How congressional leadership changes could impact supplement industry
- By: AHPA
- On: 11/03/2022 15:46:44
- In: Regulation / Legislation
November 2, 2022
Recent polls indicate the upcoming midterm elections will include numerous tight races, with growing support for Republicans being reported as inflation persists, and Democrats seek to maintain control of both the U.S. Senate and House of Representatives.
If Republicans gain control of one or both houses, changes in the leadership ranks of the two key congressional committees responsible for overseeing policy and legislation impacting FDA would occur when the 118th Congress convenes on Jan. 3, 2023.
These pending shakeups at the top of the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce (E&C) Committee would directly impact FDA and the agency's enforcement and implementation of the laws and regulations that govern dietary supplements.
Senate HELP Committee
If a Democratic majority is retained in the Senate, then—following the pending retirement of longtime Sen. Patrick Leahy (D-Vermont)—Sen. Patty Murray (D-Washington) would reportedly relinquish her current role as chair of the Senate HELP Committee to assume the reins as chair of the Senate Appropriations Committee. The Senate Appropriations Committee, currently chaired by Leahy, is a powerful panel that oversees annual federal spending and sets budget priorities.
Murray has served as the top Democrat on the Senate HELP Committee since 2015 and has been leading the charge in the Senate to enact three pieces of legislation that would significantly amend the Federal Food, Drug, and Cosmetic Act (FDCA), one of which focuses on regulatory reforms for cosmetics and another on medical devices. The third policy rider that Murray, alongside Sen. Dick Durbin (D-Illinois), has strongly advocated for is mandatory product listing (MPL) legislation for dietary supplements. The Senate HELP Committee recently advanced all three of these proposals as so-called “super riders” on FDA user fee reauthorization legislation, but the legislation that was ultimately signed into law omitted them.
Should Murray—as the next in line to take over as chair of the Senate Appropriations Committee—opt to lead the spending panel in the 118th Congress, then the next most senior Democrat on the Senate HELP Committee is Sen. Bernie Sanders (I-Vermont). Sanders has indicated he is very interested in leading the HELP panel on the Democratic side of the aisle.
It is uncertain if Sanders would prioritize MPL or the other significant amendments to the FDCA in the same way as Murray has in the 117th Congress. Sanders voted against the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (FDASLA) when the legislation was marked up by the Senate HELP Committee on June 14. MPL provisions were included in the FDASLA; however, Sanders stated the reason he voted against the proposed legislation was because it did not include drug reimportation language, which he has long advocated for.
If Republicans take control of the Senate, there would be a definite shift at the top of the Senate HELP Committee. Current ranking member Sen. Richard Burr (R-North Carolina) is set to retire at the end of 2022, with Sen. Rand Paul (R-Kentucky) next in line to serve as the lead Republican on the committee. Paul, an ophthalmologist, is widely known to be critical of FDA and the public health establishment that resides within other key federal government agencies. Further, Paul has a history of being a supporter of consumer access to natural health care options.
Paul's critical eye and often adversarial approach—as indicated by his combative relationship with Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and lead member of the White House Coronavirus Task Force under President Donald Trump—is rare amongst his colleagues in the Senate. As such, with a leadership role on the Senate HELP Committee, Paul would bring a posture that is unique for the position.
Another consideration is that Paul would have the option to serve as the head Republican on the Senate Homeland Security Committee due to the retirement of current chair Sen. Rob Portman (R-Ohio). Should Paul opt to be the top Republican on the Senate Homeland Security Committee instead of the Senate HELP Committee, Senator Bill Cassidy (R-Louisiana), a gastroenterologist, is the next most senior Republican on the HELP panel after Paul.
Though who exactly will lead the committee is yet to be determined, the next Senate HELP Committee chair will come from the party in the majority, and the next ranking member will come from the other party in the minority.
House E&C Committee
On the House side, both Rep. Frank Pallone (D-New Jersey) and Rep. Cathy McMorris-Rodgers (R-Washington) are expected to remain as leaders of their respective parties on the House E&C Committee in the 118th Congress. Should Democrats maintain their majority, Pallone would continue as chair, while McMorris-Rogers would continue as ranking member. Should Republicans take control of the House, Pallone's and McMorris-Rogers' roles would reverse.
Though McMorris-Rodgers lacks a discernible track record regarding issues impacting dietary supplements, philosophically, she employs a critical eye on legislative proposals that add to FDA's regulatory authority. Moreover, she is known for listening to and entrusting her GOP committee colleagues on key topics, including Rep. John Curtis (R-Utah), one of her very trusted confidants on the E&C panel. McMorris-Rodgers looked to Curtis to help vet early versions of proposed MPL legislation, knowing Curtis is a co-chair of the Congressional Dietary Supplement Caucus and how important the natural products community is to his state's economic vitality.
Should House control flip to the GOP, another important Republican Committee member in the 118th Congress would be Rep. Brett Guthrie (R-Kentucky). Guthrie, who is currently the ranking member of E&C's Health Subcommittee, would assume the role of chair of that important subcommittee. Even though Guthrie has not taken on a high-profile role related to dietary supplement regulatory issues, his existing membership on the Congressional Dietary Supplement Caucus is noteworthy.
With regard to Pallone, his very long history and close relationship with the dietary supplement sector is widely known. Prior to his ascendancy to chair of the House E&C Committee, Pallone served as the House's Democratic co-chair of the Congressional Dietary Supplement Caucus. While Pallone is believed to be sympathetic to proposals to establish an MPL requirement for dietary supplements, he and his office have always maintained an open line of communication to American Herbal Products Association (AHPA) representatives and the natural products community at large.
If Democrats retain control of the House, it can be assumed any of the legislative priorities not passed into law in the 117th would resurface in the 118th Congress. Whereas, should the Republications gain control of the House, the appetite for significant amendments to the FDCA would likely be diminished or, more ideally, present a structure more receptive to industry input and provide more opportunity for engagement between trade representatives and policy makers.
A significant result of Republicans' gaining control of the House in the next Congress would be that policy initiatives without broad support by industry would be unlikely to advance to the president's desk in the 2023-2024 cycle. High-profile or ambitious federal policy legislation would fall victim to House-Senate congressional gridlock. With respect to proposed regulatory reforms for dietary supplements, cosmetics and medical devices, in particular, Republicans would not be expected to give any more authority to FDA.
The next leaders of these key committees will be determined by the outcomes of the midterm elections in November. Whether Democrats retain control of both the Senate and House, or Republicans take control of one or both, legislation influencing FDA and the laws and regulations governing dietary supplements may take a different course than what has been seen in the 117th Congress.
I invite members and the industry to attend AHPA's virtual Congress on Regulatory Priorities in the Natural Products Market on Nov. 15 for a breakdown of midterm election results. In addition, AHPA legislative consultant Pete Evich and I will present an overview of what is in store for the 118th Congress and other political dynamics resulting from this November's elections in terms of legislation that would directly impact the dietary supplement sector.
Michael McGuffin has served as president of the American Herbal Products Association since 1999, leading the association in its mission to promote the responsible and sustainable commerce of herbal products to ensure that consumers have informed access to a wide variety of safe herbal goods. McGuffin also serves on the boards of directors of the American Herbal Pharmacopoeia and United Plant Savers, and on the advisory boards of the USC School of Pharmacy regulatory science master's degree program and the Appalachian Beginning Forest Farmers Coalition. An industry veteran, McGuffin has been active in the herbal community since 1974, and he has taken the lead on legislative matters and regulatory advocacy that have shaped the herbal and natural products industry over the last several decades.