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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