When conducting an M&A transaction in the pharmaceutical or medical device industry, compliance must be a top priority. Regulatory agencies like the DOJ, FDA, OIG, and OCR have strengthened oversight, emphasizing successor liability and the need for strong compliance programs. Beyond FDA regulations, companies must consider fraud prevention, HIPAA, and evolving privacy laws at both federal and state levels. Ignoring these factors can lead to serious legal and financial consequences. Stay informed—compliance isn’t optional.

Support the show

In this video, Edye Edens discusses the recent transition of ICH GCP E6 from R2 to R3, highlighting an interesting question she received: Is R3 evolving into a privacy doctrine? Given its increased focus on data protection, system validation, and privacy responsibilities, some wonder if it overlaps with regulatory frameworks like HIPAA, especially as OCR proposes significant updates to the Security Rule. However, Edens notes that while R3 contains more references to privacy, it does not explicitly mention cybersecurity, which is a major focus of OCR’s changes. She argues that R3 is not attempting to replace or overshadow existing privacy regulations but rather aligns with their broader goals of data confidentiality and integrity. She invites discussion on whether others see any regulatory overlap.

Support the show

Edye Edens and Darshan Kulkarni dive into the confirmation of RFK Jr. as Secretary of Health and Human Services and the immediate impact of President Trump’s latest executive order. The order mandates a comprehensive national health assessment, addressing issues like obesity, diabetes, and pediatric disorders, and aims to reshape the country’s approach to preventive care. While the focus on public health challenges is timely, the broad and vague nature of the directive raises questions about its execution and potential consequences.

A key concern is how the administration will interpret health data—whether it will rely on scientific evidence or lean into controversial theories, particularly regarding vaccines and chronic illnesses. RFK Jr.’s alignment with the "food as medicine" movement could bring renewed attention to nutrition and prevention, but there is also the risk of oversimplifying complex health issues. Will this shift in policy lead to meaningful improvements in healthcare access and disease prevention, or will it fuel misguided initiatives based on correlation rather than causation?

Darshan and Edye explore the broader implications, including the potential for changes in clinical trial funding, regulatory oversight, and access to medications. They emphasize the need for a balanced approach that values scientific rigor while addressing public health challenges. With major policy shifts on the horizon, this is a developing issue that will demand close scrutiny in the weeks to come. Stay tuned as they continue to break down the impact of these decisions on healthcare, research, and patient outcomes.

Support the show

Darshan Kulkarni and Edye Edens break down the significant impact of the Trump administration’s decision to cut NIH funding and reduce agency workforces, including the FDA, OHRP, and other key regulatory bodies. They discuss how these cuts could lead to serious disruptions in research funding, approval timelines, and the overall pace of medical innovation in the U.S. While some argue that such reductions could improve efficiency and reduce waste, others fear the immediate and long-term consequences—particularly for investigator-initiated trials, rare disease research, and the ability of institutions to remain globally competitive.

The conversation highlights the potential ripple effects, including workforce layoffs, the shuttering of critical trials, and delays in drug approvals. With the FDA considered the gold standard in regulatory oversight, a drastic reduction in its capacity could have global repercussions, potentially undermining trust in the U.S. approval process. Moreover, the lack of transition planning and abrupt implementation raises concerns about whether the administration has fully considered the real-world impact of these cuts.

Edye and Darshan also examine the broader economic and geopolitical implications, questioning whether these cuts align with the administration’s “America First” philosophy. They discuss how China and other countries are rapidly advancing in drug innovation, in part due to U.S.-led research. If domestic funding dries up, there is a risk that pharmaceutical and biotech breakthroughs could shift overseas, weakening America’s leadership in life sciences.

Ultimately, they stress the need for informed decision-making, transparency, and better representation of key stakeholders in these high-stakes policy shifts. Without a strategic approach, the short-term cost-cutting measures could create long-term challenges, not only for researchers and institutions but also for patients who depend on groundbreaking medical advancements.

Support the show

Darshan Kulkarni and Edye Edens discuss the recent controversy surrounding the Trump administration’s decision to cap NIH overhead funding (also known as indirect costs or F&A) at 15%. This sweeping change has already sparked significant backlash, with academic medical centers, particularly in Democratic states, filing lawsuits to challenge the policy. The cap threatens to disrupt funding structures that support essential research, potentially undermining the United States’ role as a global leader in medical innovation.

They break down the impact of this decision, highlighting how research costs vary significantly based on location—conducting studies in Boston versus Oklahoma City, for example, involves vastly different expenses. A one-size-fits-all cap could have unintended consequences, particularly in an era where supply chain disruptions and rising costs are already straining research budgets.

A major concern is how this will affect investigator-initiated and subsidized trials, which often operate at a loss but are crucial for rare diseases and specialized treatments. These trials provide hope to patients who might otherwise have no viable treatment options, and without adequate funding, such research could dwindle.

The discussion also covers the broader legal and political landscape. The Association of American Medical Colleges (AAMC) has now filed a federal lawsuit seeking a nationwide temporary restraining order on enforcing the cap, marking a significant escalation in the legal battle. With past instances of the Trump administration disregarding court orders, Darshan and Edye explore the potential for a constitutional crisis if the executive branch ignores judicial rulings.

