# 056 - "Non-Promotional Compliance" with Darshan Kulkarni

- Show: [Let's Combinate](https://hardwarepodcasts.com/podcast/lets-combinate)
- Published: 2022-10-26
- Length: 33m
- Page: https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-26-056-non-promotional-compliance-with-darshan-kulkarni
- Listen: https://podcasters.spotify.com/pod/show/letscombinate/episodes/056---Non-Promotional-Compliance-with-Darshan-Kulkarni-e1pa5nl

## Summary

Darshan Kulkarni, an FDA regulatory lawyer and host of DarshanTalks, explains the legal distinction between promotional and non-promotional speech in the pharmaceutical industry, focusing on the First Amendment protections for scientific discussion. He details how the FDA's attempt to control off-label promotion by medical affairs was challenged in the Washington Legal Foundation case, leading to a 'quiet truce' where companies maintain strict separation between commercial and scientific roles to avoid multi-billion dollar False Claims Act fines. Kulkarni also discusses the operational challenges of the Sunshine Act, noting how mandatory sharing of journal articles can inadvertently register as transfers of value, creating friction with healthcare professionals.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-26-056-non-promotional-compliance-with-darshan-kulkarni#t=0) Introduction: Darshan Kulkarni and the scope of non-promotional compliance
- [3:10](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-26-056-non-promotional-compliance-with-darshan-kulkarni#t=190) First Amendment scrutiny levels: Strict vs. Intermediate for scientific speech
- [11:59](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-26-056-non-promotional-compliance-with-darshan-kulkarni#t=719) The Washington Legal Foundation case and the FDA's loss on off-label promotion
- [17:27](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-26-056-non-promotional-compliance-with-darshan-kulkarni#t=1047) Corporate Integrity Agreements and False Claims Act penalties for medical affairs
- [21:46](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-26-056-non-promotional-compliance-with-darshan-kulkarni#t=1306) Sunshine Act compliance: Journal articles, transfers of value, and physician relations
- [26:49](https://hardwarepodcasts.com/podcast/lets-combinate/2022-10-26-056-non-promotional-compliance-with-darshan-kulkarni#t=1609) Future of FDA regulation and potential Supreme Court impacts on speech

## Topics

- [Policy, trade & tariffs](https://hardwarepodcasts.com/topic/policy-trade-and-tariffs)
- [Marketing & brand](https://hardwarepodcasts.com/topic/marketing-and-brand)
- [Intellectual property](https://hardwarepodcasts.com/topic/intellectual-property)
- [Leadership, teams & culture](https://hardwarepodcasts.com/topic/leadership-and-culture)

## Most relevant to

large enterprises

## Mentioned

- DarshanTalks (other)
- Kulkarni Law Firm (other)
- Drexel University (other)
- Washington Legal Foundation (other)
- FDA (other)
- Department of Justice (other)
- CMS (other)
- Sunshine Act (other)
- Open Payments (other)

## 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)
- [#341: What NOT to say to FDA](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2023-10-25-341-what-not-to-say-to-fda) (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)
- [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)

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