OFFICIALS LEGISLATION INTEREST GROUPS PUBLIC STATEMENTS COMMITTEES VETOES

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

Floor Speech

Date: April 14, 2021
Location: Washington, DC
Issues: Food Processing and Sales Drugs

Mr. Speaker, I rise in support of S. 415, the Ensuring Innovation Act. This legislation is the bipartisan companion to H.R. 1857 led by Representatives Guthrie and Schrader.

This legislation would ensure that only the most innovative products are eligible for certain market exclusivities and would increase the availability of lower-cost generic drugs. Great work by these Representatives.

Currently, the FDA grants 5 years of marketing exclusivity to drug products determined to be a new chemical entity. Clarifying what qualifies as a new chemical entity will prevent drug manufacturers from receiving exclusivity by making minor changes to existing drugs, which would block generic competition from the market.

This important bipartisan legislation will help lower prescription drug prices while preserving incentives to innovate.

BREAK IN TRANSCRIPT

Mr. BILIRAKIS. Mr. Speaker, I urge my colleagues to pass this great bill. I commend my colleagues for focusing on this particular issue, which is just so important to our constituents. Again, let's pass this bill as soon as possible and get it to the President.

BREAK IN TRANSCRIPT


Source
arrow_upward