Food & Drug Bulletin

Dear Reader:

One of the fin de siecle controversies sure to last well into the next millennium is the degree to which companies, doctors, and the consumer will have access to truthful information about foods, drugs, dietary supplements, devices and cosmetics. FDA, of course, has appealed the court decision overturning its regulation of prescription drug off-label reprint dissemination and the decision that its regulation of dietary supplement health claims is overly restrictive under the First Amendment. FDA's position in these matters clearly supports continuing agency control of product information, whether to health professionals or the public. While it is clear that protecting the public from unsafe or misleading products is the major counter to free speech advocates, the situation is far more tangled. Companies and physicians on record as favoring freer access to off-label drug information have opposed similar access to information about dietary supplements and other self-help medication. If this were not enough, this controversy is taking place during the most far-reach-ing revolution in communication in human history, the easy links of the world-wide web which has blurred if not erased state and national boundaries. For this reason alone, the First Amendment and public health issues currently before the courts will not be quickly resolved. In the meantime, staying on top and ahead of the changing legal regulatory foundation is more important than ever and will remain so well into the next century. We hope to be a continuing partner in your success and happiness during the coming years and send you our warmest wishes for the new millennium.

Articles In This Issue

NIH Steps Up Efforts to Investigate Alternative Medicine

CDRH Increases Enforcement Efforts Against Clinical Investigation Sponsors and IRBs

Susan Alpert Leaves Devices for Top Food Safety Position

FDA Expresses Concern Over Patient Self Medication

FDA Delays UVB Requirements for Sunscreen Makers

European Commission Developments

Dr. Roger Williams Moves to USP

FDA Issues Interim Regulation on Informed Consent Waivers

FDA Updates Congress On Industry's Y2K Compliance

Click here to access/download the Food & Drug Bulletin (November 1999) in Adobe Acrobat (PDF) format.

If you do not have the free Acrobat reader, go to www.adobe.com.

For more information, please contact: