Life Science Compliance Update: October Issue Covers Shifting Enforcement Priorities, First Amendment Challenges to FDA, New Settlement Provisions, Common Rule, and More

The latest issue is of Life Science Compliance Update is available for download. The October issue features articles on growing enforcement targets for the government, including misleading marketing and improper “cheerleading” of scientific studies. This topic is especially relevant in the wake of Pacira’s recent challenge to the FDA’s enforcement of “truthful and non-misleading” promotion, a lawsuit this month’s issue also reviews.

Also in October, David Vulcano, the Responsible Executive for Clinical Research at HCA, contributed an article entitled “Highlights of the Notice of Proposed Rulemaking (NPRM) Changes to the Common Rule.” In it, Vulcano outlines the proposed changes to the Federal Policy for Protection of Human Subjects (the “Common Rule”), and highlights some of the implications of the proposal.

This publication also explores a recent state settlement coming out of New York where a manufacturer of opioid medication agreed to broad oversight responsibilities over the physicians who prescribe its products. Lastly, the October issue includes an analysis of a recent OIG Advisory Opinion that examines the Anti-Kickback Statute implications of providing co-payment subsidies for participation in a clinical study.

Table of Contents

 Government Hones in On Misleading Marketing and Problematic “Cheerleading” of Scientific Studies

 Pacira Pharmaceuticals Adds Fuel To The Fire With First Amendment Challenge Against FDA

 New York Attorney General Requires Comprehensive Promotional Oversight and Transparency Requirements in Opioid Manufacturer Settlement

OIG Resolves “Blinding” Problem: Advisory Opinion Approves Subsidies to Medicare Beneficiaries Enrolled in Clinical Study

Highlights of the Notice of Proposed Rulemaking (NPRM) Changes to the Common Rule, by David Vulcano, Responsible Executive for Clinical Research at HCA

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