Statement on Steven Galson as Head of FDA Drug Evaluation and Research

FOR IMMEDIATE RELEASE
Friday July 29, 2005

Statement of the Hon. Rosa L. DeLauro

Steven Galson as Head of FDA Drug Evaluation and Research

WASHINGTON, D.C. - Ranking Member of the House Appropriations Agriculture Subcommittee Congresswoman Rosa L. DeLauro (Conn.-3) today issued the following statement on the appointment of Steven Galson, MD, MPH as head of the FDA's Center for Drug Evaluation and Research (CDER.) DeLauro's subcommittee has jurisdiction over FDA's budget.

"This first appointment raises serious questions about Dr. Crawford's management decisions and is further proof that politics trumps science within FDA. This appointment also sends a disturbing message to FDA employees, who have been publicly attacked for their scientific decisions by Galson. After Dr. David Graham testified last November about his work on the dangers of Vioxx, Dr. Galson publicly disparaged Graham's research.

"Dr. Galson has already come under heavy criticism for his management of the CDER - particularly, around the failed oversight of Vioxx and his decision to overturn the advisory committee's overwhelmingly favorable rulings on Plan B.

"In this announcement today, FDA praised the creation of the new Drug Safety Oversight Board under Dr. Galson's leadership. Yet this board is not transparent and is not efficient in bringing drug regulatory information to the public or credibility to the agency. The American public has a right to know about emerging drug safety concerns. Public awareness should be FDA's primary concern, not protecting the industry it is supposed to regulate."

http://www.house.gov/delauro/press/2005/July/galson_confirm_07_29_05.html