The Seventh Circuit just issued a pivotal decision in U.S. v. Sorenson, reshaping how pharmaceutical and medical device companies should think about direct-to-patient (DTP) advertising and Anti-Kickback Statute (AKS) compliance.

In this case, Sorenson’s company paid marketers to generate patient interest in orthopedic braces reimbursed by Medicare. These marketers gathered patient details and sent unsigned prescriptions to physicians. While most leads went nowhere, the court ruled this did not constitute a referral under AKS, since marketers weren’t influencing medical decisions and doctors retained full judgment.

The takeaway? The court is drawing a line between generating patient interest and influencing prescriber behavior. For pharma marketers, this clarifies that driving patient awareness without steering doctors may reduce AKS risk—at least in the Seventh Circuit.

If your DTP campaigns involve disease awareness, educational tools, or lead gen without prescriber targeting, you're likely on safer ground. But if those leads are used to nudge physicians’ decisions, compliance risks still loom.

Bottom line: Intent and influence are everything. Want help navigating this evolving space? Contact the Kulkarni Law Firm for support with risk-adjusted marketing agreements and compliance reviews.

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Darshan Kulkarni and Edye Edens discuss the potential and pitfalls of using AI—like ChatGPT—to draft informed consent documents in clinical research. With both legal and regulatory expertise, they explore how AI could save time, whether it fits institutional IRB requirements, and the real-world value (or lack thereof) for different types of organizations.

Key Takeaways:

• Drafting vs. Final Use: AI can be useful as a first-draft tool, especially for high-volume sponsors. But using it for final documents without oversight is risky.
  
  
• IRB Templates Matter: Many IRBs (especially academic or VA-affiliated) require strict templates—limiting AI's value unless those are integrated upfront.
  
  
• Regulatory Landscape: AI-drafted consents must meet not just FDA standards, but also OHRP requirements. Compliance and clarity are non-negotiable.
  
  
• Customization Is Key: Most current AI tools are just wrappers over ChatGPT. Real ROI comes from domain-specific models trained for clinical research.
  
  
• Data & IP Risks: Feeding protocols into AI raises confidentiality concerns. Plus, who owns the output remains unclear due to copyright issues with training data.
  
  
• Why ROI Falls Short: Companies often reassign internal staff instead of building bespoke solutions. Without a clear use case or strategic planning, results disappoint.

AI shouldn’t replace people—it should support them. Darshan and Edye agree: if you're using AI to generate a first draft of informed consent documents, it could help streamline high-volume workflows. But expecting it to generate a compliant final version is unrealistic. Most current tools feel more like flashy "wrappers" around existing models and often lack a strong ROI. And let’s not forget the hidden risks—like IP concerns and exposing proprietary protocols.

Bottom line? AI has potential, but without strategic investment and oversight, it’s just another overhyped shortcut. Use it wisely, or not at all.

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Imagine you're filling a script when a State Board of Pharmacy inspector walks in—no warning, just a clipboard and serious consequences. Most community pharmacists assume, "That won’t happen to me," but audits are no longer rare—they're the norm.

Controlled substances are under intense scrutiny. Inspectors now expect airtight records, ongoing (not one-time) training, and SOPs that reflect current laws—not ones from 2019. If you’re relying on outdated policies, verbal explanations, or friendly smiles to pass inspection, you’re already behind.

Logs must match dispensing. Staff must follow documented protocols. Lock zones must meet state requirements. Every mismatch? A red flag.

At the Kulkarni Law Firm, we help pharmacies:

• Conduct proactive self-audits using real board standards
  
  
• Build strong, defensible SOPs and training systems
  
  
• Respond to audit deficiencies with authority—not panic
  
  

Darshan Kulkarni, a pharmacist and regulatory attorney, brings practical, no-BS insight into what inspectors really expect and how to be prepared. Because waiting for an audit is like waiting for a hurricane to test your roof—too late.

Be ready. Be confident. Be compliant.

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In this video, Edye Edens and Darshan Kulkarni discuss whether sponsors, sites, CROs, or IRBs should self-report compliance issues. Edye, who focuses on sites, explains that whether or not to self-report is highly situation-dependent. Some situations legally require reporting, while in others, organizations might have room to implement corrective actions without immediate reporting—but they must carefully understand applicable regulations and enforcement trends.

Darshan highlights the distinction between “should you report” and “is it reportable.” Not everything unethical is legally reportable, but stakeholders must assess the risks of not reporting, including potential regulatory, investor, or reputational fallout. He also warns that just because an SOP says “do not report,” that might not align with current regulations or enforcement priorities—and could even expose the organization to greater liability.

The conversation also touches on recent Trump administration statements that encourage self-reporting by offering some protection from prosecution—though Edye cautions that administrations often shift their enforcement priorities, so organizations should not rely solely on these statements as a shield. Both agree that any self-reporting should be accompanied by a robust corrective action plan already underway to show good faith. Otherwise, agencies could still decide to prosecute, especially in egregious cases.

