Endocrine Insider: May 26, 2016

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Advocacy News

Congress Begins Work on Appropriations Bills; NIH Funding Still in Jeopardy
Senate Announces Compromise Reached on Toxic Substances Control Act (TSCA) Reform Legislation

Research News

NIDDK Advisory Council Discusses Global Health, Evidence-Based Funding
Postdocs Covered in DOL Overtime Rule 


Advocacy News

Congress Begins Work on Appropriations Bills; NIH Funding Still in Jeopardy

FY 2017 spending bills are making their way onto the House and Senate floors slowly, but not without some controversy and veto threats. While Congress is required to pass spending bills by October 1, the start of the federal fiscal year, so far lawmakers have only tackled the less controversial of the 13 spending bills -- i.e. 2017 Military Construction-VA, Transportation-HUD, Energy & Water, etc. Political tensions are expected to mount as the more contentious bills such as Labor-HHS-Education, which includes NIH funding begin to emerge. The House and Senate Labor-HHS markups are expected in mid-June.

Take Action: If you have not already done so, please join the Endocrine Society's advocacy campaign to increase funding for NIH. Please visit our on-line advocacy center, enter your zip code, and our software will direct a letter to your congressional delegation.

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Senate Announces Compromise Reached on Toxic Substances Control Act (TSCA) Reform Legislation

On May 19 the Senate released a “near-final draft” of the “Frank R. Lautenberg Chemical Safety for the 21st Century Act.” This draft represents a heavily-negotiated compromise between competing legislation in the House and Senate and has gained broad bipartisan support, including the support of Sen. Barbara Boxer and Sen. Edward Markey who previously were leading opponents. The May 19 draft includes several improvements that the Endocrine Society advocated, for instance:

  • The bill requires EPA to consider vulnerable populations, such as pregnant women and children, where appropriate.
  • The bill limits the ability of companies to keep information on chemicals secret through confidentiality claims. 
  • The bill establishes a fee structure that allows EPA to collect fees from industry to carry out testing and regulatory activities, although these fees are likely to be short of what is needed.

The draft compromise, however, is weaker in other important areas. In particular, the bill includes a complicated section on preemption that is a significant weakening of existing law. As we understand it, EPA's decisions will preempt all existing and future state regulations (except monitoring and labeling) in order to create uniform regulations. The compromise would grandfather existing state preemption laws and states may apply for a waiver to enforce new restrictions while EPA conducts risk evaluations of high-priority chemicals. States may co-enforce regulations, but are prevented from regulatory activity while the EPA conducts a risk-assessment (unless states act quickly after a chemical is designated “high-priority”).  

While we are encouraged by areas of progress, there are still notable deficiencies in the bill, precluding our support of the legislation. Members of Congress will continue to push for last-minute changes to the bill, especially regarding state preemption. We expect the final bill will be brought to both chambers for a vote by the end of the week. The administration has expressed support for the bill; we therefore expect it will be signed into law shortly afterwards.  

We will keep members apprised of further developments. Previous comments by the Endocrine Society on efforts in the House and Senate to reform TSCA are available online.

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Research News

NIDDK Advisory Council Discusses Global Health, Evidence-Based Funding

On May 18, the National Diabetes and Digestive and Kidney Diseases (NIDDK) Advisory Council met. Society members Lee Kaplan, MD, PhD; Alan Saltiel, PhD; and Joel Elmquist, PhD, DVM, are members of the Council, which advises the Director of the NIDDK on research, support activities, and functions of the Institute.

During the open session of the meeting the Director of the Fogarty International Center (FIC), Roger Glass, MD, PhD, joined the Council to provide an update on the activities of the FIC. Dr. Glass discussed how global research priorities often impact domestic treatments, and highlighted the success of international training and research programs for young investigators. Dr. Glass also noted that diabetes and other endocrine diseases rank among the most compelling global diseases. For example, the prevalence of diabetes is increasing tremendously in southeast Asia as age structures and average body weights are changing rapidly. He predicted that the fastest growth in diabetes will be in the African continent over the next twenty years.  

The NIH Deputy Director for Extramural Research, Michael Lauer, MD gave a presentation on Evidence-Based Funding: Thoughts About Extramural Research. Dr. Lauer’s presentation examined how research is currently evaluated and supported in an era where the United States’ research budget as a percentage of gross domestic product (GDP) is decreasing. He noted that there is currently no “gold standard” for assessing value in biomedical research, and that publication records are not a perfect metric because, for example, different fields cite papers at different rates. Council discussed how to understand all the components and parties that contribute to drug development, and how to evaluate projects in light of the unpredictable nature of biomedical research.

During the open session of the Diabetes, Endocrinology, and Metabolism Subcouncil, Endocrine Society member and NIDDK Program Director Dr. Corinne Silva delivered an update on large, interdisciplinary team-science projects. Dr. Silva described how applications using the R24 grant mechanism would be transitioned to an RC2 mechanism and outlined the differences between the R24 and RC2, including larger budgets, shorter windows for revisions, pre-approval process through NIDDK divisions, and a second level of editorial board review. Council was supportive of the transition and encouraged NIDDK to use this mechanism to support transformative research programs. They suggested that NIDDK carefully populate the editorial board of reviewers so that the board appreciates the differences between RC2 projects and R01s.

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Postdocs Covered in DOL Overtime Rule

On May 18, the Department of Labor (DOL) announced updated regulations governing overtime pay for workers under the Fair Labor Standards Act. The updated rule will increase the salary threshold for workers exempted from overtime pay, and is also meant to simplify and modernize rules so that individuals and businesses can apply them fairly. According to the DOL summary, the final rule will:

  • Raise the salary threshold indicating eligibility from $455/week to $913 ($47,476 per year), ensuring protections to 4.2 million workers.
  • Automatically update the salary threshold every three years, based on wage growth over time, increasing predictability.
  • Strengthen overtime protections for salaried workers already entitled to overtime.
  • Provide greater clarity for workers and employers.

Importantly, while graduate students are not covered according to the guidance for higher education institutions, postdoctoral researchers are covered by the rule. This means that postdoctoral researchers will become eligible for overtime pay if their salary is less than $47,476 per year as of December 1, 2016. While the National Institutes of Health has expressed support for the new rule and will increase awards for NRSA recipients to levels above the threshold, others within the biomedical research community have expressed concern about the impact on already restricted grant funding. We are interested in hearing from members about the revised rule and how it will impact you. Please contact Joseph Laakso, Associate Director of Science Policy at jlaakso@endocrine.org.

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