What is Next? Federal Budget Update

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.

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NIH Requests Input on NIH-Wide Strategic Plan

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

Unifying Principles

  • 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 cmullen@aadr.org by August 3rd.

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House Approves 21st Century Cures Act (H.R. 6)

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:

  • Biomarkers
  • Precision Medicine
  • Infectious diseases
  • Antibiotics

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.

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AADR Voices Opposition to the Reduction of AHRQ Funding

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.

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AADR Joins Public Health Community Opposing Tobacco Policy Rider

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.


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Senate FY16 LHHS Post Mark-Up Summary

Last week, the Fiscal Year (FY) 2016 Senate Labor, Health and Human Services, and Education (LHHS) Appropriation bill was approved by the Senate Appropriations Committee along a party line vote of 16-14. This legislation proposes $32 billion for the National Institutes of Health (NIH) an increase of $2 billion over FY15 and $415.1 million  for the National Institute of Dental and Craniofacial Research (NIDCR) which is $17.4 million over the enacted FY15 level of $397.7 million.  Some of the increases for NIH were provided for the following initiatives:

  • $200 million for Precision Medicine;
  • $350 million increase for the National Institute on Aging, the lead Institute researching Alzheimer’s disease;
  • $135 million, an increase of $70 million, for the BRAIN Initiative to map the human brain;
  • $461 million, an increase of $100 million, to Combat Antibiotic Resistance;
  • $300 million, an increase of $26.7 million, for the Institutional Development Award;
  • And increases to every Institute and Center to continue investments in innovative research that will advance fundamental knowledge and speed the development of new therapies, diagnostics, and preventive measures to improve the health of all Americans.

The Committee report also included report language pertinent to NIDCR. Specifically:

 “Temporomandibular Disorders {TMD }.-Temporomandibular Disorders affect approximately 35 million Americans; the majority affected are women in their childbearing years. The Committee encourages NIBIB, NIAMS, and NIDCR to consider the recommendations that resulted from their jointly sponsored Roundtable on the Temporomandibular Joint in Health and Disease in 2013. Research to develop safe and effective techniques for joint repair and regeneration is essential. An analysis of problems associated with current joint replacements should provide guidance in these efforts. The Committee commends NIDCR for its ongoing support for the OPPERA program, which is yielding valuable information on many physiological aspects, not only of temporomandibular disorders, but of other pain conditions that overlap with TMD. To capitalize on the research to continue the momentum gained from OPPERA, the Committee urges NIH to continue research of this caliber and direction, and to consider measures to encourage NIH-funded investigators from related fields to include TMD and comorbid conditions in their studies.”

However, since the overall allocation for this bill is $3.6 billion below the FY15 enacted level, the proposed increased funding came at the expense of other important public health programs. Funding for the Agency for Healthcare Research and Quality was cut by 35% and the National Center for Health Statistics received a $10 million reduction.

During the committee mark-up Ranking Member Mikulski (D-MD) and Senators Collins (R-ME) and Shelby (R-AL) voiced their support of the $2 billion increase for NIH, including the $300 million budgeted specifically for Alzheimer’s research.  During the committee mark-up Senator Durbin (D-IL) strongly supported NIH research and said, “There should be a standard in which the NIH would have a 5% increase in the budget every year. This would then help to break a long run of mediocre investments and sequestration.”

Senator Cassidy (R-LA) also proposed an amendment which would take $235 million away from the National Institute of Allergy and Infectious Diseases (NIAID) and reallocate those funds to the National Institute of Neurological Disorders and Stroke, the National Institute for Mental Health and the National Institute of Biomedical Imaging and Bioengineering. Senator Cassidy argued that, “The NIH spending priorities are no longer on the current main health issues that Americans are facing today.” He mentioned that AIDS research received 10% of the NIH’s funding for the past 25 years and other diseases and conditions such as Alzheimer’s disease, Parkinson’s, and ALS warrant our attention. This amendment failed by a 6-23 vote.

Senator Murray (D-WA) voted against approval of the appropriations bill noting that she would like the sequestration caps lifted so that more money is available to fund other important programs.

