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A Message to FDA Stakeholders:
FDA's Progress in Implementing FDAMA
March 1999

Last summer, the Food and Drug Administration committed to implement the FDA Modernization Act of 1997 (FDAMA) in ongoing and close consultations with all groups -- scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industries-- affected by our regulatory actions. This message is to encourage your participation in our efforts by informing you about the most significant developments since last year's message, and by inviting your suggestions for new steps that we can take to continue effective implementation of FDAMA.

At the strategic core of FDAMA was a charge for FDA to develop and publish a plan for complying with each of the agency's obligations under the Federal Food, Drug, and Cosmetic Act. This plan, which must be reviewed biannually in consultation with our stakeholders, is required to address six specific objectives. The first two objectives focus on maximizing the availability and clarity of information about our review processes, which is important for manufacturers, and about new products, which serves the needs of consumers. The third objective is to meet our inspection and postmarketing obligations, and the fourth is to ensure that we have access to the scientific and technical expertise needed to fulfill our public health obligations.

The fifth objective is to establish mechanisms by July 1, 1999 for meeting the statutory deadlines for reviewing or otherwise acting upon all product submissions received after FDAMA's enactment date. The sixth objective is to eliminate any backlogs in the review of applications and submissions by January 1, 2000.

To meet our charge, we held a series of well-attended public meetings last summer. In this series of open stakeholder meetings, FDA's senior leadership discussed the agency's obligations and challenges in meeting the requirements of FDAMA and the desire for stakeholder input in creating a blueprint for action. In response, stakeholders offered a wealth of productive suggestions, many of which reflected their desire for greater involvement in FDA's work by collaborating with and contributing to our future strategies, and for receiving clear and more timely information about our processes and new regulated products.

We not only listened carefully to you but also used your advice to guide the development of a realistic plan for complying with our legal obligations under FDAMA, as well as responding to the public's expectations. We developed and published on November 24, 1998 the "FDA Plan for Statutory Compliance." The two-part plan (which is available in its entirety on the Internet at www.fda.gov/oc/fdama/fdamapln/) consists of a broad, agency-wide strategic framework and specific performance goals for the current fiscal year. Among other items, the plan discusses our statutory obligations, authority, needs and past reinvention efforts, and outlines many bold and innovative approaches for our future efforts.

Following the stakeholder exchanges, our senior leadership identified six strategic directions on which we need to focus our energies in order to meet the FDAMA objectives:

• Establish risk-based priorities
• Strengthen the scientific and analytical basis for regulatory decisions
• Work more closely with external stakeholders
• Continue to re-engineer FDA processes
• Adopt a systems approach, rather than piecemeal review and enforcement, to agency regulation, and
• Capitalize on information technology to improve both internal efficiency and communication with stakeholders.

There are, however, a number of significant challenges that could negatively affect our efforts to implement FDAMA. Among these are greater product complexity driven by breakthroughs in technology; increases in recognized adverse effects associated with product use; unpredictable new health and safety threats; emerging regulatory challenges in the international arena including the increased volume and diversity of imports. Federal budget constraints also are a serious hurdle to performing the core business of the Agency and meeting the public's expectations.

FDA's performance-oriented strategy acquired additional impetus with last November's appointment of Jane E. Henney, M.D., as the new Commissioner of Food and Drugs. Dr. Henney is an oncologist who has an exceptional record of leadership in academia and government and who also has an intimate knowledge of FDA, having served as the Deputy Commissioner for Operations from 1992 to 1994.

As Dr. Henney recently noted, "when the Senate voted for me to be confirmed as FDA Commissioner, it signaled that the agenda that I put forward met their expectations." At her nomination hearing before the United States Senate and in subsequent public presentations, Dr. Henney identified and reiterated her priorities for FDA as follows:

First, she is committed to fully implement FDAMA, both in letter and spirit. Under her leadership, FDA is to become a more efficient, more responsive, more open and better understood agency.

