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U.S. Department of Health and Human Services

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Presiding Officer's Statement, Avastin Hearing June 28-29, 2011

Karen Midthun, M.D., Director, Center for Biologics Evaluation and Research

(presiding officer for Avastin hearing, representing Commissioner Margaret A. Hamburg, M.D.)

Thank you for your participation and your attention during this proceeding.  This administrative hearing, provided for under our regulations, is a means to prepare a record that will form the basis for the final decision by Commissioner Hamburg.

The hearing has also provided an opportunity for the public to observe and participate in the type of difficult decision-making process that the FDA engages in each day as it considers the approval, or the withdrawal of approval, of drug products.  As illustrated by the public presentations at the beginning of the hearing, FDA’s focus is always on the effect that our decisions will have on patients who will use those products, including those patients who may be benefited by them, and those who may also be harmed by them. 

In every instance, our decisions are based on the scientific data available to us.  The applicants, typically companies that develop the products, are responsible for producing the data upon which decisions are made.   They are very knowledgeable about theses data, and they thus play an integral part in informing our decision-making process.  Sometimes there are differences of opinion as to what the data mean.  When this occurs, we carefully discuss those differences, listen to all points of view, including the view of the applicant, and carefully think through the issues presented.  That was what was occurring, in a very public way, during this proceeding.

The record of this hearing will close on July 28th of this year.  While we had earlier stated that the docket would close on July 14, Genentech and the Center have jointly requested an opportunity to have until July 28 to submit their final summaries of their respective views on the issues and I have granted that request.  Thus, we will keep the docket open for everyone, including members of the public, to make submissions until July 28.

I will then sit down with Commissioner Hamburg to discuss the record that has been created in this hearing process and she will make a decision based on all of this information. 

I will work with Commissioner Hamburg to draft a written document that explains the basis for whatever decision is ultimately reached.  I cannot tell you at this point when the decision will be finalized and issued, but we all do recognize the importance of resolving these issues expeditiously.

We very much appreciate the significant efforts that so many people have put into the presentations at this hearing, and the high level of discussion that has prevailed.  The hearing is now adjourned.