H.R. 348 RAPID Act:

H.R. 348 would reform the review process for the environmental impact of federally-funded construction projects. The goal of these reforms would be to streamline the review process under the National Environmental Policy Act, or NEPA. The bill also would prohibit the consideration of the “social cost of carbon” in any environmental review or decision making process.

Only seven Democrats voted in favor of the bill. You can find them here.

It was passed in the House by a partisan vote of 233–170, with Republicans voting in favor and Democrats voting against, and it goes to the Senate next. The Obama Administration issued a veto threat on the previous incarnation of the bill which passed the House in March 2014.

National Environmental Policy Act and the Review Process

NEPA requires all federal agencies to determine the expected environmental impact of any project and consider alternative strategies to reduce impact. Agencies must prepare statements of these costs. It also established the President’s Council of Environmental Quality to oversee these statements and ensure federal agencies meet their obligations under the act.

The requirements of NEPA tend to prolong and increase the cost of federal projects that are likely to have high environmental impact. Federally funded construction or energy projects are examples. Rep. Tom Marino (R-PA10), sponsor of H.R. 348, wrote in a press release, that delaying projects and increasing costs can have a negative economic impact. Reducing the rate of federal construction and infrastructure projects prevents those projects from hiring employees. Republicans and Democrats disagree about how to maximize job growth while minimizing environmental damages. Rep. Marino and the Republican party believe that H.R. 348 will increase the efficiency of NEPA to promote job growth. Democrats disagree, claiming the bill would only cripple the review process without actually improving efficiency.

Social Costs of Carbon

A prominent subject of controversy for H.R. 348 is the prohibition of consideration of the social cost of carbon from environmental reviews of federal projects. The cost is calculated by the expected economic damages of the increase in carbon dioxide emission from the federal project. Republicans have previously criticized the cost as wasteful, arguing that the calculation is too speculative to warrant the impact it has on federal projects. Democrats and environmentalists, however, assert it is necessary to compensate for the economic costs associated with global warming and to discourage further emissions.

Ensuring Access to Clinical Trials Act:

There are 30 million Americans living with what S. 139 calls “rare diseases or conditions.” It is difficult enough facing such disorders, but it can be even more difficult finding those willing to participate in clinical trials to provide information, treat and perhaps even cure these conditions.

The definition of “rare disease” in the U.S. is “any disease or condition where the prevalence is less than 200,000 patients.” In an interview in pharmaphorum Yaffa Rubenstein, of the Office of Rare Diseases Research (ORDR), explained there are “…more than 6,800 rare diseases known today.”

On September 28, 2015, Congress maintained federal support for the participation of low-income Americans in clinical trials for these conditions. The bill, titled “Ensuring Access to Clinical Trials,” includes renewal of the Improving Access to Clinical Trials Act of 2009, which allows compensation for participation in clinical trials to those on Supplemental Security (SSI) and Medicaid. The Improving Access bill directs that “the first $2,000 per year received by individuals who participate in clinical trials for rare diseases or conditions” are not counted against the individual’s eligibility for SSI and Medicaid benefits.

The bill has passed both the House and Senate and heads to the President for a likely signature.

Trial participants

Finding clinical trial participants is a growing challenge. According to the Tufts Center for the Study of Drug Development, clinical trial enrollment rates overall have dropped 20 percent since 2000, with only 2 million volunteers now participating, thereby creating elongated timelines in 85 percent of trials.

Lack of financial reimbursement is often a major turn-down factor, especially among the low-income population. In a research report, Joseph M. Unger, PhD, a health services researcher and statistician with the Fred Hutchinson Cancer Research Center in Seattle, wrote that “patients whose income was less than $20,000 a year were 44% less likely to participate in a clinical trial” than higher-income patients.

For example, less than 5% of adult cancer patients participate in cancer trials, according to one study with the National Cancer Institute’s (NCI) State Cancer Legislative Database. These include few participants among those with low income, those in rural areas, those without some form of health insurance, those age 65-plus and others often overlooked.

The NCI study concluded: “Increasing the participation of underrepresented groups in clinical trials is a national research objective.”