DarshanTalks Podcast

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Darshan explores a critical question for life sciences companies: is your medical affairs team truly independent from commercial—or are you just pretending?

In this episode of KLF Deep Dive, Darshan highlights why organizational charts alone are not enough to satisfy regulators. He explains that regulators focus on conduct, process, and intent, not PowerPoint slides. Using the 2013 GlaxoSmithKline settlement as a cautionary example, he demonstrates how blurred lines between medical and commercial functions contributed to a $3 billion resolution. Advisory boards, medical information responses, and even scientific exchanges were scrutinized because they appeared promotional rather than purely scientific. The lesson is clear: medical affairs does not receive a free pass—regulators evaluate independence based on actual behavior, not just policy statements.

Darshan also addresses misconceptions around First Amendment protections, such as those recognized in the Coronia and Amarin cases. While these rulings allow certain truthful, non-misleading communications about off-label uses, they do not shield companies from regulatory risk when the intent behind medical affairs activities is commercial. Intended use begins long before promotional materials are drafted—it is reflected in team training, engagement strategies, patient targeting, and the creation of scientific content. If medical affairs is influenced by commercial goals, the safe harbor evaporates, leaving both the company and individuals exposed to liability under the False Claims Act, Anti-Kickback Statute, and other regulatory frameworks.

One practical solution Darshan emphasizes is leveraging tools like Ceres. Such systems enforce firewalls, track document access, and generate auditable evidence that medical affairs operates independently. This ensures that scientific exchange remains in medical’s hands, not commercial’s, providing defensible documentation when regulators inquire about separation.

Patient engagement is another critical area. While increasing patient education and support is essential, programs can inadvertently cross into promotional territory if they are influenced by sales objectives, target specific high-value prescribers, or prioritize commercial outcomes over educational goals. Properly designed, patient engagement is a compliance asset; improperly executed, it becomes a liability.

Darshan concludes with key questions medical affairs teams must ask themselves: Do we have documented processes that prove independence from commercial? Can we defend our workflows if regulators question intent? Are patient programs science-driven rather than sales-driven? Do systems like Ceres provide tangible evidence of separation, or do we rely solely on trust?

The overarching message: medical affairs is the conscience of the company, and its independence must be real, not performative. Blurring lines between commercial and medical functions carries severe consequences, from regulatory penalties to reputational damage. Companies must implement robust systems, governance, and culture to ensure genuine independence—because in today’s environment, pretending isn’t just risky; it’s potentially dangerous.

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Under the Modernization of Cosmetics Regulation Act (MoCRA), reporting serious adverse events to the FDA is now mandatory. Companies must report serious incidents—such as hospitalizations, infections, disfigurement, or medically treated allergic reactions—within 15 business days. They must also maintain records of all adverse events for six years (or three years for small businesses).

Practically, this requires setting up a system to capture and assess customer complaints, determine seriousness, and document actions taken. Beyond compliance, this serves as a safety and trust mechanism—helping protect consumers, prevent regulatory actions like warning letters or recalls, and strengthen brand credibility.

For further guidance, contact the Kulkarni Law Firm.

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Darshan Kulkarni highlights that to stay compliant with the FDA, companies don’t need an exhaustive set of SOPs—just the essential ones. Inspectors primarily focus on SOPs covering informed consent, adverse event reporting, drug/device accountability, source documentation, PI oversight, protocol deviations, and record retention. He emphasizes keeping SOPs concise, practical, and enforceable, training staff consistently, and expanding them only as operational needs grow.

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The boundary between scientific exchange and marketing in payer presentations is increasingly blurred, creating significant compliance and enforcement risks. While payers demand real-world evidence, comparative studies, and economic models beyond FDA-approved labeling, manufacturers must ensure all shared information is truthful, non-misleading, properly contextualized, and backed by competent and reliable scientific evidence.

Key pitfalls include:

1. Cherry-picking data without balanced limitations.
   
   
2. Economic models presented without caveats or assumptions.
   
   
3. Future indications framed as imminent rather than investigational.

Crossing into promotion can trigger FDA, FTC, OIG, DOJ, and plaintiff scrutiny, with false claims liability a real risk. To mitigate exposure, companies should:

• Use clear disclaimers and transparent disclosures.
  
  
• Involve compliance early in deck preparation.
  
  
• Document rationale, recipients, and underlying assumptions.
  
  
• Maintain audit trails through tools like Ceres Tracking.

The DOJ’s healthcare fraud task force has prioritized this area, making compliance essential not only to avoid regulatory letters but also subpoenas, litigation, and treble damages. Proper safeguards—including playbooks, legal review, and compliance monitoring—protect companies from costly enforcement actions.

Bottom line: Scientific exchange with payers is permitted and necessary, but once it drifts into marketing, companies face severe legal and financial consequences.

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In this episode, Darshan Kulkarni speaks with Dae Lee about the growing conflict between pharmaceutical manufacturers and pharmacy benefit managers (PBMs) — and how it’s reshaping the U.S. drug supply chain.

They unpack the recent dispute involving AstraZeneca, which alleges discrepancies between the number of branded claims submitted by pharmacies through PBMs and the rebates invoiced by those PBMs. The issue shines a spotlight on how PBMs control formulary access and drug distribution, often requiring manufacturers to pay hefty rebates to ensure their products are covered — a “pay-to-play” model that impacts pharmacies, patients, and drug pricing transparency.

