[Congressional Record (Bound Edition), Volume 158 (2012), Part 6]
[Extensions of Remarks]
[Page 8727]
[From the U.S. Government Publishing Office, www.gpo.gov]




     H.R. 5651, THE FOOD AND DRUG ADMINISTRATION REFORM ACT OF 2012

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                        HON. DENNIS J. KUCINICH

                                of ohio

                    in the house of representatives

                         Thursday, June 7, 2012

  Mr. KUCINICH. Mr. Speaker, the very mechanism dictated by the 
Prescription Drug User Fee Act and the Medical Device User Fee Act is 
flawed. It is an inherent conflict of interest for drug and medical 
device manufacturers to pay millions of dollars in fees to the FDA that 
are designed to speed up regulatory approval, when the FDA is charged 
with making sure those drugs are safe and effective. H.R. 5651, the 
Food and Drug Administration Reform Act, perpetuates that flawed model.
  At the same time, we have a shortage of affordable, and in some cases 
life saving drugs that must be addressed immediately. Currently, while 
the pharmaceutical and medical device manufacturers are allowed to pay 
to expedite approval, no such privilege exists for generic drugs. Such 
a competitive disadvantage has the result of keeping much less 
expensive and equally effective drugs off the market while boosting 
profits for pharmaceutical manufacturers. Our seniors deserve better 
than to have to split pills because pharmaceutical companies have an 
exclusive right to manipulate the market to pad their already massive 
profit margins at the expense of those in need to pharmaceuticals. This 
bill corrects that imbalance. This bill also begins to address the 
increasingly prevalent sudden episodes of shortages of drugs that are 
life-supporting or life-sustaining. Such episodes are immediately life-
threatening if caregivers are not given sufficient notice to identify 
alternative supplies or treatments.
  I support the Food and Drug Administration Reform Act of 2012 and 
will continue to work for FDA reform.

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