Harmonizing the

FDA/SEC Centralized Procedure for Referrals

With Other Applicable Laws, Guidelines and Obligations

Wednesday, January 18, 2006

About

HOW PREPARED IS YOUR COMPANY TO RESPOND TO ENHANCED FDA AND SEC INTER-AGENCY COOPERATION?

In the wake of recent scandals involving dissemination of false or misleading public statements by companies in FDA-regulated industries, the FDA announced a new Centralized Procedure for Referrals from the FDA to the SEC. Within a year-and-a-half of that announcement, the SEC District Administrator reported that the FDA already referred more than half-a-dozen cases to the SEC. This development serves as a reminder that pharmaceutical companies, which already face unique corporate governance obligations, must be even more vigilant in their corporate housekeeping to avoid the monetary, criminal and social consequences associated with scandal.

As "good corporate citizens," in-house counsel and executives in the pharmaceutical industry who deal in securities, governance, and related concerns must have a strong working knowledge of the FDA/SEC referral process, in addition to the Sarbanes-Oxley Act, the Foreign Corrupt Practices Act, the Federal Sentencing Guidelines, and the various other federal and state reporting obligations and programs. You and your company must be able to merge all these requirements at once. Further, good citizenship calls for accountability, which requires that you have up-to-the minute knowledge of the latest issues affecting the board of directors as they relate to the pharmaceutical industry. Only then can you harmonize the drug approval process with the Centralized Procedure for Referrals from the FDA to the SEC and other related obligations, to avoid the government investigations and enforcement activities from which this industry is not immune.

American Conference Institute's publication on Harmonizing the FDA/SEC Centralized Procedure for Referrals With Other Applicable Laws, Guidelines and Obligations provides thoughtful and in-depth corporate governance analysis from leading in-house counsel and compliance officers, law firm healthcare and corporate governance practitioners, regulatory attorneys and government enforcers. They provide first-hand, practical and comprehensive information on:
  • The status of the latest FDA/SEC referrals
  • Managing internal controls regarding the rules and regulations of FDA, Medicare, Medicaid and other federal and state healthcare programs as they apply to governance
  • Aligning your company's compliance program with state reporting obligations
  • Complying with governance obligations through your document retention and management policies
  • Reviewing whether there is a conflict of interest for your directors and resolving it once you find one
  • Working with the government when you're under investigation
*American Conference Institute cannot guarantee that every presentation will be included in the publication.

Contents & Contributors

About

HOW PREPARED IS YOUR COMPANY TO RESPOND TO ENHANCED FDA AND SEC INTER-AGENCY COOPERATION?

In the wake of recent scandals involving dissemination of false or misleading public statements by companies in FDA-regulated industries, the FDA announced a new Centralized Procedure for Referrals from the FDA to the SEC. Within a year-and-a-half of that announcement, the SEC District Administrator reported that the FDA already referred more than half-a-dozen cases to the SEC. This development serves as a reminder that pharmaceutical companies, which already face unique corporate governance obligations, must be even more vigilant in their corporate housekeeping to avoid the monetary, criminal and social consequences associated with scandal.

As "good corporate citizens," in-house counsel and executives in the pharmaceutical industry who deal in securities, governance, and related concerns must have a strong working knowledge of the FDA/SEC referral process, in addition to the Sarbanes-Oxley Act, the Foreign Corrupt Practices Act, the Federal Sentencing Guidelines, and the various other federal and state reporting obligations and programs. You and your company must be able to merge all these requirements at once. Further, good citizenship calls for accountability, which requires that you have up-to-the minute knowledge of the latest issues affecting the board of directors as they relate to the pharmaceutical industry. Only then can you harmonize the drug approval process with the Centralized Procedure for Referrals from the FDA to the SEC and other related obligations, to avoid the government investigations and enforcement activities from which this industry is not immune.

American Conference Institute's publication on Harmonizing the FDA/SEC Centralized Procedure for Referrals With Other Applicable Laws, Guidelines and Obligations provides thoughtful and in-depth corporate governance analysis from leading in-house counsel and compliance officers, law firm healthcare and corporate governance practitioners, regulatory attorneys and government enforcers. They provide first-hand, practical and comprehensive information on:
  • The status of the latest FDA/SEC referrals
  • Managing internal controls regarding the rules and regulations of FDA, Medicare, Medicaid and other federal and state healthcare programs as they apply to governance
  • Aligning your company's compliance program with state reporting obligations
  • Complying with governance obligations through your document retention and management policies
  • Reviewing whether there is a conflict of interest for your directors and resolving it once you find one
  • Working with the government when you're under investigation
*American Conference Institute cannot guarantee that every presentation will be included in the publication.

