[Congressional Record (Bound Edition), Volume 159 (2013), Part 12]
[Senate]
[Page 16914]
[From the U.S. Government Publishing Office, www.gpo.gov]




                              DRUG SAFETY

  Mr. REID. Mr. President, the symptoms of fungal meningitis can be 
very subtle at first: headaches, fever, even light can start bothering 
people, as well as neckaches and backaches. The disease can also cause 
strokes, seizures, and even coma.
  Fungal meningitis led to the death of at least 64 unfortunate 
Americans when they were injected with a contaminated medicine. The 
medicine--a steroid injection used to heal back pain--was tainted by 
unsanitary conditions from a facility that was masquerading as a 
compounding pharmacy in Massachusetts. The true compounding pharmacies 
provide custom-made medications for patients with unique health needs 
that cannot be treated by off-the-shelf prescription medicines. This 
practice is essential and can be critical for children, cancer 
patients, and people with severe allergies.
  The contaminated medicine mixed at the New England Compounding Center 
was sent to scores of medical facilities in 23 different States and 
given to 14,000 patients. As I have indicated, 64 of them died and 
hundreds of those patients were seriously ill.
  Recently a heart medication mixed at the same pharmacy was linked to 
the death of two young Nevada boys, ages 4 and 6, according to a 
lawsuit filed by their parents.
  The New England Compounding Center was skirting Federal regulations 
and manufacturing large batches of drugs for mass distribution in very 
unsanitary conditions. By avoiding the safety inspections required of 
large-scale drug manufacturers, companies such as this one can boost 
profits, but in the process they risk lives.
  The legislation on the floor will end that dangerous practice and 
ensure that patients have access to high-quality custom medications. 
This is not a contentious issue. On the contrary, this legislation has 
wide bipartisan support--led by Harkin and Alexander--and would pass by 
a wide margin in mere moments if not for the stall tactics by a few 
Republican Senators. This bill has already been delayed for more than a 
month because of these tactics, and Republicans continue to insist on 
running out the clock on this matter.
  As everyone knows, if all time is required on the procedural issues, 
we will not be able to finish the bill until this Sunday--that includes 
working Saturday--and the final 30 hours won't run out until sometime 
on Sunday. It is time to dispense with this noncontroversial measure--a 
measure that will safeguard the lives of vulnerable Americans, people 
with back pain and other maladies--and move on to other important 
legislative priorities.

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