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

Decision Resources
September 30, 2008
44 Pages - SKU: DECR1917689

Abstract Table of Contents Related Reports

Countries covered: United States

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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Additional Information

Mentioned in This Spectrum Report
Concepts

Access
Affordable medicines
Biogenerics
Biosimilars
Clinical trials
Direct-to-consumer adverting
Drug counterfeiting
Drug importation
Drug reimportation
Drug safety
DTC advertising
Electronic health records (EHRs)
Elections
Electronic medical records (EMRs)
e-pedigrees
FDA
Funding
Generic drugs
Gene testing
Genomics
Genetic Information Nondiscrimination Act
Healthcare delivery
Healthcare reform
Health information technology (Health IT/HIT)
Importation
Legislation
McCain
Medicare
Medicines
Obama
Personalized medicine
Pharmacovigilance
Presidential elections
Privacy
Safety
Telemedicine
Universal care

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; 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; Healthcare Information Technology Acts; 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
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

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

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