In this 45th episode of Bald Ambition, host Mookie Spitz sits down with attorney–pharmacist Darshan Kulkarni to dissect the fast-growing world of Direct-to-Patient (DTP) marketing and clinical trial models. He unpacks how DTP has evolved, why it appeals to pharmaceutical companies, and—most importantly—the hidden complexities that come with it.
From state law inconsistencies to privacy, advertising, malpractice, and consent concerns, Darshan shows how what looks like a simple shift to “just using Zoom” quickly becomes a tangled web of compliance obligations. Whether you’re in legal, clinical operations, or marketing, this conversation breaks down the real risks and why they matter for anyone thinking about engaging patients directly.
Their conversation reveals a system in freefall—chaotic, fragmented, and confusing at every level:
- Telemedicine blurred the boundaries between pharma, providers, and patients, raising questions of responsibility and compliance.
- Competing laws across states leave companies unsure whether they’re in full compliance or skating on thin ice.
- HIPAA, PHI, and data ownership are entangled with marketing funnels, referral pathways, and AI-driven documentation tools.
- PBMs (pharmacy benefit managers) continue to inflate costs while claiming to save money, adding another layer of distortion to the supply chain.
- Patients, providers, pharma, and tech firms are caught in a spaghetti bowl of shifting rules, competing interests, and massive financial incentives.
Darshan lays out clear recommendations for anyone navigating this uncertainty—whether you’re a pharmaceutical company, provider, tech startup, or pharmacy:
- Rethink your business model completely. Don’t assume past practices will hold up.
- Flow-chart every patient touchpoint. Map interactions across providers, pharmacies, telehealth platforms, and pharma.
- Bring legal oversight into the room early. Compliance isn’t an afterthought—it must be baked into design, engineering, and marketing.
- Stay on top of evolving regulations. Monitor FDA, FTC, DOJ, OIG, and state-level changes in real time.
- Balance compliance with patient care. Never lose sight of the ultimate goal: better, safer, more accessible health outcomes.
The Guest
Darshan Kulkarni is a Philadelphia-based food and drug lawyer who focuses on the legal and regulatory challenges of Direct-to-Patient (DTP) programs in pharma and medical devices. As the founder of the Kulkarni Law Firm, he helps companies balance innovation with compliance and addresses issues like privacy, advertising, informed consent, and multi-state telemedicine rules. Darshan also teaches FDA regulatory law and hosts the DarshanTalks podcast, where he breaks down the risks and opportunities of engaging patients directly.
His Firm
The Kulkarni Law Firm is a boutique life sciences law practice based in Philadelphia, dedicated to helping pharmaceutical, biotech, and medical device companies navigate FDA, FTC, and DOJ compliance. The Firm focuses on high-risk areas where law and business intersect—including Direct-to-Patient (DTP) programs, drug and device advertising, clinical research operations, and mergers and acquisitions. By combining regulatory insight with practical industry experience, the Firm supports clients in managing promotional review committees, structuring compliant patient engagement, and preparing for government scrutiny.
Resources
https://www.kulkarnilawfirm.com
Popular Podcasts
Stuff You Should Know
If you've ever wanted to know about champagne, satanism, the Stonewall Uprising, chaos theory, LSD, El Nino, true crime and Rosa Parks, then look no further. Josh and Chuck have you covered.
Dateline NBC
Current and classic episodes, featuring compelling true-crime mysteries, powerful documentaries and in-depth investigations. Follow now to get the latest episodes of Dateline NBC completely free, or subscribe to Dateline Premium for ad-free listening and exclusive bonus content: DatelinePremium.com
The Burden
The Burden is a documentary series that takes listeners into the hidden places where justice is done (and undone). It dives deep into the lives of heroes and villains. And it focuses a spotlight on those who triumph even when the odds are against them. Season 5 - The Burden: Death & Deceit in Alliance On April Fools Day 1999, 26-year-old Yvonne Layne was found murdered in her Alliance, Ohio home. David Thorne, her ex-boyfriend and father of one of her children, was instantly a suspect. Another young man admitted to the murder, and David breathed a sigh of relief, until the confessed murderer fingered David; “He paid me to do it.” David was sentenced to life without parole. Two decades later, Pulitzer winner and podcast host, Maggie Freleng (Bone Valley Season 3: Graves County, Wrongful Conviction, Suave) launched a “live” investigation into David's conviction alongside Jason Baldwin (himself wrongfully convicted as a member of the West Memphis Three). Maggie had come to believe that the entire investigation of David was botched by the tiny local police department, or worse, covered up the real killer. Was Maggie correct? Was David’s claim of innocence credible? In Death and Deceit in Alliance, Maggie recounts the case that launched her career, and ultimately, “broke” her.” The results will shock the listener and reduce Maggie to tears and self-doubt. This is not your typical wrongful conviction story. In fact, it turns the genre on its head. It asks the question: What if our champions are foolish? Season 4 - The Burden: Get the Money and Run “Trying to murder my father, this was the thing that put me on the path.” That’s Joe Loya and that path was bank robbery. Bank, bank, bank, bank, bank. In season 4 of The Burden: Get the Money and Run, we hear from Joe who was once the most prolific bank robber in Southern California, and beyond. He used disguises, body doubles, proxies. He leaped over counters, grabbed the money and ran. Even as the FBI was closing in. It was a showdown between a daring bank robber, and a patient FBI agent. Joe was no ordinary bank robber. He was bright, articulate, charismatic, and driven by a dark rage that he summoned up at will. In seven episodes, Joe tells all: the what, the how… and the why. Including why he tried to murder his father. Season 3 - The Burden: Avenger Miriam Lewin is one of Argentina’s leading journalists today. At 19 years old, she was kidnapped off the streets of Buenos Aires for her political activism and thrown into a concentration camp. Thousands of her fellow inmates were executed, tossed alive from a cargo plane into the ocean. Miriam, along with a handful of others, will survive the camp. Then as a journalist, she will wage a decades long campaign to bring her tormentors to justice. Avenger is about one woman’s triumphant battle against unbelievable odds to survive torture, claim justice for the crimes done against her and others like her, and change the future of her country. Season 2 - The Burden: Empire on Blood Empire on Blood is set in the Bronx, NY, in the early 90s, when two young drug dealers ruled an intersection known as “The Corner on Blood.” The boss, Calvin Buari, lived large. He and a protege swore they would build an empire on blood. Then the relationship frayed and the protege accused Calvin of a double homicide which he claimed he didn’t do. But did he? Award-winning journalist Steve Fishman spent seven years to answer that question. This is the story of one man’s last chance to overturn his life sentence. He may prevail, but someone’s gotta pay. The Burden: Empire on Blood is the director’s cut of the true crime classic which reached #1 on the charts when it was first released half a dozen years ago. Season 1 - The Burden In the 1990s, Detective Louis N. Scarcella was legendary. In a city overrun by violent crime, he cracked the toughest cases and put away the worst criminals. “The Hulk” was his nickname. Then the story changed. Scarcella ran into a group of convicted murderers who all say they are innocent. They turned themselves into jailhouse-lawyers and in prison founded a lway firm. When they realized Scarcella helped put many of them away, they set their sights on taking him down. And with the help of a NY Times reporter they have a chance. For years, Scarcella insisted he did nothing wrong. But that’s all he’d say. Until we tracked Scarcella to a sauna in a Russian bathhouse, where he started to talk..and talk and talk. “The guilty have gone free,” he whispered. And then agreed to take us into the belly of the beast. Welcome to The Burden.