Your essential guide to the FDA regulatory policy landscape through the end of 2024

The 2024 fiscal and calendar year is rapidly drawing to a close for the FDA, with little time in which to accomplish major reforms, release new policies, promulgate new regulations, and plan for some major potential disruptions. While we don’t have a crystal ball to predict everything the FDA will accomplish or contend with during that time, AgencyIQ has assembled this list of all the deadlines, major events and priorities that the FDA is trying to meet or prepare for. For stakeholders in the FDA life sciences space, this list is intended to help guide your decision-making and identify areas of opportunity for engagement.

Keep an eye on Congress

• Like all federal agencies, the FDA’s funding operates on a fiscal year basis starting on October 1 and ending September 30. The agency is funded through the Agriculture, Rural Development, Food and Drug Administration (Ag-FDA) appropriations bill. However, the FDA’s funding is currently in limbo owing to disagreements between the White House, Senate and House of Representatives. While the House appropriations committee did advance its proposal for the funding bill that covers the Department of Agriculture and the FDA, it was pulled from consideration on the House floor – meaning that legislators will not be moving ahead with that version of the funding bill (see POLITICO reporting here). The White House has also released a Statement of Administrative Policy in opposition to the House’s version of the bill, citing concerns about the overall spending levels in the bill and individual policies.
• It’s likely that a continuing resolution (CR) will be needed as a budget stopgap measure. CRs allow Congress to maintain current funding levels in a temporary way to avoid a governmental shut down while allowing legislators more time to finish compiling a full federal budget. With a looming fiscal deadline of October 1 (the first day of federal fiscal year 2025) and Congress only just coming back from its August recess on August 9, there is limited time frame for funding negotiations to take place. CRs have been frequently used in recent years, and it currently seems likely that one will be enacted by the end of September, although negotiations are ongoing (See POLITICO reporting here). However, it is too early to tell how long the CR would be in effect for.
• If there is a CR, watch closely for any FDA-related legislative riders. A “rider” is a piece of legislative text that is passed as part of an otherwise unrelated bill. Several major FDA-related statutes have been passed into law in recent years, including the Food and Drug Omnibus Reform Act (FDORA), which passed in December 2022 as part of the Consolidated Appropriations Act of 2023. This year, a CR would include efforts to reauthorize the Rare Pediatric Disease Priority Review Voucher Program, which is currently set to expire on September 30. At this time, however, it seems unlikely that several other FDA-related bills will be passed along with the CR (although they might be passed during the so-called “lame duck” session of Congress after the election).

Legislation that could be considered by the end of 2024

What major policies from FDA are we still awaiting?

• While the FDA has had an extremely busy year issuing policy, there are still some important things left on its agenda, including a major organizational update: The FDA’s proposed reorganization is supposed to take effect October 1, 2024. This major reorganization focuses primarily on FDA’s human foods program, but also significantly impacts FDA’s Office of Regulatory Affairs (ORA) and the medical product centers. As AgencyIQ has previously discussed, ORA – the group traditionally charged with conducting regulatory inspections of manufacturing facilities – will be re-named the Office of Inspections and Investigations (OII). A significant portion of ORA’s post-market inspections oversight will be transitioned into the individual product centers – including drugs under the Center for Drug Evaluation and Research (CDER), biologics under the Center for Biologics Evaluation and Research (CBER) and, under the Center for Devices and Radiological Health, (CDRH), medical devices and diagnostics. The transition comes as FDA will potentially be operating under a CR, which can make administrative changes difficult, and as the agency is facing challenges with its funding for staff pay increases, as well as the potential for turnover following the election. These organizational changes could have ripple-down effects for life sciences companies.
• There are also several major drug regulatory developments to watch closely. This list below is based on the FDA’s Federal Register notices, as well as its Unified Agenda.

Major pharmaceutical and biopharmaceutical regulatory actions expected during the rest of 2024

• We’re also expecting seven additional medical device-focused guidance documents through the end of September. The Center for Devices and Radiological Health’s (CDRH) Fiscal Year 2024 guidance agenda proposed an ambitious plan for policymaking, which the Center has largely fulfilled. Per the agency’s guidance database, CDRH has authored (or co-authored) 31 guidance documents alone in 2024. However, there are still some high-priority policies that remain unpublished so far this year which could be published in the next few weeks.

Medical device-related guidance we’re expecting by the end of September 2024

• Notably, a new 2025 guidance agenda for CDRH is expected shortly. CDRH’s guidance agenda runs fiscal year through fiscal year, so we are expecting to see a new agenda for FY2025 in October. This could provide some insight into what documents remain on the list, and what new priorities the device center will have for the year ahead.
• From a drug and biologics perspective, there is considerably more uncertainty about what guidance documents we might see. FDA’s Center for Biologics Evaluation and Research (CBER) maintains its own guidance agenda, as does the Center for Drug Evaluation and Research (CDER). There are also additional guidance documents required as a result of the FDA’s various negotiated user fee agreements with the drug, generic drug, and biosimilar industries.
• Taking into account some uncertainty, here’s what we are very likely to see published by the end of 2024:

