[Congressional Record Volume 154, Number 84 (Wednesday, May 21, 2008)]
[Senate]
[Page S4625]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. BROWNBACK (for himself, Mr. Casey, Mr. Coleman, Mr. 
        Specter, and Mr. Inhofe):
  S. 3046. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
create a new conditional approval system for drugs, biological 
products, and devices that is responsive to the needs of seriously ill 
patients, and for other purposes; to the Committee on Health, 
Education, Labor, and Pensions.
  Mr. BROWNBACK. Mr. President, I rise to speak about a bill I 
introduced today: the Access, Compassion, Care and Ethics for 
Seriously-ill Patients Act, ACCESS, Act. I would like to thank the 
original Senate cosponsors: Senators Bob Casey, Norm Croleman, Arlen 
Specter and James Inhofe. I also especially thank Representative Dianne 
Watson who will be introducing the companion bill in the U.S. House of 
Representatives.
  In the current era, certain cancers and other chronic diseases touch 
the lives of almost every American. If you have had the experience of a 
family member or friend struggling with terminal illness, you were 
probably aware of their need and limited timeline to access promising 
treatments. Unfortunately, the current system often does not work for 
the benefit of terminally-ill patients--during emotionally-charged 
times, patients and their families may face regulatory and bureaucratic 
hurdles if they wish to access investigational treatment options in 
order to preserve their lives. Many terminally-ill patients exhaust 
their treatment options and do not qualify for a clinical trial. They 
also do not physically have months to wait for an individual 
investigational treatment application to be approved.
  In this day and age of scientific breakthroughs, we must embrace 
these advances and do so with a ``patient-centered'' mindset. 
Terminally-ill patients often reach a point where the potential 
benefits of these breakthrough treatments outweigh their inevitable 
risk of death from their disease.
  I introduced the ACCESS Act to offer these patients an ethical 
option--compassionate access to treatments that show promise earlier in 
the drug development process. The average time for a treatment to go 
through the entire FDA approval process is 15 years. As a result, the 
current system tends to benefit future generations of patients with 
life-threatening diseases, rather than patients of the present time.
  The ACCESS Act offers a new Compassionate Investigational Access 
approval system for treatments showing efficacy during clinical trials, 
for use by the seriously-ill patient population. Seriously-ill patients 
who have exhausted all alternatives and are seeking new treatment 
options, would be offered access to these treatments with the consent 
of their physician. This bill also improves upon the existing 
accelerated approval system, using a patient-centered framework. The 
ACCESS Act also makes a technical correction that will increase patient 
access to drugs used off-label to treat life-threatening diseases.
  I ask my colleagues to join me in supporting the ACCESS Act that 
would offer patients, with little hope, a chance at life.
                                 ______