Alliance for a Stronger FDA

Web site: www.strengthenfda.org

Blog: FDA Matters - The Grossman FDA Report

bulletAbout Stronger FDA

The Alliance for a Stronger FDA unites a broad group of patient groups, consumer advocates, biomedical research advocates health professionals and industry to work to increase FDA's appropriations. It is supported by leading public health advocates, including three former HHS Secretaries and seven FDA Commissioners. The Alliance is designed to be a multi-year effort to (1) assure the FDA has sufficient resources to protect patients and consumers and (2) maintain public confidence and trust in the FDA.

bulletNews and Items of Interest

Friday Update for January 27, 2012

Advocacy

Analysis and Commentary

It was announced this week that the President’s budget request for FY 13 will be released on Monday, February 13, a week later than previously announced. The shape of the looming appropriations fight is already becoming clearer: the State of the Union (SOTU) has been presented, the budget ceilings for FY 13 have already been set by the Budget Control Act of 2011, and the Department of Defense is in high gear explaining where they are going to find the substantial “savings” required of the Pentagon.

The details released by OMB on February 13 are important, but the plot and major themes are already developing quickly.

In the next couple of columns, while awaiting release of the President’s Budget Request, we are going to look at the various hurdles that FDA’s budget must pass over before it becomes law. The first is the limitation on aggregate discretionary spending for FY 13, as imposed by the House and Senate budget resolutions.  

Instead of the usual process by which the ceilings are set each year—and which became a major cause of delay last year in moving the appropriations process forward---the Congress passed the Budget Control Act of 2011 (BCA). This law sets ceilings for FY 12 through FY 21, although there are some special facets of how the ceilings are allocated during the first two years. Note that while the aggregate amounts are set by the BCA, the budget committees are still likely to act to allocate those monies among the various functions of government. For example, all public health programs are under function 550.

For FY 12, the budget ceiling set by the BCA was divided between security and non-security programs, whereas for FY 13, the budget ceiling will be divided between defense and non-defense programs. While the overall amount (ceiling) available for non-defense is higher in FY 13, it needs to cover parts of homeland security, military construction, and state foreign operations that were paired with DOD in FY 12. Said another way, the Agriculture Appropriations Subcommittee (where FDA resides) is bidding for its share of funds from a slightly larger pot in FY 13, but with significantly more competition than in FY 12. (In FY 14 and thereafter, there is only one ceiling with no distinction between defense and non-defense).

After various adjustments are made, we are told it is possible that the Agriculture subcommittee will have about the same amount to spend in FY 13 as FY 12. If so, the specific programs and agencies funded through the Agriculture appropriations bill would be funded in FY 13, on average, at about the same or slightly less than they were in FY 12, without any upward adjustment for new responsibilities, larger demands on existing responsibilities and inflation.  

Our goal for FDA, of course, will be to gain an above average increase as a base number and have additional dollars allocated for new responsibilities and the larger demands being placed on FDA.

For FDA to do better than average, it means the subcommittee will need to eliminate or sharply reduce other programs in their jurisdiction…or, at a minimum, provide almost all other programs with below-average increases. This will be a tough fight….and will rely in large part on our ability to make the case that: FDA’s importance and growing responsibilities makes it a necessary exception to budget-cutting.

Analysis and Commentary is written by Steven Grossman, the Alliance’s Deputy Executive Director.

Alliance for a Stronger FDA Contacts:

Ladd Wiley, phone: (202) 887-4083  email:  lwiley@strengthenfda.org

Steven Grossman, phone: (301) 539-9660   email:  sgrossman@strengthenfda.org

This document is distributed for informational use only; it does not constitute legal advice and should not be used as such.
© 2012 ALLIANCE FOR A STRONGER FDA

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Alliance Recognizes Imperative for Budget-Cutting; Views FDA as an Exception  

 WASHINGTON, D.C., February 9, 2011 – The Alliance for a Stronger FDA today responded with concern to the House Appropriations Committee’s announcement of cuts to FDA that will be included in that body’s FY 11 Continuing Resolution (CR). The CR will be considered on the House floor next week.  

 “Our nation needs an effective FDA, which requires continuing increases for an agency that has been chronically underfunded for several decades,” said Nancy Bradish Myers, President of the Alliance for a Stronger FDA and President of Catalyst Healthcare Consulting. “We certainly understand the need to reduce the federal budget, but want to be sure that Congress has a clear picture of how FDA contributes to economic growth and national security, as well as protecting our public health.”

 The committee is proposing that FDA be cut by $220 million below the President’s request level for FY 11. The amount is about $74 million less than FY 10 funding, which is the level at which the agency has received and spent funds thus far in FY 11.

