The 1997 FDAMA mandates the FDA (information from the Federal Register available at: http://www.fda.gov/ohrms/dockets/98fr/032299e.txt ) „To consult with its external stakeholders as it moves forward to modernize the agency; to develop a plan, based on input from stakeholders, for complying with the agency¼s obligations under the Federal Food, Drug, and Cosmetic Act (the act); and to periodically revisit the plan in consultation with stakeholders to make appropriate adjustments. As a culmination of these requirements, FDA will issue a performance report to Congress at the end of the 1999 calendar year.¾

The agency¼s response to this mandate is:
A. Consult With External Stakeholders (Stakeholders are CONSUMERS, INDUSTRY, MEDICAL PROFESSIONALS, etc. In other words anyone that has an interest in the outcome.)
B. Develop a Plan That Reflects Stakeholders Views
C. Periodically Revisit the Plan in Consultation with Stakeholders

The FDA is now working on this. The FDA specifically wants input on how to:
(1) Strengthen its science base and (2) improve its communication processes. FDA requests that stakeholders address the five questions below in their oral and/or written views:

1. What actions do you propose the agency take to expand FDA¼s capability to incorporate state-of-the-art science into its risk-based decision-making?

2. 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 product¼s lifecycle?

3. What actions do you propose for educating the public about the concept of balancing risks against benefits in public health decision-making?

4. 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. What additional actions do you propose for enhancing communication processes that allow for ongoing feedback and/or evaluation of our modernization efforts?

RE: Docket Number: 99N-0386
Submit written comments to:
Dockets Management Branch(HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061
Rockville, MD 20852

E-mail: <FDADockets@bangate.fda.gov>

Online Web site: http://www.fda.gov/scripts/oc/fdama/comments.cfm

Comments that have been submitted can be viewed online: http://www.fda.gov/ohrms/dockets/dockets/99n0386/99n0386.htm

The FDA held a Web and teleconferenced meeting, as well as regional meetings on the 28th of April. Transcripts, videos, and Webcast of the teleconferenced meeting are available. http://www.fda.gov/oc/fdama/fdamawebcast/default.htm

Transcripts of the regional meetings are also available. „Transcripts of the meetings (from each site listed in section III f this document) may be requested in writing from the Freedom of Information Office approximately 15 working days after the meeting at a cost of 10 cents per page. Write to:
Freedom of Information Office (HFI-35),
Food and Drug Administration
5600 Fishers Lane, rm. 12A-16
Rockville MD 20857

The transcript of the meeting will be available for public examination at the Dockets Management Branch (address above) between 9 a.m. and 4 p.m., Monday through Friday, as well as on the FDA web site http://www.fda.gov

To provide you with an example: Question #5. What additional actions do you propose for enhancing communication processes that allow for ongoing feedback and/or evaluation of our modernization efforts?

MY RESPONSE:
The Internet has provided a unique means of communicating with the public. Making information readily available in a timely manner via the Internet is an important way of diseminating information. In addition, accepting comments through online formats will facilitate communication between citizens and the FDA.

Programs that moniter adverse reactions need to be set up so complaints can be filed online. This has benefits for both the FDA and stakeholders. It provides a quick convenient method of submitting information. Comments can be viewed online. Also electronic submission decreases paperwork, makes compiling the information easier, and can help more effectively utilize the FDA's limited resources. Information can be used to more quickly pinpoint problems that may be occuring.

-- Betty Bridges bcb56@ix.netcom.com

I attended the FDA Teleconference on Wednesday, April 28, at the local FDA office. The telecast was two hours and featured moderator, Mark Barnett, Jane Henney, Commissioner of Food and Drugs, and Linda Suydam, Associate Commissioner for Strategic Management, and a panel of FDA experts.

Dr. Henney seemed remarkably informed and articulate. She spoke of the need for "good science" and repeatedly mentioned the balance of risk and benefits regarding products. Questions were taken from the small studio audience as well as faxed-in questions from the other FDA locations.

ABSOLUTELY NOTHING WAS MENTIONED REGARDING COSMETICS, FRAGRANCED PRODUCTS or other related consumer goods, as if the Federal Food, Drug and Cosmetic Act concerned only drugs, foods, and the blood supply.

I submitted a comment/question, which I attempted to fit into the "proper format" regarding one of the 6 questions from the March 22, 1999 Federal Register notice we were asked to address. The moderator said at some point that they were only addressing questions which fit the format. Question No. 3 from that notice reads: "What actions do you propose for educating the public about the concept of balancing risks against benefits in public health decision-making?"

I wrote: "Inhalation of fragranced products is known to trigger asthma and migraine headaches in some individuals. The EPA names 'the use of chemically formulated personal care products' along with pesticides and household cleaners as contributors to indoor air pollution. How do you propose to raise public awareness of possible health risks from use of these products?"

The folks in the local FDA office graciously allowed me to use a separate conference room to view the teleconference. However, the building air quality was bad and there were air fresheners in the bathroom and I did not stay for the two hour local question and answer period.

The FDA is accepting comments regarding Docket Number 99N-0386 until May 14, 1999. Please email FDADockets@bangate.fda.gov.

-- Peggy L. Davis, Atlanta, GA pdavis@alston.com