Potential Revisions
There are several important potential revisions to the Hatch-Waxman Act. One of theses revisions includes a one-for-one extension, and a change from the one-half of IND period to a full IND. Furthermore; there is the issue of decreasing NDA review time. Initially the legislation was enacted because of the concern that overall drug development time was getting longer and longer however, the FDA has done a remarkably good job in cutting back the time for NDA review. Despite this major improvement the human clinical trials are taking even longer. Another proposal has been to remove the two-year extension limit for drugs under review and the arbitrary five and fourteen year limitations. This last particular revision also would permit multiple extensions of the same patent and change the five-year limit to ten years to match competing international standards.
Read more about this topic: Drug Price Competition And Patent Term Restoration Act
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