I am pleased today to speak on my bill, H.R. 1503, the Orange Book Transparency Act, and the critical issue of transparency in the drug and medical device development space. Should my colleagues vote in favor of this significant bill, the Orange Book Transparency Act will more efficiently achieve lowered costs and higher quality life-saving medicines for consumers. It will enhance market competition by getting generic drugs to market more rapidly. As much data show us, enhancing the market for generic drugs is one of the quickest ways to lower the costs that consumers pay at the pharmacy. Two things matter to me with respect to healthcare costs. One, we must be proactive in enhancing transparency with regard to the information made available to generic drug developers. Most importantly, we must improve efficiency in the market for prescription drugs in order to ultimately lower costs to patients, their families, and their caregivers. The Orange Book Transparency Act addresses both of these points by ensuring clarity in patent and exclusivity information maintained by FDA. It also requires that the Government Accountability Office study the effects of listing drug delivery patents in the Orange Book.…
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