On March 25, the Senate voted 53-47, along party lines, to confirm Jayanta Bhattacharya, M.D., PhD to be Director of the National Institutes of Health (NIH). Following the vote, Senator Bill Cassidy, M.D. (R-La.), Chair of the Senate Health, Education, Labor, and Pensions Committee, issued a statement saying “The NIH needs a leader that will restore Americans’ trust in public health institutions and find unbiased solutions to Americans’ most challenging health problems,” and “Dr. Bhattacharya is ready to take on this responsibility and implement President Trump’s vision to Make America Healthy Again.”
Category: Biomedical Research
NIH & FDA Director Nominees Advance
Dr. Jay Bhattacharya, President Trump’s pick to lead the National Institutes of Health, was advanced by the Senate Health, Education, Labor and Pensions Committee. The Committee voted 12-11 along party lines, with all Republicans voting in favor and all Democrats voting against.
Similarly, Trump’s pick to head the Food and Drug Administration, Marty Makary, was advanced out of the committee by a 14-9 vote, with Democrats Maggie Hassan of New Hampshire and John Hickenlooper of Colorado joining all Republicans in voting to advance.
Bhattacharya and Makary will now appear for a confirmation vote before the entire Senate, with the Republican majority all but ensuring that they will be confirmed.
Multiple Lawsuits Filed Against NIH Indirect Cost Move
On Monday, two separate lawsuits were filed in response to a policy change from the National Institutes of Health (NIH) announced late Friday. In the first suit, filed Monday morning, attorneys general from 22 states, including Washington, sought to prevent NIH’s move to unilaterally lower the “indirect cost” rates on research grants to 15 percent.
The action in question occurred Friday evening, when the NIH announced a significant reduction in grant funding for research institutions. The announcement declared that the NIH will limit the amount granted to research universities for indirect costs at 15 percent moving forward, on both future and existing grants.
Indirect costs, also referred to as “facilities and administration” (F&A) costs, are the essential-but-behind-the-scenes costs of conducting research. These costs include, but are not limited to, laboratory materials, high-speed data processing, security protections, patient safety, radiation safety and hazardous waste disposal, personnel required to support administrative and compliance work, and many other necessary activities.
Typically, when the government provides a grant to a research university, it includes support for both direct and indirect costs. The indirect cost rates are based on allowable direct costs of research that can be assigned to a research grant. Historically, the federal government has reimbursed the university for a percentage of these allowable direct costs. Indirect costs are never fully reimbursed by the federal government, meaning full costs of research are never fully recovered by the institution performing the research. The level of F&A expenses that the federal government covers for each institution is determined by either the Department of Defense Office of Naval Research or the Department of Health and Human Services and is reviewed every 2 to 4 years through a comprehensive negotiation process.
Late last evening, the court in Massachusetts issued a temporary restraining order against the NIH in response to the suit.
Given the potential implications of such a move by the NIH, three higher education associations in which UW is active—the Association of American Universities (AAU), Association of Public and Land-grant Universities (APLU), and American Council on Education (ACE)—took the unprecedented step of also filing a separate lawsuit against the agency Monday evening. The suit seeks a temporary restraining order as well as an injunction against the NIH.
Currently, as a result of the language in funding bills for the NIH dating back to FY2017, the NIH is prohibited from lowering the indirect cost rates unilaterally.
The NIH’s move has received criticism from several Members of the Senate, including Republicans. Appropriations Committee Chair Susan Collins (R-ME), has issued a statement strongly opposing the NIH move. Republican Senator Katie Britt of Alabama issued a statement encouraging the agency to take a “smart, targeted approach…in order to not hinder life-saving, groundbreaking research at high-achieving institutions…”
Over the weekend, Sen. Patty Murray of Washington, the Ranking Member of the Appropriations Committee, issued a statement raising strong objections about the NIH move.
Please continue to check back here for additional updates.
Monica Bertagnolli, M.D. Confirmed as New NIH Director
Monica Bertagnolli, M.D. was confirmed as the new NIH Director last week. Now that she is confirmed, she has taken the helm immediately as the 17th director. She is the first surgeon and the second woman to hold the position and joins the NIH after being the director at the National Cancer Institute.
In his nomination announcement earlier this year, President Biden stated: “Dr. Bertagnolli has spent her career pioneering scientific discovery and pushing the boundaries of what is possible to improve cancer prevention and treatment for patients and ensuring that patients in every community have access to quality care. Dr. Bertagnolli is a world-class physician-scientist whose vision and leadership will ensure NIH continues to be an engine of innovation to improve the health of the American people.”
Read more about about Dr. Bertagnolli and her confirmation here.
Nominee to Head NIH Clears Committee
Earlier this morning, the nomination of Monica Bertagnolli to head the National Institutes of Health (NIH) was approved by the Senate Health, Education, Labor, and Pensions Committee by a bipartisan vote of 15 to 6. Bertagnolli, the current director of the National Cancer Institute, was nominated by President Biden earlier this year to take over the NIH, which has not had a permanent head since the retirement of Francis Collins.