Science fares well in FY 2018 appropriations bill

Funding is healthy, and NIH clinical trial policy is suspended.

The congressional appropriations committees have labored mightily and produced a $1.3 trillion final funding bill for Fiscal Year 2018, the current fiscal year. In February Congress raised the budget caps that had made reaching agreement on a full year’s spending legislation difficult. With a two-year budget agreement and extra money in hand, the appropriations committees produced a bill that is likely to pass both houses before the temporary funding expires at 11:59 p.m. on March 23. The House of Representatives approved the bill with a bipartisan vote today, March 22, 2018.

The bill was worth waiting for: it repudiated many of the proposed cuts and reorganizations that appeared in President Trump’s Fiscal Year 2018 budget. Some of the increases are, frankly, astounding: a $3 billion, 8.3 percent increase for the National Institutes of Health (NIH), including $414 million for Alzheimer’s research and $500 million for opioid research. (The Trump budget had proposed a 22% cut.)

Other science agencies and their allies have reason to celebrate:

  • The National Science Foundation would receive a 3 percent increase overall ($7.8 billion), but a 5 percent increase to its research account ($6.3 billion). This is an increase of $295 million. The omnibus bill includes no language regarding cuts to the Social, Behavioral and Economic Sciences Directorate.
  • The Centers for Disease Control and Prevention (CDC) would receive $8.3 billion, about $1.1 billion above the Fiscal Year 2017 level. The bill includes language (p. 23) that tweaks the ongoing amendment affecting CDC’s research on firearms violence prevention. The language makes clear that such research is permitted while continuing to emphasize that CDC research may not advocate or promote gun control.
  • The Institute of Education Sciences (IES) in the Department of Education would receive $613 million, an $8 million increase over the 2017 level. While this increase is a step in the right direction, it is worth recalling that in Fiscal Year 2010 the IES budget was $660 million.
  • The Agency for Healthcare Research and Quality received an additional $10 million, for a total of $334 million, despite last year’s efforts by the administration to defund the agency and its Fiscal Year 2019 proposal to integrate it with NIH.
  • The National Aeronautics and Space Administration would receive $20.7 billion, an increase of $1.1 billion, and science programs within NASA would increase by 7.9 percent, to 6.2 billion.
  • The Environmental Protection Agency udget remains at $8.1 billion this year, as lawmakers rejected deep proposed cuts.

Significantly for basic psychological scientists, the omnibus includes language (p. 34-35) suspending NIH’s new definition of clinical trials and calling for NIH to revamp the policy with input from the scientific community. NIH’s controversial new definition of clinical trials, which went into effect in late January, swept in almost all research using human participants, and instituted new requirements for the research now deemed “clinical.” APA had advocated vigorously with the Federation of Associations in Behavioral and Brain Sciences and other scientific associations to modify the definition.  Watch for more information about how the implementation of this congressional directive will unfold and affect grant applications, review and other matters at NIH. 

President’s Budget Picks a Few Science Favorites

But Congress Will Have the Last Word

There has been quite a bit of budget-related news this month.  Last week Congress passed a two-year agreement to raise the budget caps put in place by the Budget Control Act of 2011, allowing for $312 billion in additional spending on defense and nondefense accounts in Fiscal Years 2018 and 2019.  This is a major victory for research advocates who weighed in on many occasions about inadequate budgets.  Many were frustrated with years of sub-inflationary budget increases and long months during which the agencies operated on temporary funding authority, as they continue to do for FY 18 (through March 23). The budget agreement is not ideal, but it allows room for the House and Senate Appropriations Committees to advance funding bills that promise to be friendlier to research budgets than the Continuing Resolutions have been (friendlier, too, than the Administration has been).  For example, the budget deal calls for an additional $2 billion for the National Institutes of Health over the next two years, though the FY 18 omnibus funding bill has not yet appeared for final action. See this update for more details on the budget agreement.

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FDA initiates review of all research with nonhuman animals

APA raises concerns about precedent, channels for scientific advice, and importance of animal models.

In a statement released on January 26, 2018, Scott Gottlieb, MD, Commissioner of the Food and Drug Administration (FDA) announced that he had initiated an “independent, third-party investigation of the agency’s animal research programs.”  However, he provided no details about who would conduct this investigation or what processes it would follow.

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We break down a potential shutdown: What will and won’t happen?

Yes, the federal government will likely shut down at midnight.

Temporary funding for the federal government will expire at midnight tonight (Jan. 19, 2018) unless both houses of Congress approve a temporary extension or a longer-term funding deal that includes several pieces of legislation that have been negotiated for the past couple of weeks. The House of Representatives yesterday approved a one-month Continuing Resolution (CR), the fourth since September 30, 2017, when the 2018 fiscal year began.

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Implementation of revised Common Rule delayed by at least six months

Revision raises complex challenges for research institutions. 

On January 17, 2018, just two days before the newly revised Federal Policy for the Protection of Human Subjects (also known as the Common Rule) was scheduled to go into effect, the Department of Health and Human Services’ Office for Human Research Protections announced an Interim Final Rule that delayed the effective and general compliance date of the new rule by six months, making it effective on July 19, 2018.

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FDA shuts down nicotine research study, overlooking concerns of scientific organizations

American Psychological Association Science Alert

Background In September 2017, the American Psychological Association, the American College of Neuropsychopharmacology, and the College on Problems of Drug Dependence wrote to Food and Drug Administration Commissioner Scott Gottlieb, MD, following the FDA announcement that it was suspending a program of nicotine research with nonhuman primates on the advice of Dr. Jane Goodall and the White Coat Waste Project, an organization that is fundamentally opposed to all research with non-human animals. Dr. Gottlieb announced that FDA would conduct an independent review of the research program and release a report. The scientific organizations asked that FDA provide public information about the review including naming members of the review committee and explaining its timeline and rationale. The FDA has not responded.

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