Mr. Chairman, on this amendment, with all due respect to the author of the amendment, it is a poorly drafted amendment. What it says is the FDA has to approve drugs if they appear to be FDA-approved drugs and do not appear to be a controlled substance and appears to be manufactured or processed in an establishment registered pursuant to section 501. Well, look at these drugs we found in our investigation. Again, energy and commerce has done this investigation. This is Hong Kong, 1999, here is the counterfeit. Here is the genuine. It appears to be the same, even though they are not. Here is one from 1986, Great Britain. This is Zantac. Again, there is a counterfeit; and there is a genuine. Everything appears to be the same all the way down to the blister pack, all the writing, everything on here. The Gutknecht amendment says this 'all appears.' I do not think we want 'to appear' with the health and safety of our people. Where is the safety net for our senior citizens underneath this amendment? We cannot allow reimportation if it 'appears' okay.
Bart Stupak: “Mr. Chairman, on this amendment, with all due respect to the author of the amendment, it is a poorly drafted amendment.…”
Editor's note · Context
Critiquing an amendment related to drug safety and FDA approval during a committee discussion.
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