Dear Readers:
As most of you know, the White House has recently announced that it is nominating Dr. Jane Henney as the proposed FDA Commissioner. Most likely, Dr. Henney's confirmation hearing will not occur until after Congress' August recess.
What does a new Commissioner mean for FDA's activities in the near future? First and foremost, it means a period of transition. The agency's new Commissioner will have to delineate the agency's priorities. Many of us remember when Dr. Kessler became Commissioner, but few would have predicted that "fresh" orange juice labeling, breast implants and tobacco would be significant issues under his leadership. Similarly, a new Commissioner confirmed in 1998 will likely bring a number of new agenda items to the agency. Even without a new Commissioner, however, transition continues within the agency. The new Center for Food Safety & Applied Nutrition Director, Joe Levitt, held a two-day informal conference on what the Center's priorities should be while it attempts to respond to President Clinton's food safety initiative (FSI). Both the Center for Drugs and the Center for Devices continue to work to implement the Food and Drug Administration Modernization Act.
As everyone knows, the tobacco legislation did not pass, so the agency is faced with implementing tobacco regulations that are presently being challenged in the courts.
For those who work in the field, a period of transition is a difficult time because yesterday's policies may not be in place today. People who have held positions for years either have new opportunities or are replaced. For some, this time of transition will offer new opportunities. For others, it will mean that months of hard work will be re-examined and rejected in whole or in part. However, before we ruminate on transition for too long, we must remember that Dr. Henney must go through Senate confirmation, and one can expect that it will not be the same kind of confirmation as experienced by David Kessler. Dr. Henney will likely face questions on tobacco, RU-486, enforcement procedures, and the agency's dedication to certain programs and ideas. As has been true in the past, the confirmation of a new Commissioner will usher in a time of change, which means it will be an interesting time. We all you keep an eye on the confirmation hearing. Questions for insight into what this transition will mean to those of us who work in this regulatory environment.
As always, we welcome your questions and comments.
Sincerely,
Articles in this Issue:
HHS Office of Inspector General Recommends IRB Reform
FDA Proposes Regulations for the Dissemination of Information on Unapproved Uses
CFSAN Requests Assistance in Setting Priorities
FDA Issues Guidance on General/Specific Intended Use
FDA Implements Accredited Persons Program
FDA Amends Regulations on Medical Device Reporting
FDA Releases Final Rules Concerning Nutrient Content Claims
Product Liability Bill Stalls But Biomaterials Reform May Yet Pass
Click here to access/download the Food & Drug Bulletin (July 1998) in Adobe Acrobat (PDF) format.
If you do not have the free Acrobat reader, go to www.adobe.com.
For more information, please contact: