'Improving Access to Clinical Trials Act' Passes U.S. Senate in Victory for CF Advocates

/PRNewswire/ -- The U.S. Senate last night passed the "Improving Access to Clinical Trials Act" (I-ACT), a bipartisan piece of legislation championed by the Cystic Fibrosis Foundation, its advocates and 120 other health advocacy organizations.

The legislation enables patients with rare diseases to participate in clinical trials without losing eligibility for public healthcare benefits.

"We are one step closer to breaking down a serious barrier to participation in clinical trials, which one day could deliver a cure for cystic fibrosis," said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation. "This legislation represents an important opportunity for people with CF to take part in groundbreaking research that was previously out of their reach. We are elated that this bill has been approved by the Senate."

The legislation was introduced by Senator Ron Wyden, D-Ore., with Senators Chris Dodd, D-Conn., James Inhofe, R-Okla., Richard Shelby, R-Ala., Dick Durbin, D-Ill. as original co-sponsors and an additional 14 co-sponsors also signed on.

Current law prevents many people who receive Supplemental Security Income (SSI) from accepting research compensation because it makes them ineligible to receive government medical benefits. This penalty has stopped significant numbers of people with rare diseases from participating in clinical studies.

Following Senate approval, the bill now awaits consideration by the U.S. House of Representatives. Reps. Edward Markey, D-Mass., and Cliff Stearns, R-Fla., are leading the effort to pass the bill in the House. The legislation, HR 2866, is co-sponsored by 135 members.

Passage of this legislation is particularly important for people with CF, a rare genetic disease that affects 30,000 people in the United States. A limited patient population makes it challenging to find enough people to participate in research studies evaluating the effectiveness of promising new drugs.

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