FDA Safety and Innovation Act

Floor Speech

Mr. BLUMENTHAL. Mr. President, today I rise to say a few words about the Food and Drug Administration Safety and Innovation Act, legislation Congress passed with strong bipartisan support just before we returned home to our States for the Fourth of July.

This bill was a big one. It was a big bill with complex provisions and an essential purpose: to safeguard the public, to protect patients and encourage innovation and invention, which are so important to treating and curing diseases in this country as well as other problems. And this measure was revolutionary in many ways. It contained complex, new provisions, provisions that we must make sure are implemented as Congress intended.

I was proud to work on many parts of this bill with my colleagues, including title VIII of this legislation, to generate new antibiotics to treat emerging serious and life threatening superbug infections. I want to clarify two points for the record on this legislation: I want to be clear that pathogens identified in this title are illustrative, not all-inclusive. There are many deadly pathogens that we may not even know of yet; title VIII is intended to spur innovation against all superbug infections as soon as they arise. And, I want to be clear, language in section 801(b) is not intended to prohibit or preclude innovative drug products that will spur the antibiotic pipeline, so long as they meet the definition for a qualified infectious disease product.

FDA approval of new antibiotics has decreased by 70 percent since the mid-1980s, yet reports from the CDC suggest that resistant MRSA infection deaths are now at more than 17,000 lives lost in the United States each year--more than AIDS. Resistant infections have now been elevated to one of the World Health Organization's top three threats to human health. It is my sincere hope that title VIII will spur production of the weapons we need to fight this threat.

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