Orange Book Transparency Act of 2019

Floor Speech

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Ms. KELLY of Illinois. Mr. Speaker, 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.

To be very clear, I support intellectual property protections for those researching and developing innovative treatments, but we have the responsibility to close loopholes that allow drugmakers to prevent timely access to information that would lead to new generic drug development, increasing patient access and affordability.

Today, I present a strong and straightforward piece of legislation in order to get lower-cost drugs to Americans in my district and across the country. I am ecstatic that this bill is not only straightforward but also bipartisan.

Mr. Speaker, I thank my colleague from Kentucky, Mr. Guthrie, for his work on this bill and key stakeholders for their feedback throughout the process.

The Orange Book Transparency Act moves us in the right direction toward transparency and lower drug costs.

Mr. Speaker, I urge all my colleagues to vote in support of H.R. 1503 today.

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