[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 10910-10911]
[From the U.S. Government Publishing Office, www.gpo.gov]




                          FDA REAUTHORIZATION

  Mrs. MURRAY. Mr. President, all of us in the Senate share the same 
goal of making sure the Food and Drug Administration stays as the gold 
standard for drug safety and effectiveness, and

[[Page 10911]]

the legislation that is before the Senate today moves us toward that 
goal.
  Throughout our country, researchers, scientists, and doctors are 
making 21st century medical advances, and the legislation we are 
looking at will ensure we have a 21st century FDA. It provides the 
resources, the authority, and the oversight to ensure that safe drugs 
move from the lab to our medicine cabinets without delay.
  Like other Members of the Senate, I worked on the FDA reforms back in 
the 1990s. Those reforms responded to the challenges we faced then. The 
bill before us now responds to the challenges we face today.
  In recent years, we have seen a lot of problems at the FDA with drug 
approval and postmarket surveillance. The bill we have addresses those 
challenges and ensures the FDA has the resources and the tools to 
promptly and thoroughly review new drugs and medical devices.
  The bill reauthorizes and improves two pieces of legislation that 
will be critical in providing a timely review process. It creates a new 
system to actively monitor drugs after they have been approved by the 
FDA. It strengthens science at the FDA and, importantly, improves 
transparency. It improves oversight and information about clinical 
trials, and it works to prevent potential conflicts of interest among 
advisory committee members.
  Like many Americans, I was shocked at the recent revelations 
concerning drugs that posed risks to public safety but remained on the 
market for far too long. This legislation moves to address those 
concerns by instituting strong, new protections, including postmarket 
studies that will be made available to the public. I believe this new 
transparency and vigorous oversight is the right path toward restoring 
public confidence in the FDA.
  The bill takes critical steps also to improve medical care for our 
children. The Best Pharmaceuticals for Children Act that is included in 
this bill uses incentives and regulations to put America's children 
first. It builds upon the legislation we enacted back in 1997 that 
ensures pediatric medicine is a priority and that information on 
pediatric drugs is readily available. It extends and improves a program 
that has undertaken nearly 800 studies and has helped to provide 
pediatric labeling information for 119 drugs.
  The Pediatric Research Improvement Act included in this bill is 
another critical component of improving pediatric care. It provides 
needed safety measures through mandatory clinical trials. It will help 
to continue pediatric oversight programs that have required trials for 
more than 1,000 pediatric drugs since 1998. All too often, doctors are 
not given guidance on the proper dose of prescription drugs for 
children. This bill is going to eliminate that guesswork so our 
children get the right doses for safer, more effective treatment.
  The bill also provides help to our Nation's children through the 
Pediatric Medical Devices Safety and Improvement Act. Every year, we 
see these wondrous technological improvements in medical devices. 
However, sometimes those improvements do not account for the needs of 
the children and the pediatricians who treat them. What that means is 
essential, often lifesaving devices do not meet the size or the scope 
or the needs of sick children. This bill will push manufacturers to 
develop and produce devices that are safe and effective for children 
and infants. Through incentives and investor outreach, this bill will 
ensure that exciting advances in lifesaving devices are not just 
limited to adults.
  This legislation also delivers greater safety while providing better 
access. I believe it will improve the way we deliver safe innovative 
health care in America, and it is really my hope it will also begin to 
restore confidence in the institutions that safeguard our public 
health.
  The American public deserves nothing less than the gold standard of 
care from our FDA. When a nervous parent or worried senior visits their 
corner pharmacy, they deserve to know the product they buy on that 
shelf has been approved by a thorough and complete process. When a 
patient begins to take a new drug, they deserve a system that has 
actively tracked that drug and provides the patient with information on 
any risks they might face. Everyone--drug companies, researchers, 
patients, and doctors alike--deserves a system that supports an 
efficient and timely FDA approval process.
  So I am very eager to move this legislation forward and get it to a 
vote so we can begin to deliver what the American people deserve. I 
hope this Senate moves quickly on this bill and we are able to move it 
along in the process very shortly in the Senate.
  Mr. President, I yield the floor.
  The ACTING PRESIDENT pro tempore. The Senator from Ohio is 
recognized.

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