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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.

McMahon confirmed as Secretary of Education

The Senate voted along party lines on Monday evening to confirm Linda McMahon as the next Secretary of Education. McMahon, a former professional wrestling executive and wealthy Republican donor, served as the administrator of the Small Business Administration in the first Trump Administration. She now leads a department that President Trump has proposed eliminating.

A former CEO of World Wrestling Entertainment and chairman of America First Action, a pro-Trump Super PAC, McMahon has been a longtime ally of President Trump. She launched two unsuccessful campaigns to represent Connecticut in the Senate and previously served on the Connecticut State Board of Education for one year. She has also served as a trustee at Sacred Heart University for over a decade.

McMahon told reporters during her confirmation process that she “wholeheartedly” agrees with President Trump’s mission to dismantle the “bureaucracy in Washington” and return education to the states. She added that her goal is to make the Education Department “operate more efficiently,” not to defund programs. Her confirmation, however, comes in the midst of an aggressive government overhaul project, led by Elon Musk, that has targeted the department and its employees. On Friday, employees in the department were given an offer of up to $25,000 if they agreed to retire or resign by the end of the day. President Trump has also told reporters that he hopes McMahon will “work herself out of a job.”

McMahon will now take over leadership of the department of over 4,200 employees in charge of sending federal money to schools, administering college financial aid, and managing federal student loans.

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.

Federal Funding Freeze Rescinded

A controversial memo released by the Trump Administration last week has been rescinded after a federal judge in Rhode Island temporarily blocked it. Just over a week after the inauguration, the new administration announced that it would temporarily halt federal payments to ensure that they were ideologically aligned with the administration’s priorities. The order caused wide-spread concern before U.S. District Chief Judge John McConnel of Rhode Island granted the request for a temporary restraining order sought by a coalition of Democratic-led states, preventing the now-rescinded memo from taking effect. Links to the documents can be found below.

Temporary Restraining Order

Original Office of Management and Budget Memo

 

 

 

 

President Biden Announces Intent to Nominate Dr. Bertagnolli as NIH Director

President Biden announced today his intent to nominate Dr. Monica Bertagnolli as Director of the National Institutes of Health (NIH).

Dr. Bertagnolli is currently the Director of the National Cancer Institute and was previously the Richard E. Wilson Professor of Surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute.

Read more about Dr. Bertagnolli and President Biden’s statement here.