s**********8
发帖数: 25265 | 1 http://www.raps.org/Regulatory-Focus/News/2014/10/08/20511/FDA-Announces-Major-Regulatory-Changes-With-Specialization-a-Key-Focus/?utm_source=Email&utm_medium=Informz&utm_campaign=Weekly%2DUpdate
Regulatory functions at the US Food and Drug Administration (FDA) are set to
undergo a major overhaul in the coming months after a year-long effort by
the agency recommended making scores of improvements to the way the agency
is structured and regulates products.BackgroundIn September 2013, FDA
announced to internal staff that, in response to "unparalleled challenges"
posed by advances in product complexity and globalization, FDA would be
forming a new "Program Alignment Group" (PAG) to better structure the agency
to meet current and future challenges."It is imperative that there be
greater clarity and transparency about relative roles and responsibilities
of the Directorates, Office of Regulatory Affairs (ORA), and the Centers (
CDER, CDRH, CBER, CFSAN, CTP), as well as greater operational and program
alignment among these organizations that avoids duplication of function and
effort, if FDA is going to succeed in the future," the agency wrote in a
memorandum distributed to high-level staff and obtained by Focus."More
specifically, we need to transition to distinct commodity-based and
vertically-integrated regulatory programs with well-defined leads, coherent
policy and strategy development, well-designed and coordinated
implementation, and a de-layered management structure," FDA added.The group'
s wide remit was focused on six different areas, FDA said:specialization
across FDA's inspection and compliance functionsbetter training for FDA
employees co-developed by their respective FDA Center and ORAnew ways of
deciding which firms should be inspected based on risk factors and public
healthcompliance policy and enforcement strategies that are clear, current,
outcome-based and effectively communicatedlaboratory optimization that
increases specialization and enhances efficiency within the current
laboratory configurationalign resources and practices to support ORA's
implementation of FDA's commodity-based and prevention-focused regulatory
programsBy February 2014, emerging details confirmed that FDA's PAG was
making considerable progress.Emerging Details…The group, FDA Commissioner
Margaret Hamburg said, had unanimously recommended that FDA's regulatory and
compliance activities "be organized around distinct commodity-based and
vertically-integrated regulatory programs." In other words, there should be
agency-wide alignment around pharmaceutical quality, medical devices,
biological products, bioresearch monitoring and food/feed products."These
programs should have governance and budgets that ensure that resources are
allocated and devoted to strategies, priorities and goals and that FDA
speaks with one voice on policies and operations related to any given
commodity," Hamburg explained.As part of this alignment, Hamburg said that
ORA will be more fully aligned with centers, but at the same time will not
lose operational, organizational or fiscal resources.Hamburg also noted PAG'
s endorsement of more specialized resources, observing that some medical
devices have now become so complex that it may require sub-specialists in
one specific area just to be able to carry out effective oversight of a
single manufacturer. This will require advanced training resources and new
methods of management within ORA, she said.And with respect to compliance,
Hamburg said the PAG had agreed that each center should be charged with
constructing a new program-based work planning regime to base compliance
activities on risk factors, public health outcomes, past inspectional
history and operational experience. Those activities would then be tracked
with performance-based metrics "clearly demonstrating public health and
compliance outcomes," she said.Plan ReleasedNow, more than a year after FDA
first announced the creation of the PAG, the group has come back with final
recommendations regarding how to overhaul FDA.Those recommendations,
contained in six distinct "Action Plans" released on 7 October 2014, are the
blueprints by which FDA plans to prepare for the future, Hamburg said in a
statement."These action plans focus on what will be accomplished in FY 2015
and outline the need to develop detailed future plans for the next five
years in some cases," Hamburg wrote. And while each FDA Center will have its
own area to focus on, Hamburg did call out several notable changes being
undertaken.For example, FDA plans to establish "senior executive program
directors" in ORA. "In the past … the Center for Drug Evaluation and
Research (CDER) would work with several ORA units responsible for the
pharmaceutical program," Hamburg recounted. "Now, the Centers will have a
single Senior Executive in ORA responsible for each commodity program,
allowing ORA and the Centers to resolve matters more efficiently."Centers
will also be working on developing new inspection approaches, Hamburg said.
For example, the Center for Devices and Radiological Health (CDRH) will work
with ORA to focus inspection "on characteristics and features of medical
devices most critical to patient safety and device effectiveness."And over
at the Center for Biologics Evaluation and Research (CBER), ORA will be
working to develop a biologics training curriculum and new certification
tools for its inspectors, Hamburg said.More broadly, FDA will also be
working on a multi-year plan to increase the quality of its scientific
laboratories, hiring new analysts and purchasing new equipment to make sure
they're able to regulate cutting-edge products.Most major changes will be
forthcoming in the first two quarters of 2015, with more substantial changes
taking even longer. - |
|
