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The October issue of Life Science Compliance Update provides the life sciences industry with important news and analysis, covering:
* New enforcement priorities, including the government’s willingness to interrogate the science behind promotional claims
* Pacira’s First Amendment lawsuit
* In-depth summary of the proposed changes to the Common Rule
* An opioid manufacturer’s recent state settlement, requiring broad oversight responsibilities over prescribing doctors
* OIG’s Advisory Opinion on kickback implications of clinical study co-pay subsidies
The October issue of Life Science Compliance Update 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 requirements 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