[Congressional Record (Bound Edition), Volume 154 (2008), Part 12]
[Senate]
[Page 16695]
[From the U.S. Government Publishing Office, www.gpo.gov]




                               ACCESS ACT

  Mr. BROWNBACK. Mr. President, I rise to speak about S. 3046 and H.R. 
6270, the Access, Compassion, Care, and Ethics for Seriously Ill 
Patients Act or ACCESS Act. The intent of this bipartisan, bicameral 
legislation is to expand access to investigational treatment options 
for patients with serious or life-threatening diseases.
  A provision of the ACCESS Act provides for three requirements for a 
patient to become eligible for access to investigational treatments 
that have completed at least phase one of the clinical trials process, 
labeled as compassionate investigational access, CIA. The second of the 
three requirements provides that a physician document in writing that a 
seriously ill patient has exhausted all treatment options approved by 
the Secretary for the condition or disease for which the patient is a 
reasonable candidate. For this particular provision, the intent of the 
congressional sponsors of the ACCESS Act is that a patient has 
examined, not necessarily tried, all Food and Drug Administration-
approved treatment options for which the patient is a reasonable 
candidate.
  Accordingly, it is not the intent of the congressional sponsors of 
the ACCESS Act that a seriously ill patient has tried every combination 
of treatments for which the patient is eligible before the patient is 
granted compassionate investigational access or expanded access to the 
investigational treatment. Moreover, it is not the intent of Congress 
that the seriously ill patient has exhausted every treatment option for 
which the patient is a reasonable candidate where a treatment option is 
known to have severe negative side effects.
  The ACCESS Act will ensure that a patient with a serious or life-
threatening disease has access to the largest scope of treatment 
options available to the patient and their doctor. I encourage my 
colleagues to join me in cosponsoring this important piece of 
legislation.

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