Legislation Provides Increased Access to Trials, Offers New Hope for Cures to Diseases
WASHINGTON
(September 23, 2010) – Legislation that will open up access to clinical
trials for diseases like Cystic Fibrosis to low-income and other
patients today passed the House of Representatives, clearing the way for
President Obama’s signature to make the bill law. The legislation was
authored in the House by Reps. Edward J. Markey (D-Mass.) and Cliff
Stearns (R-Fla.), co-chairs of the Congressional Cystic Fibrosis Caucus,
and Sen. Ron Wyden (D-OR) in the Senate. It would exclude the
compensation that patients receive from participating in clinical trials
for rare diseases from Supplemental Security Income and Medicaid income
threshold rules, so that this modest compensation given to patients for
their participation in these trials will not count against their
eligibility in these programs.
“This bill will ensure that no
patient will have to choose between their health benefits and the
promise of a clinical trial,” said Rep. Markey. “If we want to increase
the chances of finding cures to diseases like Cystic Fibrosis, we also
need to increase participation in these trials. This legislation gives
low-income people a higher probability to help advance medical science,
and helps save lives in the process, hopefully including their own.”
The
legislation, the Improving Access to Clinical Trials Act, would exclude
up to $2,000 in compensation a patient receives from a clinical drug
trial from his or her income calculation for SSI and Medicaid
eligibility. The Congressional Budget Office has determined that the
bill has no cost to the federal government.
The bill only applies
to rare disorders, which are defined as diseases affecting less than
200,000 people in the United States. There are currently more than 6,000
rare disorders that, taken together, affect approximately 25 million
Americans. Examples of rare diseases include ALS, Crohn’s Disease,
Cystic Fibrosis, Huntington’s Disease, and Parkinson’s Disease.
“Research
is the 'Field of Dreams' from which we harvest the cures to diseases
that devastate individuals and their families,” said Rep. Markey.
“With passage of this bill we will provide a boost to research and
clinical trial participation for rare disorders without a cost to the
federal government.”
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