[Congressional Record Volume 153, Number 145 (Thursday, September 27, 2007)]
[Extensions of Remarks]
[Pages E2005-E2006]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




   H.R. 2900, THE FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007

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                           HON. MIKE FERGUSON

                             of new jersey

                    in the house of representatives

                      Thursday, September 27, 2007

  Mr. FERGUSON. Madam Speaker, I rise today to express my strong 
support for the passage of the Food and Drug Administration Amendments 
Act of 2007 (FDAAA). This critical piece of legislation reauthorizes 
the Prescription Drug User Fee Act (PDUFA) and provides the Food and 
Drug Administration (FDA) with additional resources to further promote 
and protect the public health. The FDAAA reinforces and expands FDA's 
comprehensive authority in all aspects of drug regulation--including 
with respect to drug safety and labeling--and takes the nation's drug 
safety system, which is already the most rigorous, and makes it even 
stronger. I commend my colleagues and their dedicated staff on both 
sides of the aisle who worked tirelessly to ensure that this bill was 
completed in a bipartisan manner before the September 30, 2007 
expiration of the existing PDUFA program.
  The funds from PDUFA are used to allow FDA to hire additional staff 
to perform its critical drug review functions while maintaining the 
same exacting standards for safety and efficacy. Additional funding 
provided as part of FDAAA will allow the FDA to expand drug safety 
monitoring, hire additional staff for post-market surveillance, and 
modernize its information technology systems. Expanded resources will 
also enable FDA to hire additional employees to review broadcast drug 
advertisements prior to public dissemination, helping to ensure that 
benefits and risks of prescription drug products are clearly and 
accurately communicated to the public. The legislation creates strong 
incentives for companies to submit

[[Page E2006]]

such advertisements to the FDA before they are aired.
  In passing the FDAAA, Congress also reauthorizes the Best 
Pharmaceuticals for Children Act (BPCA) and the Pediatric Research 
Equity Act (PREA), both of which were set to expire on September 30. 
Since its original passage, the BPCA has done more than any other 
initiative to generate vital information about the use of medicines in 
pediatric populations and to promote research on the use of 
pharmaceutical products in children. The BPCA and PREA were designed to 
work in tandem to promote and support pediatric research. Therefore, it 
is critical that these two programs remain linked, as they are in the 
FDAAA.
  Since its original enactment in 1992, PDUFA has been a resounding 
success. It has enabled the timely review of new medicines while at the 
same time preserving FDA's strict and objective review process. As a 
result, more than 1,000 new medicines have been made available to 
patients over the past 15 years. These medicines have helped millions 
of people lead healthier, more productive lives, and contributed to a 
longer life expectancy than ever before. By reauthorizing PDUFA and 
passing the drug safety enhancements contained in the FDAAA, Congress 
has helped to ensure FDA's continued role as the authority on drug 
safety and drug regulation.

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