Update Nov Dec 2013 - (Page 12)

Self-Enforcement of Regulatory Compliance through a Culture of Credibility By Joshua Axelrod, Esq., M.B.A. A t the 2013 Food and Drug Law Institute's Advertising and Promotion Conference in September, 2013, Mary Riordan from the Office of Counsel to the In- spector General, Department of Health and Human Services, incorporated into four CIAs since the beginning of 2012, is tailoring risk assessment "to company practices rather than 'standard' language." This is a customized approach that recognizes that drug noted that when enforcing regulatory compliance through companies require the autonomy to self-enforce compliance to Corporate Integrity Agreements ("CIAs") with drug manu- effectively mitigate their particular compliance risks. This strat- facturers, her agency allows for "flexibility in annual moni- egy also implicitly acknowledges that companies, as opposed toring plans," focuses on "case-specific issues," and recogniz- to regulators, are best-situated to most-effectively identify, es "variability among companies." To that end, Kirke Weaver monitor, and mitigate company risks internally. from Merck indicated, at the FDLI conference, a new trend, Josh Axelrod (josh.axelrod@comcast. net) is Compliance Counsel for Jazz Pharmaceuticals in Philadelphia and a veteran of the AstraZeneca and Novo Nordisk Compliance Departments. The Value of Self-Enforcement Effective "self-enforcement" by pharmaceutical companies lowers the risk of both non-compliance and uncertainty that can result from litigation against those companies. At the same time, it aligns with regulators' concerns for patient safety and on-label promotion without using government resources to enforce adherence to regulations. But effective self-enforcement is easier said than done, with the relentless pressures for drug 12 Update November/December 2013 www.fdli.org http://www.fdli.org

Table of Contents for the Digital Edition of Update Nov Dec 2013

Update Nov Dec 2013