Hardware Podcasts

056 - "Non-Promotional Compliance" with Darshan Kulkarni

Let's Combinate · 26 Oct 2022 · 33m

What this episode covers

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.

Most relevant to

large enterprises

Topics

Mentioned

Also
DarshanTalks, Kulkarni Law Firm, Drexel University, Washington Legal Foundation, FDA, Department of Justice, CMS, Sunshine Act, Open Payments

Related episodes from other shows

Other shows on the same ground, closest first.

  • Global Medical Device Podcast · 1h 26m

    Ad Promo and The Difference in Regulatory & Legal

    Mark DuVal, founder of Duval & Associates, explains the '4 buckets' framework for medical device promotion: on-label promotion, off-label dissemination, off-label communication, and the emerging fourth bucket of off-label promotion with disclosures. He contrasts the scientific perspective of regulatory affairs professionals with the advocacy-driven approach of regulatory attorneys, emphasizing the legal tension between FDA enforcement and First Amendment rights established in cases like *Howard Root* and *Washington Legal Foundation*. DuVal details how companies can navigate these boundaries using guidance documents, ensuring all communications are 'truthful, not misleading, and fairly balanced,' while managing risks like strict liability for executives and compliance monitoring of contract sales forces.

    Marketing & brandCertification & compliance
    8 chapters

  • Global Medical Device Podcast · 55m

    #366: Cardiac Arrest: Five Heart-Stopping Years as a CEO on the Feds Hit-List

    Howard Root, former CEO of Vascular Solutions, and Mark DuVal, President of DuVal & Associates, discuss Root's five-year federal criminal trial for alleged off-label promotion of a vascular device. Root details how a disgruntled whistleblower triggered a DOJ investigation into a product representing only 0.1% of sales, leading to a $25 million legal battle and the application of the Responsible Corporate Officer doctrine. DuVal explains the legal precedents, including the First Amendment protections for truthful speech, that ultimately led to Root's acquittal and shifted industry regulatory strategies. The episode highlights the critical importance of robust compliance programs, careful hiring practices, and maintaining a 'gray area' in corporate policy to avoid becoming a target for aggressive prosecutors.

    Certification & complianceIntellectual property
    10 chapters

  • Global Medical Device Podcast · 49m

    #341: What NOT to say to FDA

    Mike Drues, a regulatory consultant and expert witness, joins host Etienne Nichols to discuss strategies for communicating with the FDA during inspections and pre-market reviews. Drues emphasizes the mantra 'tell, don't ask, lead, don't follow' and advises companies to manage FDA expectations by providing objective evidence of their processes rather than just citing procedures. He highlights the importance of being prepared for unannounced inspections, answering only the question asked, and using clarifying questions to buy time when necessary.

    Certification & complianceQuality & yield
    8 chapters

  • The Startup CPG Podcast · 57m

    #216 - Food Labeling Law 101 with Lauren Handel

    Lauren Handel, founder of Handel Food Law, explains the regulatory framework and litigation risks for CPG brands, distinguishing between FDA-regulated foods and USDA-regulated products. She details specific claim categories including nutrient content, 'natural,' 'organic,' and health benefits, emphasizing that consistency across packaging, websites, and advertising is essential to avoid costly class-action lawsuits. Handel advises founders to understand the difference between regulatory consultants and attorneys, noting that legal advice offers privilege and risk assessment that consultants cannot provide, while recommending third-party certifications to mitigate exposure to litigation.

    Certification & complianceMarketing & brand
    10 chapters

  • Global Medical Device Podcast · 37m

    Part 1: The Theranos Loophole & Lab Developed Tests

    Mike Drues, president of Vascular Sciences, explains the regulatory distinction between Lab Developed Tests (LDTs) and In Vitro Diagnostics (IVDs), noting that LDTs are currently exempt from FDA pre-market review under the guise of the 'practice of medicine.' He argues that this loophole, highlighted by the Theranos case, allows companies to bypass rigorous safety and efficacy testing, creating a double standard where hospitals face no oversight for modifying commercial devices while manufacturers do. Drues emphasizes that the VALID Act, which would bring LDTs under FDA jurisdiction, has been stalled in Congress despite bipartisan support, leaving a significant regulatory gap that risks patient safety.

    Certification & complianceMedical & health devices
    8 chapters

The summary, chapters and topics are generated from the episode’s audio by this directory, not written by Let's Combinate. The episode itself belongs to its publisher.