I appreciate the concern by the Senator from Vermont, but I have to oppose the amendment, No. 2109, because of some of the unintended consequences it will have. This amendment would require drug companies to forfeit exclusivity for certain violations of the Federal Food, Drug, and Cosmetic Act and other laws. ``Exclusivity'' means exclusive market rights granted by the Food and Drug Administration upon approval of a drug. It may or may not run concurrently with a patent. Exclusivity is a very important type of intellectual property protection. Without it, innovators cannot predictably obtain returns on their drug development investments. The stated purpose of the amendment is to combat healthcare related fraud. The premise is, if companies know their profits are at risk, they will be strongly discouraged from engaging in fraudulent activity. But this amendment is counterproductive: It will make it more costly for law enforcement to fight fraud and could hurt patients. Congress is also thinking of ways to improve healthcare antifraud programs. For example, in a recent open letter to the health care community, six members of the Senate Finance Committee, led by Chairman Baucus and Ranking Member Hatch, announced a bipartisan effort to solicit ideas from the healthcare community on ways to reduce healthcare waste, fraud and abuse. Estimates of the amount of fraud and misspending in Medicare and Medicaid vary widely, from $20 billion to as much as $100 billion.…
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