 “FDA touches every American multiple times each day through its jurisdiction over drugs, biologics, medical devices, 80 % of the food supply, cosmetics, dietary supplements and varied consumer products. Altogether, the agency oversees nearly 25% of consumer spending in the United States,” said Margaret Anderson, Vice President of the Alliance and Executive Director of FasterCures. “FDA funding should reflect that the agency’s responsibilities and workload increase each year--through globalization, scientific complexity, and the growth of industry, as well as through new mandates.”

 Ms. Myers added: “Today’s investment of 2 cents per American per day is small compared to the benefits of a strong FDA and the risks from an underfunded FDA. We look forward to working further with Congress to be sure that the needs of the American people are being met.” 

 The Alliance’s 180 (and growing) membership is comprised of consumer, patient, professional and research groups, companies, trade associations, and individuals who support increased appropriated funding for FDA.  The Alliance is the only multi-stakeholder group that advocates for increasing resources at FDA to match the agency’s responsibilities.

 More information about the Alliance can be found at www.StrengthenFDA.org. 

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Alliance for a Stronger FDA "Disappointed"
By President’s FY 11 Budget Request for FDA
Three Years of Above-Inflation Increases Have Not Offset the Impact of a Decade of Neglect

WASHINGTON, D.C., February 2, 2010 –While acknowledging that the U.S. Food and Drug Administration (FDA) received a budget increase while many federal agencies did not, the Alliance for a Stronger FDA today expressed disappointment with President Obama’s FY 11 funding request for FDA The President’s request is for an increase of $146 million, which would bring FDA's appropriated funding to $2.508 billion (see attached chart).

The Alliance said the President’s request is consistent with the amount by which FDA’s costs increase each year. It will sustain FDA’s current programming and personnel in FY 11. It will not enable FDA to add necessary new programs or personnel.

"We are grateful that the President has proposed an inflationary increase of about 6 percent for FDA in a year in which most domestic discretionary programs will be frozen or cut," said Wayne Pines, President of the Alliance.

"However, the FDA needs a real increase if it is to establish needed new programs and hire new people to carry them out. The American people must rely on FDA to assure the safety of products that constitute 25 cents of every consumer dollar spent. Continuing chronic underfunding of FDA affects our public health, our economy and our national security."

Pines added: "We are disappointed in the President’s budget request and our Alliance will seek to work with the Congress and the Administration to increase FDA’s budget for FY 2011 beyond a simple inflation increase. We will have the support of our entire membership in this goal."

The Alliance for a Stronger FDA is a coalition of more than 180 consumer, patient, professional and research groups, companies, trade associations, and individuals who support increased appropriated funding for FDA. The Alliance is the only multi-stakeholder group that advocates for increasing resources at FDA to match the agency’s responsibilities.

"Even with funding increases over the last three years, FDA’s appropriation in FY 10 supported about the same number of full-time employees as 1994, a time period in which FDA faced fewer challenges in both number and complexity," said Nancy Bradish Myers, Vice President of the Alliance and President of Catalyst Healthcare Consulting. "A larger financial investment is necessary to help alleviate the agency’s severe resource constraints caused by years of chronic underfunding and a rapidly growing list of complex public health challenges."

The erosion of FDA’s budget has coincided with a time in which the agency's workload has soared to include major public health initiatives such as H1N1 influenza, bioterrorism, and the inspection of an unprecedented amount of food and medical products from around the globe. "The imbalance between FDA’s funding and its expanding portfolio of public health responsibilities has left the agency overextended and ill equipped to effectively carry out its mission as the world's premier protector of public health," Pines said.

"Currently, FDA lacks the regulatory tools, expertise and processes to help spur the development of life-saving therapies from emerging biomedical fields such as stem cells and personalized medicine," said Dan Perry, an Alliance board member and Executive Director of the Alliance for Aging research. "Our broad and diverse Alliance of more than 180 members looks forward to ensuring that policymakers are apprised of FDA's need for consistent multi-year budget increases to bring FDA’s scientific and regulatory capacities up to speed with these sophisticated new areas."

"We realize that the President is committed to reducing the deficit, including lowering overall government spending," said Caroline Smith DeWaal, an Alliance board members and Food Safety Director at the Center for Science in the Public Interest. "Investments in FDA that prevent foodborne outbreaks and intentional contamination are important to achieving these goals as they reduce overall health care costs and losses to industry."

More information about the Alliance can be found at www.StrengthenFDA.org.

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FDA Issues Final Rules To Help Patients Gain Access To Investigational Drugs

 

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