February 12, 2014 Life Sciences Enforcement Year in Review: Examining Hot Button Areas for FDA &...
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Transcript of February 12, 2014 Life Sciences Enforcement Year in Review: Examining Hot Button Areas for FDA &...
February 12, 2014
Life Sciences Enforcement Year in Review: Examining Hot Button Areas for FDA & Related Government Enforcement
Peter Spivack, Hogan Lovells US LLP
www.hoganlovells.com 2
Federal and State Enforcement
• Off-Label Promotion• Consumer Protection statutes• Anti-Kickback Statute• cGMP
www.hoganlovells.com 3
Off-Label Enforcement
• Court decisions• United States v. Caronia• United States v. Harkonen
• Settlements– Drug
• Johnson & Johnson• Par Pharmaceuticals• Amgen• Boehinger Ingelheim
– Device• TranS1/Baxano Surgical• Orthofix International NV
www.hoganlovells.com 4
Off-Label Enforcement
• Court decisions– United States v. Caronia
• 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– United States v. Harkonen• In an unpublished decision, the Ninth Circuit affirmed the former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.
www.hoganlovells.com 5
Off-Label Enforcement
• Johnson & Johnson– Settlement terms
• 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• 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.
www.hoganlovells.com 6
Off-Label Enforcement
• Johnson & Johnson (Nov. 4, 2013)– Corporate Integrity Agreement
• 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.
www.hoganlovells.com 7
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
www.hoganlovells.com 8
Anti-Kickback Statute
• Sanofi Aventis (Dec. 19, 2012)• Settlement terms
– $109 million in False Claims Act civil settlements– Corporate Integrity Agreement
• Conduct– Free units of Hyalgan to physicians to lower its effective price and
increase the “spread”– False ASP reports submitted to CMS
www.hoganlovells.com 9
cGMP
• Consent Decrees– Shamrock Medical – Med Prep Consulting – Ben Venue Laboratories– Ranbaxy consent decree extension
www.hoganlovells.com 10
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)
www.hoganlovells.com 11
Questions?
• Thank you!
www.hoganlovells.com 12
Contact Information
• Peter Spivack(202) 637-5631
www.hoganlovells.com
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