[Congressional Record (Bound Edition), Volume 158 (2012), Part 9]
[Senate]
[Page 11965]
[From the U.S. Government Publishing Office, www.gpo.gov]




                     FDA SAFETY AND INNOVATION ACT

  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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