On the recordFebruary 23, 2016
I believe the FDA needs new leadership, a new focus and a new culture, and Dr. Robert Califf's past involvement with the pharmaceutical industry reflects that he will not be this person. He will not have the impact or leadership capabilities the Nation needs to stem the tide of the opioid crisis we have all over this country, even in your great State of Oklahoma and my State of West Virginia, which has been ravaged by this. I would like to put this in context for a little bit. He has been there over a year--a good man. I am not speaking about his ability, his honesty, his integrity, his education, his background, and all the good work he has done. But he has been there for a year, and for the past 20 years Dr. Califf basically has come from the institutional research side, from education, and with that, his support has come from the pharmaceutical industries, those that are putting opioids on the market. I just feel it would be hard, human naturewise, for him to change and rule to keep these products from coming onto the market. So to put this in context, this is not personally about Dr. Califf. This is about the culture he comes from and the year he has been there as the No. 2 man and what has happened during that period of time. Let me go over some things. Over the last decade, the FDA has approved new drugs at historically high rates. In 2008, companies filing applications to sell never-before-marketed drugs were denied 66 percent of the time.…
Source
govinfo.gov




