Update 3: The government columnist for Applied Clinical Trials, Jill Wechsler, writes about the increased enforcement of good clinical practice regulations for clinical trials. See the link in interesting articles, Applied Clinical Trials…
In her first discussion of her goals and priorities for FDA with the media, new FDA Commissioner Dr. Margaret Hamburg made it clear that she would place an increased emphasis on enforcement. When I conducted FDA inspections (1993-2005) we used to call this, “enforcing the Act.” We saw our primary job as enforcement of the US Food Drug & Cosmetic Act, which we modestly referred to as the “foremost consumer protection law in the world.” I am attaching a NY Times article (1: New FDA chief says she’ll toughen enforcement standards) that describes Hamburg’s new emphasis on enforcement activities (see Blogroll on the right). The Times also reports that FDA warns against using Zicam, a popular cold remedy that evidently can destroy your sense of smell (see NY Times website).
Update: Matrixx defends Zicam, read their views under Interesting Articles on the right (scroll down).
Update 2: Time seems to think that FDA is getting tougher. See: 2 Is FDA Getting Tougher on the blogroll
Update 3: Take a look at Dr. Hamburg’s speech to FDLI in the latest 2 posts. This post has been confirmed!