Below is additional information about programs of importance to AADR:

  • HRSA Title VII Training in Oral Health Care received $32 million  which is a slight decrease from the FY15 level of $33.9 million The Committee provides $32,000,000 for Training in Oral Health Care programs, which includes not less than $9,000,000 each for general and pediatric dentistry. Funds may be used to expand training in general dentistry, pediatric dentistry, public health dentistry, dental hygiene, and other oral health access programs. Funds may also be used to plan and operate training programs, as well as to provide financial assistance to students and residents. The Committee directs HRSA to prioritize programs that support underserved communities and applicants from disadvantaged background in any new grant competition. Further, the Committee encourages HRSA to focus on training programs that target vulnerable populations in risk-based clinical disease management of all populations. The Committee urges HRSA to work with Centers for Medicare and Medicaid Services [CMS] on the evaluation and support of additional models for expanding access to oral healthcare. Such models should include emergency room diversion programs and efforts under State law to deploy and evaluate new provider types.  The Committee continues long-standing bill language that prohibits funding for section 340G-1 of the PHS Act.
  • HRSA Maternal and Child Health Bureau Prenatal Oral Health.-The Committee recognizes the importance of prenatal oral healthcare for the health of both mother and child and encourages the MCH Bureau within HRSA to continue its efforts to improve the oral health of pregnant women. on these activities in the fiscal year 2017 CJ.
  • CDC Division of Oral Health received $15.7 million which is level with FY15. The Committee urges CDC to support clinical and public health interventions that target pregnant women and young children at highest risk for dental caries. These interventions result in significant cost-savings to State Medicaid programs. CDC is encouraged to continue to work across the Department to improve coordination of oral health surveillance that reliably measures and reports health outcomes.

AADR will continue to work with Congress to lift the caps on discretionary spending so all research and public health programs received increased, sustained and predictable funding.

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AADR Voices Opposition to FASTR Act (S. 779)

This week the International and American Associations for Dental Research sent a letter to members of the Senate Homeland Security and Governmental Affairs Committee voicing our opposition to the Fair Access to Science and Technology Research Act (S. 779).  As a result of our efforts and those of the broader scientific advocacy community, the Senate Committee pulled the bill from the mark-up schedule. Committee staff agreed to meet with advocates to learn more about our concerns with the bill.

This legislation proposed to require Federal research 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. The current embargo period established by the National Institutes of Health (NIH) is 12 months and a reduction of the embargo period would have a detrimental effect on many biomedical research publications. As co-owners of the Journal of Dental Research, the association invests significant resources in the peer-review process, manuscript copyediting and layout and since 2002 in publishing the JDR online. Moreover, the scientific community relies on the publishers to manage the post-grant peer review process to evaluate the merit and authenticity of the conclusions of the research. Unlike the federal funding provided during the pre-grant peer review process, post-grant peer review is not funded by the agencies at all. The only way for the Associations to cover these significant costs is to retain the copyrighted materials and to offer individual and institutional subscriptions.

What’s Next? IADR and AADR will continue to partner with coalitions to help develop legislative language for the Senate Committee’s consideration. We are extremely grateful that Congress is willing to listen to the concerns of the community and will keep our members informed as this process moves forward.


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SCOTUS Upholds ACA Subsidies in King v. Burwell Decision

By Johanna Gray, Vice President CRD Associates

Yesterday, the Supreme Court released its decision in King v. Burwell, the latest case challenging the Affordable Care Act (ACA).  At issue was whether subsidies can be extended to low-income people who live in the 34 states that have federally-facilitated rather than state-based marketplaces.  The plaintiffs argued that Congress wrote the ACA in a way that only people who live in states with state-based marketplaces should receive subsidies, which would have jeopardized assistance for more than 6 million Americans currently receiving subsidies.  In a 6-3 ruling drafted by Chief Justice Roberts, the Court upheld the subsidies and kept the ACA intact.  People who live in states using www.healthcare.gov for their marketplace can continue to receive subsidies.

Besides answering the immediate question about subsidies, the decision more broadly defends the current implementation of the ACA and will make it more difficult for other cases to successfully challenge the law.  This is because the decision says that ambiguous aspects of the ACA must be interpreted through the lens of Congress’ intent for the ACA to improve the health insurance market.  The decision even makes it more difficult for future administrations to remove subsidies from these states.  The decision concludes with this remarkable statement: “Congress passed the Affordable Care Act to improve health insurance markets, not to destroy them. If at all possible, we must interpret the Act in a way that is consistent with the former, and avoids the latter.”

Policymakers in Washington and state houses across the country have been drafting various contingency plans anticipating that subsidies may be struck down.  Many plans would have traded extended subsidies for other reforms to the ACA, such as elimination of the individual mandate or other insurance policies.  While Congress is likely to continue to consider bills to repeal part or all of the ACA and state policymakers will continue to influence ACA implementation in their states, this decision means that the ACA is likely to continue as-is for the near future.


