ADVOCACY
Office of Domestic Policy Council Meeting. Next week the Alliance is meeting with the White House Office of Domestic Policy Council.
Alliance Written Testimony for House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. Please click here for the written testimony that the Alliance submitted to the Subcommittee regarding FY 11 appropriations.
ANALYSIS AND COMMENTARY
From the beginning, the purpose of the Alliance has been to advocate for increased appropriations for FDA. Depending on context, we might say appropriated funding, budget authority appropriations, or support from public funds. Everyone knew we meant the support for the agency that came from general revenue and not from user fees.
And so the Alliance has led the charge through three fiscal years in which the FDA’s appropriated funding has increased by $776 million. This is more than a 50% cumulative increase in three years. We also helped get a $150 million one-time supplement for the agency. For perspective, in the prior four fiscal years, the agency had grown by only $180 million, about a 13% cumulative change with no supplemental.
Congressional staff and media often ask about user fees. We have told them that our focus is appropriated funding … monies that can be used to strengthen the agency and not just pay for specific activities. We acknowledged that user fees are necessary, but returned to our raison d’etre: increased public funding of the agency.
In our Hill visits so far this year and our interactions with media, we have spent more and more time explaining why the President’s claim of a 23% increase for FDA is inflated by proposed user fees that might never become law and by the doubling of the amount of user fees from tobacco companies. Budget authority appropriations are only slated for a 6% increase. That was the number to focus on … and the basis of our concern that more funding is needed. I am sure that this was the message delivered in every Hill meeting on Lobby Day last week.
Alliance members may have said more about user fees, hopefully being clear that it was their opinion and not the Alliance’s. Certainly, we have not provided our lobbying teams with a formal position or message points on the relationship between public funding and user fees. To do so could be tricky. We have 180 members devoted to strengthening the agency through increased appropriated funding. We cannot take a position on user fees that risks our Alliance and its cause.
What can we all agree upon? Ladd and I have chatted and our starting point is the need for a balance between user fees and appropriated funding. It might be articulated as follows:
- FDA is a public health agency. Its mission is to serve the American public.
- The bulk of FDA funding should come from appropriated funding (general revenue).
- User fees should not replace appropriated dollars or become a dominant funding source for FDA or specific programs within FDA (except tobacco).
This topic will be on the agenda for discussion at the Board of Directors meeting in mid-April. In the interim, Ladd and I welcome your thoughts and will compile them as part of our presentation to the Board. As you think about the Alliance’s position, please remember that the goal is a statement that all members can agree upon and that does not make us a user fee coalition. We are — and always should be — about appropriated funding. We just want a comfortable and consistent answer to provide when we are asked: what about user fees?
Note: This analysis and commentary is written by Steven Grossman, Deputy Executive Director of the Alliance.
MEDIA ACTIVITIES/RELEVANT ARTICLES
ADVOCACY
The Alliance met with over 50 member offices on Thursday, March 11, as part of its annual Hill day. Thank you to all who participated and made the day a success.
Congressional Hearings
- Chairwoman DeLauro’s opening statement at the House Appropriations Committee hearing on the FDA budget for 2011
- Commissioner Hamburg’s statement at the House Appropriations Committee hearing on the FDA budget for FY 11
ANALYSIS AND COMMENTARY
Another Alliance lobby day is done. We were pleased at the expressions of support yesterday and the opportunity to educate Hill staff. We dare not get lulled by positive feedback.
The appropriations cycle is like a long Shakespearian drama and Congress is still on the opening lines of Act 1. Untold twists and turns are still ahead in what will be an extraordinary difficult appropriations cycle. While we have done about 70 Hill meetings this year (before and during lobby day), there is more hard work ahead.
Both parties are trying to position themselves politically for a bruising Fall election. The hottest items are: health reform, jobs and the economy, banking reform, and immigration. None of these are easy to resolve and they have been sucking dry the energies and patience of Congress. The Hill is testy.
Somewhere within the next 10 to 12 weeks, deficit reduction is going to be caught up in this same vortex — commanding headlines and stimulating politically-driven positions. In a sense, this has already started with a skirmish between House Appropriations Committee Democrats and Republicans over who is more committed to getting rid of earmarks.
FDA doesn’t seem to be on anybody’s cut list, but nothing is guaranteed. For the moment, the focus is on President Obama’s recommendation for a $154 million increase for FDA, a little over 6% when you take out some earmarks. It is a good start compared to the President’s recommendation for other agencies, but not nearly enough to keep FDA on the path to getting stronger. As analyzed in last week’s Friday Update, it will take at least a $250 million increase to fund both inflationary cost increases at FDA and program growth recommended by the President. One of our greatest risks is that Congress might think that a $154 million increase covers both.
As we fight to get further increases for FDA, we have many things going for us. Through the efforts of our members, we are considered one of the “good guys,” with an important cause and strong logic to back up our requests. The Hill does seem to understand that we represent a unique confluence of interests. They give us credit for being able to speak with one voice for all the stakeholders.
Notably different this year is that Commissioner Hamburg and Deputy Commissioner Sharfstein are not hesitant to say: more resources will help us deal with the concerns of Congress and the American people.
A reminder for those planning to submit testimony for the record, the deadline for the House Appropriations Committee is March 19 and for the Senate side it is March 26.
Note: This analysis and commentary is written by Steven Grossman, Deputy Executive Director of the Alliance.
MEDIA ACTIVITIES/RELEVANT ARTICLES
Senate Appropriations Committee Hearing on FDA Budget for FY 2011 On Line
A complete video recording of this week’s Senate Appropriations Committee hearing on the FDA budget for FY 2011 is now available on line, inclusive of the testimony of Commissioner Hamburg.
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
- Senate Agriculture Appropriations FDA Budget Hearing, Tuesday, March 9 at 10:00 am.
- House Agriculture Appropriations FDA Budget Hearing, Wednesday, March 10 at 10:00 am.
- House Energy and Commerce Hearing on Drug Safety, Wednesday, March 10 at 10:00 am.
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.
