[Congressional Record Volume 158, Number 98 (Wednesday, June 27, 2012)]
[Extensions of Remarks]
[Pages E1147-E1148]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




         FOOD AND DRUG ADMINISTRATION SAFETY AND INNOVATION ACT

                                 ______
                                 

                               speech of

                         HON. CHRIS VAN HOLLEN

                              of maryland

                    in the house of representatives

                        Wednesday, June 20, 2012

  Mr. VAN HOLLEN. Mr. Speaker, I rise in support of S. 3187, as 
amended, the Food and Drug Administration Safety and Innovation Act.
  I am proud to represent many of the hard working employees at the 
Food and Drug Administration (FDA), and this legislation provides them 
with the resources to fulfill FDA's mission to protect and advance 
public health and safety. This bipartisan legislation enables FDA to 
review drugs and medical devices in a

[[Page E1148]]

timely fashion, reduces costs by authorizing a new user fee program for 
generic drugs, and takes important steps to prevent and mitigate 
critical drug shortages.
  As the co-chairman of the Childhood Cancer Caucus, I am pleased that 
this legislation contains several provisions that will facilitate the 
development of safe and effective childhood cancer treatments. The 
legislation makes permanent two key complementary pediatric drug 
programs--the Best Pharmaceuticals for Children Act (BPCA) and the 
Pediatric Research Equity Act (PREA). Both of these programs foster the 
development of prescription drugs for children and the safe use of 
drugs by children. Finally, I am pleased that this legislation 
incorporates the Creating Hope Act, which I introduced with 
Representatives McCaul, Butterfield, and Myrick. Under this incentive 
program, a pharmaceutical company that develops a drug specifically to 
treat a rare pediatric disease will be rewarded with a priority review 
voucher for another drug. I'm hopeful that this program will kick start 
private sector investment in new and innovative treatments for children 
and families affected by cancer.
  I strongly urge my colleagues to support S. 3187 to provide FDA the 
resources it requires to guarantee the safety of American's 
prescription drugs and medical devices.

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