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
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