Further, they examine the possible influence of private corporations on this policy shift. Many corporations that fund research typically limit their overhead contributions to around 15%, and some members of the administration have ties to these corporations. The hosts speculate that the policy may have been designed to align federal funding with corporate standards—potentially at the expense of public research institutions.

Ultimately, they question whether these cuts truly support the administration’s “America First” philosophy. If the goal is to maintain U.S. dominance in scientific research, slashing funding without strategic adjustments could have the opposite effect, weakening the country’s ability to innovate and compete globally.

With legal challenges underway and research institutions scrambling to adjust, this conversation is just the beginning of what promises to be a rapidly evolving and highly contentious issue.

Support the show

The Trump administration’s early actions have significantly impacted federally funded programs, particularly in the clinical trial space, by rolling back diversity, equity, and inclusion (DEI) initiatives. This shift raises serious concerns for scientific research, as diversity in clinical trials ensures that drugs and devices are effective across different populations. Historically, most approved treatments have been tested primarily on white males, creating gaps in data for other demographic groups.

Despite the removal of DEI-related FDA guidance, clinical trial sponsors, sites, and institutions must consider broader legal and financial risks. The Department of Justice (DOJ) and other agencies are scrutinizing compliance, and organizations receiving federal funding could face funding cuts or legal action for perceived discrimination. Companies must carefully assess the regulatory landscape and determine their risk tolerance while ensuring their trials remain scientifically sound.

Darshan Kulkarni and Edye Edens discuss the rapidly evolving situation, the potential risks for the clinical research industry, and what companies should do to navigate these shifting regulations.

Support the show

When acquiring a pharmaceutical company, evaluating its quality and compliance programs is crucial. A strong program starts with well-documented policies and procedures, followed by comprehensive training to ensure employees understand and follow them. However, having policies in place isn’t enough—regulatory bodies like the FDA and DOJ stress that enforcement and documentation are essential. If an issue isn’t written down, it effectively never happened. No regulator expects perfection, but they do expect companies to investigate mistakes, determine their root causes, and take corrective and preventive actions (CAPAs) to ensure compliance issues don’t recur.

A well-structured CAPA process demonstrates a company’s commitment to regulatory standards and operational excellence. Corrective actions address immediate issues, while preventive actions ensure systemic improvements. When evaluating a potential acquisition, look beyond vendor agreements and examine the entire supply chain. A company with a proactive compliance culture is less likely to face regulatory penalties and will provide greater long-term value.

Support the show

On Friday, the Trump administration announced a 15% cap on NIH indirect costs, raising important questions about its impact on research funding. Edye Edens breaks down what this means, clarifying that while direct costs like salaries and equipment remain unchanged, the cap affects crucial behind-the-scenes expenses such as lab maintenance, IT infrastructure, cybersecurity, and compliance. Understanding these distinctions is key as institutions adapt—watch as Edye unpacks the details.

Support the show

The Trump administration’s actions have effectively halted USAID-funded clinical research worldwide, creating an unprecedented situation with significant ethical, legal, and medical implications. Clinical trials that relied on USAID funding have stopped, leaving ongoing research in limbo and raising serious concerns about what happens to trial participants and who bears responsibility for any resulting harm.

Key Legal and Ethical Questions:

1. Who is the sponsor?

If the U.S. government was the official sponsor of a trial, sovereign immunity could come into play. This legal doctrine generally protects governments from being sued unless they explicitly waive immunity. Whether the U.S. government would assert sovereign immunity in this situation remains unclear.

2. Can individuals be held responsible?

Legal action against government officials, including former President Trump and members of his administration, would depend on whether they were acting in their official capacities. If they were, they may be shielded from personal liability.

3. What about pharmaceutical companies?

If a trial was co-funded by multiple entities—such as the NIH, USAID, and a private pharmaceutical company—the company might still bear responsibility. The extent of its liability would depend on contractual agreements, funding structures, and trial oversight mechanisms.

This situation is virtually without precedent, making it difficult to predict outcomes. However, if trial participants suffer harm due to halted research, legal action is almost certain. The coming months may bring lawsuits, debates over liability, and broader discussions about the role of government funding in global clinical research.

Support the show

On January 30, 2025, Uganda confirmed an outbreak of the Ebola Sudan virus, and in an unprecedented global first, a clinical trial to assess the efficacy of a vaccine against the virus was launched within just four days. This rapid response was made possible by proactive planning following a 2022 outbreak, during which the Ugandan Ministry of Health, Makerere University, and the Uganda Virus Research Institute implemented a strategy to fast-track future trial activations. By pre-selecting investigators, securing protocol approvals, and ensuring regulatory readiness, they positioned themselves to immediately initiate the trial once a new outbreak emerged. With WHO’s support, this initiative represents a groundbreaking moment in clinical research—offering real-time data collection during an active outbreak while potentially saving countless lives. The WHO’s press release details the extensive collaboration and meticulous groundwork that made this possible, reinforcing the importance of preparedness in global health crises.

Support the show