Pharma and the Feds: Key Government Activities and How They Affect the Biopharmaceutical Industry

Published by: Decision Resources

Published: Sep. 30, 2008 - 44 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

Introduction

Select Enacted Legislation by the 110th Congress

Genetic Information Nondiscrimination Act

Food and Drug Administration’s Amendment Act of 2007

Post-Approval Safety Studies

Risk Evaluation and Mitigation Strategies

Public Disclosure of Clinical Data

Labeling Changes

Active Monitoring of Adverse Events

Direct-to-Consumer Advertising

Medicare Improvements for Patients and Providers Act of 2008

Select Proposed Legislation in the 110th Congress

Pharmaceutical Market Access and Drug Safety Act: Addressing the Issue of Drug Importation

Prior Activities on the Importation Front

How Will S. 242 Fare?

Healthcare Information Technology Acts

The Wired for Health Quality Act

The Healthcare Enterprise Integration Act

The PRO(TECH)T Act

Health IT: Potential Upsides for Biopharma

Access, Compassion, Care and Ethics for Seriously Ill Patients (ACCESS) Act

Stem Cell Research

Biologics Price Competition and Innovation Act of 2007: Focus on Biosimilars

All Eyes on the White House

Overview of the Race for the Presidency

President McCain: Implications for Biopharma

President Obama: Implications for Biopharma

Timeline for Change

Outlook: Issues to Watch on the National Healthcare Front

Rise in Personalized Medicine

Scrutiny of Access to Medicine

Shift in Patient Paradigm

Expert Commentary

Building an Operational REMS Framework to Enhance Product Value

Jeffrey Stoddard, M.D., Vice President, Medical and Scientifi c Affairs, Risk Management and Postmarketing Programs, Covance, Periapproval Services

Edgar H. Adams, Sc.D., Executive Director, Epidemiology, Covance, Periapproval Services

Tables

1. Select U.S. Health-Related Statistics

2. Factors Necessitating the FDA to Issue REMS

3. FDA-Approved Products That Must Have REMS in Place by September 21, 2008

4. Select Federal Health IT Initiatives

5. U.S. Patent Expiries of Key Biologics

6. Prices of Leading Biologics in the Major Markets as a Percentage of U.S. Prices

7. EMEA’s Adopted Biosimilar Guidelines as of August 2008

8. Comparison of Presidential Candidates’ Positions on Biopharma Issues

Figures

1. U.S. Healthcare Statistics Relative to Select Other Nations

2. U.S. Health Expenditures by Expense Type

3. Sales of Prescription Drugs, 2003-2007

4. Number of Prescriptions Dispensed in the United States, 2003-2007

5. Number of DDMAC Warning Letters, 1998-2008

6. Drug Reimportation Timeline: Politics, Patients’ Rights, and Pharmaceutical Industry Lobbying

7. Mean Length of FDA Approval Processes for New Molecular Entities

8. Main Constraints on Biogeneric Use: U.S. Physicians

A. Risk Management Framework

Abstract

Introduction

This is a critical time in U.S. history for examination of the delivery of healthcare services. Some 47 million people in the United States lack healthcare coverage; the country spends $2.2 trillion annually on healthcare; the United States ranks 37th in terms of healthcare outcomes. Healthcare is thus in the spotlight among the population, the legislators who represent the population, and candidates in this year’s presidential elections.

Certain healthcare issues—because they represent a confl uence of the pending elections, recent legislative activity, and volatile trends affecting the U.S. healthcare marketplace—have near-term and/or powerful consequences for biopharma and thus pose an opportunity for biopharma players to act now so as to best navigate change. In the current landscape, there are opportunities to tap, threats to weather, and waves to ride.

Get the Answers You Need to Shape Your Strategy

• The November elections are fast approaching. McCain? Obama? What is the outlook for biopharma if either is elected?
• Spectrum has followed developments in personalized medicine with ever-growing interest. How does recent legislation fuel the move toward personalized medicine? What are the presidential candidates’ positions on this issue?
• Cost issues that threaten the traditional biopharma business model are on the table and are being served up with particular enthusiasm given the general economic situation. Is it likely that legislation approving importation and biosimilars will be enacted? What will the impact be?
• As cost-consciousness moves to the fore, the question of funding innovation ascends with it. What do stakeholders say? What does legislation affecting privacy of genetic and other patient data mean for innovation? What is the outlook for stem cell research? For clinical trials?
• Patient safety, scrutiny of messages to consumers, and personal security in the health IT arena are priority issues for the government. What steps are being taken by the government to protect the public in these areas? Which legislative activities will address these issues, and how?

Scope

• Presidential elections: positions of the candidates relevant to biopharma and select legislation; timeframe for change.
• Issues to watch: health information technology, clinical trials, affordable medications, genetic information, biosimilars, and generics.
• Recently approved legislation: GINA, FDAAA, and Medicare.
• Pending legislation: The Pharmaceutical Market Access Act. The Wired for Health Quality Act. The Healthcare Enterprise Integration Act. The PRO(TECH)T Act. The ACCESS Act. The Stem Cell Research Enhancement Act of 2007. The HOPE Act of 2007. Biologics Price Competition and Innovation Act of 2007.
• Expert Commentary: The impact of REMS on the value of a product in the pharmaceutical industry is discussed in a commentary by Covance’s Jeffrey Stoddard, M.D., VP, Medical and Scientifi c Affairs, Risk Management and Postmarketing Programs, and Edgar H. Adams, Sc.D., Executive Director, Epidemiology

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