Continuing Resolution Unveiled; Take Action to Protect NIH Funding
On December 6, House and Senate Republicans released a continuing resolution (CR) that would extend through April 28. The current CR expires on December 9. Congressional action is necessary to avert a government shutdown. The Endocrine Society has advocated for passage of a regular appropriations bill that includes at least $34 billion for the National Institutes of Health (NIH) and has urged Congress to avoid funding through CRs, which are dangerous to research funding because they provide flat or decreased funding to the NIH.
The new continuing resolution maintains the current budget cap of $1.07 trillion and continues the policy and funding provisions in the currently enacted fiscal year 2016 appropriations legislation. It does not include controversial policies riders, or major changes in existing federal policy. Included in the bill is $872 million in FY 2017 funding for the soon-to-be enacted Cures bill, including $20 million for FDA, $352 million for the NIH, and $500 million for states to respond to the opioid epidemic.
The CR also includes an expedited process for Senate consideration of a bill next year with language that specifically exempts the next secretary of Defense confirmed by the Senate from a law that requires retired officers to be out of the service for seven years before being considered for the post. This would allow for President-Elect Donald Trump’s nominee to move forward.
Take Action: We are very concerned about the impact of a CR on the NIH budget and will continue to advocate vigorously for a real funding bill to be passed for FY 2017. If you have not done so, please take a minute to join our online advocacy campaign. Every Representative and Senator needs to hear from constituents about the impact on research if we are to secure a funding increase.
After three years of debate and consideration, the US House of Representatives and Senate passed the biggest health reform bill since the Affordable Care Act. The legislation known as the 21st Century Cures Act is a controversial, bipartisan effort designed to spur medical innovation, improve the mental health system, and help the states deal with opioid abuse.
The legislation includes $6.3 billion over a decade deposited in three dedicated accounts that would channel money to states responding to the growing opioid crisis, the National Institutes of Health, and the Food and Drug Administration (FDA).
Like any piece of large legislation, there are some provisions in the bill viewed favorably and some that are worrisome. Supporters have touted the legislation as a means to get medical cures to patients faster; opponents argue that the bill’s research spending is offset by cutting public health spending elsewhere and that the bill could seriously damage the regulatory authority of the Food and Drug Administration and compromise patient safety.
At a time when research funding is in jeopardy, the Cures Act would increase money for the National Institutes of Health (NIH) by about $4.8 billion over 10 years. The bill also includes $1 billion over two years to help state governments with opioid painkiller abuse prevention and treatment programs and it would expand Medicaid to children with severe mental illnesses. These are all things viewed positively by the public and most policy makers.
However, the NIH funds are not actually guaranteed as originally discussed, but rather they only materialize if federal appropriators approve them each year. In addition, nearly half of the funds for the legislation come from cutting $3.5 billion from other public health efforts like immunizations and tobacco prevention. Further, the funding in the bill is strictly designated to four initiatives at NIH: Precision Medicine; the Cancer Moonshot; regenerative medicine; and the BRAIN initiative, rather than across all Institutes and/or areas of study.
FDA Approval Process
A majority of the bill is devoted to the FDA and its approval process. Currently, before a new drug can come on the market, the drugmaker needs to present high-quality evidence in the form of randomized clinical trials to the agency. The bill, however, will allow drugmakers to submit “real-world evidence” as proof their drugs work. Critics of the measure contend that this would undermine the rigor of the FDA review process and result in drugs that are unsafe or ineffective. The bill would also allow drug companies to submit “summary-level reviews for new indication approvals instead of raw data, which the FDA currently requires. This would limit the ability of FDA reviewers to analyze the data and force them to rely on industry information.
While there were a small number of legislators who opposed some provisions, the bill passed by a landslide in the House of Representatives and Senate. Vice President Joseph R. Biden presided over the Senate’s final procedural vote on the bill, tearing up as senators spoke in favor of the Cancer Moonshot initiative, which he has overseen since its launch following the death of his son to cancer. NIH Director Francis Collins has spoken favorably about the bill. Some original opponents voted in favor believing this might be the best package of biomedical research measures they could before the new Congress and Trump Administration. President Obama has indicated he would sign the bill and last Saturday praised it during his weekly address. “There’s a bill in Congress that could help unlock cures Alzheimer’s, end cancer as we know it, and help people seeking treatment for opioid addiction finally get the help they need,” Obama said. “It’s an opportunity to save lives, and an opportunity we just can’t miss.”
A summary of the major provisions as “pros” and “cons” from the Endocrine Society perspective can be found here.
Society Applauds Novo Nordisk for Pledging to Limit Price Hikes, Calls for Greater Transparency on Insulin Pricing & More Steps to Ensure Access to Therapy
On December 6, Novo Nordisk announced that it would limit price increases for its therapies, including insulin. Insulin pricing has come under increased scrutiny in recent years because of dramatic price hikes. The Endocrine Society strongly advocates for people with diabetes who depend on insulin to treat their disease to have affordable access to this life-saving therapy.