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House Appropriations Cmte Approves Funding Bill for Health Agencies

Yesterday, the Fiscal Year (FY) 2016 House Labor, Health and Human services, and Education (LHHS) was brought to the full Appropriations Committee and was approved along a 30-21 party line vote. Interestingly, this was the first time in 3 years the bill has been reported out of subcommittee and 6 years since the bill was brought before the full committee for mark-up. Sub-committee Chairman Cole (R-OK) was overall very pleased with the bill and noted that while the overall allocation was $3.7 billion below FY15 the bill exceeds the President’s Budget request in several areas. Specifically, the National Institutes of Health (NIH) received an increase of $1.1 billion dollars from FY15 and a $100 million dollar increase from the President’s Budget Request and the National Institute of Dental and Craniofacial Research (NIDCR) received an increase of $7.1 million increase from the FY15 enacted level of $397.7 million and $1.9 million below the President’s Budget Request.

During the mark-up, Ranking Member DeLauro (D-CT) proposed an amendment which would provide an even larger increase in the budget for NIH spending. She stated currently only 1 in 6 grant proposals are able to be funded as opposed to 1 in 3 a few years back. Rep. DeLauro tried to resonate with the committee the vast importance of the NIH and its continued research. Unfortunately, this amendment did not pass, but the importance of NIH funding was agreed upon by both sides of the aisle.

As previously reported, this bill terminates funding for the Agency for Healthcare Research and Funding (AHRQ). Rep. Roybal-Allard offered an amendment to restore funding for AHRQ, but this amendment was voted down along a party line vote. Chairman Cole noted that he would have to vote against the amendment because it would increase spending in the bill. However, the opened the window to potential negotiations with the Senate to reinstate the agency. According to CQ Healthbeat, “Cole signaled that the final version of the spending bill funding the Department of Health and Human Services for fiscal 2016 might not kill AHRQ funding, which Republicans have sought for a year. The measure will be the product of negotiations with Democrats in the White House and Senate appropriators.”

If adopted several programs received an increase in funding. Below is additional information about other oral health programs included in the legislation:

  • Oral Health Training Programs received $34,998,000 for Training in Oral Health Care programs, which is $1,070,000 more than the FY15 enacted level and the budget request. Within the funds provided, the Committee intends no less than $10,000,000 for General Dentistry Programs and no less than $10,000,000 for Pediatric Dentistry programs.
  • The Maternal and Child Health Block Grant received $5 million for dental health projects. This will help to support early childhood oral health interventions and prevention programs encompassing the medical/dental interface, topical fluorides, school and community-based sealant programs, and systems working in collaboration with the Women, Infants, and Children (WIC) and Head Start programs.
  • The Center for Disease Control (CDC) received $20 million for oral health, which enables support for State and community programs, surveillance, prevention research, evaluation, and health promotion. In addition, the National Center for Health Statistics received a $5 million dollar increase from FY15 and matched the president’s budget request.

    Finally, please click here to view a funding chart which details AADR’s other funding priorities included in the legislation.

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House Proposes Increased funding for NIH, NIDCR and Termination of AHRQ

This week the House Labor, Health and Human Services and Education Appropriations Subcommittee voted to move its version of the fiscal year (FY) 16 LHHS appropriations bill forward to the full Appropriations Committee. According to the summary and accompany bill text released by the subcommittee this legislation proposes the following:

  • $31.2 billion for the National Institutes of Health, a $1.1 billion increase from FY15 and $100 million increase from the President’s Budget Request. According to the summary provided by the subcommittee: “The increases for several targeted research initiatives including $886 million a $300 million increase for Alzheimer’s diseases research initiative; $461 million a $100 million increase for an antibiotic resistance initiative; $150 million a $95 million increase for the BRAIN initiative for the full $200 million requested for the Precision Medicine Initiative (PMI).”
  • $404.8 million for the National Institute of Dental and Craniofacial Research (NIDCR), a $7.1 million increase from the FY15 enacted level of $397.7 million and $1.9 million below the President’s Budget request of $406.7 million.
  • The termination of the Agency for Healthcare Research and Quality (AHRQ)
  • A prohibition would be placed on the use of appropriated funding for patient-centered outcomes research.
  • None of the funds may be used for the release or implementation of the eighth edition of the dietary guidelines. The scientific evidence used must be rated strong for each of the revisions to the dietary guidelines.
  • Defunds many provisions of the Affordable Care Act.

The House LHHS bill also proposes to reallocate funding within the NIH Institutes and Centers. Some institutes and centers received a proposed cuts of 9-6% whereas others received large increases. According to Research!America, “These shifts can have a major impact on the pace and direction of medical progress.”

Today, AADR submitted a letter to the subcommittee expressing our gratitude for the increased funding for NIH and NIDCR and also our opposition to the elimination of AHRQ. We strongly urged the committee to end sequestration so that NIH and other public health programs can have stable, predictable and increased funding.

What’s Next? Additional details about other programs including HRSA Title VII, CDC Division of Oral Health and the National Center for Health Statistics, will be forthcoming with the full Appropriations Committee scheduled to consider the bill next week. We will provide further analysis about these areas after the committee report is released.

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