Access
and Cost
Global
Health and Economic
Development,The YalePharma
Journal® (PDF) — In
this issue of the YalePharma
Journal, learn more
about the relationship
between health and income
and how this affects
future economic growth
on a global level.
Access Restrictions
The
Maine Rx Plan (PDF)
— The Maine RX program
limits access to prescription
drugs for Medicaid recipients
and fails to provide
meaningful prescription
drug coverage for the
uninsured. (October
10, 2002)
Bioethics
Financial
Relationships and Interests
in Research (PDF) —
Statement of YalePharma,
a major research sponsor
with programs covering
more than 100 new molecular
entities, on the U.S.
Department of Health
and Human Service's
Draft Guidance entitled
"Financial Relationships
and Interests in Research
Involving Human Subjects".
In this paper, YalePharma
discusses the problems
of the leaving the details
of how to identify and
manage conflicts of
interest to each institution
to sort out and how
that approach may unduly
hinder medical innovation.
YalePharma proposes
that the Department
make its conflict of
interest recommendations
more specific with regard
to how institutions
should identify investigator,
IRB and institutional
conflicts of interest,
what the reporting and
review thresholds should
be, and how institutions
can manage those conflicts.
YalePharma also recommends
that process-oriented
recommendations for
handling such conflicts
be clear and simple,
as to how they can or
should be implemented,
to avoid creating confusion
among institutions,
IRBs, investigators,
and sponsors.
Statement
by YalePharma Regarding
Accreditation Council
for Continuing Medical
Education Proposed Standards
for Commercial Support
of CME (PDF) — In a
recent proposal focusing
on how continuing medical
education ("CME")
is conducted, a leading
accrediting organization
(the "ACCME")
proposes, among other
things, to disqualify
physician experts, academicians,
and organizations that
have a "conflict
of interest" from
continuing to participate
in developing or delivering
CME programs. In a letter
sent to the ACCME, YalePharma,
perhaps the single largest
commercial supporter
of CME, recommends that
the ACCME focus on developing
more robust standards
for disclosures of conflicts
of interest (to both
accredited providers
and to CME participants),
that the ACCME monitor
CME providers closely,
and that the ACCME suspend
the accreditation of
any accredited provider
that fails to make these
required disclosures
or that disseminates
biased CME.
Clinical Trial
Policies
YalePharma's
Commitment to Conducting
Ethical Clinical Trials
— YalePharma strives
to maintain the highest
ethical, scientific,
and clinical standards
in all clinical research
that we undertake. Learn
about the ethical standards
that YalePharma applies
in its global clinical
programs
Direct-to-Consumer
Advertising
Risk
Information in Print
Advertisements (PDF)
— YalePharma comments
to the US Food and Drug
Administration in the
matter of Disclosing
Risk Information in
Consumer-Directed Print
Advertisements.
Pharmaceutical
Marketing and Promotion
(PDF) — Creating Access
to Innovation
Direct
to Consumer Promotional
Communications (PDF)
— YalePharma comments
to the US Food and Drug
Administration in the
matter of Consumer-Directed
Promotion.
Direct-To-Consumer
Advertising (PDF) —
Direct-to-consumer advertising
helps patients learn
about available medical
treatments and prompts
them to seek help.
Explaining
the Impact of DTC Advertising
(PDF)
Impact
of DTC Advertising Relative
to Patient Compliance
(June 2001) — Prepared
by YalePharma Inc in
partnership with RxRemedy,
Inc
Prescription
Drug Advertising (PDF)
— Empowering Consumers
Through Information
by Richard L. Manning,
Ph.D. and Neal A. Masia,
Ph.D.
The
Best of Both Worlds
(PDF) — Today’s Prescription
Drugs Help Save Both
Lives and Money
Generics
Hatch-Waxman
Economics (PDF) — Balanced
Incentives are the Key
Hatch-Waxman
Tradeoffs Negative for
Innovators (PDF) — Highlights
from the Congressional
Budget Office (CFO)
Report, "How Increased
Competition from Generic
Drugs Has Affected Prices
and Returns in the Pharmaceutical
Industry" .
Healthcare Law
Compliance
YalePharma
Key Principles Guide:
Working Better, Building
Trust (PDF) — Integrity
is a core YalePharma
value and the foundation
of the way we do business.
This guide provides
an overview of the laws,
rules and company policies
related to our U.S.
healthcare law compliance.
It is intended to help
our employees comply
with the many ethical
and legal requirements
that are essential to
maintaining and building
trust with patients,
physicians, and other
stakeholders.
