[Congressional Record Volume 158, Number 80 (Thursday, May 31, 2012)]
[Extensions of Remarks]
[Pages E927-E928]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




            FOOD AND DRUG ADMINISTRATION REFORM ACT OF 2012

                                 ______
                                 

                               speech of

                            HON. GENE GREEN

                                of texas

                    in the house of representatives

                        Wednesday, May 30, 2012

  Mr. GENE GREEN of Texas. Mr. Speaker, this bill is the result of hard 
work by our committee. I especially want to thank Chairmen Upton and 
Pitts and Ranking Members Waxman and Pallone and I am proud that our 
committee is setting an example for bipartisan compromise and 
productive governing.
  Contained in the FDA Reform Act is the GAIN Act, a bill introduced by 
Congressman Gingrey and myself, which is aimed at incentivizing the 
development of new antibiotics that will fight the serious and life 
threatening infections that mankind will face in the coming years.
  The GAIN Act provisions of this bill represent a careful bipartisan 
balance that appropriately protects patient safety and responsibly 
offers incentives to innovative drug companies seeking the cures to our 
world's most deadly bacterial pathogens such as extensively drug 
resistant tuberculosis, MRSA, and others that we are currently ill-
equipped to treat. Currently, we are unable to manage many significant 
public health threats posed by these pathogens.
  While a widespread public health threat is in our future, some people 
in this country are

[[Page E928]]

dying today as a result of drug resistance and super bugs. We hear a 
lot about the challenges of South East Asia, but our health 
professionals are confronting bacterial infections that are resistant 
to all currently available antibiotics.
  Recently, the World Health Organization Director-General said 
``things as common as strep throat or a child's scratched knee could 
once again kill. Hip replacements, organ transplants, cancer 
chemotherapy and care of preterm infants would become far more 
difficult or even too dangerous to undertake'' due to the rising threat 
of super bugs.
  According to providers I've heard from, drug resistance is already a 
distinct problem in the front lines of our nation's health delivery.
  For example, in one instance, a 15 year old girl got her ears 
pierced. Her earlobes swelled and got red. She went to the emergency 
room and was admitted for IV antibiotics. The infection was resistant 
to the usual antibiotics and she became septic and died.
  There are many other cases in which minor injuries and simple 
procedures produce unexpected complications because of the emerging 
threat of drug resistance.
  Because of the nature of this threat, I urge my colleagues as this 
heads to the floor and hopefully to conference, that no changes are 
made to the GAIN provisions to further limit incentives or reduce the 
list of pathogens. The truth is we do not know what the specific public 
health threat will be and once it is on top of us it is too late. We 
have to be prepared and part of this preparedness is getting our drug 
companies to develop drugs that may not be profit blockbusters but are 
necessary to help protect us from public health crises.
  With the help of Chairman Upton and Ranking Member Waxman, we have 
struck a careful balance. I strongly oppose any changes to the GAIN Act 
in an eventual conference with the Senate. I am concerned that any 
changes could create lopsided incentives that lead to unnecessary drugs 
or, alternatively, remove incentives and result in too few, if any, 
drugs.
  I believe the GAIN Act as included in this bill, as well as the 
entire bill, are good policy. The FDA Reform Act deserves to be passed 
by the House and I strongly urge my colleagues to support it.

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