By Josh Evans, AADR Gert Quigley Fellow
The Gert Quigley Fellowship was an unforgettable six week advocacy experience. During my time in Washington, DC I was able to participate in several important facets of advocacy. For example, I attended coalition meetings; observed hearings and bill mark-ups; visited the National Institute of Dental and Craniofacial Research; helped develop a call to action to inspire students to perform grassroots advocacy during the Congressional August recess and I met with members of Congress and their staff to discuss the importance of oral and craniofacial research.
I am currently a fourth year dental student at Indiana University School of Dentistry, but have been active in research since I attended Butler University, where I received my bachelors of science in chemistry. However, at that time I never got involved or took an interest in politics. I was unaware of the intricacies of Congress and its role in providing funding for research via annual appropriations bills to help curb prevalent disease in America. Early in my research career all I knew is that my proposals would “magically” get funded and I was allowed to conduct my research. Due to my experience in Washington, DC I better understand the role Congress plays in funding the federal governmental agencies such as the National Institutes of Health and the National Institute of Dental and Craniofacial Research.
In my short time here I have seen advocacy work first hand. Specifically, the Senate proposed legislation that would require Federal agencies with research expenditures over $100 million to develop a policy for free online public access to peer reviewed manuscripts no later than six months after publication in peer reviewed journals. It is important to note that the IADR and AADR Journal of Dental Research adhere to the current embargo period of 12 months established by NIH. As a result of advocacy efforts of the broader community and AADR compromise legislative language was developed–to preserve the current embargo period–in partnership with the Senate. The revised version of the bill will move forward this week.
In addition, since coming to The Hill I have noticed how Congress is trying to increase funding dedicated to research with the Senate and House Appropriations Committees approval of the fiscal year 2016 appropriations bills. While this attention is great for research it should also increase caution with advocates. These proposed increases in funding are coming at the expense of other important public health programs due to the continued tight budget climate. I was able to witness how AADR works with a broad coalition of research, public health and science advocates urging Congress to lift the caps on discretionary spending so the entire public health continuum can benefit.
Now that I understand more of the process of Congressional decision making I realize that advocacy is needed more than ever. Many members of Congress know only what they are told by their constituents which them helps prioritize how limited resources are spent by the federal government. Therefore researchers, dentists and students play a vital role as advocates to carefully and thoroughly explain the importance of dental research and discovery to help Congress understand the value and importance of their work. Though advocacy can seem overwhelming at first it can actually be very simple. There are a variety of venues to start advocating, such as responding to action alert emails, sending letters of support, or students can schedule a meeting with their members of Congress. Getting involved in advocacy can help make a difference for the future of research.
I look forward to continuing my work as the Gert Quigley Fellow this year as an active member of the AADR government affairs committee and National Student Research Group. If you want to become more involved with AADR advocacy please contact Carolyn Mullen, director of government affairs at firstname.lastname@example.org
Last month for the first time in many years both the US House of Representatives and the US Senate moved their versions of the fiscal year 2016 Labor, Health and Human Services and Education (LHHS) Appropriations bills through the committee mark-up process. The House proposed $31.2 billion for the National Institutes of Health and $404.8 million for the National Institute of Dental and Craniofacial Research (NIDCR) whereas the Senate proposed $32 billion for NIH and $415.1 million for NIDCR. Unfortunately, it is unclear is these proposed funding increases will ever become law.
Due to the sequester level caps on discretionary spending set in place by the Budget Control Act of 2011 the aforementioned increases came at the expense of other important public health programs. For example, the House terminated the Agency for Healthcare Research and Quality (AHRQ) and the Senate decreased funding for AHRQ by 35% and decreased funding for the National Center for Health Statistics by $10 million. Importantly, President Obama has vowed to veto any legislation that adheres to the sequester level caps in the hopes of spurring Congress to negotiate a budget deal that would increase discretionary spending for defense and non-defense discretionary programs. The Democrats in both the House and Senate are holding firm that the caps must be raised in order for the appropriations process to continue.
