The “Improve Access to Clinical Trials Act” was introduced to congress on June 15 in an effort to allow participation in clinical trials by patients with rare diseases. The legislation is co-sponsored by Representatives Edward J. Markey (D-Ma) and [removed]Cliff Stearns (R-Fla)[/removed] and nearly 30 members of the House of Representatives.
According to the Cystic Fibrosis Foundation < www.cff.org > (CFF), “Current law prevents many people who receive Supplemental Security Income (SSI) from accepting research compensation because it would make them ineligible to continue receiving government medical benefits. This financial penalty prevents significant numbers of people with rare diseases from participating in clinical studies.”
This also causes difficulty for researchers developing drugs for rare diseases by causing a struggle to recruit participants for clinical trials among already limited patient populations. Currently, more than 30 cystic fibrosis (CF) drugs are in development, according to the CFF, but only about 30,000 people in the United States have this life-threatening, genetic disease.
“Clinical research is critical to our progress towards curing rare diseases such as cystic fibrosis, especially at a time of tremendous opportunity and hope in medical research. Current SSI eligibility rules are forcing patients to choose between participating in important clinical trials and keeping their SSI benefits — a cruel choice no one should ever have to make." said Markey in an announcement from the CFF. "The bi-partisan Improving Access to Clinical Trials Act will encourage patients suffering from rare diseases to participate in promising clinical research that may lead to cures, better treatments, and ultimately, saved lives, without having to worry that they could lose the SSI benefits they depend on.”
“As the Co-Chair of the Congressional Cystic Fibrosis Caucus, I am honored to be the lead Republican sponsor of this legislation, which will help ensure that individuals suffering from rare and life-threatening diseases, such as cystic fibrosis, can participate in vital clinical trials that will lead to new treatments and cures for these diseases,” said Stearns.