February 12, 2014 Life Sciences Enforcement Year in Review: Examining Hot Button Areas for FDA & Related Government Enforcement Peter Spivack, Hogan Lovells US LLP

Federal and State Enforcement Off-Label Promotion Consumer Protection statutes Anti-Kickback Statute cGMP 2

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 3

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 –United States v. Harkonen In an unpublished decision, the Ninth Circuit affirmed the former CEO of Intermmune’s conviction for wire fraud.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. 4

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. 5

Off-Label Enforcement Johnson & Johnson (Nov. 4, 2013) –Corporate Integrity Agreement Supersedes Janssen CIA and extends to Oct 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 7

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 8

cGMP Consent Decrees –Shamrock Medical –Med Prep Consulting –Ben Venue Laboratories –Ranbaxy consent decree extension 9

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) 10

Questions? Thank you! 11

Contact Information Peter Spivack (202)

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