of inflation. Despite three good years of increases, we are still fighting decades of neglect. Appropriated staffing levels in 2010 are only back to where they were in 1994. Over a 25-year period, CDC has grown from an agency the size of FDA to one that is three times as large. Meantime, FDA has new responsibilities and an ever more-complex environment in which to function. Much more than 6% per year is needed for the agency to achieve its public health mission and meet the needs of the American people.

It is also important to explain what a 6% increase (about $145m) actually buys the agency. We estimate a little more than $100 million of this will be taken up by increases in salaries, benefits and rents. Other costs go up also. On a FY 10 base of $2.35 billion, about $40M is available for new programming in FY 11 and will probably go to hire more food inspectors.

This suggests that the rest of the agency (apart from food inspectors) will be able to operate in FY 11 at their FY 10 staffing/program levels. In reality, this won’t be the case unless the Congress increases FDA’s appropriation above the President’s request.

Here is why the picture is actually quite grim. According to FDA budget documents, the increased cost of salaries in FY 11 is $66 million. As far as I can tell, only about $3 million is actually part of the President’s request. So, what we consider as an increase to cover inflation … actually does nothing of the sort. The President has told Congress: give FDA a $146M increase in monies and it will provide a $143M in increase in programming.

Absent lay-offs, something has to give because FDA would only be getting about $40M toward the cost of providing the increased programming.  So, food inspections, patient safety and advancing regulatory science  (the President’s budgetary priorities) will happen … and parts of the rest of the agency will shrink (because they can’t cover inflation) OR vital, existing services will continue, but FDA won’t be able to deliver on the President’s request, even if it gets the money to do so. It will take an extra $100M to both cover inflation in salary, rents, etc., and provide the new programming in the President’s request.

To bring this down to specifics, the President has requested $25M for advancing regulatory sciences. This is a priority of Commissioner Hamburg and much lauded by the stakeholder communities. At an IOM meeting last week, there was palpable excitement that the President had made a great first-year commitment. But follow the logic of this analysis and it is unclear whether there really would be $25M to get started in FY 2011.

The bottom line: FDA needs more than the increase in the President’s request. In a sense, the President, by his budget justification, agrees with us.

Note: This analysis and commentary is written by Steven Grossman, Deputy Executive Director of the Alliance.

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