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FOCR Partners with
NPAF to Testify on The Hill
On March 1st, 2005, Friends of Cancer Research and the
National Patient Advocate Foundation
(NPAF)
partnered to present testimony on patient safety issues
and the FDA before the Senate Health, Education, Labor,
and Pensions
(HELP)
Committee. Nancy Davenport-Ennis, CEO of the NPAF, participated
in a 5-member witness panel and provided oral remarks that
highlighted the key elements of the full statement
submitted for the record available at http://help.senate.gov/testimony/t201_tes.html.
The purpose of the joint testimony was to provide insights
into the complex nature of cancer, and explain why timely
access to new technologies for the prevention, detection,
and treatment of cancer is so essential. Although it was
generally supportive of efforts to strengthen the FDA's
role in evaluating and monitoring safety concerns, our
testimony urged caution because some strategies might
unintentionally slow down the flow of better tools for
fighting cancer, or worse, discourage their creation
altogether.
"We
want safer and more effective drugs moved through
the system as efficiently as possible,” the testimony
states, “so they can be used as soon as possible by those
who need them most, such as cancer patients and/or those
at high risk for cancer. We would prefer strategies and
solutions designed to improve the FDA’s capacity in the
areas of safety, efficacy, and efficiency simultaneously."
As a
foundation for developing an even more effective FDA, our
testimony outlined five key "Pillars of Safety" critical
to reforms:
1.
Safety and Efficacy must continue to be the foundational
elements of the FDA regulatory process. Safety cannot
exist in a vacuum apart from efficacy.
2. Mechanisms to enhance existing structures and
processes for post market safety monitoring and adverse
event reporting should be explored.
3. Efforts to bring even greater efficiency and
scientific expertise to the FDA’s review and monitoring
processes must continue; such efforts must be done in a
manner that empowers the Agency to keep pace with the
rapid advancements now occurring in areas such as
genomics, proteomics, and nanotechnology.
4. FDA must continue to work with industry,
patient groups, physicians, hospitals, academia, and other
government agencies to enhance the critical path.
5. The FDA must be sufficiently resourced in order
to insure more effective pursuit of its existing
mandates. Additional resources are even more essential if
FDA is to successfully implement a comprehensive suite of
reforms.
For the full testimony,
please visit the U.S. Senate's Website at:
http://help.senate.gov/testimony/t201_tes.html
FOCR and NPAF Respond to Senate HELP Committee
Questions on Safety Issues
On March 1 of this
year, Friends of Cancer Research and the National Patient
Advocate Foundation partnered to present testimony on drug
safety concerns before the Senate HELP Committee. As a
follow-up to that testimony, the Chairman Enzi (R-WY)
submitted 2 questions in writing the responses to which
were included in the public record. Below are the
questions and a highlight from the response. To read the
responses in their entirety, please
click here. Also, please
click here to view the complete testimony.
1) In light of
recent controversies, some people have proposed requiring
longer-term and larger studies of drugs before they are
approved. Could you comment on whether and how this might
impact patients?
Time is a highly
precious commodity to someone diagnosed with a life
altering and/or life threatening condition like cancer,
AIDS, or diabetes. The diagnosis not only impact the
patient, but also their families, friends and communities.
When you are suffering from a potentially fatal or
severely debilitating disease, you shouldn’t have to wait
any longer than is necessary for the FDA to approve new
medical products. Any attempt to mandate longer or larger
clinical trials would obviously increase the length of
time before patients would have access to new products if
they are deemed safe and effective. When you are suffering
and dying, the risk/benefit ratio of significantly
different than in patient populations in other
circumstances.
2) Many have called
for a greater separation between the Office of New Drugs,
which is responsible for drug approvals, and the Office of
Drug Safety, which is responsible for post-market
surveillance of drugs that have already been approved. Are
you concerned that an independent Office of Drug Safety
would only look at risks and problems, potentially
ignoring the benefits?
Patients and their
families, physicians and caregivers must always weigh the
benefits and risks associated with a particular treatment
option. Similarly, we feel that the FDA must carefully
weigh the benefits and risks associated with a new drug
when making decisions about approval or post marketing
activity. Safety and efficacy are the inseparable
foundation of the FDA’s ability to best define the
appropriate risk/benefit ratio of a product. Risk cannot
be considered separately from benefit, nor safety from
efficacy. To review one without an equal measure of the
other could easily lead to misjudgments and false
conclusions. For that reason, we would advise against any
effort that creates new regulations or bureaucracy that
isolates or further separates the drug safety function
from the overall drug review and monitoring process.
For the full
responses, please
click here.
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