|
|
IMMEDIATE RELEASE
P ATIENTS,
SCIENTISTS, AND ADVOCATES SPEAK OUT ON DRUG SAFETY ISSUES
Committee of leading medical experts and
patient advocates stresses
importance of evaluating safety and efficacy simultaneously
with a systematic approach that supports science and innovation
WASHINGTON, DC, March 12, 2007 –
With Congress considering a
number of bills on enhancing drug safety and strengthening the Food and Drug
Administration (FDA), a n
independent committee of leading medical experts and patient advocates
released a report on drug safety today titled, “Drug Safety and Efficacy:
Two Sides of the Same Coin,” to ensure the voices of scientists, physicians,
and patients are heard in this important debate. The report, available
online at
www.focr.org/drugsafetyreport.htm,
emphasizes the importance of a systemic approach to simultaneously
evaluating drug safety and efficacy that supports science and innovation.
Chair of the Committee and President of
the Fox Chase Cancer Center, Dr. Robert Young, explained, “We need a system
which improves drug safety monitoring and post-marketing surveillance, but
does not increase the drug approval complexity, result in delays, or inhibit
future innovation."
The report outlines four major
recommendations that would enhance drug safety and strengthen the FDA:
-
Continually and
simultaneously evaluate safety and efficacy when determining public access
to, and marketing of, new products.
-
A systematic approach
to safety surveillance should be established to allow the use of a variety
of existing healthcare databases in order to identify and describe
post-market safety and efficacy signals associated with new drugs.
-
IT advancements and
increased personnel and training are needed within the FDA to enhance
post-market safety surveillance and product review.
-
Advance current
scientific opportunities to create a stronger, safer, science-based FDA.
With nearly 3.2 billion prescriptions filled annually, decisions affecting
drug regulation impact a majority of Americans. Friends of Cancer Research
(Friends), a cancer non-profit, brought the committee together last year to
explore scientific, medical, and policy issues relevant to assessing the
benefits and risks of prescription drugs. Friends Chair and Founder Dr.
Ellen Sigal emphasized the importance of the committee’s resulting
recommendations in saying, “In the end, this has to be about the patient and
what is best for the patient. All drugs pose risks, but it will be the
patient who suffers the most if we fail to take a balanced approach to
safety and efficacy.”
The authoring committee includes experts from major cancer organizations,
medical institutions, and other disease groups, such as Susan G Komen For
the Cure, American Cancer Society, Dana-Farber Cancer Institute, and M.D.
Anderson Cancer Center. For a full list of authors, please see the
Authors list online at
www.drugsafetyreport.htm/authors.htm. The resulting report from the
committee has already received endorsement from several other leading groups
in the health community including Lance Armstrong Foundation, Alliance for
Aging Research, Men's Health Network, and the National Alliance on Mental
Illness (NAMI). For a full list of supporting organizations, please see the
report
Sign-on list online at
www.drugsafetyreport.htm/signons.htm.
###
"Drug Safety & Efficacy: Two Sides of
the Same Coin"
represents the collective view of expert academic scientists and clinicians,
research advocates, and representatives of the patient community. This
committee was convened in order to recommend ways in which policy makers in
the United States Congress and the United States Food and Drug
Administration (FDA) could further improve drug safety, ensure new drug
access and foster the development of innovative new treatments. Individuals
on this panel have expert knowledge of FDA processes, drug safety, product
development, and scientific and clinical research. They have volunteered
their time and expertise for the benefit of the patients and the public.
www.focr.org/drugsafetyreport.htm
|
|