Dae explains how PBMs, through vertically integrated structures and rebate aggregators, dominate prescription benefit management, often retaining portions of rebates meant for plan sponsors. Manufacturers like AstraZeneca, meanwhile, face limited visibility into claims data and have no direct contractual relationship with dispensing pharmacies — making it difficult to reconcile payments or validate rebates.

The conversation also delves into the consequences for independent pharmacies, who are subject to increasing audits, lower reimbursements, and complex purchasing requirements dictated by PBMs. While eliminating PBMs altogether may be unrealistic, both Darshan and Dae agree that growing regulatory scrutiny and transparency reforms could help rebalance the system.

Takeaway: PBMs’ influence reaches every corner of the prescription drug market. For pharmacies and manufacturers alike, maintaining strong records, understanding rebate structures, and preparing for evolving regulations are essential steps toward fairer and more transparent operations.

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The FDA has criticized the industry for not taking advertising and promotion seriously and is now cracking down, as evidenced by hundreds of non-compliance letters. This raises the question: if similar scrutiny applied to clinical research, what would stand out first? Likely areas include proper informed consent, accurate recordkeeping, and potential upticks in physician enforcement. While this use of AI in research compliance hasn’t fully emerged yet, AI is already being applied in promotion oversight and will likely accelerate compliance monitoring. Industry now needs to identify and tighten key processes to stay ahead as AI scales enforcement.

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Cosmetics companies must now register both their facilities and products with the FDA under the new MoCRArequirements, a shift from the previous voluntary system. Each facility must register, and product listings — including categories, ingredients, and manufacturing sites — must be submitted and updated annually. Growing companies face challenges in tracking reformulations, rebrandings, or acquisitions, as missing updates can trigger FDA enforcement or product removal. To scale safely, companies should register early and implement a repeatable compliance process.

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Darshan discusses the potential role of AI in medicine. He believes fears of AI replacing doctors for diagnosis are currently overblown, as trust in physicians remains crucial. However, he suggests AI could assist with preliminary research tasks, such as reviewing inclusion/exclusion criteria and conducting initial screening. Have you seen AI being used in this manner? 

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Direct-to-Patient (DTP) models are transforming how medications reach patients, moving beyond clinical research into commercial distribution. Originally developed to help rare disease trial participants avoid long travel to research sites, DTP has become a standard solution for improving patient access and convenience. Today, patients can receive small molecules, complex biologics, and even medical devices directly at home, making what was once exceptional now routine.

Despite the benefits, DTP introduces significant operational and regulatory challenges. Compliance is complex because different states have different rules for pharmacy shipments, and FDA promotion rules still apply to delivered medications. Privacy is another critical concern: each shipment involves sensitive health data protected under HIPAA and state-specific laws. Additionally, liability questions arise—who is responsible if shipments fail during transit, or if temperature-sensitive biologics are compromised?

Equity and safety are other key considerations. Companies must ensure patients in rural or underserved areas can access DTP services and maintain oversight to prevent fraud or improper inducement. Temperature-sensitive products require careful supply chain management, and transparency in patient communication is essential to build trust and minimize risk.

To navigate these challenges, organizations need strong governance and clear processes. SOPs should define responsibilities, vendors must be closely monitored, and privacy should be integrated into systems from the start. Early engagement with regulators helps align expectations, and proactive patient communication fosters confidence. DTP is here to stay, and implementing it responsibly can empower patients while reducing regulatory and operational risk.

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Darshan Kulkarni speaks with Thomas Siepka, CEO of HCI Healthcare Consultants, to take a deep dive into the often-misunderstood world of the 340B drug pricing program. Drawing on Siepka’s extensive experience as a pharmacist and healthcare leader, they explore how the 340B program was designed to support covered entities—such as disproportionate share hospitals and federally qualified health centers—by requiring manufacturers to provide steep discounts. These savings allow organizations serving large underinsured and uninsured populations to “stretch scarce federal resources” and reinvest in patient care and community programs.

The conversation unpacks the registration and qualification process, how HRSA and wholesalers determine eligibility, and what it means in practice for both hospitals and health centers. A major point of discussion is the growing reliance on contract pharmacies. While small community health centers may need one or two outside pharmacies to dispense medications, some large academic systems now contract with hundreds. Manufacturers see this as escalating their financial liability and potentially expanding the program beyond its original intent, whereas covered entities argue it is necessary to ensure broad patient access.

Another challenge Siepka highlights is the risk of duplicate discounts, where manufacturers may be required to give both a 340B discount and a rebate on the same prescription claim—an issue complicated by the sheer volume of transactions processed across the healthcare system. This tension reflects the program’s broader challenge: balancing patient care needs, provider sustainability, and manufacturer obligations.

As Siepka and Kulkarni note, the statute that created 340B is broad, leaving room for differing interpretations. Both manufacturers and covered entities agree on one thing: the need for greater regulatory clarity. With new rebate guidance tied to the Inflation Reduction Act and CMS’s role in drug price negotiations, the future of the 340B program will likely see even more scrutiny and debate.

This discussion sheds light on why the 340B program has lasted more than 30 years, why it continues to spark controversy, and what healthcare professionals should watch for as policies evolve.

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