Food and Drug Law Institute
Understanding cGMPs:
What attorneys need to know
July 10, 2013
Carmen M. Shepard*
*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.
 Legal consequences
− Criminal prosecutions: company and individual
exposure
− Seizures
− Consent decrees
− Warning letters
− Navigating consequences of OAI Status
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 Ascertaining legal requirements and options
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GMP requirements come from laws and regulations
Appeal or litigation options
Effect on other jurisdictions
Disclosure obligations
Privilege Issues
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Company
Settlement
TAP Pharmaceutical
Products
$875 million
Schering-Plough
Country
Violation(s)
Year
Product(s)
Laws allegedly violated
USA
Medicare fraud/kickbacks
2001
Lupron
False Claims Act/Prescription Drug
Marketing Act
$500 million
USA
Poor manufacturing practices
2002
Claritin
FDA Current Good Manufacturing
Practices
AstraZeneca
Pfizer
$355 million
$430 million
Medicare fraud
Off-label promotion
2003
2004
Zoladex
Neurontin
Prescription Drug Marketing Act
False Claims Act/FDCA
Schering-Plough
$345 million
UK
USA
USA
Medicare fraud/kickbacks
2004
Claritin
False Claims Act/Anti-Kickback Statute
Serono
$704 million
Switzerland
Off-label
promotion/kickbacks/monopoly
practices
2005
Serostim
False Claims Act
Schering-Plough
$435 million
USA
Off-label promotion
/kickbacks/Medicare fraud
2006
Temodar/ Intron A/ KDur/Claritin RediTabs
False Claims Act/FDCA
Purdue Pharma
$601 million
USA
Off-label promotion
2007
Oxycontin
False Claims Act
2007
Abilify/Serzone
False Claims Act/FDCA
Bristol-Myers Squibb
$515 million
USA
Off-label
promotion/kickbacks/Medicare
fraud
Merck
$650 million
USA
Medicare fraud/kickbacks
2008
Zocor/Vioxx/Pepsid
False 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
False Claims Act/FDCA
GlaxoSmithKline
$750 million
UK
Poor manufacturing practices
2010
Kytril/Bactroban/Paxil
CR/Avandamet
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
UK
Off-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
India
Poor manufacturing
practices/failure to timely file
2013
required reports/false statements
Various
False Claims Act/FDCA
4
 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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 Leadership needs
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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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 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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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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