This means that with 16 legislative days remaining Congress is at an impasse. It is unclear if Congress will be able to negotiate a broader deal on the budget prior to October 1 which is the start of the new fiscal year. Congress has three options before them either: 1) shutdown the federal government 2) approve continuing resolution funding the federal government at the current levels or 3) negotiate a budget deal prior to the October 1st deadline. It is possible that Congress will approve a short term continuing resolution through December to buy “more time” to negotiate a deal. Many members of Congress are urging leaders to negotiate a deal now to avoid turmoil in the near future.
AADR remains actively engaged with the broader non-defense discretionary community (NDD United) urging Congress to replace sequestration with a balanced approach to deficit reduction that takes into account the deep cuts NDD has already incurred since 2010.
On July 22nd the National Institutes of Health (NIH) solicited input from the stakeholder community on a NIH-wide five year strategic plan. This plan outlines a vision for biomedical research that identifies areas of opportunity across all biomedicine and unifying principles to guide NIH’s support of the biomedical research enterprise. With input from all 27 Institutes, Centers and Offices (ICOs) The framework identifies crosscutting areas of research exemplifying the breadth of ICOs priorities and aims to outline a set of unifying principles to guide NIH in pursuit of its mission. According to the request for information the NIH-wide strategic plan includes the following:
NIH-wide Strategic Plan Framework
- This section will include a discussion on subjects such as the NIH mission, the status of and opportunities in biomedical research, the current NIH-supported research landscape (i.e., basic and applied research, extramural and intramural research, ICOs with their own strategic plans, Common Fund, challenges), and constraints confronting the community in the face of lost purchasing power
Areas of Opportunity that Apply Across Biomedicine
- Promote Fundamental Science
- Basic Science is the foundation for progress
- Consequences of basic science discoveries are often unpredictable
- Advances in clinical research methodologies stimulate scientific progress
- Leaps in Technology often catalyze major scientific advances
- Data science increases the impact and efficiency of research
- Improve Health Promotion and Disease Prevention
- Importance of studying healthy individuals
- Advances in early diagnosis/detection
- Evidence-Based interventions to eliminate health disparities
- Advance Treatments and Cures
- Unprecedented opportunities on the basis of molecular knowledge
- Breakdown of traditional disease boundaries
- Breakthroughs need partnerships and often come from unexpected directions
- Set NIH Priorities – NIH sets priorities by incorporating measures of disease burden, understanding the need to foster scientific opportunity through nimble and adaptable methods, supporting opportunities presented by rare disease research, and considering the value of permanently eradicating a pandemic
- Enhance Stewardship – NIH enhances stewardship of the research enterprise by recruiting and retaining an outstanding biomedical research workforce, enhancing workforce diversity, , encouraging innovation, optimizing approaches to guide how decisions are made, enhancing partnerships, promoting scientific rigor and reproducibility, reducing administrative burden, and employing risk management strategies in decision-making.
How can you provide input? AADR will be responding as an organization, but AADR members are strongly encouraged to provide feedback and input. We need a robust response from the oral, dental and craniofacial community. You can either submit comments to NIH directly by clicking here by August 16 or send them to Carolyn Mullen email@example.com by August 3rd.
Earlier this month, the U.S. House of Representatives approved the 21st Century Cures Act (H.R. 6) by a 344-77 vote. This bill reauthorizes the National Institutes of Health (NIH) for three years; establishes a fully paid for mandatory funding stream known as the Innovation Fund; revamps the Food and Drug Administration drug and medical device approval process and includes a number of provisions related to the interoperability of electronic health records.
Throughout the process, AADR monitored and analyzed provisions related to the National Institutes of Health. Specifically, the Innovation Fund provides $1.75 billion per year from FY16-FY20 for the Director of NIH to provide funding for basic, translational and clinical research. The funding provided via this mechanism can only be used for very specific activities including a new Accelerating Advancement Program; early stage investigators and promising investigators; high risk high reward programs and intramural research. Funding allocations are determined by the Director and tied to the NIH-wide strategic plan, which is still in development (see above). The resources of the NIH Innovation Fund can contribute to the goals of expanding knowledge to address and find more effective treatments for unmet medical needs including:
- Precision Medicine
- Infectious diseases
The legislation also states that the Innovation Fund will be used to supplement not supplant other amounts available to the Department of Health and Human Services (HHS). Essentially, Congress shouldn’t cut programs and back fill it with this mandatory funding. It is important to note, this provision is largely unenforceable.
