Life Sciences Enforcement Year in Review:
Examining Hot Button Areas for FDA & Related
Government Enforcement
Peter Spivack, Hogan Lovells US LLP
February 12, 2014
Federal and State Enforcement
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Off-Label Promotion
Consumer Protection statutes
Anti-Kickback Statute
cGMP
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Off-Label Enforcement
• Court decisions
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United States v. Caronia
United States v. Harkonen
• Settlements
– Drug
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Johnson & Johnson
Par Pharmaceuticals
Amgen
Boehinger Ingelheim
– Device
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TranS1/Baxano Surgical
Orthofix International NV
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Off-Label Enforcement
• Court decisions
– United States v. Caronia
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Truthful and non-misleading off-label marketing is protected
speech under the First Amendment and cannot be the basis of a
criminal prosecution.
– United States v. Harkonen
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In an unpublished decision, the Ninth Circuit affirmed the former
CEO of Intermmune’s conviction for wire fraud.
A press release that misrepresented the results of a clinical trial
(involving the drug Actimmune®) is not protected speech.
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Off-Label Enforcement
• Johnson & Johnson
– Settlement terms
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Janssen Pharmaceuticals misdemeanor plea
Scios, Inc. misdemeanor plea (prior)
$485 million in criminal fines and forfeitures
$1.72 billion in False Claims Act civil settlements
Corporate Integrity Agreement
– Conduct
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Promotion of Risperdal and Invega for elderly patients with
Alzheimer’s and dementia.
Promotion of Natrecor for outpatient cardiovascular use.
Market share rebates, data purchase agreements, and speakers
fees as kickbacks.
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Off-Label Enforcement
• Johnson & Johnson (Nov. 4, 2013)
– Corporate Integrity Agreement
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Supersedes Janssen CIA and extends to Oct. 2018.
Clawbacks for bonuses and other long-term incentive
compensation.
Board and senior executive certifications for compliance with the
CIA.
Risk assessment and mitigation planning.
Detailed controls over third-party educational programs.
6
State Enforcement: Consumer Protection Laws
• Premised on broad consumer protection laws that
prohibit unfair and deceptive practices.
• Often contain per occurrence penalties.
• Often can be enforced by state attorneys general or
consumers.
• Examples:
– Johnson & Johnson / Risperdal
– GlaxoSmithKline / Avandia
– BMS / Sanofi / Plavix
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Anti-Kickback Statute
• Sanofi Aventis (Dec. 19, 2012)
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Settlement terms
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$109 million in False Claims Act civil settlements
Corporate Integrity Agreement
Conduct
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Free units of Hyalgan to physicians to lower its effective price and
increase the “spread”
False ASP reports submitted to CMS
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cGMP
• Consent Decrees
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Shamrock Medical
Med Prep Consulting
Ben Venue Laboratories
Ranbaxy consent decree extension
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cGMP: The Next Wave?
• “When companies fail to follow current good manufacturing
practices, they often place patients at great risk of harm that
neither they nor their doctors have any way of mitigating or
even recognizing.” CPB will take “an especially hard look
whenever patients are placed at an unacceptably high risk of
harm by those violations of current good manufacturing
practices.”
–
Maame Ewusi-Mensah Frimpong, Deputy Assistant Attorney General (DAAG)
for DOJ's Consumer Protection Branch (CPB), remarks at Pharmaceutical
Compliance Congress (PCC) (Jan. 2013)
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Questions?
• Thank you!
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Contact Information
• Peter Spivack
(202) 637-5631
Peter.Spivack@hoganlovells.com
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