BCBSA Strongly Supports FDA Nominees Hamburg, Sharfstein

Statement from Scott P. Serota, President and CEO Blue Cross and Blue Shield Association

March 16, 2009

WASHINGTON – Scott P. Serota, president and chief executive officer of the Blue Cross and Blue Shield Association (BCBSA), released the following statement regarding the nominations of Margaret Hamburg and Joshua Sharfstein to be commissioner and deputy commissioner, respectively, at the U.S. Food and Drug Administration (FDA):

"In nominating Margaret Hamburg and Joshua Sharfstein to lead the FDA, President Obama has sent a clear signal that he intends to promote balance and enhance oversight at a critically important agency whose work touches all Americans.  Both Drs. Hamburg and Sharfstein are well-respected and have been on the front lines in New York and Maryland working to improve public health and safety across the societal spectrum.

"The FDA faces a wide array of immediate and pressing challenges and the nation's 39 Blue Cross and Blue Shield companies pledge our support and assistance.  With Blue Plans providing coverage to 102 million Americans residing in every zip code in America, we have first-hand knowledge of what is working here and now and where improvement is needed.

"In particular, we believe that reforming the process for evaluating and approving medical devices will substantially enhance the safety of healthcare in America. We believe strongly that a clear regulatory pathway for biogenerics needs to be established as soon as possible and that the Office of Generic Drugs needs additional resources to meet its mandate.

"Blue Cross and Blue Shield companies have been at the forefront of efforts to promote generic drugs and we look forward to working with the FDA to help expand access to safe and effective generic drugs throughout the entire U.S. healthcare system."