Second National In-House Counsel Forum on

Prescription Drug Pricing

The Latest Information from the Front Lines of Federal and State Investigations and Enforcement Actions, Private and Public Litigation and Political Debate

Monday, October 20, 2003

About

Does your company have the strategies it needs to avoid improper pricing practices and defend against new allegations?

The pharmaceutical industry is under ongoing siege by public, private and political forces for alleged indiscretions in its pricing practices. The most recent legal and political activities in this arena have lead to new fines - civil and criminal - for Medicaid/ Medicare fraud, pending motions (in the AWP consolidated class action case), on-going FTC investigations, and vigorous Congressional debate. Moreover, investigations and actions involving off-label issues, PBMs and medical device tie-ins are ticking time bombs, creating new vulnerabilities and potential exposures.

In this unsettled and high risk environment, counsel to the pharmaceutical industry and their outside advisors must have in-depth knowledge and a complete understanding of the latest legal, regulatory, legislative - not to mention political - developments that are affecting prescription drug pricing today.

These Second National American Conference Institute Forum on Prescription Drug Pricing materials will arm you the latest information from those on the front lines of the federal and state investigations and enforcement actions, and private and public litigation. The outstanding faculty of leading attorneys, top federal and state prosecutors and key government officials provided important insights on key issues including:
  • Making sense of "best price" and other controversies arising from the Medicaid Rebate Statute
  • The latest on the AWP Consolidated Class Action suit and other pending pricing actions of significance
  • Qui Tam Actions: what are the latest hot spots under the Federal False Claims Act and its state equivalents?
  • How the PhRMA Code and the OIG Guidance have set the pace of the pricing controversy
There was also a special Focus on New Pricing Hot Spots: Off-Label Issues, PBMs and Medical Device and interactive Federal and State Enforcement Roundtables. In the Federal Roundtable, Assistant United States Attorneys from Boston and Philadelphia - the two most watched offices in the pricing arena - explored lessons learned from the latest round of federal investigations and actions. In the States Roundtable, assistant state AGs from California, Maryland, Maine, Vermont, and Texas discussed the latest phases of their particular state's pricing actions.

Other highlights of this program included two keynote addresses. Patrick Morrisey, Deputy Staff Director of the House Committee on Energy and Commerce gave a "Legislative and Political Update on The Actual, The Proposed and the Challenged". Markus H. Meier, Deputy Assistant Director Healthcare Services and Products Division, Bureau of Competition at the FTC provided a "Status Report on the FTC's Continuing Role in the Prescription Drug Pricing Controversy".

Contents & Contributors

About

Does your company have the strategies it needs to avoid improper pricing practices and defend against new allegations?

The pharmaceutical industry is under ongoing siege by public, private and political forces for alleged indiscretions in its pricing practices. The most recent legal and political activities in this arena have lead to new fines - civil and criminal - for Medicaid/ Medicare fraud, pending motions (in the AWP consolidated class action case), on-going FTC investigations, and vigorous Congressional debate. Moreover, investigations and actions involving off-label issues, PBMs and medical device tie-ins are ticking time bombs, creating new vulnerabilities and potential exposures.

In this unsettled and high risk environment, counsel to the pharmaceutical industry and their outside advisors must have in-depth knowledge and a complete understanding of the latest legal, regulatory, legislative - not to mention political - developments that are affecting prescription drug pricing today.

These Second National American Conference Institute Forum on Prescription Drug Pricing materials will arm you the latest information from those on the front lines of the federal and state investigations and enforcement actions, and private and public litigation. The outstanding faculty of leading attorneys, top federal and state prosecutors and key government officials provided important insights on key issues including:
  • Making sense of "best price" and other controversies arising from the Medicaid Rebate Statute
  • The latest on the AWP Consolidated Class Action suit and other pending pricing actions of significance
  • Qui Tam Actions: what are the latest hot spots under the Federal False Claims Act and its state equivalents?
  • How the PhRMA Code and the OIG Guidance have set the pace of the pricing controversy
There was also a special Focus on New Pricing Hot Spots: Off-Label Issues, PBMs and Medical Device and interactive Federal and State Enforcement Roundtables. In the Federal Roundtable, Assistant United States Attorneys from Boston and Philadelphia - the two most watched offices in the pricing arena - explored lessons learned from the latest round of federal investigations and actions. In the States Roundtable, assistant state AGs from California, Maryland, Maine, Vermont, and Texas discussed the latest phases of their particular state's pricing actions.

Other highlights of this program included two keynote addresses. Patrick Morrisey, Deputy Staff Director of the House Committee on Energy and Commerce gave a "Legislative and Political Update on The Actual, The Proposed and the Challenged". Markus H. Meier, Deputy Assistant Director Healthcare Services and Products Division, Bureau of Competition at the FTC provided a "Status Report on the FTC's Continuing Role in the Prescription Drug Pricing Controversy".

Contents & Contributors

OVERVIEW OF SELECTED ENFORCEMENT ACTIVITIES IN THE PHARMACEUTICAL INDUSTRY AUGUST 2003 UPDATE
Joseph F. Savage, Jr., Testa, Hurwitz & Thibeault, LLP

AWP LITIGATION: THE CONSOLIDATED CLASS ACTION AND RELATED PRICING CLAIMS
Michael L. Koon, Shook Hardy & Bacon
Richard D. Raskin, Sidley Austin Brown & Wood
Mark H. Lynch, Covington & Burling

INDIVIDUAL MEMORANDUM OF BAYER CORPORATION IN SUPPORT OF ITS MOTION TO DISMISS
Richard D. Raskin, Sidley Austin Brown & Wood

THE FTC'S PHARMACEUTICAL CASES
Markus H. Meier, Federal Trade Commission

QUI TAM: FUNDAMENTALS AND PRACTICALITIES
Neil V. Getnick, Getnick & Getnick
Lesley Ann Skillen, Getnick & Getnick

OFF-LABEL PROMOTION
Raymond A. Bonner, Sidley Austin Brown & Wood
Nathan C. Sheers, Sidley Austin Brown & Brown

PBMS UNDER THE MICROSCOPE
David A. Balto, White & Case

PHARMACY BENEFIT MANAGERS IN THE CROSSHAIRS?
Brien T. O'Connor, Ropes & Gray
Peter L. Welsh, Ropes & Gray

THE LINK BETWEEN MEDICAL DEVICE AND PRESCRIPTION DRUG PRICING
Harvey A. Yampolsky, Arent Fox Kitner Plotkin & Kahn

SETTLEMENT AGREEMENT AND RELEASE
Susan G. Winkler, Office of the United States Attorney for the District of Massachusetts

LIFE AFTER TAP: LESSONS LEARNED FROM THE LATEST FEDERAL CIVIL AND CRIMINAL INVESTIGATIONS AND PROSECUTIONS
Nicholas Theodorou, Foley Hoag LLP

STATE ENFORCEMENT EFFORTS IN THE PHARMACEUTICAL INDUSTRY
Meredyth Smith Andrus, Office of Maryland Attorney General

MAINE RX WHAT NOW?
Andrew S. Hagler, Law Office of Andrew S. Hagler, LLC

OIG FINAL PHARMACEUTICAL GUIDANCE: MORE BALANCED, EMBRACES, PhRMA CODE
Harvey A. Yampolsky, Arent Fox Kitner Plotkin & Kahn
Larri A. Short, Arent Fox Kitner Plotkin & Kahn



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