Putting the “c” in cGMP: How to remain current

*All views contained in this presentation reflect the personal views of the presenter only. They do not necessarily reflect the views or position of Mylan Inc. and may not be attributed to Mylan Inc.

July 10, 2013Carmen M. Shepard*

Food and Drug Law InstituteUnderstanding cGMPs: What attorneys need to know

Legal consequences− Criminal prosecutions: company and individual

exposure− Seizures− Consent decrees− Warning letters− Navigating consequences of OAI Status

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Why Lawyers?

Ascertaining legal requirements and options− GMP requirements come from laws and regulations− Appeal or litigation options− Effect on other jurisdictions− Disclosure obligations− Privilege Issues

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Why Lawyers? Cont…

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Company Settlement Country Violation(s) Year Product(s) Laws allegedly violated

TAP Pharmaceutical Products$875 million USA Medicare fraud/kickbacks 2001 LupronFalse Claims Act/Prescription Drug Marketing Act

Schering-Plough $500 million USA Poor manufacturing practices 2002 ClaritinFDA Current Good Manufacturing Practices

AstraZeneca $355 million UK Medicare fraud 2003 Zoladex Prescription Drug Marketing Act

Pfizer $430 million USA Off-label promotion 2004 Neurontin False Claims Act/FDCA

Schering-Plough $345 millionUSA

Medicare fraud/kickbacks 2004 Claritin False Claims Act/Anti-Kickback Statute

Serono $704 million SwitzerlandOff-label promotion/kickbacks/monopoly practices

2005 Serostim False Claims Act

Schering-Plough $435 million USAOff-label promotion /kickbacks/Medicare fraud

2006Temodar/ Intron A/ K-Dur/Claritin RediTabs

False Claims Act/FDCA

Purdue Pharma $601 million USA Off-label promotion 2007 Oxycontin False Claims Act

Bristol-Myers Squibb $515 million USAOff-label promotion/kickbacks/Medicare fraud

2007 Abilify/Serzone False Claims Act/FDCA

Merck $650 million USA Medicare fraud/kickbacks 2008 Zocor/Vioxx/PepsidFalse Claims Act/Medicaid Rebate Statute

Cephalon $425 million USA Off-label promotion 2008 Actiq/Gabitril/Provigil False Claims Act/FDCA

Pfizer $2.3 billion USA Off-label promotion/kickbacks 2009 Bextra/Geodon/Zyvox/Lyrica False Claims Act/FDCA

Eli Lilly $1.4 billion USA Off-label promotion 2009 Zyprexa False Claims Act/FDCA

GlaxoSmithKline $750 million UK Poor manufacturing practices 2010Kytril/Bactroban/Paxil CR/Avandamet

False Claims Act/FDCA

Allergan $600 million USA Off-label promotion 2010 Botox False Claims Act/FDCA

AstraZeneca $520 million UK Off-label promotion/kickbacks 2010 Seroquel False Claims Act

Novartis $423 million Switzerland Off-label promotion/kickbacks 2010 Trileptal False Claims Act/FDCA

GlaxoSmithKline $3 billion UKOff-label promotion/failure to disclose safety data

2012 Avandia/Wellbutrin/Paxil False Claims Act/FDCA

Abbott Laboratories $1.5 billion USA Off-label promotion 2012 Depakote False Claims Act/FDCA

Amgen $762 million USA Off-label promotion/kickbacks 2012 Aranesp False Claims Act/FDCA

Ranbaxy $500 million IndiaPoor manufacturing practices/failure to timely file required reports/false statements

2013 Various False Claims Act/FDCA

Navigating product availability issues− Effect on contracts, bids

• Company’s obligations to third parties• Third party obligations to company

− Reporting requirements for shortages

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Why Lawyers? Cont…

Leadership needs− How did we get here?− What are the consequences?− What is our strategy for dealing with this?− How do we keep it from happening again?

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Why Lawyers? Cont…

Steps to take when an inspection is imminent− Check performance metrics, backlogs, repeating issues,policies

• APRs completed• Investigations and deviations• Change controls, etc.

− Status of previous inspection commitments− Awareness of current trends by regulatory entities− Inspection readiness audits− Use of third parties

Data Integrity Issues

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Immediate issues:

Corporate governance Maintaining state of control Culture of Quality Education in trends, the “c” in cGMP Evaluation of effectiveness Product robustness Early warning signs

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Long-Term Issues