Contents & Contributors


FDA'S SHARING NON-PUBLIC INFORMATION WITH OTHER FEDERAL OVERNMENT AGENCIES 21 CFR 20.85
Sharon M. Sheehan, U.S. Food and Drug Administration, ORA

INCORPORATING KEY SOX PROVISIONS INTO CORPORATE COMPLIANCE PROGRAMS
Robert L. Hickok, Pepper Hamilton LLP

ENSURING BEST PRACTICES IN YOUR COMPLIANCE PROGRAM
Tanya Dobash, Taro Pharmaceuticals
Katayun I. Jaffari, Saul Ewing LLP

SOX PAYS AN (IN) HOUSECALL
Joel S. Goldberg, Millennium Pharmaceuticals, Inc.

MAKING SENSE OF THE RECENT DEVELOPMENTS IN SENTENCING GUIDELINES COMPLIANCE: BOOKER AND BEYOND
Michael Horowitz, Cadwalader, Wickersham & Taft LLP Commissioner, U.S. Sentencing Commission

INCORPORATING FCPA CONTROLS INTO YOUR COMPANY'S COMPLIANCE BLUEPRINT
Gary Giampetruzzi, Pfizer

PHARMACEUTICAL MANUFACTURERS: PUBLIC SETTLEMENTS AND RECENT INVESTIGATIONS RELATED TO MARKETING, PRICING AND ASSOCIATE ACTIVITIES
Wendy Goldstein, Epstein Becker & Green

BEST IMPLEMENTATION STRATEGIES STATE REPORTING LAWS
Wendy Goldstein, Epstein Becker & Green
Elizabeth A. Lewis, Millennium Pharmaceuticals, Inc.

EMERGING GOVERNANCE CHALLENGES WITH RESPECT TO MEDICARE AND PRICING REFORM
Michael D. Bell, Mintz Levin

GOVERNANCE FOR THE GLOBAL SUPPLY CHAIN GXP'S PLUS
Gary Budney, Schering-Plough Corporation

ADDING HIPAA TO THE FDA/SEC OLIGODISCLOSURE MIX: TOWARD OR AWAY FROM GLOBAL COMPLIANCE IN A PUBLIC HEALTH/CAPITAL MARKETS/SOCIAL SECURITY INTEGRATED INFORMATION DISCLOSURE SYSTEM?
Alan Jakimo, Sidley Austin Brown & Wood LLP

SAFE HARBORS AND THEIR IMPACT ON GOVERNANCE
Bruce Levy, Gibbons, Del Deo, Dolan, Griffinger & Vecchione

RECORDS MANAGEMENT AND BEST PRACTICES IN E-DISCOVERY
Charlene Allyson Brownlee, Fulbright & Jaworski L.L.P.

DOCUMENT MANAGEMENT: COMPLYING WITH GOVERNANCE OBLIGATIONS WHILE MINIMIZING RISK AND COST
Charlene Allyson Brownlee, Fulbright & Jaworski L.L.P.
Robert Joel Slomoff, Fulbright & Jaworski L.L.P.

BUILDING AN EFFECTIVE COMPLIANCE PROGRAM: ISSUES FOR COMPLIANCE PROGRAM ARCHITECTS
Kathleen Meriwether, Office of the United States Attorney for the Eastern District of Pennsylvania
Marc Wilenzick, Pfizer

MAJORITY VOTING FOR DIRECTORS
Anne (Polly) G. Plimpton, McDermott Will & Emery
Stephanie Tsacoumis, Gibson, Dunn & Crutcher LLP

RECOGNIZING AND RESOLVING CONFLICTS OF INTEREST FOR DIRECTORS
Phillandas Thompson, Barr Laboratories Inc.

PROTECTIONS FOR INDEPENDENT DIRECTOR
Lisa M. Butera, American International Group/National Union

REGULATION FD UPDATE
Justin P. Klein, Ballard Spahr Andrews & Ingersoll, LLP

MAKING BIOTECH AND PHARMA PARTNERSHIPS WORK THROUGH GOVERNANCE
David L. Lopez, Discovery Laboratories, Inc.
Deni M. Zodda, Discovery Laboratories, Inc.

BRISTOL-MYERS SQUIBB: A CASE STUDY
Jacqueline C. Wolff, Covington & Burling

STATE QUI TAM STATUES AND THE INCREASING COMPEXITY OF PROGRAM FRAUD INVESTIGATIONS OF PHARMACEUTICAL MANUFACTUREERS
Jonathan L. Diesenhaus, Hogan & Hartson LLP

HOW TO BE A GOOD CORPORATE CITIZEN: RISING TO THE CHALLENGE OF CITIZENSHIP REPORTING
Richard F. Langan Jr., Nixon Peabody LLP

INTERNAL INVESTIGATIONS: TIPS, TRAPS AND TECHNIQUES
Thomas M. Gallagher, Pepper Hamilton LLP

SOME ISSUES TO BE CONSIDERED BY CORPORATIONS FACING EXTERNAL GOVERNMENT INVESTIGATIONS AND ENFORCEMENT ACTIONS
Stuart M. Gerson, Epstein Becker & Green



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