Search Form
Now choose a category »

Public Statements

Food and Drug Administration Safety and Innovation Act

Floor Speech

By:
Date:
Location: Washington, DC

BREAK IN TRANSCRIPT

Mr. MENENDEZ. Madam President, I ask to be recognized to engage in a colloquy with my good friend from Iowa, the Chairman of the HELP Committee, Senator Harkin.

I want to thank the Chairman for his leadership on this bill, the Food and Drug Administration Safety and Innovation Act. This is a critically important piece of legislation and I am proud to support it. I wanted to ask the Senator to clarify something for me regarding language in the bill dealing with the development of new antibiotics. This bill contains language to incentivize the development of antibiotics, both for newly-discovered infections where antibiotics do not yet exist as well as for those resistant infections where currently available antibiotic treatments may no longer work. These incentives are available for qualified infectious disease products, that is, products intended to treat serious or life-threatening infections, including those caused by resistant gram positive pathogens and multi-drug resistant gram negative bacteria. It is my understanding that products intended to treat serious or life-threatening infections caused by gram negative anaerobic bacteria are also considered qualified infectious disease products, and therefore eligible for the incentives contained in this provision. Is that the case?

BREAK IN TRANSCRIPT

Mr. MENENDEZ. I appreciate the Senator clarifying that point. As he knows, infections caused by gram negative anaerobic bacteria such as Bacteroides and Garnerella have a disproportionate impact on women of color and cause an increased risk of HIV infection and complications of pre-term labor. I am pleased that this bill takes the steps necessary to ensure treatments for these infections can come to market and help those in need. Again, I thank the Senator for his leadership on this bill and for clarifying this point today.

BREAK IN TRANSCRIPT


Source:
Skip to top
Back to top