Episode Description

In this episode, Darshan Kulkarni sits down with former FDA Commissioner Robert Califf for a wide-ranging conversation on FDA authority, politics, guidance, and public trust. From the loss of Chevron deference to the role of FDA as a referee, Dr. Califf explains how regulation really works and why wealth inequality has become the most serious health issue in the United States.

Episode Summary

What does it really take to run the FDA, and how political should the agency be? Former FDA Commissioner Robert Califf reflects on his path to the role, the skills a commissioner actually needs, and why FDA must act as an impartial referee rather than a political actor. The conversation explores guidance versus regulation, the loss of Chevron deference, industry expertise, the revolving door debate, and how social determinants of health shape outcomes far more than medicine alone. A candid, opinionated look at regulation from someone who has seen every side of it.

Key Topics Discussed

• How Dr. Califf became FDA Commissioner twice
• Why FDA should act as a referee, not a combatant
• Guidance documents and how they really function
• Politics, policy, and product level decision making
• Preparing for the loss of Chevron deference
• Wealth inequality as the biggest health problem in the U.S.
• Social determinants of health and FDA’s role
• Generic drugs, tobacco, and public health impact
• Digital health hype versus real-world impact
• The FDA–industry revolving door debate

Why This Episode Matters

As courts, politicians, and industry challenge agency authority, understanding how FDA decision making actually works matters more than ever. This episode explains what regulation can and cannot do, where political pressure becomes dangerous, and why ignoring inequality undermines health outcomes no matter how advanced the science becomes.

Guest

Robert Califf
Former Commissioner, U.S. Food and Drug Administration
Instructor in Medicine, Duke University

Dr. Califf has served twice as FDA Commissioner and brings decades of experience across clinical medicine, academia, industry, and government.

Host

Darshan Kulkarni
 Founder, The Kulkarni Law Firm
 Host, DarshanTalks

Call to Action

Subscribe for more conversations on FDA regulation, enforcement, policy, and healthcare compliance.
 Questions or ideas for future episodes? Call, click, or email.

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GLP-1 weight loss programs are everywhere right now, especially in the med spa space. For M&A lawyers and deal teams, that popularity comes with serious regulatory risk.

In this episode, Darshan breaks down why GLP-1 compliance has quietly become a dealbreaker in healthcare acquisitions. What used to be framed as an FDA issue is now actively being enforced by state attorneys general using consumer protection and deceptive trade practice laws.

You’ll hear how the end of the FDA shortage changed what compounding pharmacies are legally allowed to do, why “research grade” GLP-1 products are not a workaround, and how recent enforcement actions in Alabama and Connecticut are reshaping diligence expectations.

This episode walks through the red flags buyers must catch before signing, including opaque supply chains, misleading marketing claims, research washing, and misaligned informed consent. It also explains why missing these issues can lead to asset freezes, injunctions, multi-state investigations, and massive post-closing remediation costs.

If you advise on med spa transactions, private equity healthcare deals, or GLP-1-driven growth strategies, this conversation is essential listening.

For deeper diligence support on GLP-1 programs and healthcare transactions, reach out to the Kulkarni Law Firm.

Subscribe for more conversations at the intersection of M&A, FDA regulation, state enforcement, and healthcare compliance.

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For decades, biotech M&A followed a familiar script. Patents drove value. Molecules closed deals.

That script is breaking.

In today’s precision medicine transactions, the real asset is data. Longitudinal patient records, real-world evidence, and genomic datasets are now central to valuation. But unlike traditional IP, data comes with strings attached. Privacy laws, patient consent, and transfer restrictions can quietly determine whether that data is an asset or a liability.

In this episode of KLF Deep Dive, we explore why clinical data is being treated as the new IP in biotech M&A, how weak consent frameworks can destroy deal value, and what acquirers should be asking during diligence before it’s too late.

If you work in biotech, pharma, corporate development, or private equity, this episode breaks down a risk that is reshaping how deals get priced and structured.

Listen in, and reach out if this issue is sitting inside one of your transactions.

Episode Highlights

• Why patents alone no longer drive biotech valuations
• How precision medicine changed the M&A playbook
• Clinical data as a regulated asset
• Patient consent and data transfer risks
• When valuable datasets become compliance liabilities
• What smart buyers are doing differently in diligence

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Staffing and training are not just operational issues. They are inspection risks. In this episode, we break down what sponsors and regulators actually expect when it comes to site staff training. Competent staff is not enough if training is not documented. We walk through common failure points seen during FDA inspections, including missing GCP documentation, unclear staff roles, and poor escalation processes. We also discuss how structured SOPs, training logs, and clear contracts with coordinators and sub-investigators help demonstrate a real culture of compliance. The goal is simple. When sponsors or the FDA review your site, your records should tell a clear, defensible story.

