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Chuck Schumer: I will be brief. First, a specific point. One of the objections was on the language for what we call bioequivalence. In…

On the recordJuly 15, 2002
I will be brief. First, a specific point. One of the objections was on the language for what we call bioequivalence. In other words, what makes the drug the same drug? I am not a member of the committee, but I sat there as Chairman Kennedy presided. As I recall, there was a consensus on that issue, which was, let us codify what the FDA does now. That is what the language was supposed to do. There was not supposed to be a change. There was not supposed to be a wrinkle. There was not supposed to be anything different. And now, all of a sudden, we are hearing an objection based on that provision. I do not quite understand it because there was some discussion early on in the bill that the Senator from Arizona and I introduced about whether bioequivalence was the same. We intended it to be the same, but we were silent. Adding this provision just clarified it. So there is no new change here, none. To not move forward on the bill on that basis, when there seems to be a complete meeting of the minds of what to do, does not make sense. The second point is this, and both my colleague from Massachusetts and my able colleague from Michigan, who has been such a leader on this bill, have made it clear: The people are waiting. Every day, every minute, someone--a senior citizen, a family with a child who is ill--approaches the prescription drugstore counter with trepidation wondering what that bill will be. They want the best drugs for themselves and their loved ones.
Said by
Chuck Schumer
Democratic · New York

Editor's note · Context

Discussing objections to language on bioequivalence in a prescription drug bill.

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