The Society applauds Novo Nordisk for its promise to limit drug price increases and hopes that other entities in the insulin supply chain (manufacturers, pharmacy benefit managers, insurers) will also demonstrate similar restraint to address this important issue. We also hope to work with all stakeholders to determine both the cause of increasing prices for insulin as well as additional ways to ensure access to insulin. Last month, we participated a roundtable with our corporate partners, patient advocates, and other provider groups to begin this discussion. Recently, the American Diabetes Association also launched a similar campaign for transparency across the supply continuum. It is our expectation that with greater transparency across the insulin supply chain we can work together to make drug pricing more predictable, reduce out-of- pocket costs, and help patients and physicians have access to affordable, patient-centered therapies.
You can read the Society’s press statement online.
The American Medical Association (AMA) recently held its interim meeting of the House of Delegates (HOD), which is the policy-making body of the AMA. The Society’s delegates—Vineeth Mohan, Amanda Bell, MD, Palak Choksi, MD, and Robert Vigersky, MD—represented the interests of endocrinologists in the debates surrounding issues that impact the practice of medicine. Discussion of new AMA policy focused on a range of issues relevant to endocrinologists, including compounding hormone therapies, infertility benefits, and drug pricing. A resolution introduced by the American Association of Public Health Physicians and co-sponsored by the Society called on the AMA to support efforts to set a national goal to eliminate lead exposures to pregnant women and children by 2030 and ensure that no child has a blood lead level >1 µg/dL. It also offers policy changes to reduce lead exposure and remediate current and potential new sources of lead exposure. The resolution is based on the Project TENDR (Targeting Environmental Neuro-Developmental Risks) consensus statement, which the Society has endorsed.
The Endocrine Society’s delegates also worked closely with the delegates from the American Association of Clinical Endocrinologists, American Society for Reproductive Medicine, and American Association of Endocrine Surgeons during the meeting on issues of importance to endocrinologists.
The Food and Drug Administration (FDA) calls on its Network of Experts to provide information on issues under consideration by the FDA to supplement existing knowledge and expertise within the Centers. The Network of Experts is a vetted network of partner organizations and their member scientists and clinicians who can provide FDA staff with rapid access to expertise. The program is designed to broaden staff exposure to clinical and scientific viewpoints, but not to provide external policy advice or opinions. The Society has recently joined the Network, and as a member, we may reach out to you to serve in this capacity and ask for your engagement as we support the work of the FDA on endocrine topics. You will be asked to fill out a simple conflict of interest form, and if selected, will be asked to participate on a brief conference call (20-60 minutes on average). Although we will reach out to members based on their self-identified areas of expertise, please contact Stephanie Kutler, Director, Quality Improvement (email@example.com) if you wish to be included in a standing list of experts or would like to update your areas of expertise on the membership application.
NIH Will Increase Postdoc Pay Despite Injunction Against DOL Rule
As reported previously in Endocrine Insider, 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 proposed to increase the salary threshold for workers exempted from overtime pay, and also covered postdoctoral researchers. On October 12, 21 states filed a preliminary injunction to delay the implementation of the rule; the injunction was granted on November 22 and applies to the entire country.
Consistent with previously announced policy, the National Institutes of Health (NIH) will increase the stipends of postdoctoral fellows covered by National Research Service Awards (NRSA) to comply with the exemptions from overtime pay in the updated regulations, irrespective of the injunction. However, institutions have announced various pay policies regarding those postdoctoral researchers who are not funded by individual NIH fellowships, in response to the injunction.
The Endocrine Society will continue to closely monitor and keep members informed of this evolving situation.
On Thursday, December 1, the Director of the NIH Office of Research on Women’s Health (ORWH) and members of the ORWH staff team visited the Endocrine Society for a meeting with Endocrine Society member and Associate Director of the Center for Women’s Health Research at the University of Colorado Anschutz Medical Campus, Jane Reusch, MD; and the Director of the Center for Women’s Health Research at the University of Colorado Anschutz Medical Campus, Judy Regensteiner, PhD.
During the meeting, participants discussed research gaps and opportunities identified during the National Conference on Women’s Health Research, “Sex Differences Across the Lifespan: A Focus on Metabolism” (see Endocrine News article). The group also discussed the new NIH policy on the “Consideration of Sex as a Biological Variable in NIH-funded Research.” The meeting highlighted the natural synergies between the policy priorities and research interests of ORWH and the Endocrine Society. Participants also discussed how the Endocrine Society could help develop and promote educational resources about sex as a biological variable, such as the online courses developed by ORWH.
Calling All Diabetes Experts: Endocrine Society Scientific Statement Available for Comment
A working draft of an Endocrine Society Scientific Statement has been posted online for members to view and submit comments. This Statement addresses the state of science on diabetic microvascular disease, and all Endocrine Society members with expertise in this area are invited to review the manuscript. Comments are due Thursday, December 22 at 5 PM EST. Interested parties will need to provide their member ID to access the document.
Scientific Statements are designed to highlight the state of the science of endocrinology by providing a comprehensive literature review to identify knowledge gaps and areas of consensus. Unlike Clinical Practice Guidelines, which are used to establish clinical best practice, Statements do not use meta-analysis, nor the GRADE system. They are designed to produce recommendations for research and policy, and to help raise awareness of the central role endocrinology plays in science and medicine.