In the aftermath of the repeal of Chevron, FDA faces a Congressional ‘brain drain’


Jul. 03, 2024

The FDA has a Congress problem – one made all the more acute following the Supreme Court’s decision last week to overturn a decades-old legal precedent known as the Chevron Doctrine. Now, at the same time the FDA needs to work even more closely with legislators to ensure that FDA-focused legislation is able to withstand legal scrutiny, the agency faces the troubling reality that many of the legislators who are most knowledgeable about the agency are set to retire at the end of this year, resulting in a regulatory brain-drain at an especially inopportune moment.

The FDA is principally overseen by two types of committees: Appropriations committees, and health-focused committees.

  • Whether an introduced bill is a standalone measure or part of a larger legislative package, those with relevance to FDA are primarily subject to the jurisdiction of two Congressional committees. In the House of Representatives, FDA-related bills are generally first considered by the Committee on Energy and Commerce’s (E&C) Health Subcommittee before they are taken up by the entire E&C Committee. In the Senate, the Health, Education, Labor and Pensions (HELP) Committee considers FDA-related measures.
  • These committees, along with others, also have oversight capacity. While the E&C and HELP Committees typically cover most FDA-related hearings, other committees such as the House Committee on Oversight and Accountability, Senate Committee on Homeland Security and Governmental Affairs, Senate Judiciary Committee, House Judiciary Committee, and Senate Committee on Finance will all touch on FDA-related matters intermittently.
  • However, budgetary matters involving the FDA are overseen by the House Appropriations Committee and Senate Committee on Appropriations. As AgencyIQ has previously discussed, the federal government is technically funded through 12 separate “appropriations” bills, each of which funds a specific subset of federal programs and authorities. While most of the U.S. Department of Health and Human Services (HHS) funding comes through the Labor-HHS appropriations bill, FDA (which is an agency within HHS) is funded through the Agriculture, Rural Development, Food and Drug Administration (Ag-FDA) appropriations bill. This is because FDA began as an agency in the Agriculture Department, and wasn’t moved into what was then called the Department of Health, Education and Welfare (HEW) until 1953. The House of Representatives’ appropriations subcommittee on agriculture has retained authority over FDA’s funding.

Now the importance of these committees is set to increase following last week’s ruling by the Supreme Court in the case of Loper Bright v. Raimondo. Let’s explain:

  • To understand the impact of Loper Bright, you first need to understand the importance of Chevron deference, named for the titular case Chevron U.S.A. Inc. v. Natural Resources Defense Council. In the 1984 case, the Supreme Court stated that determining whether an agency has interpreted a statute correctly requires the court to answer two questions. The first question is whether Congress has directly spoken to the precise question at issue. If Congressional intent is clear, then the agency must “give effect to the unambiguously expressed intent of Congress.” If Congress has not directly addressed the precise question, then courts must move to the second question: if the statute is silent or ambiguous with respect to the specific issue, is the agency’s regulation a permissible construction of the statute?
  • In short, the Court’s 1984 decision led to a greater deference to agency interpretations of regulations in the ensuing years by providing three reasons. First, the Court held that when Congress explicitly leaves a gap for an agency to fill, there is an “express delegation” from Congress to the agency to interpret that provision. Second, the Court noted that agencies may have a greater institutional competency as compared to courts, especially regarding superior subject matter expertise. The third and final reason rested on a general concern about the separation of powers, and that judges should not be in the business of reconciling competing political interests. In the nearly four decades since Chevron was decided, the case has become one of the canons of administrative law and expanding agency power. [ See AgencyIQ’s analysis here for more background on Chevron deference.]
  • But on June 28, 2024, the Supreme Court overruled Chevron. Two cases known respectively as Loper Bright Enterprises v. Raimondo (Loper Bright) and Relentless, Inc. v. Department of Commerce (Relentless) served functionally as vehicles to allow the Supreme Court to review Chevron to determine whether it was still good law. The opinion in the cases reversed the lower courts and established that going forward, limited deference will be given to agency interpretations. [ See AgencyIQ analysis here for more on the ruling and opinion.]
  • The ruling has massive implications for the Executive Branch’s regulatory reach, leaving FDA in unchartered waters. Since decades of regulation and legislation have been written with Chevron in mind, its absence opens significant room for re-interpretation and legal challenges. In addition, the ruling is likely to increase the length and complexity of agency rulemaking and regulations, with additional time necessary for legal reviews and anticipating lawsuits. [ See AgencyIQ analysis here for more on the repercussions.].
  • In the short term, what is clear is that Congress will likely need to be more prescriptive about what it wants regulators to do. Legislators are likely to need to grant agencies more specific flexibilities under the laws they pass as a way to guard against future challenges to desired agency rulemaking. However, since many existing statutes lack these flexibilities, legislators will likely find themselves facing an avalanche of requests – from regulators, industry, advocacy groups and the public – to address or fix statutory gaps in the coming years, and especially to the extent that popular regulatory interpretations of laws are overturned by the courts in the years to come.
  • As explained by former Senator RICHARD BURR (R-N.C.), the ruling puts more onus on Congress to write better laws.

