On the recordMay 3, 2007
the first flaw Secretary Shalala identified was the lack of any requirement that the drug manufacturers give importers permission to use the FDA-approved labeling for imported medicines. The Dorgan amendment addresses that concern. The second flaw identified by Secretary Shalala was the lack of any ban on drug companies discriminating against foreign companies that export medicines to the United States. The Dorgan amendment addresses that concern. The third flaw identified by Secretary Shalala was the 5-year sunset in that version of the bill. That sunset would limit the public benefit from the investment the public would be making to put a safe reimportation system in place. In other words, she was saying, why should we go through all this effort if we are to only have a 5-year process. The Dorgan amendment addresses that concern. Finally, the Secretary noted the absence of a long-term income stream to fund enforcement of the reimportation system. The Dorgan amendment addresses that concern. In short, to characterize Secretary Shalala's letter as one that says reimportation is unsafe is to mischaracterize the essence of that letter. What Secretary Shalala was critical of was poison pills, what she called ``flaws and loopholes'' that were put in, or allowed to remain in the bill at the bidding of the pharmaceutical industry so they could defeat reimportation. I have been involved in this issue for a long time, and that is what the drug companies do.…
Source
govinfo.gov