Bottom line:
Self-reporting can build trust and potentially reduce penalties, but only if handled thoughtfully. Assess the legal requirements, business risks, and your agency’s enforcement climate before deciding to disclose.

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In this must-listen episode for pharma marketers and corporate counsel, we break down the recent $14.25M False Claims Act settlement involving Diopsys, a neurodiagnostic company accused of offering free tech to physicians—tech that allegedly led to medically unnecessary tests billed to Medicare and Medicaid.

This wasn’t just bad billing—it was a marketing strategy gone wrong. The DOJ saw it as a kickback scheme, and the case highlights how well-meaning “value-add” services can turn into legal liabilities.

Key takeaways:

• Value can become a liability – Helpful services may violate anti-kickback laws if not vetted legally.
  
  
• Volume-based strategies invite scrutiny – More testing isn’t always better—especially without medical necessity.
  
  
• You’re accountable—even if you don’t bill – Diopsys didn’t submit claims but still paid $14M for allegedly enabling them.
  
  

For legal and compliance teams, this is a compliance case study in what happens when oversight misses the risk signals. From fair market value to OIG advisory opinions—this episode explores what should have been done and how you can avoid the same fate.

Are your support services audit-proof? If you're unsure, this episode is for you. Tune in, stay informed, and stay compliant.

Questions? Contact the Kulkarni Law Firm to assess your risk before you become the DOJ’s next target.

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In this episode, we talk to Martin Van Trieste about Civica Rx, nonprofit pharmaceutical company designed to address drug shortages in the U.S. The company focuses on sterile generics and biosimilars that have become economically unviable for other manufacturers. Initially operating as a broker, Civica transitioned into manufacturing, filing multiple ANDAs monthly and building a plant in West Virginia capable of producing 200 million doses annually. Civica's mission-driven approach includes transparency, cost-plus pricing with an 18–20% operating margin, and governance by health systems and philanthropic organizations to ensure adherence to its nonprofit goals.

Civica recently expanded into biosimilar insulin production to combat high retail prices. While Civica is transparent with financials and prioritizes solving drug shortage problems, it avoids traditional retail models like memberships. Its innovations, such as labeling maximum retail prices on products, are supported by the FDA. Civica distinguishes itself by addressing systemic issues in the generic drug industry, emphasizing its commitment to solving problems over profit-making.

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In this discussion, Joseph Wolfson, an attorney at Stevens and Lee, and Darshan explore the intersection of law, marketing, and compliance in the pharmaceutical and medical device industries. Joe focuses on both antitrust litigation and advising private equity firms, pharmaceutical companies, and medical device companies on legal matters, particularly around unfair competition and antitrust concerns.

Joe explains how his firm helps private equity clients during the investment process by conducting due diligence, analyzing IP protection, and addressing potential FDA and marketing issues. Post-investment, the firm often acts as outside general counsel for the medical device or pharmaceutical companies, ensuring they stay compliant while maximizing shareholder value.

A key focus of the conversation is the complex regulatory landscape for medical products, where both the FDA and FTC play critical roles. While the FDA regulates the safety and efficacy of products, the FTC ensures that marketing practices do not mislead consumers. State Attorneys General (AGs) also play a role in protecting consumers, though their jurisdiction can differ depending on the state. Joe stresses that companies need to be aware of the overlapping but distinct concerns from these agencies when marketing their products.

Joe also highlights the ongoing risks of non-compliant marketing, specifically discussing litigation related to false advertising and misleading claims under the Lanham Act, as well as consumer litigation for personal injury claims arising from product misuse or misrepresentation.

Finally, Joe offers advice for marketers, emphasizing the importance of distinguishing between "puffery" (subjective opinions) and factual claims, especially in advertising. He warns companies to be able to back up any factual claims with solid evidence, as misleading marketing can lead to serious legal consequences.

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In this episode, Darshan Kulkarni and Edye Edens explore whether sites should consider whistleblowing on non-compliant sponsors. They acknowledge that non-compliance is a non-negotiable issue, but emphasize the difficulty of deciding when to report, especially given the financial and relational ties between sites and sponsors.

They discuss examples, like overpayments or data integrity violations, which might compel a whistleblower to act. However, they highlight the gray areas where judgment calls blur the lines between compliance and ethical obligations. Both caution that despite legal protections, whistleblowers often find themselves unemployable in the industry afterward.

Darshan and Edye stress the importance of thoughtful, informed decision-making, advising that while some situations clearly demand reporting, others might warrant cautious documentation and internal discussion first. They underscore that reporting mechanisms vary—from internal sponsor compliance officers to IRBs, FDA, or even the Attorney General’s office—depending on the severity of the issue.

Ultimately, they urge potential whistleblowers to weigh the risks carefully, seek legal advice, and remember that every situation is unique.

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