Dr. Henney places a high premium and priority on making sure that science anchors FDA's decision-making processes and critical policy decisions. To that end, she stresses the need to strengthen FDA's science base -- not only infrastructure but also the expertise of FDA's reviewers and inspectors. Their professional development, scientific competence and credibility need to be enhanced by training and exchanges and partnerships with academia and other government agencies.

Finally, Dr. Henney pledged to fully support the Administration's initiatives to ensure the safety of the food supply, the safety of the blood supply, and to protect children from the dangers of tobacco.

This past February, the administration sent forward to Congress a substantial increased request for our budget. This will allow us to begin rebuilding our capabilities, strengthen our science base, which is the foundation of sound regulatory decisions, and to continue several long-range, high-priority programs that are vital for the protection of the public health. Although the budget request is larger than in previous years, it is only the first step toward rebuilding an effective Agency able to carry out our statutory mandates and to respond to emerging public health problems in the 21st century.

We are following the strategies in the FDAMA compliance plan, which continue to improve and reinvent our programs that protect the public health. To ensure that our implementation strategies are effective and to adjust them, if necessary, to changed circumstances; we will periodically reexamine our compliance plan with our stakeholders. We will report the outcome of these consultations in a mandated year-end report to Congress that analyzes the plan's strengths and shortcomings, and compare our performance against the plan's goals.

We are, therefore, planning to enter the second cycle of our formal consultation with stakeholders, this time focused on specific ways to attain FDAMA's demanding performance targets. Two of the underlying themes that emerged from stakeholder input in the first cycle, which will be the focus of phase two: (1) strengthening FDA's science and (2) improving communication processes with the public.

As part of this ongoing consultative process, we will conduct an extensive outreach to all our stakeholders through mailings, information on the Internet, and a nationwide live satellite teleconference on April 28 (details will be announced in the Federal Register and posted on FDA's Internet home page). The object of this effort is to elicit your best and most specific answers to the following questions:

1. Science-based decisions are made throughout the life span of products from initial research, development and testing, through production, marketing and consumption. These decisions require the best science to identify, evaluate and balance product risks and benefits. It is crucial that FDA's staff in collaboration with product sponsors develop a shared understanding of new science and technologies and their effect throughout a product's life span. What actions do you propose the Agency take to expand FDA's capability to incorporate state-of-the-art science into its risk-based decision-making?
2. As the agency attempts to meet its public health responsibilities, the speed of discovery results in an avalanche of new information from government, academic and industry scientists. What actions do you propose to facilitate the exchange and integration of scientific information to better enable FDA to meet its public health responsibilities throughout a products life cycle?
3. Most products in the American marketplace, especially medical ones, have two facets. On one side they benefit users and often improve lives. They are, however rarely without risk and their use can result in known and unknown side effects. Consumers must weigh benefits and risks before using these products, oftentimes with incomplete information. What actions do you propose for educating the public about the concept of balancing risks against benefits in public health decision-making?
4. The Agency stated in the FDA PLAN FOR STATUTORY COMPLIANCE, that inflation has eroded real assets that can be applied to meet its public health mission while Congress has increased its responsibilities. Because the Agency must allocate its scarce resources to achieve the greatest impact, what actions do you propose to enable FDA and its product centers to focus resources on areas of greatest risk to the public health?
5. FDAMA requires the agency to continue to meet with stakeholders on key issues. Meetings have ranged from explaining Agency positions to working with sponsors on product applications. Historically, these interactions have benefited both stakeholders, through better knowledge of the FDA, and the Agency, by leading to changes in its operations. Because the Agency wants to assure that its stakeholders are aware and participate in its modernization activities, what additional actions do you propose for enhancing communication processes that allow for ongoing feedback and/or evaluation of our modernization efforts?

FDA has established a docket for input on these and other objectives of section 406(b) of FDAMA. The more concrete your suggestions, the more helpful they will be in evaluating the FDA compliance plan. The docket number is 99N-0386. Comments may be sent to:

Electronic responses may also be emailed to fdadockets@oc.fda.gov.

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