What’s Happening in Washington:
While much of the country’s attention has been on the continuing Supreme Court Justice confirmation, Congress worked on the following health-related legislation this week:
Spending Bills – We started the week and the new fiscal year (FY) Monday, October 1 with a signed appropriation bill covering all Department of Health & Human Services agencies and programs. As a result of advocacy, the National Institutes of Health received a $2 billion increase for FY 2019. Unfortunately, Congress did not complete appropriations for all of the federal government. Congress has seven unfinished spending bills on its plate and will need to complete before the current Continuing Resolution expires December 7. We anticipate a knockdown, drag-out fight during the upcoming lame duck session of the unfinished spending bills.
Opioid Crisis – The Senate approved the conference opioid legislation (HR 6), sending it to President Trump who is expected to sign. The House passed the bill last month before it left for its pre-election recess. Health policy analysts report that the legislation falls short of wholly addressing the national opioids crisis, but it is a step to address.
What We Are Working On – See below for a summary of our recent advocacy activities and the latest Federal Announcements affecting endocrinology.
Clinician Hill Day – On October 1 members of the Clinical Affairs Core Committee joined with diabetes patients and caregivers from the Diabetes Patient Advocacy Coalition (DPAC) to visit congressional offices and discuss access to affordable insulin and diabetes self-management training legislation.
Diabetes Briefing – On October 1 we conducted a Congressional Briefing about diabetes self-management training and barriers to affordable access to insulin. The briefing was standing-room-only. Congressional staff appreciated learning about these issues from us.
Diabetes Champion Award – On October 2 Endocrine Society President Susan J. Mandel presented Senator Jeanne Shaheen (D-NH) with our Diabetes Champion Award for her work with the other co-chairs of the Congressional Diabetes Caucus to reauthorize the Special Diabetes Program earlier this year. Senator Shaheen is an incredible champion of diabetes prevention, research, and treatment and we have worked with her on several issues, including funding for the Diabetes Prevention Program, Medicare coverage of CGM, and diabetes self-management training. We will present the award to the other 3 recipients: Representative Tom Reed (R-NY), Representative Diana DeGette (D-CO), and Senator Susan Collins (R-ME) at a later date.
Women’s Health Research – Genevieve Neal-Perry, the Society’s vice president for Basic Science and chief of Reproductive Endocrinology & Infertility at the University of Washington, rounded out a week full of Hill activity with a series of meetings on Capitol Hill on October 3. Focusing on women’s health and research funding, Neal-Perry met with representatives from Washington state as well as members of the Congressional Women’s Caucus. During the meetings, she discussed the impact of infertility and the need for insurance coverage, and asked members of Congress to co-sponsor the Access to Infertility Treatment and Care Act (S2960/HR5965). Neal-Perry also expressed the Society’s appreciation for the $2 billion increase for the National Institutes of Health in FY 2019 and urged Congress to provide consistent, predictable increases to ensure a strong research workforce pipeline.
Award Recognizing the Diabetes Disaster Response Coalition – On October 3 the Society and our partners in the Diabetes Disaster Response Coalition (American Diabetes Association, JDRF, Insulin for Life USA, T1D Exchange, Research!America, AADE, and AACE) received the American Society for Association Executives (ASAE) top award for our work last year responding to Hurricanes Harvey, Irma, and Maria.
Federal Announcements:
On September 28, the National Institutes of Health (NIH) Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) issued a report to the Secretary of Health and Human Services and Congress that includes advice for agencies and other stakeholders to improve the representation of pregnant and nursing women in research. The Endocrine Society’s comments were reflected in some of the final recommendations in the report, including the removal of regulatory barriers to the participation of pregnant women in clinical research; considering the time dependency of physiologic changes during pregnancy and lactation; leveraging opportunistic studies to capture information on standard-of-care; and studying existing therapeutic products used off-patent in pregnant women.
On October 2, the NIH Office of Disease Prevention (ODP) issued the ODP Strategic Plan for Fiscal Years 2019-2023. The plan reflects the contributions of many external stakeholders, including the Endocrine Society, given the importance of prevention research in reducing the incidence of a variety of diseases in the United States. The plan includes a strong emphasis on addressing health disparities and working with stakeholders to promote implementation research.
The Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) will hold a meeting on October 24th and 25th to discuss the current mandate to evaluate cardiovascular (CV) risk in new antidiabetic therapies for Type 2 Diabetes. This mandate has been in place since December 2008 when the FDA published guidance requiring a cardiovascular outcomes trial for any new diabetes therapy in response to a meta-analysis associating rosiglitazone with increased CV risk. Society members may submit written testimony to the FDA by October 10 for consideration by the EMDAC or by October 23 for consideration by the FDA. Testimony can be submitted through https://www.regulations.gov/docket?D=FDA-2018-N-3159.
Loading ...