What Life Sciences Companies Need to Know in 2025

The ArentFox Schiff Life Sciences team takes a look at what changes may impact life sciences companies in 2025.

Key Insights for Pharma Manufacturers Regarding the AKS

In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s long-standing interpretation of the Anti-Kickback Statute (AKS).

FDA Finds Significant Bioequivalence Concerns in Raptim Studies Leading to ANDA and NDA Reviews

In a highly unusual move, on March 27, the US Food and Drug Administration (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications (NDAs) that relied on bioequivalence studies conducted by Raptim Research Pvt. Ltd, a contract research organization based in Navi Mumbai, India.

FDA’s Attempt to Regulate Lab-Developed Tests Struck Down in Federal Court

On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests as medical devices under the Federal Food, Drug, and Cosmetic Act.

Enhancements to FDA’s Accelerated Drug Approval Pathway

Here we discuss three significant changes to the accelerated drug approval process, focusing on novel endpoints, confirmatory trials, and expedited withdrawal of approvals. The 2024 draft guidance encourages drug developers to engage with the FDA early if they plan to use novel surrogate or intermediate clinical endpoints for accelerated approval. These overhauls aim to streamline the approval process for treatments targeting life-threatening illnesses.

Revising the GRAS Self-Affirmation Process: Ensuring Transparency and Safety in the US Food Supply

The FDA has been instructed to explore rulemaking to revise the GRAS (Generally Recognized as Safe) self-affirmation process. This directive aims to eliminate the self-affirmed GRAS pathway, which has historically allowed food and beverage companies to bypass FDA approval. The move signals a shift towards more stringent regulatory oversight in food safety.

Legal Challenges and State Legislation in the 340B Drug Pricing Program: Navigating Contract Pharmacy Regulations

As more states pass laws to enforce 340B discounts, the tension between drug manufacturers, the Health Resources and Services Administration, and state governments continues to escalate. This evolving situation may prompt further congressional action to address the complexities of the 340B program.

Adapting to Regulatory Shifts in Pharma: Off-Label Promotion and Compliance Challenges in 2025

In 2025, the pharmaceutical industry is experiencing significant changes under the Trump Administration, particularly concerning off-label promotion. Key discussions highlight evolving regulations for off-label pharmaceutical promotion, emphasizing the need for firms to build trust with sovereign governments to enhance their global presence. The integration of artificial intelligence technology presents new compliance challenges, while the FDA’s guidance is seen as an unreliable indicator of enforcement priorities. Additionally, there is increasing scrutiny on the role of medical affairs, requiring a careful balance between patient access and regulatory compliance. These shifts necessitate strategic adaptation by pharmaceutical companies to navigate the complex regulatory landscape effectively.

Overview of Regulatory Impacts for Life Sciences Companies in 2025

Recently, members of our Life Sciences group hosted a webinar discussing matters that directly impact the industry and its trajectory. Here are the topics covered:

Good Manufacturing Practices

We discuss how to handle an FDA GMP inspection and how these have changed since the new administration took over. We give you very important tips on how to prepare when you know an inspection is coming and what your staff should and should not provide during the inspection.

Drug Supply Chain Security Act compliance

Here we take a look at what the legislative and regulatory process looks like and provide an overview of the DSCSA. We also look at what the current environment is with the new administration and try to predict where we will go from here. Finally, we answer some of the most common questions we get about DSCSA compliance.

Country of Origin issues

We examine the various rules for country of origin and what purpose they serve. We help you understand the complications related to products which have pieces from multiple countries or are built across more than one country by providing specific examples and looking at court decisions.

BIOSECURE Act

Our group will provide insights into the BIOSECURE act and its development, along with what the current status is. We explain what this act will mean to life sciences companies and provide insight into what some of the terminology may mean.

Impacts of the New Administration

Former US Congressman and Government Relations Co-Chair Philip English discusses emerging health policy leaders and relays their stances on various life sciences topics. He also examines where political leaders may be adjusting to cover for deficits.

View a recording of this webinar here: Regulatory Issues for Life Sciences Companies in 2025