New FDA Commissioner wants to “enforce the Act.”


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!

Read the NY Times Article:

http://www.nytimes.com/2009/06/17/us/17fda.html?_r=1

2 Responses to New FDA Commissioner wants to “enforce the Act.”

  1. Scott Mace says:

    The Time article link is broken, and I couldn’t find the article at time.com. Maybe it made it to the print edition.

    • Carl's Blog on FDA Stuff says:

      I have inserted the link to the New York Times article into the post. It wasn’t at Time Magazine. I have learned a little more about posting links since this was written. Newer posts have the links inside the post.

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