Endocrine Insider: September 1, 2016

Printable Version

Past Issues


Advocacy News

NIH Funding in Jeopardy; Take Action TODAY to Urge Congress to Pass Funding Bill

Endocrine Society Continues Work on Personal Care Products Safety

Endocrine Society Weighs in on TSCA Implementation

Clinical News

FDA Workshop Looks at Outcomes Beyond A1c

Research News

New Director of NICHD Named

Five Common Myths about FDA and Women's Health


Advocacy News

NIH Funding in Jeopardy; Take Action TODAY to Urge Congress to Pass Funding Bill

When Congress returns to DC on September 6, they will have less than a month to pass a funding bill to keep federal agencies operating after fiscal year 2016 ends on September 30. Because of partisan gridlock, the Congress is not expected to do that, but it can still prevent a shut-down of the federal government by passing a stop-gap funding bill known as a “Continuing Resolution (CR).” Fiscally conservative Republicans are expected to demand a six-month CR to fund the government through March 2017. Several conservatives also said they would accept the $1.067 trillion overall spending level that was agreed to last fall (instead of seeking additional spending cuts) if the CR runs through March. Democrats prefer a much shorter CR so that Congress will have to come back after Election Day to pass an omnibus appropriations bill that will finalize the 2017 agency budgets. It’s possible that the CR may also include emergency funding to address Zika, the opioid crisis, or other issues.

What’s at Stake: Under a CR, NIH will not fund new projects and probably will not release the full amount of awarded grant funds. A CR through March also jeopardizes the bipartisan $2 billion increase for NIH that the Senate Appropriations Committee approved in June. We must let Congress know that a long-term CR will be very harmful to the research community and convince lawmakers to pass an omnibus appropriations bill by the end of this year.

Take Action: To make our voices heard on Capitol Hill, the Endocrine Society is planning the following advocacy activities in September:

  • E-Action Alert: to generate emails to Congress urging them not to adopt a long-term CR and to focus on passing an omnibus spending bill. Please respond to the alert that will be sent on September 6 or take action today by visiting our campaign. Taking action is quick and easy. Click to access the campaign, and a pre-written letter will be provided for you. You will only need to either provide your email and member ID, OR enter your address information so that the system will send your message to the correct recipients.
  • NIH Advocacy Toolkit: to provide Society members with several ways to share our message about the importance of NIH funding. Our toolkit includes information to help Society members use social media, write op-ed articles, share their story, etc. Please visit the NIH Advocacy Toolkit today.
  • Rally for Medical Research: to visit Congress and share our message. Members of the Advocacy and Public Outreach Core Committee will be coming to DC to participate in a Rally for Medical Research with other members of the research community on September 22. We will be visiting Members of Congress and urging them to support NIH.

(back to top)

Endocrine Society Continues Work on Personal Care Products Safety

As mentioned previously in Endocrine Insider, the Society is working with the Senate on bipartisan legislation introduced by Senators Dianne Feinstein (D-CA) and Susan Collins (R-MA) known as the Personal Care Products Safety Act (S. 1014). If passed, this bill would amend the Federal Food, Drug, and Cosmetic Act to allow the FDA to collect information on the ingredients of personal care products and prohibit distribution of a personal care product if an ingredient could cause serious adverse health consequences. It would also require the FDA to review the safety of at least five cosmetic ingredients each year.

On August 30-31, the Society participated in a Hill Day with other supporters of the bill, including several cosmetic companies. We met with staff from the offices of Senators Michael Bennet (D-CO), Chuck Schumer (D-NY), Lamar Alexander (R-TN), Sheldon Whitehouse (D-RI), and Patty Murray (D-WA). During the meetings, we learned that the bill faces an uncertain future, as the short work period before the election will prevent action on many pending bills in the Congress.

Take Action: It is important that all Senators hear from their constituents. Please join our online campaign to urge Senators to support S. 1014 so that the Congress will prioritize reform of personal care products. Joining our campaign is quick and easy. Click to access the campaign, and a pre-written letter will be provided for you. You will only need to either provide your email and member ID, OR enter your address information so that the system will send your message to the correct recipients.

(back to top)

Endocrine Society Weighs in on TSCA Implementation

As reported previously in Endocrine Insider, the Endocrine Society has been engaged in reform of the Toxic Substances Control Act and is closely following implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act. On August 22, the Endocrine Society submitted comments to the EPA with recommendations to address deficiencies in the existing regulatory approach.

Our recommendations included the following:

  • EPA should develop a consistent approach and criteria that is applied in the same way to all studies in the risk assessment and chemical prioritization processes. This includes peer-reviewed academic literature.
  • The term “Weight of Evidence” (WOE) should explicitly refer to a systematic review method that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently, identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based on strengths, limitations, and relevance.
  • WOE approaches should also ensure that the EPA consider academic studies fully along with any other category of evidence.
  • The default approach for evaluating risks from chemicals should be that there are risks at low doses and that a dose at which there is no effect must be proven.

Implementing these recommendations will ensure that EPA is able to consider the latest scientific studies when making regulatory decisions to protect the public from harms due to EDC exposures. For more information on the Society’s comments, please see the full letter here. The Endocrine Society will continue to engage with EPA as it continues the development of guidance documents towards the full implementation of the new law.

(back to top)

Clinical News

FDA Workshop Looks at Outcomes Beyond A1c

The Food and Drug Administration (FDA) conducted its first public workshop on the potential to consider other criteria beyond A1c when reviewing drug applications. The workshop was attended by over 900 people at the FDA campus or through a webcast, and included speakers from the FDA, patient community, and pharmaceutical companies. Among these stakeholders, there appears to be widespread support for consideration of time-in-range, hypoglycemic events, and quality-of-life factors. By including these criteria in clinical trials, pharmaceutical companies will have greater latitude to include relevant information beyond A1c reduction on product labeling, thereby allowing providers and patients the opportunity to individualize their treatment based on factors most important to the patient. The workshop concluded with a commitment to bring these stakeholders together again determine how these outcomes can be included in FDA decision-making.

We are supportive of efforts to include all of these criteria in future trials and regulatory review and have been working with JDRF across the past two years on their initiative to gain consensus in the community on outcomes beyond A1c. We look forward to working with the FDA as they move forward with their efforts.

The recording of the full meeting can be viewed through diaTribe’s Facebook page.

(back to top)

Research News

New Director of NICHD Named

Francis Collins announced Diana W. Bianchi, M.D., as the new director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). Her first day on the job is expected to be Oct. 31, 2016. Dr. Collins said of the appointment:

"Diana's accomplishments as a prenatal geneticist, along with her leadership, clinical and research experience in both pediatrics and obstetrics, make her ideally suited to lead NICHD. We are excited to have her join our team and lead this important area of research.

(back to top)

Five Common Myths about FDA and Women’s Health

FDA looks for sex differences when reviewing products and works to address sex differences and women’s health through our research, guidance for industry, scientific meetings, trainings, and other activities. Check out the latest OWH blog that counters common myths about FDA’s women’s health efforts.

Read the “Busting 5 Common Myths about FDA and Women’s Health” blog post.

(back to top)