People Places Practices

it follows a thorough investigation into difficulties
encountered with our production line during
secondary processing operations of the injection
system. Our investigation into the challenges with
the commercial production of the cPAD injection
system showed that significant efforts would be
needed to solve the technical issues that had
been identified. These efforts would also require
a substantial investment of resources and time.
We would like to emphasize that the problems
are not related to the quality of the vaccine or
the injection system, but concern secondary
processing issues. Together with GlaxoSmithKline,
we continue to provide QUINVAXEM ® in the
vial presentations for routine immunization and
vaccination campaigns for five major childhood
diseases; tetanus, diphtheria, whooping cough,
Haemophilus influenza, and hepatitis B. While
we are disappointed to have to take this action,
Janssen Vaccines and GlaxoSmithKline remain
committed to advancing global health by
addressing the world’s unmet medical needs
through meaningful innovation.
Pricing
We are deeply committed to providing access
to our medicines and making our medicines
affordable to those in need. For the period
2005–2015, in the U.S., the weighted average
compound annual growth rate of the Company’s
net price increases for health care products
(prescription and over-the-counter drugs,
hospital and professional products) was below
the U.S. Consumer Price Index (CPI).
We engage strategic, innovative and equitable
pricing strategies for a variety of diseases, suited
to regional and individual market needs around
the world.
Information about specific Pricing Strategies
and Programs is provided on our Citizenship &
Sustainability website.
Access to Investigational Medicines
In keeping with the Company’s long-standing
commitment to the highest standards of ethical
decision-making that serves the needs of
patients, in 2015 Janssen forged a first-of-its-kind
partnership with the Division of Medical Ethics at
the NYU School of Medicine to further ensure that
the evaluation of compassionate use requests for
investigational medicines are treated in the most
fair and ethical manner.
Compassionate use is a pathway for patients
to gain access to investigational drugs, biologics
and medical devices not yet approved by the
FDA. By ensuring compassionate use requests for
our investigational medicines are evaluated by a
well-informed, external committee, we can make
the most responsible decision for each patient.
As part of this collaboration, the NYU School of
Medicine will establish the Compassionate-Use
Advisory Committee (CompAC), an external group
of 10 internationally recognized medical experts,
bioethicists and patient representatives to pilot
the new approach. Commencing with one of
Janssen’s investigational medicines, the CompAC
will make recommendations regarding individual
patient requests from anywhere in the world.
If successful, the program will become a
model that will be applicable more broadly across
Johnson & Johnson.
Access to Medicines Index Performance
In 2015 and early 2016, Johnson & Johnson
prepared a response for the 2016 Access to
Medicine Index (ATMI) survey, covering accessoriented
activities across our entire Family of
Companies from June 2014 to May 2016. Results
are slated for release in late 2016.
Results of the 2014 Access to Medicines Index
(ATMI) saw Johnson & Johnson ranked No. 3
among 20 global companies. It was noted by ATMI
that: “Of all companies, Johnson & Johnson is
adapting the most products for pediatric use that
target diseases within the scope of the Index.”
The products from our pipeline most relevant
to ATMI include fixed-dose combinations and
pediatric formulations of medicines for HIV/AIDS,
MDR-TB and hepatitis C.
Feedback received from ATMI regarding
opportunities for improving access to medicines
included extending our engagement in licensing,
developing access strategies for relevant
investigational products, and including accessoriented
terms systematically in product
development partnerships. We continue to
consider this feedback in our strategic discussions
about access moving forward.
Prescription Assistance
Over the past 12 months, the Johnson & Johnson
Patient Assistance Foundation, Inc. (JJPAF),
a nonprofit that assists patients without
adequate financial resources and prescription
coverage in obtaining free products donated
by Johnson & Johnson operating companies,
provided medicines to more than 97,000 patients
in the U.S.
The JJPAF website helps users find programs
that provide assistance with medication costs.
Johnson & Johnson is a member of the
Partnership for Prescription Assistance, a broad
private-sector effort funded by the pharmaceutical
industry, which offers a single point of access
to 475 public and private patient-assistance
programs.
Our Company is also one of the founding
members of Together Rx Access, which since
2005 has helped more than 2.5 million Americans,
including approximately 400,000 children who
have no prescription drug coverage and are not
eligible for Medicare, access prescription
drug savings.
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