Alliance for a Stronger FDA

Web site: www.strengthenfda.org

Blog: FDA Matters - The Grossman FDA Report

About 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.

News and Items of Interest

Friday Update for March 12, 2010

Advocacy

The Alliance met with over 50 member offices yesterday as part of its annual hill day. Thank you to all who participated and made the day a success.

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 turn 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 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.

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

Media Activities/Relevant Articles

Drug Safety: A Duet

Alliance for a Stronger FDA Contacts:

Ladd Wiley, phone: (202) 887-4083 email: lwiley@akingump.com
Steven Grossman, phone: (301) 879-5600 email: sgrossman@hpsgroup.com

This document is distributed for informational use only; it does not constitute legal advice and should not be used as such.
© 2009 ALLIANCE FOR A STRONGER FDA

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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.