In the scramble to approve the FDA reform legislation and increase user fees, one item was largely overlooked - the creation of a new drug research center. But there’s an interesting wrinkle - it will be financed by the same drugmakers the agency regulates. The goal of the Reagan-Udall Foundation, which was signed into law late last month, is to streamline and improve the development of drugs and medical devices.

This comes at a time when the FDA’s reputation is in the toilet thanks to the perception that it’s soft on safety and too cozy with pharma. For this reason, consumer advocates say the loosely defined partnership increases the agency’s vulnerability to industry clout. And the undertaking puts the agency and drugmakers in a relationship unlike that of any other industry. Some liken it to placing foxes in the chicken coop.

For better or worse, the FDA this morning announced the foundation’s board members and chair, who will be Mark McClellan, currently the director of the Engleberg Center for Health Care Reform at the Brookings Institution, a former FDA commish and a former administrator of the Centers for Medicare and Medicaid Services.the foundation. Here are the new board members…

Georges Benjamin, executive director, American Public Health Association;
Bill Brody, president, The Johns Hopkins University;
Helen Darling, president, National Business Group on Health;
Cal Dooley, ceo and president, Grocery Manufacturers Association;
Michael Doyle, director, Center for Food Safety, University of Georgia;
Joseph Hogan, ceo and president, GE Healthcare;
Kay Holcombe, senior health policy advisory, Genzyme;
Sharon Levine, associate exec medical director, The Permanente Medical Group;
Gary Neil, group president, J&J Pharmaceutical Research & Development;
Phil Sharp, Institute Professor, Center for Cancer Research, MIT;
Ellen Sigal, chair and founder, Friends of Cancer Research;
Tadataka Yamada, president, global health program, Bill & Melinda Gates Foundation;
Diana Zuckerman, president, National Research Center for Women and Families

One person who may prove to be a questionable choice is Yamada, a former Glaxo exec who was recently fingered as having threatened a diabetes expert at the University of North Carolina for suggesting the Avandia diabetes pill - which has since received Black Box warnings for heart failure and heart attack risks - was a questionable med. Yamada called John Buse a “liar” and a “scoundrel,” and threatened Glaxo would sue him.

Still, the ever-optimistic FDA commish Andy von Eschenbach had this to say in a statement: “By agreeing to serve on the board, these distinguished representatives will help FDA continue to bridge scientific discovery into the development of safe and effective products. They reflect the areas served by FDA, all of which have a stake in a transparent and collaborative process. The broad representation from science, academia and industry in addition to strong Congressional support for this foundation is indicative of its mission, which will be about building the science of product safety.”

This is the rest of the FDA statement: The statute calls for a 14-member board: four representatives from the general pharmaceutical, device, food, cosmetic, and biotechnology industries; three from academic research organizations; two from patient or consumer advocacy groups; one representing health care providers; and four at-large representatives with expertise or experience relevant to the foundation’s purpose.

In addition, a majority of the foundation’s board members—nine out of 14—must be appointed from a list of candidates provided by the National Academy of Sciences and the remaining five from nominations submitted by patient and consumer advocacy groups, professional scientific and medical societies and industry trade organizations.

As required by statute, four government health care officials—the commissioner of the FDA, the director of the National Institutes of Health, the director of the Centers for Disease Control and Prevention, and the director of the Agency for Health Care Research and Quality—appointed the board members from the two lists of candidates. The FDA commissioner and NIH director will continue participating in foundation activities as non-voting board members.

Congress established the Reagan-Udall Foundation to identify and address unmet scientific needs in the development, manufacture and evaluation of the safety and effectiveness of FDA-regulated products, including post-market evaluation. The foundation will establish scientific projects and programs to address those needs and help accomplish the scientific work FDA needs to support its regulatory mission.