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

Floor Speech

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Mr. SCHRADER. Mr. Speaker, I rise today to speak in support of S. 415, a bill that has the same policy as my own and Mr. Guthrie's here in the House, H.R. 1857, the Protecting Access to Safe and Effective Medicines Act.

This bill is a simple fix, providing clarity around the drug approval process by increasing the specificity of the language companies may use when submitting these complex and often lengthy applications. Simply put, utilizing the term "active ingredient'' opens the unintended opportunity for pharmaceutical companies to make minor, relatively nonpharmacological changes to the same chemical and prevent generic alternatives from coming to the marketplace. By changing this language, as this bill does, to "active moiety,'' we will be able to close another loophole that can be exploited by companies to inappropriately obtain exclusivity and hold back competition in the marketplace, the key mechanism for lowering drug prices.

While this is good policy, it is one small piece of the larger drug- pricing conversation that we need to have. It demonstrates, yet again, that the policies to lower drug prices are bipartisan and bicameral. In fact, there are many such policies that did not get done in the last Congress that offer a starting point for a comprehensive approach addressing drug pricing, and now is the time to continue this important work.

I thank my colleagues on both sides of the aisle for the help in supporting this important bill before us today, and I urge its passage.

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