On the recordJuly 11, 2001
I would confess that the Gutknecht amendment sounds good on the surface, but when you begin to scratch that surface, it is not so good. In fact, as some have suggested this afternoon, it is outright dangerous. Americans want a standard of excellence, and this amendment, at least the way it is worded, simply does not work. Under present law, the FDA can stop drugs at the border if they appear to not be approved. That is sensible. If something looks bad, it certainly should not be allowed into this country. But under this amendment, it says that the FDA cannot stop a drug if it appears to be in compliance, even if it is not approved. The FDA simply does not have the resources or the manpower to enforce an amendment of this magnitude, and as my colleague from Michigan (Mr. Stupak) suggested a little bit earlier, this amendment could actually legitimize counterfeiting of drugs. I would urge my colleagues to vote no on this amendment.
Source
govinfo.gov




