Minutes of a Meeting of the
Food & Drug Law Section Council of the
Minnesota State Bar Association
September 24, 2002

The meeting called to order at approximately 10:00 a.m. and was held by conference call. Present for the meeting were the following members of the Section Council: Greg Thompson (Chair), Anne Miller (Vice-Chair), Sonia Miller-Van Oort (Treasurer) and Renee Anderson, (MSBA staff). Mark Robbins (Secretary) was unable to attend due to a conflict.

1. Mission and Goals. The first order of business was a discussion of the Section's current mission statement. Following a discussion on the matter, it was agreed that the mission should be amended to reflect the Sections interest in product liability and other matters not currently listed in the mission statement. It was further agreed that the revised mission should be published in the Section Brochure and on the web site.

2. Membership. The Council next discussed the composition of the current Section membership and offered ideas regarding potential members for the Section. It was agreed that the Section Council members should, in their discretion, contact potential members that are likely to benefit from Section activities.

3. Programs. A range of topics and ideas for Section programs were discussed. It was agreed that the Section should continue to offer lunch programs as in the past, and that the topics should generally include food, drugs, medical devices, products liability and one session should include a speaker from the local FDA District Office. The following is a brief summary of ideas that were discussed on each topic.

a. Food. The Council discussed a variety of potential food topics including some recently recommended by a Section member. The topics included: recent developments in food labeling and advertising, health claims, structure/function claims, acrylamides, trans fatty acids, biotechnology, food security, allergens, adverse event reporting, Proposition 65, and other newsworthy topics. It was agreed that a speaker from a large food company or law firm should be considered for the food topic. Some specific suggestions were made on speakers and will be pursued.

b. Drugs. A number of drug topics were discussed including a recent suggestion by a Section member that we obtain an FDA speaker to discuss how FDA plans to work with OHRP in making rules for IRBs consistent so that institutions that do both NIH funded research and studies for data submitted to the FDA can follow one set of rules. Other suggestions included a presentation on biotech issues, and working together with other organizations to present joint CLEs.

c. Medical Devices. Potential device issues for presentations were also discussed, and it was noted that Section members from a device company have offered to develop a presentation on current issues for a meeting in the Spring of 2003.

d. Products Liability. Strong interest was also expressed in a holding products liability presentation, the details of which will be developed in the next few months.

e. FDA District Office. Finally, it was agreed that last year's presentation by Jim Rahto was a great success, and we should attempt to have a speaker from the local FDA District office again this year. Consideration was also given to seeking a speaker from the FDA headquarters in Washington, D.C.

4. Section Brochure. The Section brochure was discussed, and it will be revised in accordance with the suggestions made at the meeting.

5. Additional Issues. The Council discussed other miscellaneous issues, such as whether there is a need for a Section newsletter or a legislative coordinator. It was agreed that there was no need for such at the present time. Finally, it was discussed and agreed that the Section web site should be updated to include the information in the revised Section brochure.

There being no further business to come before the Section, the meeting was adjourned at approximately 10:45 a.m.

- Last Updated 1/5/04 -