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Ed. Note: The following
is a press release from the Food and Drug Administration.
February 15, 2005
FDA Press Office
FDA Improvements in Drug Safety Monitoring
On February 15, 2005 , HHS Secretary Mike Leavitt and Acting FDA
Commissioner Lester M. Crawford unveiled a new emboldened vision for FDA
that will promote a culture of openness and enhanced oversight within the
Agency. As part of this vision, FDA will create a new independent Drug
Safety Oversight Board to oversee the management of drug safety issues,
and will provide emerging information to health providers and patients
about the risks and benefits of medicines.
Acting FDA Commissioner Crawford announced specific proposals for
immediate and fundamental steps to improve the way the FDA manages drug
safety information. These proposals focus on making FDA's review and
decision-making processes more independent and transparent.
FDA will enhance the independence of internal deliberations and decisions
regarding risk/ benefit analyses and consumer safety by creating an
independent Drug Safety Oversight Board (DSB). The DSB will oversee the
management of important drug safety issues within the Center for Drug
Evaluation and Research (CDER). The DSB will comprise members from the FDA
and medical experts from other HHS agencies and government departments
(e.g., Department of Veterans Affairs) who will be appointed by the FDA
Commissioner. The board also will consult with other medical experts and
representatives of patient and consumer groups.
FDA will also increase the transparency of the Agency's decision-making
process by establishing new and expanding existing communication channels
to provide targeted drug safety information to the public. These channels
will be used to help ensure that established and emerging drug safety data
are quickly available in an easily accessible form. The increased openness
will enable patients and their healthcare professionals to make
better-informed decisions about individual treatment options. The Agency
is proposing a new "Drug Watch" Web page for emerging data and risk
information and increased use of consumer-friendly information sheets
written especially for healthcare professionals and patients.
As FDA develops these communications formats, the Agency will be
soliciting public input on how FDA should manage potential concerns
associated with disseminating emerging information prior to regulatory
action. The Agency will issue draft guidance on procedures and criteria
for identifying drugs and information for the Drug Watch Web page. In
addition, FDA will actively seek feedback from healthcare professionals
and patients on how best to make this information available to them.
A cornerstone of all information collection, evaluation, and communication
proposals in an age of increasing electronic health information must be a
strict adherence to maintaining patient privacy. FDA is committed to
maintaining patient privacy as it undertakes these steps.
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