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U.S. Department of Health and Human Services

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Office of Health Affairs Stakeholders Meeting Summary September 8, 1998

Report on the Office of Health Affairs
Stakeholders Meeting
September 8, 1998



This meeting was part of FDA's consultation with its external stakeholders--"appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups and the regulated industry"--for development of a plan for how the agency can best meet its obligations. It was one of a series of meetings and was designed for input from health care professionals. Under the FDA Modernization Act (FDAMA), input from the meetings will be incorporated into a plan that is to be completed by November 21, 1998.

Meeting Structure

The meeting took place from 1:00-4:00 p.m. on Tuesday, September 8 at the Hyatt Regency Hotel in Bethesda, Maryland. Representatives of 53 health professional organizations attended.

Michael A. Friedman, MD, Acting Commissioner of Food and Drugs, made an opening presentation in which he explained the environment in which the agency's plan is being developed. He described the need for the agency to be able to handle increasing numbers of product applications and other activities. Linda Suydam, Associate Commissioner for Strategic Management, explained the process for developing the plan, emphasizing the importance of stakeholder comments for formulation of agency priorities. Sharon Smith Holston, Deputy Commissioner for External Affairs, summarized some of the themes from stakeholders thus far, indicating that the views of the health professionals at the meeting would be a valuable addition.

Speakers representing eight major broad-based health organizations, such as the American Medical Association, composed a panel on which each gave a 5-minute presentation. An FDA "reactor" panel of representatives from each of the five product-related FDA Centers asked questions as needed to clarify issues. The same procedure was used for a second panel consisting of six representatives of other organizations that had asked to make presentations.

Stuart Nightingale, MD, Associate Commissioner for Health Affairs, concluded the meeting by summarizing some of what FDA had heard and reminding attendees that written comments could be submitted to the agency's public docket up until the deadline of September 21.

Themes of Stakeholder Presentations

Among the numerous comments and suggestions from the presenters, the following ideas were frequently expressed:

  • Health professional organizations want to help FDA and have a number of ideas on how to do so.
  • Better communication is needed between the organizations and FDA. Among the suggestions were offers to provide speaking opportunities for FDA representatives at their annual meetings, and offers of "hotlinks" from the organizations' web pages to the FDA.
  • FDA's processes should be more transparent. Health professionals need a better understanding of how FDA balances the need to make innovative therapies available with the need to assure safety. The organizations would like more input into FDA processes.
  • There was much support for FDA's tobacco activities.
  • FDA should not lower its approval standards. International harmonization and related activities are supported, provided they do not lower standards.
  • The need for additional research to answer various scientific questions was cited with respect to pediatric, gender, and ethnic minority differences. Medication error analysis and design to prevent medication error are of particular interest.
  • Professional and public education are important activities for FDA. The agency should work with other agencies--CDC and HCFA were named--as well as health professional organizations and others, in order to be most effective. Food safety and medical product adverse event information are areas where more education is desirable.
  • Institutional Review Boards play a vital role in human subject protection and the agency should endeavor to work effectively with this community.


The agency is most appreciative of the input received from health professional organizations and other stakeholders. All of the comments, whether written or oral, will be studied by agency staff as the FDAMA implementation plan is prepared.

FDA Plan for Statutory Compliance