Food & Drug Bulletin

Dear Reader:

As I write this, the Year 2000 lurks less than 215 days away. Are you ready? Well, FDA wants to find out. In late April, it sent a survey to all drug makers seeking information on how they were validating and verifying their various computer systems to be "Y2K" compliant. A similar survey is planned of medical devices companies. And, in a move that drew much less attention, the agency quietly released a new compliance policy guide on Y2K compliance.

McKenna's Food & Drug Law Department, working with the firm's Year 2000 legal experts, has identified many pitfalls both in the questions in the April drug industry Y2K survey and the new compliance guide. While many of you are carefully preparing for the next millennium, we urge you to approach with caution the legal and regulatory issues presented by the Year 2000. Traps lie for the unwary and some of those dangers, such as those that might be caused by third parties not fully prepared for Y2K, lie beyond your control, but could adversely impact your operations. In a transition of another type, this spring brought a new senior leader to FDA with the May 4 naming of David Feigal, MD, to head CDRH. We will be watching closing to see if Feigal, whose agency roots are in the Drugs and Biologics Centers, continues the trend seen by some towards the "pharmatization" of device regulation.

As always, if you have any specific questions or comments about these developments or the other articles in this Food & Drug Bulletin, we welcome your calls.

Best regards,

Michael A. Swit

Articles In This Issue

FDA Issues Final Rule On Over-The-Counter Human Drugs Labeling Requirements

Inspector General Issues Reports On FDA Warning Letters

U.S. District Court For The District Of Utah Overturns FDA's Decision Concerning Cholestin Regulatory Status

Federal District Court Rules In Pediatric Exclusivity Lawsuit

EU Will Adopt New Rules On GMOS

FDA and Washington Legal Foundation Trade Briefs in Off-Label Dissemination Case

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