[Congressional Record (Bound Edition), Volume 158 (2012), Part 7]
[Extensions of Remarks]
[Page 10201]
[From the U.S. Government Publishing Office, www.gpo.gov]




         FOOD AND DRUG ADMINISTRATION SAFETY AND INNOVATION ACT

                                 ______
                                 

                           HON. ANNA G. ESHOO

                             of california

                    in the house of representatives

                        Wednesday, June 27, 2012

  Ms. ESHOO. Mr. Speaker, I rise today to speak in support of H.R. 
5651, the Food and Drug Administration Safety and Innovation Act, to 
reauthorize the Prescription Drug User Fee Act and the Medical Device 
User Fee Act. These critically important laws have improved patient 
access to important therapies and expedited the FDA's approval times 
while upholding the most rigorous standards for patient safety.
  The Prescription Drug User Fee Act, PDUFA, was enacted in 1992 when 
drug review times were lagging and FDA simply couldn't keep up with the 
flood of new drug applications. Through user fees paid by applicants, 
the FDA gained resources it needed to hire and support more staff. The 
program has been successful at reducing review-time backlogs, and 
expediting safe and effective therapies to patients.
  Along with faster drug approvals, Congress also recognized the need 
to study drugs in children. As the original author of the Best 
Pharmaceuticals for Children Act, BPCA, and the Pediatric Research 
Equity Act, PREA, I'm proud of how successful these programs have been 
in treating children, resulting in new dosing information, new 
indications of use, new safety information, and new data on 
effectiveness. Before BPCA and PREA, the vast majority of drugs, more 
than 80 percent, used in children were used off-label, without data for 
their safety and efficacy. Today, that number has been reduced to 50 
percent.
  We know that children are not just small adults. They have unique 
medical needs and drugs react differently in their bodies. That's why 
in this year's reauthorization, it was important for us to look at 
areas in need of improvement. The bipartisan legislation gives FDA the 
tools it needs to ensure companies are thinking about pediatric 
populations as early as possible in the drug development process, and 
that they're able to enforce timelines that are routinely missed. The 
language encourages further study into untested age groups, like 
neonates, and clarifies any confusion over what some see as 
``loopholes'' to allow companies to access the market exclusivity 
incentive without completing additional studies.
  The legislation also ensures that companies routinely submit their 
pediatric plans earlier in the process by establishing a clear timeline 
and expectations.
  I thank my House colleagues, Representatives Mike Rogers and Edward 
Markey who have worked very hard with me to improve these programs. I 
applaud the bipartisan and bicameral efforts of the House and Senate 
staffers who were able to combine the bills from both chambers to 
produce strong consensus language that has broad support from Members 
and stakeholders.
  I have confidence that the bill we vote on today will improve BPCA 
and PREA to benefit children for generations to come, and I urge my 
colleagues to support it.

                          ____________________