Rep. DeLauro Requests that FDA Cease Activities to Create the Reagan-Udall Foundation

Title VI of the recently-enacted FDA Amendments Act (“FDAAA”) amended the FDC Act to establish a non-profit corporation whose purpose is to advance FDA’s Critical Path Initiative to “modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.”  (The Critical Path Initiative is FDA’s effort to modernize the scientific process through which a potential drug, biologic, or medical device is transformed from discovery into a medical product.)  This corporation, known as the Reagan-Udall Foundation for FDA, is intended to allow FDA to collaborate with other researchers to foster newer methods of testing that are needed to assess newer technologies. 

On October 3, 2007, FDA issued a Federal Register notice seeking nominations for the Reagan-Udall Foundation.  The Foundation’s Board of Directors will initially include four ex-officio members — the FDA Commissioner, and the Directors of the National Institutes of Health, Centers for Disease Control and Prevention, and the Agency for Healthcare Research and Policy — who appoint the remaining 14 members from industry, academia, patient/consumer groups, and health care providers. 

On November 1, 2007, Representative Rosa DeLauro (D-CT) issued a press release with a copy of a letter sent to FDA Commissioner Andrew von Eschenbach requesting that FDA cease all activities related to the creation of the Reagan-Udall Foundation.  According to Rep. DeLauro’s letter:

Although the mission of the foundation is intended to support research that encourages an expedited FDA approval process, I believe the Reagan-Udall Foundation has the potential of endorsing the approval of drugs and devices based on lower standards for safety and efficacy, and without appropriately designed clinical trials.  For example, rather than having new drugs be tested to ensure their efficacy in reducing symptoms or curing diseases, the Foundation could play a significant role in recommending the use of biomarkers and other measures that may not be true measures of efficacy. . . .  The result could be patients spending billions of dollars on drugs that are not as effective as other products on the market.  Therefore, I am very concerned that undue influence by industry could harm the work of the FDA.

Rep. DeLauro’s letter to Dr. von Eschenbach was presumably related to a recent press report in which Francesca Grifo, Director of the Union of Concerned Scientists, stated with respect to the Reagan-Udall Foundation that “Given FDA’s track record in the past, I’m not confident in their ability to create something that is free of influence from industry.”

Peter Pitts, the co-founder of the Center for Medicine in the Public Interest (“CMPI”) and former FDA Associate Commissioner for External Relations (and who has referred to the Reagan-Udall Foundation as the “bi-partisan crown jewel” of the FDAAA), immediately authored an article published in the Journal of Life Sciences stating that “FDA should not be chastised, but applauded for working with industry to tackle the big problems of drug development.” 

CMPI runs the blog DrugWonks.com.  In his latest post on this issue, Mr. Pitts pillories Rep. DeLauro for her press release and letter.  Mr. Pitts’ colleague, Robert Goldberg, also recently posted on this issue stating that Rep. DeLauro and the media have been misled on what biomarkers do and can offer people in terms of safer drugs.

FDA has not (to our knowledge) indicated whether the Agency plans to cease activities to create the Reagan-Udall Foundation.  We will update you as we learn more information.