FDA Layoffs, RFK Jr. at HHS, and More Including What This Means for FDA-Regulated Companies

In recent weeks, the FDA has faced significant cuts, including the layoffs of probationary employees. These employees, many of whom had been hired to fill roles left by retirees or to bolster the agency’s staffing during the COVID-19 pandemic, were let go as part of a broader government-wide initiative. While these layoffs affected areas such as CDRH (Center for Devices and Radiological Health) and the Human Foods Program (HFP), it’s worth noting that CDER (Center for Drug Evaluation and Research) was impacted less.

For now, this means that drug reviews should proceed without major delays, as CDER's essential functions remain intact. However, these cuts could still have downstream effects, particularly if the FDA faces more layoffs in the future. The FDA’s drug review process is funded through a combination of appropriations and user fees, which has allowed the agency to continue reviewing submissions without significant disruption during times of political uncertainty, such as during a government shutdown.

Yet, the FDA's broader challenges are evident. Many of the staff cut from CDRH, for example, were specialists in fields such as AI/ML, cyber technologies, and digital health—areas that are pivotal to the evolving landscape of medical devices. These layoffs could slow down the review and approval of new devices, as the FDA’s capacity to assess such cutting-edge technologies appears diminished.

What does this mean for FDA-regulated companies? Staffing shortages could strain the FDA’s ability to handle the growing number of submissions across all sectors, leading to delays in other areas, including compliance, enforcement, and pre-market inspections. FDA-regulated companies should prepare for potential disruptions by ensuring their quality management systems (QMS) and compliance programs are robust and efficient, as delays in reviews, inspections, and approvals could impact timelines for bringing products to market.

RFK Jr. and Potential Shifts in FDA Oversight 

Robert F. Kennedy Jr.’s confirmation as Secretary of Health and Human Services (HHS) has sent ripples through the healthcare regulatory landscape. Known for his vocal stance on vaccines and concerns about pharmaceutical industry influence, Kennedy’s leadership at HHS could result in significant shifts in how the FDA oversees drug approvals, vaccine regulations, food safety, and medical device reviews.

RFK Jr. has expressed skepticism about the influence of large pharmaceutical companies on regulatory agencies, which could lead to a stricter approach to oversight. His past advocacy for stronger vaccine regulations, greater transparency in clinical trials, and more scrutiny of food additives could have far-reaching consequences for FDA-regulated businesses. Pharmaceutical and biotech companies might face increased hurdles in the approval process, particularly for vaccines and biologics. Meanwhile, food manufacturers and dietary supplement companies are likely to see tighter enforcement of food additives and food safety standards.

For companies navigating these regulatory waters, it will be essential to stay informed about potential policy shifts under Kennedy’s leadership. His history of advocating for heightened safety protocols and more stringent regulatory measures suggests that companies may need to strengthen their QMS and compliance programs in anticipation of increased scrutiny.

Dr. Marty Makary and the Future of FDA Leadership

In addition to the confirmation of RFK Jr., the potential appointment of Dr. Marty Makary as FDA Commissioner could further shape the direction of the agency. As a well-known public health advocate, Dr. Makary has been outspoken about the need for regulatory reform, especially in the areas of medical device approvals, drug pricing, increasing healthcare transparency, fostering innovation, and improving the FDA’s efficiency and independence. While the Senate has yet to schedule confirmation hearings for Dr. Makary, his leadership could signal a push for more transparency and flexibility in FDA’s processes, particularly for devices and drugs.

As the FDA continues to grapple with staffing shortages and shifting leadership, the focus for FDA-regulated businesses should remain on proactive compliance. Companies should be prepared for potential changes in how the agency enforces regulations and handles submissions, especially as the FDA navigates its leadership transition.

Government Shutdown and FDA Operations

The threat of a government shutdown remains a looming concern, particularly with the FDA's funding scheduled to expire on March 1, 2025. If Congress does not pass a budget or continuing resolution, the FDA will be forced into a shutdown, which could significantly impact its operations. While the FDA's review functions supported by user fees (such as drug and medical device approvals) are likely to continue, other areas of the agency may be more severely impacted. Inspections, enforcement actions, and policy development could all face delays if the shutdown extends beyond a short period.

In the event of a shutdown, FDA-regulated companies should prepare for potential disruptions in inspections, compliance enforcement, and even product reviews in certain cases. Planning for these scenarios, including understanding which areas of the agency are most likely to be affected, will help companies navigate any temporary slowdowns.

Conclusion  

The FDA, under new leadership and amidst staffing cuts and potential funding lapses, is entering a period of uncertainty. For FDA-regulated companies, staying informed and prepared for changes in product reviews, inspections, and enforcement is critical. While the immediate future of drug reviews appears unaffected by recent layoffs, companies should anticipate potential delays and disruptions across other sectors, particularly in light of potential shifts in policy under RFK Jr.'s leadership at HHS.

Companies should ensure their QMS and compliance programs are robust, monitor policy developments closely, and prepare for possible changes in the regulatory environment. Proactive planning will help mitigate risks and keep operations on track, even as the FDA navigates this period of change.

Reach out to Gardner Law for help mitigating risks and preparing for the uncertainty ahead.