Election impacts

• Of course, the Presidential and Congressional elections are also set to take place in early November. Both will have significant impacts on the FDA. The entirety of the House of Representatives, 33 Senate seats, and the White House are up for election in November 2024.
• As AgencyIQ has previously explained, several key legislators with oversight over FDA are set to retire at the end of this Congress, while others may lose their elections. This poses a significant risk for regulatory policymaking, as a lack of FDA-specific expertise could slow down or otherwise negatively affect the passage of new legislation in the years to come. At a minimum, it will likely require the FDA and other stakeholders to spend significant time and effort to educate new legislators and their staff.
• The Presidential Election will also have significant impacts on the FDA. Either a President KAMALA HARRIS or President DONALD TRUMP is expected to nominate a new FDA Commissioner after assuming office in January 2025, with the nominee then requiring Senate confirmation. It is unclear if the current FDA Commissioner, ROBERT CALIFF, would stay on until a new Commissioner is confirmed, or if he would depart before then. If he does depart, that would require the current President to select an Acting Commissioner to lead FDA on an interim basis.

While many election impacts will only start to take shape in 2025, there are a few key questions that should be top of mind through the end of the year:

• Turnover of FDA staff is expected to be a major issue through the end of the year as well. CDRH has already begun to experience some high-level turnover, with longtime CDRH Director JEFF SHUREN recently announcing his departure from the director’s seat and imminent departure from the agency. As AgencyIQ previously discussed, Shuren is staying on as Center Director Emeritus to support the transition, while CDRH Deputy Director and Chief Transformation Officer MICHELLE TARVER is serving as Acting Director. Further, a new Director of CDRH’s Office of Product Evaluation and Quality (OPEQ), ROSS D. SEGAN, is expected to start soon. Segan, a longtime medical device executive, will be the second-ever OPEQ Director, following the early 2024 retirement of BILL MAISEL who had led the Office since its establishment in 2018.
• But the pace of departures may accelerate, depending on the outcome of the election. Former President Donald Trump has said he is likely to re-implement reforms to the federal bureaucracy (known as Schedule F) intended to eliminate certain employment protections for staff involved in policymaking. If Trump does win the election, some FDA staff currently in policymaking roles may choose to depart the agency early as a result. Regardless of who wins the election, some FDA staff are still likely to depart. These include Deputy Commissioner for Policy and Legislation KIMBERLEE TRZECIAK, Associate Commissioner for External Affairs LEAH HUNTER, Chief Counsel MARK RAZA, and Chief of Staff ELIZABETH JUNGMAN – all political appointees or persons appointed by the FDA Commissioner.

Additional issues

• There are a few other major regulatory policy topics and deadlines that we are expecting to see through the end of the year.

Timelines to remain aware of: Major FDA comment periods closing soon

• There are several comment periods closing on major FDA actions soon, including on guidance documents in specific therapeutic areas (e.g., development of drugs for pediatric inflammatory bowel disease), new policies like the Diversity Action Plan (DAP) requirements, and requests for information (RFIs) from the agency on new regulatory areas – including rare diseases, biosimilars, and health equity.
• The topics range across the scope of FDA’s oversight, including drugs, devices, and combination products. Altogether, this will be a busy time for both the regulatory professionals tasked with compiling the comments and the regulators receiving them.

Select guidance documents and requests for comment with comment periods closing in 2024

Final thoughts for FDA policy stakeholders

• While some of the FDA’s largest and most controversial policies (like its Laboratory Developed Test final rule) were published earlier this year to avoid scrutiny under the Congressional Review Act, there is still a significant amount of policymaking set to take place during the final four months of 2024. Many of these policies are required by law or binding commitments and are therefore highly likely to take place. Other policies, even if not legally binding, are almost certain to be released due to contextual circumstances (such as the pending departure of their sponsor). So although the general policy landscape will be turbulent due to the election, stakeholders in the FDA policy space have a degree of certainty and control over the next few months.
• Still, the next few months are likely to be more about building a foundation for future work or putting a small capstone on existing work. For example, FDA’s plan for further reforms to its advisory committee system and its good guidance practices will require additional efforts before they take effect. Therefore, stakeholders should pay close attention not only to FDA’s plan of action, but also the pace of action and the extent to which it reflects (or deviates from) what stakeholders want. At a time of great turnover (including of the FDA Commissioner and other senior leaders at FDA), work that is left unfinished could be deprioritized in the future – or taken in an entirely new direction.
• Knowing what’s ahead can help stakeholders plan for policy actions. For example, some events like the anniversary of the passage of the Hatch-Waxman Act of 1984, which created the modern generic drug approval pathway, could potentially be used to call attention to perceived issues with the pathway. In other cases, efforts may intersect with one another, such as FDA’s efforts to pass a regulation on initial Pediatric Study Plans (iPSPs) and legislators’ efforts to pass the Give Kids a Chance Act, which are both focused on pediatric study requirements for molecularly targeted products. Because the events in this piece are largely those that are required to take place, stakeholders can reliably plan associated messaging and events.

To contact the authors of this item, please email Laura DiAngelo ( ldiangelo@agencyiq.com) and Alexander Gaffney ( agaffney@agencyiq.com).
To contact the editor of this item, please email Kari Oakes ( koakes@agencyiq.com).