 |
 |
 |
|
 |
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
A number of people thought it might be of interest for me to post on FDA's external Web site my first "Commissioner's Comments," an internal communication that I send every week to FDA staff. The comments are identical to my first "Viewpoint" already posted on the FDA Web site, with the exception of the last paragraphs. This internal communication, "Commissioner's Comments," is provided in its entirety below.
— Frank Torti
I am using this first communication as an opportunity to introduce, in my own words, some thoughts about the FDA. I will develop these in more detail in subsequent communications. I intend these comments to communicate both to my colleagues at the FDA and to our many constituencies.
I will need your help. The job of Acting Commissioner is more difficult (if that is possible) than that of the Commissioner. For many issues, we await the guidance of our new administration. This is as it should be, and we embrace the opportunity to help them implement their vision for the FDA. Yet the work at FDA must be neither tentative nor delayed. Rather, we must steer the Agency with continued energy, enthusiasm and insight. We must continue to apply scientific thought and process to our regulatory decisions — based, as always, on the laws that govern our food and drugs.
To our consumers, we promise to provide you with clear, timely and accurate information on the risks and benefits of the products we regulate, earn your respect and trust, and further build a reputation for rock solid integrity, accuracy and transparency. For many issues of risk, science does not give us all the answers. When we do not yet know the answers, the FDA will be honest and forthcoming about our uncertainty.
To members of Congress and others who oversee our Agency, we need your partnership to reshape the agency and to provide us with the resources and legislative authorities necessary to support our work.
To our academic community and our medical, scientific and other professionals, we want to engage you to a much greater extent than before to help us tackle the difficult scientific problems that underpin FDA regulation.
To the companies we regulate, we acknowledge and respect the creativity and imagination involved in the development of your products, many of which began at our great academic institutions. You represent the essence of what has made America a great economic force and set us apart as a people, as Americans: creativity and focus. We promise you that our deliberations will be completed with respect, diligence and speed, but always remembering the old, but wise admonition of Hippocrates, to first do no harm.
To our own large family of FDA colleagues, we must continue to develop an environment in which scientific discourse and at times disagreement is accepted and respected, where politics has no standing in regulatory decisions, and where excellence is rewarded. We must be open to criticism, willing to change, and apply our decisions with humility and courtesy, bearing in mind that our sometimes imperfect judgments profoundly affect not only the fate of companies but the health and welfare of all Americans.
I want you to know that my door remains open. I will maintain the practice I began as Chief Scientist, leaving Tuesday afternoons free to meet with anyone at the FDA to discuss any issue of their choice, without any requirement for supervisory permission, without the necessity of providing a discussion topic prior to the meeting, and with the promise that issues mentioned in confidence will remain in confidence. To meet with me, please contact Kelly Palmer at 301-796-5000.
I look forward to serving you during this transition.
Frank
Frank M. Torti, M.D., MPH
Acting Commissioner of Food and Drugs