But the need for better, more specific lawmaking around regulatory topics comes amidst an exodus of health policy-focused legislators on various Congressional committees

  • In fact, several prominent health care-focused legislators are set to retire at the end of this term in January 2025, and several others are facing challenging re-election battles in their respective districts.
  • According to AgencyIQ’s analysis, retirements are of particular concern for the E&C Health Subcommittee. A total of eight members of the subcommittee will not pursue reelection this term. This includes all three of the highest-ranking Democrats on the panel. In addition, the Republican chair of the E&C Committee, Rep. CATHY McMORRIS RODGERS (R-Wash.), is also retiring, sparking a succession race on the broader committee which may further re-shuffle committee staff and leaders. Rep. BRETT GUTHRIE (R-Ky.), the current chair of the Health subcommittee, is in the race to succeed her, as is BOB LATTA (R-Ohio).


Member (by party and seniority) Party District 119th Congress
Brett Guthrie (Chairman) R KY-02 Election
Michael Burgess R TX-26 Retiring
Bob Latta R OH-05 Election
Morgan Griffith R VA-09 Election
Gus Bilirakis R FL-12 Election
Larry Bucshon (Vice Chairman) R IN-08 Retiring
Richard Hudson R NC-09 Election
Buddy Carter R GA-01 Election
Neal Dunn R FL-02 Election
Greg Pence R IN-06 Retiring
Dan Crenshaw R TX-02 Election
John Joyce R PA-13 Election
Troy Balderson R OH-12 Election
Diana Harshbarger R TN-01 Election
Marianette Miller-Meeks R IA-01 Election
Jay Obernolte R CA-23 Election
Cathy McMorris Rodgers (Ex Officio) R WA-05 Retiring
Anna Eshoo (Ranking Member) D CA-16 Retiring
John Sarbanes D MD-03 Retiring
Tony Cardenas D CA-29 Retiring
Raul Ruiz D CA-25 Election
Debbie Dingell D MI-06 Election
Ann Kuster D NH-02 Election
Robin Kelly D IL-02 Election
Nanette Diaz Barragán D CA-44 Election
Lisa Blunt Rochester D DE-At large Seeking other office (Senate)
Angie Craig D MN-02 Election
Kim Schrier D WA-08 Election
Lori Trahan D MA-03 Election
Frank Pallone (Ex-Officio) D NHJ-06 Election


  • The Senate HELP Committee is set to retain its current leadership, who have been outspoken both on routine FDA matters as well as the recent Supreme Court rulings.


Member (by party and seniority) Party District 119th Congress
Bernie Sanders (Chair) I VT  
Patty Murray D WA  
Robert P. Casey, Jr. D PA Election
Tammy Baldwin D WI Election
Christopher Murphy D CT Election
Tim Kaine D VA Election
Maggie Hassan D NH  
Tina Smith D MN  
Ben Ray Luján D NM  
John Hickenlooper D CO  
Ed Markey D MA  
Bill Cassidy (Ranking Member) R LA  
Rand Paul R KY  
Susan Collins R ME  
Lisa Murkowski R AK  
Mike Braun R IN Seeking other office
Roger Marshall R KS  
Mitt Romney R UT Retiring
Tommy Tuberville R AL  
Markwayne Mullin R OK  
Ted Budd R NC  


  • The Senate Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies has the most potential for shakeup in the majority, with six of eight seats either retiring or up for reelection.


