The 2022 midterm election resulted in putting Republicans in control of the House of Representatives by the narrowest of margins (222 to 213). With the Democrats succeeding in maintaining control of the Senate under a very slim 51 to 49 margin, the leadership of the nation’s two legislative chambers would both need to overcome steep hurdles to achieve effective governance in the 118th Congress.
As history has shown, the dynamics of divided government at the federal level typically results in a strong dose of legislative paralysis, low productivity, and gridlock. Barring very few exceptions, those attributes best reflect what has thus far resulted from the 118th Congress. The current legislative atmosphere in Washington is in stark contrast to the 117th Congress (2021–2022) that saw the enactment of several monumental pieces of legislation (e.g., American Rescue Plan Act, IIJA, Inflation Reduction Act). Those accomplishments came to be as a result of the momentum stemming from the 2020 Presidential election, which ushered in single-party control of both Congress and the White House.
In light of the traditional swinging of the political pendulum, there was an expectation that the 2022 midterm elections would alter the balance of power in Congress and immediately short circuit the legislative advantage previously enjoyed by Congressional Democrats and the Biden Administration. However, the unforeseen drama and turbulence that overcame the House of Representatives in the days after the session began would ultimately set in motion unprecedented events that resulted in the removal of Rep. Kevin McCarthy (R-CA) as Speaker of the House — a mere nine months after he was elected to the position.
The uncertainty that descended upon the House of Representatives as a result of the ousting of Speaker Kevin McCarthy was a direct outgrowth of the circumstances that transpired at the onset of the 118th Congress when it took a dramatic 15 ballots for McCarthy to secure the speaker’s gavel. However, McCarthy’s speakership came at a steep cost. To gain the votes of a dissident band of hardline GOP holdouts, McCarthy made some risky concessions. One of McCarthy’s concessions to this group was to grant a House rule change that would allow a single lawmaker to make a motion for the speaker’s removal. This would ultimately be the weapon employed against McCarthy. Shortly after McCarthy worked with Congressional Democrats to pass a short-term continuing resolution to avert a government shutdown in late September, an anti-McCarthy Republican (Rep. Matt Gaetz of Florida) — claiming McCarthy broke his promises on fiscal policy — called for a motion to vacate the Speaker chair. On Oct. 3, eight House Republicans, in tandem with the votes of every Democratic member of the House, successfully ended McCarthy’s short reign as Speaker.
After 22 days without a speaker, the House Republican conference rallied behind the candidacy of Rep. Mike Johnson, a relatively unknown fourth-term member from Louisiana. On Oct. 25, Johnson secured the speakership by winning the votes of all 220 House GOP lawmakers who were present in the chamber. Newly minted House Speaker Johnson was able to score his first major victory this month by corralling a temporary, stopgap spending bill through the House that averted a government shutdown on Nov. 17. The Senate accepted the legislation that President Biden signed into law. Congress now has until early next year to address and finalize its annual budget process.
While leadership stability in the House has been restored, the new speaker will continue to face the challenge of unifying an often-divided House GOP conference on the major issues and legislation that will need to be addressed in the remainder of the 118th Congress. As both the House and Senate move forward, the expectation should be that only the most bipartisan, bicameral, and relatively noncontroversial pieces of legislation will be able to successfully make their way through both chambers of Congress.
On the FDA policy side, except for a couple of very targeted FDA related measures — which do not directly impact the homeopathic drug sector — it has been quiet year on the legislative front. The only FDA user fee program that needed to be reauthorized this year was the Animal Drug User Fee Program. In a noncontroversial fashion, that reauthorizing measure hitched a ride on the continuing resolution that was signed into law on Sept. 30.
With this backdrop, AAHP has continued to maintain some targeted Congressional engagements this year, as well as engaged in productive dialogues with our aligned partners. These communications entailed strategizing on potential opportunities to promote homeopathy and approaches to manage the current challenging and uncertain regulatory environment.
As an outgrowth of these strategic engagements, AAHP is in the very early stages of eyeing a potential legislative opportunity for homeopathy, which would be tied to the Congressional reauthorization of FDA's Over-the-Counter Monograph Drug User Fee Program (OMUFA). The OMUFA reauthorization measure will need to be addressed by Congress in 2025 as the program’s current authority expires on Sept. 30 of that year. While we are a little less than two years from OMUFA’s expiration, FDA kicked off its first public meeting on Sept. 28 to discuss proposed recommendations for the reauthorization of this OTC user fee program.
The Consumer Healthcare Products Association (CHPA), which is the trade association of record for allopathic OTC companies, will play a prominent role in its discussions with FDA and Congress on the upcoming reauthorization of OMUFA. The AAHP’s Legal and Regulatory Committee members have been in communication with CHPA officials to discuss possible opportunities to address homeopathic GMP challenges as part of the OMUFA reauthorization process. As the association’s membership is aware, AAHP has prioritized efforts to enhance FDA’s GMP inspection regime of homeopathic drugs in a way that better comports with the unique nature of the products.
In discussing this topic with CHPA representatives, they expressed an openness to working with AAHP to further the dialogue with FDA to address homeopathic cGMP gaps. Should momentum build in the coming months on this opportunity to address homeopathic GMP issues as part of the OMUFA reauthorization measure, the association’s federal program will need to ramp up Congressional advocacy engagements to educate, inform, and build support on Capitol Hill for this effort.
So, while the 118th Congress (2023–2024) will continue to see only limited legislative productivity, preparations by the association for a more active 119th Congress (2025–2026) may need to shortly begin surrounding this potential opportunity for homeopathy as part of the upcoming OMUFA reauthorization measure.