[Congressional Record Volume 158, Number 81 (Friday, June 1, 2012)]
[Extensions of Remarks]
[Pages E950-E951]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




            FOOD AND DRUG ADMINISTRATION REFORM ACT OF 2012

                                 ______
                                 

                               speech of

                         HON. LAURA RICHARDSON

                             of california

                    in the house of representatives

                        Wednesday, May 30, 2012

  Ms. RICHARDSON. Mr. Speaker, I rise in support of H.R. 5651, The 
Bipartisan Food and Drug Administration Act of 2012, which modifies the 
Food and Drug Administration's (FDA) policies and procedures to enhance 
Americans' access to effective healthcare. This bill improves the 
safety, development, and distribution of medications and medical 
devices to patients and medical providers.
  This bill reauthorizes the FDA's user fee program for prescription 
drugs and medical devices through fiscal year 2017. Further, it 
introduces a new user fee program for generic medications. These fees, 
collected from drug and medical device companies, will give the FDA the 
funding it requires to grant patients rapid access to the treatments 
they need. This will improve the accessibility of vital medicines to 
patients throughout the U.S.
  Mr. Speaker, this bill permanently reauthorizes two beneficial 
pediatric drug programs. The first, the Best Pharmaceuticals for 
Children Act, enhances the safety and availability

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of prescription drugs for children. It does this by providing 
mechanisms through which drug companies can test their products for use 
in pediatrics, and offering a six month patent extension as an 
incentive to companies who do so.
  The second pediatric drug program that is permanently reauthorized is 
the Pediatric Research Equity Act. This act increases the safety of 
prescription drugs for children by requiring pediatric testing of 
certain medications intended for adults in order to fully understand 
their effects. This will ensure that physicians have a clearer grasp of 
the effects these medications have before prescribing small dosages to 
children.
  This bill also provides for a vital update of the FDA's global drug 
supply chain authority, requiring drug importers to register with the 
FDA, and disallowing the import of medicines from organizations that 
have limited or denied inspections.
  Most importantly, the bill expands the jurisdiction of the Federal 
Food, Drug, and Cosmetic Act. This allows for the FDA to prosecute 
foreign violators of the act, and thus discourages such violations in 
the future. These updates will improve the safety of the prescription 
drugs that are provided to American patients.
  Finally, Mr. Speaker, this bill will implement new FDA requirements 
that will help to prevent drug shortages. The bill does this by 
updating the FDA's reporting policies for manufacturers, and ensuring 
that the agency maintains a drug shortage list that is made available 
to healthcare providers. Additionally, should a shortage still occur, 
this bill outlines steps to be taken to mitigate the problem. If 
enacted, these new policies will help protect the country's 
prescription drug supply, ensuring that Americans always have access to 
the medication they need.
  Mr. Speaker, it is for these reasons that I support H.R. 5651.

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