Over-The-Counter Monograph Safety, Innovation, and Reform Act of 2018

Floor Speech

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Mr. CARTER of Georgia. Mr. Speaker, I would like to thank my colleagues for introducing this critical legislation.

As it stands, the OTC monograph system is slow and outdated, leading to new changes being stuck in the pipeline for years with no light at the end of the tunnel. As a pharmacist, I know how important it is to my patients that they have access to new uses and applications.

Regardless of the application needed under a monograph, today's legislation puts in place changes that will help those who I have spent my life assisting: the patient.

This legislation establishes a mechanism for safety label changes, giving these new efforts an outlet through which to get changes for the public quickly available and on shelves.

This critical legislation will shorten market exclusivity by 6 months for certain new over-the-counter products approved without a new drug application and will also bolster the staffing capability at the FDA overseeing the OTC drug industry.

Over-the-counter drug innovation has faced challenges for years, and, with this legislation, we finally have an opportunity to open up these channels that will help everyone.

I voted for this legislation through the subcommittee and through full committee and am proud to offer my full support to pass this legislation.

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