U.S. Senate Introduces Bill to Increase Participation in Clinical Trials for Rare Diseases

September 16, 2009

Last night, the Senate followed the House’s lead in introducing legislation to allow patients with rare diseases to participate in clinical studies without losing their eligibility for government healthcare benefits.

“The CF Foundation applauds the Senate co-sponsors for introducing this vital bill to allow more people with rare diseases — including cystic fibrosis — to participate in clinical trials," said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation. “If successful, this legislation will help ensure swift advancement of life-lengthening and potentially lifesaving drugs from the research phase to the people who need them.”

Currently, Supplemental Security Income (SSI) rules require that compensation provided for participation in a clinical trial be counted as income when determining benefits.

Because Medicaid benefits are tied to SSI eligibility, patients who take part in clinical trials may be disqualified from receiving the government healthcare coverage. This penalty prevents many people with rare diseases from participating in clinical studies.

Researchers developing drugs to treat rare diseases like cystic fibrosis struggle to recruit participants for clinical trials because of limited patient populations. More than 30 promising CF drugs are in development, and about 30,000 people in the United States have the disease.

The bill is co-sponsored by Sens. James Inhofe (R-OK), Richard Durbin (D-IL), Richard Shelby (R-AL), Ron Wyden (D-OR), and Chris Dodd (D-CT).

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