Key Topics Covered

• GCP training and documentation expectations
• Why undocumented training creates inspection risk
• Common staffing failures seen during FDA inspections
• Training SOPs and staff training logs
• Defining roles and liability in staff contracts
• Managing protocol deviations and escalation paths
• Demonstrating a culture of compliance at the site level

Who This Is For

• Clinical trial sites
• Sponsors and CROs
• Principal Investigators
• Study coordinators
• Clinical operations leaders

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 Early termination by a sponsor can leave a clinical research site holding the bill for prep work, fees, and staffing. In this episode, Darshan explains the contract language every site should insist on to stay protected. He covers guaranteed payment for all work performed up to the termination date, reimbursement for non-cancelable expenses like IRB fees and advertising, and why a wind-down clause is essential for chart reviews, final visits, and data queries. He also explores when minimum payments or upfront funds are realistic to request. Protecting these terms upfront keeps an unexpected sponsor exit from destabilizing your operations. If you have question, Call 302.252.6959, click www.kulkarnilawfirm.com , or email [email protected]. 

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Your skincare product may look like a cosmetic, but one wrong claim can legally turn it into an unapproved drug.

In this episode of KLF Deep Dive, we break down the exact words, phrases, and influencer mistakes that push cosmetic brands straight into FDA drug territory. Anti-inflammatory claims. Acne treatment language. Collagen rebuilding promises. Detox buzzwords. These are not harmless marketing fluff. They are regulatory landmines.

We explain how the FDA actually classifies products, why intent does not matter, how influencers can sink your brand, and what cosmetic companies should do right now to stay compliant.

If you work in beauty, skincare, or wellness marketing, this episode can save your next launch.

If compliance, enforcement, or deals matter to your business, subscribe to KLF Deep Dive.

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Influencers can boost visibility fast, but they also create real regulatory exposure if they go off script. The FTC requires influencers to clearly disclose any material connection to your brand, and the wrong claim in a single post can trigger enforcement or lawsuits. In this episode, I explain how I build influencer contracts with mandatory disclosure language, claim restrictions, and takedown rights. I also describe how I design monitoring systems so brands can review influencer content before or after posting, and how I create influencer playbooks to keep everyone aligned. When done right, influencer marketing becomes a compliant and scalable growth channel. Call, click, or email if you need help. 

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www.kulkarnilawfirm.com

 A lot of brands start with harmless wellness promises like better mood, more energy, or improved sleep. As the business grows, though, marketing often becomes bolder, and that’s where risk creeps in. The FDA steps in when your claims imply treating or preventing a disease, which can flip your product into drug or device territory. The FTC expects every wellness claim to be truthful and supported by real evidence. In this episode, I explain how I review labels, websites, and social content, map each claim to the right regulatory bucket, and draft compliant alternatives that keep your marketing appealing without triggering expensive oversight. I also build claim checklists to help teams avoid drift in the future. Call, click, or email if you need support. 

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 A knee implant meant to restore mobility. A surgeon secretly collecting international trips and consulting checks. A device company accused of selling a product they allegedly knew would fail. This episode breaks down the Aesculap case, the $38.5M settlement, and what it teaches us about kickbacks, forged FDA documents, and the catastrophic cost of weak compliance controls. If your team works in pharma, med-tech, or clinical research, you don’t want to miss this one. 

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In this episode of DarshanTalks, you dive into what U.S. Food and Drug Administration (FDA) inspectors will demand when they show up on-site. You walk through the five critical documents every life-sciences or pharma company should have ready, because without them, an inspection can become a deal-breaker fast.

You stress that compliance isn’t just paperwork; it’s the backbone of long-term viability. A weak document trail, sloppy record-keeping, or missing records can lead to penalties, regulatory exposure, or even shutdowns. Tight compliance and strong documentation aren’t optional. They’re deal insurance.

The episode gives concrete guidance on what to have in place before regulators knock. It’s essential listening for executives, compliance officers, and M&A advisors in biotech, pharma, and medical device businesses.

Support the show

www.kulkarnilawfirm.com