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市場調査レポート
医薬品業界と政府：政府の政策とバイオファーマ業界に及ぼす影響
Pharma and the Feds: Key Government Activities and How They Affect the Biopharmaceutical Industry
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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 Scientific Affairs, Risk Management and
Postmarketing Programs, and Edgar H. Adams, Sc.D., Executive Director,
Epidemiology.
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 (GINA)
- 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
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
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