Political Quotes

“let me reiterate what my colleague just said, which is that Chairman Harkin and Ranking Member Enzi have done a wonderful job with a very complicated bill in navigating what was a negotiation that Members of Congress never played a part in-- negotiations that happened between the Food and Drug Administration and the pharmaceutical industry for one piece, the device industry for another piece, and the generic drug industry for a third piece; and, I might say, the third piece is the first time Congress will consider this. I think it is important that Members of the Senate, Members of Congress, and the American people understand that, typically, all legislation is crafted in the Congress of the United States. It is not negotiated in the back room of the Food and Drug Administration or in the back rooms of the device, pharmaceutical, and generic drug manufacturers--except for this. In fact, my amendment gets at the heart of that issue. It is called the amendment ``to ensure transparency in the Food and Drug Administration user fee agreement negotiations.'' The amendment is straightforward. It would ensure transparency in FDA's drug and device user agreement negotiations by allowing Members of Congress or their designated staff to attend the negotiations between the FDA and the industry. What a novel thing to say, that those who are responsible to actually implement the policy could sit in the room and listen. I am not talking about playing a role in negotiating.…”