330: How a Trump presidency could affect the FDA, the biotech industry, and its stocks
Nov 7, 2024
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Lizzy Lawrence, STAT’s FDA reporter, joins biotech experts Brian Skorney and Daphne Zohar to discuss the impact of a potential Trump presidency on the FDA and the biotech industry. They delve into concerns over regulatory changes, FDA leadership stability, and investor sentiments regarding vaccines and antivirals. The conversation also explores how immigration policies may affect talent acquisition in biotech. Finally, they analyze the Inflation Reduction Act’s effects on drug development and pricing, shedding light on innovation in a politically charged landscape.
Trump's presidency may instigate significant shifts at the FDA, raising concerns about regulatory stability and job security for employees.
The biotech industry expresses cautious optimism about navigating regulatory changes, focusing on drug pricing and seeking innovative pathways for adaptation.
Deep dives
Impact of Trump's Election on the FDA
Trump's election raises significant concerns regarding potential shifts at the FDA, particularly with Robert F. Kennedy Jr.'s involvement. Kennedy's agenda includes reducing corporate influence within regulatory agencies and addressing chronic diseases, which could lead to a significant reshaping of the FDA’s operations. His promises, which involve firing departments and focusing on public health, have sparked apprehension among career employees about their job security and the direction of the agency. The uncertainty surrounding who will lead the FDA and the potential for chaos in regulation have financial analysts and industry professionals on high alert.
User Fees and FDA Funding Challenges
The discussion highlights the FDA's reliance on user fees, which contribute nearly 50% of its budget, and the implications if these fees were eliminated. Many view these fees as a conflict of interest, but completely forgoing them could destabilize the FDA’s operations and hinder the drug approval process. The drug industry, accustomed to these arrangements, may push back against changes that jeopardize such funding. Therefore, while Kennedy’s agenda might resonate with some, eliminating user fees seems unlikely due to the resulting backlash and potential devastation to FDA functions.
Concerns Over Agency Integrity and Staffing
There are increasing anxieties about the integrity of the FDA and the potential loss of experienced personnel due to the hostile political environment. Industry experts suggest that, although FDA employees are generally resilient, there is a palpable fear among those who witnessed the previous administration's upheaval. Many are contemplating leaving the agency, leading to a possible exodus of valuable expertise and impacting regulatory stability. This uncertainty could hinder the expected outcomes of the FDA's role in public health and drug development, diverting focus from essential scientific rigor.
Opportunities and Optimism within Biotech
In spite of political uncertainties, biotech executives express a cautious optimism regarding potential regulatory changes and opportunities in the drug development landscape. The checks and balances inherent in the U.S. government are believed to mitigate extreme outcomes that could disrupt the industry. Additionally, the anticipated focus on drug pricing and middlemen in healthcare, such as PBMs, could benefit the biotech sector. These perspectives indicate that while challenges exist, the industry may find pathways to adapt and innovate in a changing regulatory environment.
To dig into how the election results could affect all things biopharma, we brought on three guests for this episode: Lizzy Lawrence, STAT’s FDA reporter, Baird analyst Brian Skorney, and longtime biotech executive Daphne Zohar.
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