Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 29 September 2015 | By Zachary Brennan
Late Monday evening, the House of Representatives cleared the final congressional hurdle for a bill that would compensate individuals who participate in clinical trials for rare diseases.
If signed by President Barack Obama, the legislation -- the Ensuring Access to Clinical Trials Act of 2015, which passed the Senate in July -- would enable those with rare diseases to receive compensation of up to $2,000 for participating in clinical trials without having the compensation be counted as income when calculating eligibility for Supplemental Security Income (SSI) and Medicaid.
The short, two-page bill would permanently allow this exclusion by making permanent the Improving Access to Clinical Trials Act of 2009, which is scheduled to expire in October.
If the bill is not signed into law, some people with rare diseases who receive SSI and Medicaid may end up not participating in clinical research because of the fear that the compensation received would make them ineligible to receive government medical benefits.
In a statement, the Cystic Fibrosis Foundation celebrated the House's passage of the bill, saying it will remove barriers for clinical trial participants with rare diseases, including cystic fibrosis.
In addition to the CF Foundation, 75 patient, industry, academic and medical organizations support the Ensuring Access to Clinical Trials Act, including the National Organization for Rare Disorders, the Muscular Dystrophy Association and the industry group Biotechnology Industry Organization.
The bill was introduced by Sens. Ron Wyden (D-OR), Orrin Hatch (R-UT), Sherrod Brown (D-OH) and Edward Markey (D-MA) in the Senate, and by Reps. Lloyd Doggett (D-TX), Tom Marino (R-PA) and James McGovern (D-MA) in the House.
Text of the Bill
Tags: clinical trials, House, Senate, clinical trials legislation