On the recordMay 24, 2012
I would oppose this amendment. We do need to combat health care fraud, but this amendment goes too far in several aspects. First and most important, it would discourage any settlement agreements. People would fight it to the death if they are going to lose their exclusivity. Second, as drafted, the amendment would require companies to forfeit exclusivity anytime there is a civil or criminal liability under the Federal Food, Drug, and Cosmetic Act. It is disproportionate. This could be triggered by a misdemeanor. In addition, such liability may not reflect fraud. The amendment would discourage the development of new cures for patients. If manufactures know they could lose exclusivity for even minor infractions, they will not invest the millions of dollars necessary to create new lifesaving therapies for patients. I ask that the Senate oppose the amendment. I yield the floor. The PRESIDING OFFICER. All time has expired. Under the previous order, this amendment is subject to a 60-vote threshold for adoption. The question is on agreeing to the amendment.
