[Congressional Record (Bound Edition), Volume 153 (2007), Part 18]
[Senate]
[Page 25357]
[From the U.S. Government Publishing Office, www.gpo.gov]


              FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT

  Mr. ALEXANDER. Mr. President, last week the Senate passed H.R. 3580, 
the Food and Drug Administration Amendments Act of 2007, and sent it on 
to the President for his signature. This is the biggest drug safety 
reform in a decade, and I was proud to support it. Among other things, 
this legislation will help the FDA do a better job approving and 
monitoring prescription drugs and medical devices, encourage the 
research and development of medical treatments for children, and 
provide needed resources to the FDA.
  I am very pleased that the incentive which encourages more studies of 
medicines in children was preserved in the final version of this bill. 
Over the last 10 years, this program has helped provide worried parents 
and concerned physicians with information they need to make better 
decisions in prescribing treatment for young children. By extending 
drug patents in exchange for additional research on how these drugs 
affect children, this program has prompted studies on 144 products and 
led to 122 label changes on some of the most frequently prescribed 
medicines for children. Clearly the system works and should be 
continued, especially since to date only a third of drugs prescribed to 
children have been studied and labeled for children.
  I also am pleased that this legislation reinforces FDA's broad 
authority over prescription drug labels. Under current law, States are 
preempted from substituting their judgment for the FDA's scientific 
decisions based on exhaustive reviews of clinical data. If this weren't 
the case, medicine labels would become so overwhelmed with warnings 
designed to avert lawsuits that most Americans will simply stop paying 
attention to them.
  Additionally, Congress has decided to give FDA the authority to make 
expedited labeling changes, so that when prescription drug safety 
problems are identified the FDA and drug manufacturers can work 
together to quickly update product labels to ensure that the American 
people have the latest safety information. If a drug manufacturer comes 
to the FDA in good faith to discuss the possible need for an expedited 
labeling change--and if the FDA does not respond in a timely manner or 
decides that the science does not require a labeling change--then that 
drug manufacturer should not be subject to frivolous lawsuits.
  I am pleased that Congress came together in a bipartisan manner to 
approve this legislation. It can serve as a model for how the parties 
can come together to pass other meaningful bills during the remainder 
of the 110th Congress.

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