# 047 - "Truthful Not Misleading" with Darshan Kulkarni

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-08-24
- Length: 1h 00m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-24-047-truthful-not-misleading-with-darshan-kulkarni
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/047---Truthful-Not-Misleading-with-Darshan-Kulkarni-e1majhk

## Summary

Darshan Kulkarni, an FDA regulatory attorney and Adjunct Law Professor at Drexel University, explains the distinction between regulatory and legal compliance in the life sciences industry. He details how the First Amendment influences US promotional compliance, particularly regarding off-label speech and the 'truthful not misleading' standard established by recent court cases. Kulkarni also discusses the operational differences between FDA divisions for drugs (OPDP) and devices (CDRH), noting the latter's limited enforcement resources, and highlights the implications of the Sunshine Act on physician interactions.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-24-047-truthful-not-misleading-with-darshan-kulkarni#t=0) Introduction: Darshan Kulkarni and his background
- [9:19](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-24-047-truthful-not-misleading-with-darshan-kulkarni#t=559) Promotional compliance importance and multi-billion dollar fines
- [13:45](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-24-047-truthful-not-misleading-with-darshan-kulkarni#t=825) Legal vs. regulatory compliance and the flow from Congress to FDA
- [22:35](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-24-047-truthful-not-misleading-with-darshan-kulkarni#t=1355) Misbranding, labeling definitions, and the 'truthful not misleading' standard
- [29:12](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-24-047-truthful-not-misleading-with-darshan-kulkarni#t=1752) Direct-to-consumer advertising and First Amendment protections
- [33:53](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-24-047-truthful-not-misleading-with-darshan-kulkarni#t=2033) Off-label use versus off-label promotion and court precedents
- [44:27](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-24-047-truthful-not-misleading-with-darshan-kulkarni#t=2667) Regulatory differences between drugs (OPDP) and devices (CDRH)
- [48:34](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-24-047-truthful-not-misleading-with-darshan-kulkarni#t=2914) Physician prescribing controls and pharmacist responsibilities
- [52:19](https://hardwarepodcasts.com/podcast/lets-combinate/2022-08-24-047-truthful-not-misleading-with-darshan-kulkarni#t=3139) Sunshine Act, transfers of value, and international comparisons

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Intellectual property](https://hardwarepodcasts.com/topic/intellectual-property)
- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)

## Most relevant to

established companies

## Mentioned

- Kulkarni Law Firm (company)
- Drexel University (other)
- Thomas Jefferson University (other)
- FDA (other)
- OIG (other)
- DOJ (other)
- Sunshine Act (other)
- OPDP (other)
- CDRH (other)
- Saras (product)

## Related episodes from other shows

- [Ad Promo and The Difference in Regulatory & Legal](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-05-24-ad-promo-and-the-difference-in-regulatory-legal) (Global Medical Device Podcast)
- [#366: Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2024-05-09-366-cardiac-arrest-five-heart-stopping-years-as-a-ceo-on-the-feds-hit-list) (Global Medical Device Podcast)
- [#216 - Food Labeling Law 101 with Lauren Handel](https://hardwarepodcasts.com/podcast/the-startup-cpg-podcast/2025-09-30-216-food-labeling-law-101-with-lauren-handel) (The Startup CPG Podcast)
- [How Jon Speer Met His Most Frequent Guest: Mike Drues](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2020-08-26-how-jon-speer-met-his-most-frequent-guest-mike-drues) (Global Medical Device Podcast)
- [Part 1: The Theranos Loophole & Lab Developed Tests](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-02-10-part-1-the-theranos-loophole-lab-developed-tests) (Global Medical Device Podcast)

## Citing this page

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