Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

T98-82                        Print Media: 301-827-6242
November 23, 1998             
                              Consumer Media: 800-888-Info FDA


As the first year anniversary of the enactment of the Food and Drug Modernization Act of 1997 (FDAMA) approaches, FDA has met nearly all of the deadlines for implementing the many varied provisions of the law. In many cases the agency was able to complete these important initiatives well ahead of schedule.

FDAMA is a wide-ranging piece of legislation affecting the work of each the agency's key components. The law explicitly required FDA to complete 17 regulations, 11 guidance documents, 6 regulatory notices, 9 reports and at least 18 other tasks. In addition, scores of other regulatory measures were deemed necessary by the agency in order to effectively meet the law's objectives.

To date the agency has issued 16 final rules, 9 proposed rules, 36 guidance documents, 11 regulatory notices and 1 report.

Initiatives that have been completed during FDAMA's implementation include:

-- A final rule establishing parameters for distributing sound and balanced information about "off-label uses" for marketed drugs, biologics and medical devices. The new rule requires that the dissemination of off-label information by a sponsor be tied to a commitment to adequately research this use and submit it to the agency for approval.

-- A guidance on FDA's fast track programs, which are designed to facilitate the development and evaluation of new drugs and biologics and designed to treat serious and life-threatening illnesses. The guidance provides product sponsors and researchers with vital information on how to maximize their product development efforts.

-- An agency plan for statutory compliance with FDAMA developed through a series of "stakeholder" meetings conducted throughout the United States. During these meetings, agency officials reached out to the general public and to those segments of society most directly affected by FDA work to solicit their views on how the agency can best meet its public health mission. Representatives from consumer groups, industry, health professional organizations, academia and other groups participated in these forums, which provided the agency with valuable insights, that will be used in its future policy and budgetary considerations.

There are many other important aspects of the law which have been implemented or are well on their way to being implemented. FDA is continuing its efforts to attain all of the FDAMA objectives as quickly as possible.

For further information on FDA's FDAMA-related activities one can visit FDA's FDAMA website at www.fda.gov/opacom/7modact.html. This site provides an updated, comprehensive listing of all of the agency's FDAMA implementation activities as well as their current status.