McClellan: Reagan-Udall Will Be 'Transparent'

In response to criticism that the newly created Reagan-Udall Foundation won't be unduly influenced by ties to industry, former FDA commish Mark McClellan insists the foundation won't make agency policy, sway regulatory decisions or seek to benefit one interest over another.

While acknowledging "the climate is one of a high level of concern," he maintains the purpose will be to support the FDA by "focusing on science and doing the right thing for patients." And he tells The Star-Ledger of New Jersey (which owns Pharmalot) that all decisions on research projects, acceptance of private funding and collaborations between the public and private sectors will be "transparent."

Last month, Congress passed an appropriations bill that would give the FDA nearly $1.73 billion in funding for fiscal 2008. But none of the appropriated funds can be used to finance the Reagan-Udall Foundation, a move championed by Rosa DeLauro a Democrat from Connecticut and head of a House appropriations panel with jurisdiction over FDA funding, who worried the foundation would be influenced by industry. The move, however, creates a vaccuum. Ellen Sigal, a foundation board member and head of the nonprofit Friends of Cancer Research, says the prohibition on using FDA money this year will "slow down" progress, but will not stop the new organization from raising money from outside sources to begin fulfilling its mission.

Where will the money come from? Besides McClellan, the other 13 board members include seven with various direct ties to pharma, although only four are obvious: Kay Holcombe of Genzyme; Joe Hogan, ceo of GE Healthcare; Gary Neil, the group prez for Johnson & Johnson's pharma R&D, and Tadataka Yamada, who heads the global health progam Bill & Melinda Gates Foundation and is a former Glaxo exec who has drawn congressional scrutiny for allegedly bullying an Avandia critic.

As Roy Poses at Health Care Renewal points out, other board members have ties that aren't readily apparent from reading the FDA announcement...

...For instance, Phil Sharp (see photo), is listed as a professor at the Massachusetts Institute of Technology, but he is also on the scientific advisory boards at Sirtris Pharmaceuticals and Fidelity Biosciences, Sharp also co-founded Biogen, Anylam Pharmaceuticals and Magen Biosciences, and is a director of all three companies.

Then there's Ellen Sigal, who is listed as the chair and founder, Friends of Cancer Research, which gets funding from from Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Genentech, Glaxo, Johnson & Johnson, Novartis, Pfizer and PhRMA, according to its most recent report. And as Health Care Renewal also notes, William Brody, the president of Johns Hopkins University, was a Medtronic board member until recently and held stock and options, according to the July proxy.

This adds up to seven of the 13 members, not including McClellan, with some type of tie to pharma or a device company. Of course, such connections do not automatically guarantee industry will dominate the foundation's mission. But the mix raises questions about the extent to which the board can truly operate with an independent mind.

Foundation board member Diana Zuckerman, head of the nonprofit National Research Center for Women and Families and an early critic of the new organization, says she still has qualms regulated industries may seek to dominate the agenda. "I had concerns about it from the beginning," she tells The Ledger, "and now, as a board member, I want to make sure those concerns don't come to pass." We shall see.

Hat tip to Health Care Renewal