Guiding Principles for Leveraging at FDA
FDA invites the public to comment on these draft Guiding Principles for
Leveraging at FDA. We intend to use these principles to guide us as we
explore and implement new collaborative ventures with academia, health
providers, other government agencies, regulated industry, and, of course,
consumers, so your comments are very important to us. You can send us your
By choosing to work with other organizations that share our public health and
safety goals, FDA can significantly amplify its public health impact, leverage
the intellectual capital of others, and make wise use of its resources. FDA has
been quite successful with its past collaborations and the agency intends to
expand and build upon this solid foundation in developing new partnerships.
What is leveraging? Leveraging is the creation of relationships and/or
formal agreements with others outside the FDA that will ultimately enhance FDA's
ability to meet its public health mission. Leveraging is a continuum.
The guiding principles for leveraging at FDA are:
- Leveraging can produce greater net benefits, e.g., by sharing talent and
material resources and achieving results through synergism.
- Successful leveraging provides benefits and incentives for all
participants. In addition to FDA this may include consumers, industry,
academia, health providers, and other government agencies. In particular,
leveraging efforts should increase consumer confidence in regulated products.
- Successful leveraging requires
- identification of tasks to be accomplished
- identification of partners with whom we share goals
- agreement on the roles of each partner in accomplishing those tasks
- shared responsibility for obtaining and evaluating results
- an open and credible process for those parties involved
- recognizing accomplishments
- Leveraging must work within established FDA legal authority.
- FDA's status as a scientific regulatory agency requires an added dimension
of due diligence and management of leveraged relationships by professionals at
all levels within the agency.
- Leveraging activities should not
- compromise the Agency's commitment to high standards in terms of
timeliness, predictability, and quality of our science and decision making,
- jeopardize FDA's role as an independent, impartial scientific agency,
- result in the occurrence or the appearance of a conflict of interest, or
- be seen as a means to avoid or off-load work and responsibilities or
merely as a response to an inadequate budget.
- Leveraging can be accomplished through a wide variety of collaborative
arrangements, both formal and informal. December 13, 1999.
How Will FDA Look in Five Years In Regard to Outside Leveraging?
- Seeking out partners with shared interests -- FDA will look first
to those with shared interests to assist in addressing emerging issues or
concerns. We will move away from "FDA first and only" and toward an approach
that also seeks out willing and capable partners.
- Considering partners early in the process -- All staff throughout
FDA, when recognizing an issue or concern, will first ask, "Who, in addition
to FDA, shares an interest in addressing this?"
- Developing courses of action together -- FDA will vigorously pursue
collaborations from the first stages of identifying a shared issue or concern,
devising possible solutions, and selecting the most expeditious and efficient
course of action.
- Defining the broader issues -- FDA will share its knowledge to help
define critical public health issues even if FDA has little or no direct
responsibility for addressing that issue today.
- Partners seek-out FDA's involvement -- Partners from industry,
health providers, academia, other government agencies, and consumer groups
will bring problems of public health significance to FDA and eagerly work
together to solve them.
- Partners and FDA contacts -- A compendium of potential partners
will be maintained to enable expeditious leveraging.
- Partnerships yield long-term benefits -- Outside leveraging
opportunities will provide long term remedies to some of the most complex
public health issues facing the Agency.
- Increased consumer confidence -- Leveraging efforts will increase
consumer confidence in FDA's public health protection role.
- Commitment to mutual recognition -- When describing or reporting
successes through collaboration, FDA and any partners will expressly recognize
each other's contributions.
FDA's Current Vision Supports a Leveraging Commitment
The following components of FDA's Vision Statement support outside
- An enabling agency - it stewards needed products and promotes
- A collaborative agency - it strengthens its ties to the domestic
and international scientific, health provider, and regulatory communities.
- A high-performance agency - it capitalizes on state-of-the-art
information and communication technologies and management systems to enhance