Other Provisions in the Bill
In addition to the funding, the H.R. 6 proposes the following:
- reauthorizes NIH for three years, increasing the authorization (but not the allocation) by $1.5 billion annually
- requires the development of a NIH-wide strategic plan;
- requires a 5 year appointment term of Directors of National Research Institutes and Centers (they can be reappointed after 5 years);
- requires each Director of National Institutes and Centers to review and approve each R-series award;
- requires a IOM study on duplication in federal biomedical research;
- requires a plan to reduce the administrative burdens on researchers;
- exempts NIH from paperwork requirements;
- includes a Sense of the Congress that participation in sponsorship of scientific conferences and meetings is essential to the mission of the NIH;
- Requires each research institute to develop a high risk high reward program to support research projects that pursue innovative approaches to major contemporary challenges in biomedical research that involve inherent high risk but have the potential to lead to breakthrough. This initiative will be paid for by a specific percentage set aside determined by the Director of NIH.
- Creates a loan repayment program of no more than $50,000 for qualified health professionals to engage in research; updates other NIH loan repayment programs from $35,000 to $50,000 to help support young scientists
- Establishes a capstone grant program to facilitate the successful transition or conclusion of research programs. An individual who receives the capstone award shall not be eligible to have principle investigator statues on subsequent awards from NIH.
What’s Next? This legislation faces an uncertain future in the Senate. According to CQ Healthbeat Senator Alexander indicated his version of the bill will not be released until later this fall and it is expected the Senate version will have a narrower focus. AADR will continue to work with members of Congress to ensure increased funding for NIH benefits the entire biomedical research enterprise, the National Institute of Dental and Craniofacial Research and our members.
This month, AADR joined 184 other organizations voicing our concern with the proposed 35 percent reduction in funding for the Agency for Healthcare Research and Quality (AHRQ) in the Senate’s fiscal year (FY) 2016 Labor, Health and Human Services and Education (LHHS) appropriations bill. We urged lawmakers to enact sequestration relief, increase the LHHS subcommittee allocation and restore AHRQ’s budget authority to $364 million.
This month, AADR joined 42 organizations expressing opposition to a policy rider that would weaken the Food and Drug Administration (FDA) regulation by exempting e-cigarettes marketed since 2007 from premarket review. This policy rider was added to the fiscal year 2016 House Agriculture Appropriations Bill. During the appropriations committee consideration of the bill Rep. Lowey (D-NY), proposed an amendment that would strike this language in the bill, but unfortunately this amendment failed by a vote of 23-26. According to an article included in The Hill Rep. Lowey stated, “This bill would allow them (e-cigs) to stay on the market … without an FDA pre-market review and open the door for similar products to avoid FDA review down the road.”
The Family Smoking Prevention and Tobacco Control Act of 2009 provided FDA with the authority to regulate the manufacture, distribution and marketing of tobacco products. In 2014 the FDA proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products including e-cigarettes. This rule is expected to be finalized during the next couple of months and would require the additional tobacco products to register with FDA and report product and ingredient listings; provide minimum age and identification restrictions to prevent sales to underage youth; include health warnings and prohibit vending machine sales, unless the facility never admits youth.
AADR recently revised our science policy statement on tobacco which includes the following, “Smokeless tobacco, snus and e-cigs are, although considered harm reduction alternatives to smoked tobacco, are not without their risks.” As a result of the revised policy statement, AADR will continue to partner with the public health community to emphasize the importance of additional research to assess the oral health effects of established and newly emerging tobacco products in the United States. In addition, AADR will urge FDA to consider oral health effects in evaluating the public health impact of all tobacco products under its regulatory jurisdiction, including e-cigs.