Member (by party and seniority) Party District 119th Congress
Martin Heinrich (Chair) D NM Election
Jon Tester D MT Election
Jeff Merkley D OR  
Tammy Baldwin D WI Election
Joe Manchin I WV Retiring
Gary Peters D MI  
Kyrsten Sinema I AZ Retiring
John Hoeven (Ranking Member) R ND  
Mitch McConnell R KY  
Susan Collins R ME  
Jerry Moran R KS  
Cindy Hyde-Smith R MS  
Deb Fischer R NE Election


  • However, the House Appropriations panel responsible for funding the FDA must only contend with the upcoming elections. In contrast to the E&C Health Subcommittee, the Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration does not have any members retiring after this term. This potentially offers increased institutional knowledge moving forward.


Member (by party, seniority) Party District 119th Congress
Andy Harris (Chair) R MD-01 Election
David Valadao R CA-22 Election
John Moolenaar R MI-02 Election
Dan Newhouse R WA-04 Election
Julia Letlow R LA-05 Election
Ben Cline R VA-06 Election
Ashley Hinson R IA-02 Election
Jerry Carl R AL-01 Election
Scott Franklin R FL-18 Election
Tom Cole (Ex-Officio) R OK-04 Election
Sanford Bishop, Jr. (Ranking Member) D GA-02 Election
Chellie Pingree D ME-01 Election
Lauren Underwood D IL-14 Election
Marcy Kaptur D OH-09 Election
Barbara Lee D CA-12 Election
Debbie Wasserman Schultz D FL-25 Election
Rosa DeLauro (Ex Officio) D CT-03 Election


Is FDA ready for the Congressional shakeup post-Chevron?

  • FDA’s Office of Policy, Legislation and International Affairs (OPLIA) must maneuver more high stakes Congressional relationships. Nested within the Office of the Commissioner, OPLIA is led by Deputy Commissioner for Policy, Legislation, and International Affairs KIMBERLEE TRZECIAK. Per its webpage, OPLIA “staff serves as FDA’s focal point for engagement with the U.S. Congress, the Administration, global counterparts and partners, and state, local, territorial, and tribal policymakers.”
  • Within OPLIA, two offices manage the agency’s interactions with Congress. First, the Office of Legislation (OL) serves as “the focal point for overall legislative liaison activities within FDA.” Responsibilities include developing legislative proposals, advising and assisting Congressional members and staff (including briefings and visits), and prepping FDA leadership for Congressional hearings. According to the OL webpage, the office is led by Acting Associate Commissioner for Legislative Affairs ERIN O’QUINN, with six additional members of senior staff.
  • Second, the Office of Congressional Appropriations (OCA) has a more narrow remit: to manage the agency’s relations with appropriators and advise on appropriations matters. The OCA senior staff, according to its webpage, consists of two leaders in an acting capacity.
  • In the wake of the post-Chevron framework, these offices will likely experience an influx of requests for assistance and briefings from Congress moving forward. To manage this workload and increase bandwidth, OPLIA may need invest in its staffing and communications bandwidth. It is worth noting that these challenges are not unique to FDA and will be problematic across HHS and the broader Executive Branch. FDA and other agencies also detail agency staff to various posts in Congress, and it’s unclear if this type of arrangement will increase or slow with the new dynamics.
  • However, it’s worth noting that many of these staff members are political appointees, according to the Plum Book, which lists political appointees who may be replaced by a President. As a result, if former President DONALD TRUMP wins the 2024 Presidential Election, OPLIA would likely see significant turnover.
  • Congress is already looking for answers from FDA on some of its regulations following the Loper Bright decision. On June 30, 2024, HELP Committee Ranking Member BILL CASSIDY (R-La.) penned a letter to FDA Commissioner ROBERT CALIFF articulating his perspective that, “The Court’s Loper Bright decision should impel FDA to more faithfully follow the law, and Congress to more attentively update the law, as warranted.” The letter included a list of questions “to understand how FDA will abide by and implement the Court’s new framework.” Cassidy questions how the agency will implement the framework on a widescale basis and in relation to specific policy issues, like the regulation of laboratory-developed tests (LDTs) – a rule the FDA finalized in late April 2024. Cassidy also asked the FDA to provide information on plans for “regular briefings, trainings and seminars,” as well as increased “responsiveness to oversight and technical assistance requests from Congress.”

