Amending Federal Food, Drug, and Cosmetic Act with Respect to Scope of New Chemical Exclusivity

Floor Speech

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Mr. PALLONE. 415.

Mr. Speaker, rising prescription drug costs are a concern for so many Americans. Skyrocketing costs can result in some people postponing or altering treatment because the necessary drugs are simply priced out of reach.

One way to help reduce drug costs is to provide early access to generic drugs. This legislation we are considering today will help to do that by ensuring that exclusivity, which can delay generics from entering the market, is only made available to truly innovative products. This will ensure that drug manufacturers cannot game the system by simply making small tweaks to old drugs as a way to block or delay competition. The legislation will also codify the Food and Drug Administration's current approach to awarding exclusivity.

I thank Representatives Schrader and Guthrie for their bipartisan work on this legislation with Senators Cassidy, Smith, and Marshall.

Mr. Speaker, I urge my colleagues to support the bill, and I reserve the balance of my time.

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Mr. PALLONE. Mr. Speaker, I also urge support for this bill, and I yield back the balance of my time.

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