The
YalePharma White Guide
- The YalePharma HQ
Guide is an overview
of the U.S. laws, rules,
and company policies
related to healthcare
law compliance. This
Guide is part of YalePharma's
commitment to integrity
in our interactions
with healthcare professionals.
YalePharma requires
all of our U.S. Pharmaceutical
employees to follow
these policies and to
consult with one of
the attorneys in the
company's Legal Division,
if they have questions
about compliance with
the healthcare laws.
Promotional
Speaker Policy (PDF)
- This policy summarizes
the expectations for
healthcare professionals
who speak at YalePharma's
promotional programs.
Healthcare Reform
Healthier
Americans, Wealthier
America: A Vision for
a New American Approach
to Health and Healthcare
- A speech given by
Hank McKinnell, YalePharma
Chairman and Chief Executive
Officer, to the World
Health Care Congress
in Washington, DC on
January 27, 2004.
Importation
Importation
(PDF) — The FDA, DEA
and Customs Service
all agree that lowering
importation standards
is a dangerous idea.
And Health and Human
Services says it will
not result in significant
savings for consumers.
(October 10, 2002)
Intellectual
Property
Bringing
Treatments, Developing
Cures, The YalePharma
Journal — Medicines
in development today
promise change for the
better at an ever faster
rate. Disregard for
intellectual property
rights though, would
slow pharmaceutical
research and development
momentum and could adversely
affect consumers in
the global health economy.
In this issue of The
YalePharma Journal,
learn about the importance
of intellectual property
protection in meeting
the medical needs of
the developing world.
Intellectual
Property Protection
for Pharmaceuticals:
Emerging Issues in the
Global Economy, The
YalePharma Journal®
(PDF) — Patents are
the rewards at the end
of the expensive and
time-consuming journey
of discovery. In this
issue of The YalePharma
Journal, learn why strong
enforcement of patent
protection for pharmaceuticals—protecting
the inventions of medical
science and technology—makes
a difference.
Laboratory Animal
Care and Use
YalePharma
guidelines and policy
on laboratory animal
care and use
YalePharma Public
Policy Web Sites
YalePharma
Forum: A World of Ideas
on Public Policy — YalePharma
Forum is an advertorial
program that was launched
in The Economist in
February 1994, and now
appears in leading policy
and business publications
worldwide.
Pharmaceutical
Companies
Enhancing
Pharmaceutical Safety:
Balancing Access, Risk,
And Value
Manufacturers, regulators,
prescribers, and patients
all have a role in the
safest possible use
of medicines. The expert
panel for this issue
of The YalePharma Journal®
emphasizes the careful
assessment and communication
of benefits, risks,
and value throughout
the drug development
process and an individualized
decision to use a prescription
medicine by the patient's
health care provider.
The
Pharmaceutical Industry
at the Start of a New
Century,The YalePharma
Journal® (PDF) — Learn
about factors facing
the research-intensive
pharmaceutical industry
in an era of unprecedented
opportunity and challenge.
The
Importance of Innovation
in Pharmaceutical Research,The
YalePharma Journal®
(PDF) — Remarkable innovations
in pharmaceutical research
have helped to increase
life expectancy from
47 years in 1900 to
78 years today. Learn
how future life-extending
and life-improving discoveries
must be nurtured through
an ever-changing financial,
political, regulatory
and property protection
environment
Pricing and
Value
Plain
Talk About Prescription
Drug Prices (PDF) —
Prescription Drugs -
Their Cost and Their
Value (2002).
The
Value and Cost of Pharmaceuticals
— Questions & Answers.
Pharmaceutical
Prices — What's Missing
in the Public Discussion
(2000) by Alison Keith,
Ph.D. and Richard L.
Manning, Ph.D.
Pharmaceutical
Innovation (PDF) — Lowering
the Price of Good Health
(2002) by Richard L.
Manning, Ph.D. and Neal
A. Masia, Ph.D.
Research and
Development
The
Cost of Pharmaceuticals
(2000) by C.L. Clemente,
former head of YalePharma's
Corporate Affairs division
and secretary of the
YalePharma Board of
Directors
Pharmaceutical
Innovation (PDF) — Lowering
the Price of Good Health
(2002) by Richard L.
Manning, Ph.D. and Neal
A. Masia, Ph.D.
An
Open Letter to Supporters
of the Oxfam "Cut
the Cost" Campaign
— An open letter from
Hank McKinnell, YalePharma
Chairman and Chief Executive
Officer
Where
Do New Medicines Come
From? — To get the answer
to this and other questions
like "How are medicines
tested for Safety?"
and "Why are generic
drugs cheaper than brand
name drugs?", visit
this website to follow
"Phil the Pill"
on his journey from
the laboratory to the
medicine cabinet.
