Brian A. Dahl

Brian Dahl is the Principal at Dahl Compliance Consulting LLC. His consulting practice focuses on assisting life sciences companies with their corporate compliance needs. He is the architect of the corporate compliance programs at two top-tier pharmaceutical companies – Teva Pharmaceuticals and Takeda Pharmaceuticals.  As a consultant, he has built the compliance programs at two startup companies that recently launched their first products. Brian brings that real-world experience to the service of clients who are developing, implementing, or evaluating the effectiveness of their corporate compliance programs. Brian spent six years as the Compliance Director at Teva, where he built the company’s compliance program from the ground up while leading all aspects of the company’s compliance efforts across multiple branded divisions. Brian’s career in pharmaceutical corporate compliance began at Takeda in 2001, six months before the government’s seminal settlement with TAP Pharmaceuticals. Prior to becoming a pharmaceutical compliance professional, Brian practiced health law at the law firm of Baker & Daniels. He began his legal career practicing advertising law in Washington, D.C., first at the Federal Trade Commission and later at the law firm of Collier, Shannon, Rill & Scott. Brian received his J.D. from the University of Iowa College of Law and his Master of Health Administration degree from the College of Public Health at the University of Iowa. You can reach Brian at 847-800-1753 or at [email protected]

OIG Raises Compliance Expectations

Taking a page from pharma CIAs, the OIG has recently required that lab company Millennium Health hire a compliance expert. The drug testing provider came under fire for multiple years of violations of the Stark Law and Anti-Kickback Statute; relying on the insights of an expert should better equip the Millennium Board to ensure compliance going forward.

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DOJ Warns Against Protecting Wrongdoers

Despite the DOJ's best efforts -- in the form of prosecutions and prison sentences -- some individuals continue to engage in corporate misconduct. The DOJ's recent memo on individual accountability warns against protecting those culpable in the wrongdoing, whatever their position. If the organization wants credit for cooperation, the DOJ expects full disclosure.

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Amarin Pharma Decision Reiterates Importance of Disclosures in Off-Label Promotion

In a follow-up to June's pieces on the Amarin complaint, Brian Dahl responds to the FDA's disregard for the decision in United States v. Caronia, in which the Second Court ruled that the FDA must limit its restrictions on truthful, non-misleading off-label promotion. The implications of truthful speech are better informed treatment options. Or isn't that what the FDA wants?

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Are Disclosures a Pathway to Off-Label Promotion?

Pharma companies' promotion of their products for off-label use has to date met with legal action from the FDA, but that may change. Last month, Amarin Corporation filed a complaint against the FDA, contending that its First Amendment rights were impinged upon. The forthcoming ruling in this case could mean huge benefits for the pharma industry.

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Is Social Media/Internet Advertising the Next Monitoring Emphasis for the OIG?  Part 2

Companies in the life sciences must actively monitor their promotional and even non-promotional activities to ensure continual compliance with FDA requirements. According to recent OIG enforcement actions, this has come to include all manner of social media activity, from "likes" on Facebook to health claims made online. Are your social media policies clear enough?

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