February 4, 2009
The Honorable Barack Obama
President of the United States
Washington, DC 20500
Dear Mr. President:
On behalf of America’s consumers, we hope you will be able to make an early nomination of a new, effective FDA Commissioner who has solid expertise on FDA issues, is committed to public health and safety, and is independent of the industries that the FDA regulates.
In recent years, the FDA has had a history of interim or acting Commissioners and this has hurt the ability of the agency to move decisively on the innumerable life-and-death consumer issues for which it is responsible. An early appointment would undoubtedly help the morale at the agency.
In addition, there is a terrible backlog of key consumer issues before the FDA that top leadership needs to resolve. These issues range from the implementation of the key 2007 FDAAA legislation; obtaining more resources; restoring scientific integrity (on issues such as BPA, women’s health, and nano-technology); strengthening the device approval process; ensuring the safety of imported and domestic foods, drugs, and devices; and leading the FDA in the health reform effort (by ending the backlog of generic drug approvals, creating a pathway for follow-on biologics, and giving consumers better information about the quality and effectiveness of new drugs).
Finally, there is clear evidence from polling of FDA career staff that the current system of user fees has placed great stress on the FDA to be overly responsive to the fee-paying pharmaceutical and device industries. The ‘ties’ that come with the user fee revenue must be broken if the FDA is to have long-term independence and truly serve the American public. In the meantime, it is critically important that your nominee be a true scientist or public servant who is independent from industry. For far too long, the agency has seemed slanted toward those it regulates and away from those whose duty it is to protect– U.S. consumers. We urge you to appoint an FDA Commissioner who will restore the public’s confidence in the agency with a commitment to ensuring that public safety, not industry interests, is the first priority.
Thank you for your consideration of these views.
Sincerely,
Center for Medical Consumers
Center for Science in the Public Interest
Consumers Union
Government Accountability Project (GAP)
National Research Center for Women & Families
National Women’s Health Network
Reproductive Health Technologies Project
Title II Community AIDS National Network
The TMJ Association
Union of Concerned Scientists
WoodyMatters
For the letter in a PDF format, click here or go to: http://www.consumersunion.org/pdf/Obama-FDA-0209.pdf