What’s next?

  • The basic problem is this: Just as some legislators are asking for FDA to be more deferential to Congress, there are fewer legislators who deeply understand the FDA. And for the FDA next year, those problems are likely to intersect in powerful ways that may result in difficulties for the FDA. The agency’s regulations are inherently complex, and developing an understanding of not only what the FDA does but why it does (or does not) those things can take years.
  • The scope of the legislative brain drain is likely to be enormously detrimental to the FDA, who will need to not only find new champions, but also invest significant energies into educating new members about the nuances of what and how it regulates. Between just Reps. ANNA ESHOO (D-Calif.), MICHAEL BURGESS (R-Texas) and BRAD WENSTRUP (R-Ohio, who is on the Ways and Means’ Subcommittee on Health), the House will lose about six decades of combined experience from leading health policymakers after this term.
  • There will likely be waves of issues facing the FDA and Congress. First, there may be a short-term, urgent need to solve certain issues where FDA thinks it may not be on solid ground to regulate, but feels that Congress could make that authority more explicit. Bills being worked on, such as the 21st Century Cures Act 2.0 legislation, may be an early test case of how legislators are adapting to the post-Chevron realities of lawmaking. Next, and on a long-term basis, FDA is likely to need Congress’ help to regulate highly complex or novel industries that exist on (or in) the margins of existing regulatory frameworks. While FDA has always run the risk of not moving quickly enough to properly oversee certain industries, if it relies on Congress to explicitly provide it with the authority to regulate specific areas, this oversight gap is likely to expand.
  • It’s not just an exodus of legislators – there’s also a shortage of policy staffers. Among the Energy and Commerce Committee’s staff, for example, many have relatively little tenure, according to AgencyIQ’s analysis. While some have prior work experience (or in the case of GRACE GRAHAM, another decade working for the Senate’s HELP Committee), most have only served on the Energy and Commerce Committee for less than two full years, and only three staff members have more than five years of experience. This comes as some highly experienced staff have recently left the committee, such as former Senior Health Counsel STEPHEN HOLLAND, and more are likely to leave after the election (and the retirement of E&C leads McMorris Rodgers and Eshoo) as well.


E&C Staff Name Position E&C Tenure
Lydia Abma Policy Analyst August 2021
Jennifer Black FDA Detailee January 2024
Molly Lolli Professional Staff January 2023
Jolie Brochin Jr. Professional Staff January 2023
Corey Ensslin Senior Policy Advisor January 2023
Grace Graham Chief Counsel, Republican January 2021
Saha Khaterzai Sr. Professional Staff January 2019
Una Lee Chief Counsel March 2015
Gayle Mauser Health Policy Adviser December 2023
Katja Morgan Health Policy Fellow September 2023
Emma Schultheis Clerk February 2023
Jacquelyn Bolen Senior Counsel, Democratic January 2016
Caitlin Wilson Counsel May 2023


  • It will likely take some time for a new relationship and processes between FDA and Congress post-Loper Bright to materialize. There are few in-session days for the House and Senate prior to the upcoming election, with both chambers set to be on vacation and campaigning for much of the months of August and October. In addition, the potential for a Presidential administration transition could lead to leadership and policy changes within FDA and other agencies.
  • Ultimately, the same dynamic affecting the FDA will also affect the life sciences industry and issue-specific advocates as well. With a shortage of experienced legislators and staff, companies and groups will have their work cut out for them as they request legislative changes that require greater specificity than they did before Chevron was overturned. They will need to invest in educating new legislators and staffers at a minimum, but more complex efforts likely will require government affairs staffers to have a deeper understanding of each agency’s existing and proposed regulatory authorities to be able to propose specific changes to legislators.

Featuring previous research by Walker Livingston and Laura DiAngelo.
To contact the authors of this item, please email Amanda Conti ( and Alexander Gaffney (
To contact the editor of this item, please email Alexander Gaffney (

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