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Obama Signs Clinical Trials Bill into Law

On October 5, 2010, President Obama signed the "Improving Access to Clinical Trials Act" or I-ACT (

S. 1674

, P.L. 111-255). The legislation was drafted to clarify that financial compensation patients receive to participate in clinical trials for rare diseases or conditions (as defined in section 5(b)(2) of the Orphan Drug Act, P.L. 97-414) would not be considered "extra income" for the purposes of determining eligibility for public assistance such as Supplemental Security Income (SSI) or Medicaid. The law excludes the first $2,000 of such compensation in determining eligibility for the benefits and becomes effective 180 days after enactment, unless the Commissioner of Social Security promulgates final regulations sooner.

The measure also directs the Government Accountability Office to conduct a study within three years to determine if the law affects the percentage of SSI beneficiaries enrolled in clinical trials for rare diseases or conditions, as well as the average amount of compensation such beneficiaries receive. The law is set to expire after five years.

In a joint statement, the sponsors of the legislation, Senators Ron Wyden (D-Ore.) and Jim Inhofe (R-Okla.) described the benefits of the law. Senator Inhofe observed, "Clinical trials for those suffering with rare diseases, provides hope, better understanding of the disease, and possible life-saving treatment for both themselves and others suffering from the same disease." Senator Wyden noted, "To force someone with a rare disease to choose between the treatment that could save their life or Medicaid and SSI is unfair, uncompassionate and thankfully, because of this bipartisan health care legislation, will be a thing of the past." A bipartisan group of 20 other senators had joined the two as co-sponsors.

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