Below is a list of compliance resources all of us routinely use. The initial version of this guide was previewed at the PCF meeting in May 2005, and I revised and expanded it based upon your input and suggestions.

The resource guide will be an on going project, and I welcome your additional suggestions concerning other resources that should be included.

Please feel free to contact me at the email address below or contact the PCF office at info@pharmacomplianceforum.org.

Keith M. Korenchuk, JD, MPH
Partner, McGuire Woods
KKorenchuk@mcguirewoods.com

I. Federal Statutes

• Federal Anti-Kickback Law
• Federal Public Contract Anti-Kickback Act
• Medicaid Rebate Program Statute
• False Claims Act
• Lanham Act
• Veterans Health Care Act of 1992
• Sarbanes Oxley

II. Federal Regulations/Guidance

• OIG Compliance Guidance for the Pharmaceutical Industry
• Federal Sentencing Guidelines
• Fraud and Abuse Safe Harbors
• Holder & Thompson Memos
  • Holder Memo
  • Thompson Memo
• Medicaid Rebate Agreements
  • Medicaid Rebate Agreement
  • Medicaid Rebate Agreement Attachment A
• FDA Guidance (1997) on Medical Education
• FDA Guidance on DTC Broadcast Advertisement
• FDA Guidance on Off-label Drug Promotion
• HIPAA Privacy Rules
• OIG 2005 Workplan
• OIG Special Fraud Alert - 1994
• OIG Advisory Opinion 98-2

III. Federal Case Law

• Washington Legal Foundation v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998)
• Washington Legal Foundation v. Henney, 56 F. Supp. 2d 81 (D.D.C. 1999)
• Washington Legal Foundation v. Henney, 202 F.3d 331 (C.A.D.C. 2000)
• U.S. ex rel. David Franklin v. Parke-Davis, Division of Warner-Lambert Co., 147 F. Supp. 2d 39 (D. Mass 2001)
• U.S. ex rel. David Franklin v. Parke-Davis, Division of Warner-Lambert Co., 2003 WL 22048255 (D. Mass 2003)
• U.S. v. Booker, 125 S.Ct. 738, 160 L.Ed. 2d 621 (2005)

IV. Settlements/Corporate Integrity Agreements

• Astra Zeneca Corporate Integrity Agreement
• Bayer Corporation Corporate Integrity Agreement
• Fresenius Corporate Integrity Agreement
• Gambro Healthcare Laboratories Corporate Integrity Agreement
• Pfizer Corporate Integrity Agreement
• Schering-Plough Corporation Corporate Integrity Agreement
• GlaxoSmithKline Corporate Integrity Agreement
• TAP Corporate Integrity Agreement
• Novartis Nutrition Corporation Corporate Integrity Agreement
• Eckerd Corporation Corporate Integrity Agreement

V. State/Local Laws

• California False Claims Act
• California Unfair Competition Law
• California Health & Safety Code Pharma Certification Law
• Vermont
  • Vermont Statute
  • Vermont Guide
• Maine
• Minnesota
• District of Columbia
• New York City

VI. Industry/Association Guidance

• Pharmaceutical Research and Manufacturing Association Code of Conduct
• ACCME Guidelines
• Clinical Medical Journal Editors Policy on Publications [external link]
• AMA Guidance to Physicians on Relationships with Industry [external link]
• AdvaMed Code of Conduct
• IFPMA Code of Pharmaceutical Marketing Practices
• Pfizer Materials
  • Pfizer Materials
  • More Pfizer Materials