Regulatory Information

FDA Public Meeting on Section 406(b) Summary September 14, 1998

FDA Public Meeting on Section 406(b) of the FDA Modernization Act of 1997


September 14, 1998

As part of the ongoing process to consult with its stakeholders about how it can best meet its statutory obligations, the Food and Drug Administration [FDA] held a public hearing on September 14, 1998 focusing on the crosscutting issues and themes that are fundamental to its consumer protection obligations. There were 11 speakers representing a diversity of FDA stakeholder groups and approximately 80 registered attendees at this meeting. The agenda for this meeting is attached.

The Federal Register notice for the September 14 meeting set out FDA's consumer protection functions and posed specific questions related to these functions for stakeholders to address at the meeting. Based on the views expressed by the presenters representing a variety of stakeholder groups, the following is a summary of the key issues and comments presented at this meeting.

Regarding the discussion of what should be FDA's priorities, there was a consensus that the Agency should view its specific statutory obligations as its priority and limit its participation in new activities, especially those activities that are not within the scope of its core statutory requirements. There was a difference of opinion among stakeholders about whether or not consumer education and information were a priority for FDA. This difference was expressed in terms FDA's role in providing consumer education as well as the value of consumer education in improving health outcomes. While there were some stakeholder groups who believed that FDA had no role in consumer education and information, there were other stakeholder groups who saw FDA's role as essential in providing consumers with access to objective information and in leading to improved patient interaction with physicians and thus better treatments.

Consistent with what the Agency has heard at other meetings with its stakeholders, making trade-offs in the context of constrained resources is difficult. In general, stakeholders believe that adequate resources should be appropriated, that FDA should continue to reengineer its systems, and that the Agency should access the expertise of other organizations to meet its goals. For example, third party arrangements were seen as valuable in such areas as research, standard-setting, and some aspects of product reviews [e.g. the review of efficacy supplements]. User fees for medical devices and the blood banking industry were not supported; the concept of an "FDA seal" was viewed as a form of user fee and, in conjunction with other misgivings, this concept was likewise not supported.

Making new, safe, and effective treatments available to patients in a timely way is a high priority for FDA. In order to bring the premarket review and approval system to its optimal performance level, stakeholders recommended that FDA continue to strive for efficiencies, conserve resources, and limit new activities that may compete with or interfere with the Agency carrying out this obligation. Most stakeholders supported a role for third-party arrangements in these system. They did not support user fees or the FDA seal as means for funding premarket review responsibilities. In order to increase the beneficial impact of its product approvals for patients, it was recommended that the Agency coordinate with other Federal agencies to bridge policy inconsistencies [such as FDA's approval of products and HCFA reimbursement]. In addition, it was also recommended that the Agency should support more research by culturally-competent scientists to ensure that products can be used beneficially by minority consumers.

Public participation and collaboration were recurring themes in the stakeholder presentations. Collaboration with stakeholder organizations was viewed as an essential means for FDA meeting its statutory obligations, especially for making new products available to patients in a timely way. There was a general call for FDA to make its processes and procedures for public participation more effective, particularly those processes involving public meetings, advisory committees, and the Consumer Consortium. In this regard, concerned stakeholders emphasized that public participation processes should be open, transparent, and receptive to outside views; that better qualified and disease-specific consumer representatives should be involved on advisory committees; and that FDA should allocate sufficient resources and provide needed training to support its public participation commitment. The FDA Office of Special Health Initiatives and the Office of Women's Health were highlighted as having model approaches for promoting education and interactions with their respective constituents.

FDAPlan for Statutory Compliance

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