Attorneys have played a role in the FDA’s evolving approach to enforcement

Armand Rossetti
Armand Rossetti
Contributor
Posted by Armand RossettiAugust 07, 2009 9:45 AM

Today’s headlines are replete with news about the FDA’s recent commitment to stronger enforcement. I suspect that attorneys’ public comments over the years, concerning the FDA’s seeming lack of vigilance, strategy, timeliness, and visibility have reached the eyes and ears of someone who is going to act efficiently and effectively in the public interest.

I was quite pleased to learn that FDA Commissioner, Margaret Hamburg, MD, after only eight weeks on the job, has boldly advanced an agenda that if followed will give the current FDA a welcome “makeover.”

Some readers may remember Commissioner Hamburg’s appearance on Charlie Rose to discuss the Ebola virus. Dr. Hamburg is eminently qualified for her position. In fact, the US Senate gave Dr. Hamburg unanimous approval to become FDA Commissioner. For a more comprehensive idea of Dr. Hamburg's plans for the FDA, please view the webcast of Commissioner Hamburg’s address before the Food and Drug Law Institute (FDLI).

If Commissioner Hamburg can ensure improved consumer safety without undue delay, because of red tape laden road blocks, it will definitely be a consumers’ "dream come true."

1 Comment

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Carl Anderson
Posted by Carl Anderson
August 07, 2009 6:37 PM

I also support Dr. Hamburg's new stance on enforcement of FDA regulations. I have two concerns however. First, Dr. Hamburg cited cracking down on internet fraud regarding the H1N1 virus. She also cited cracking down on phony "nutritional supplements" that contain steroids.

Then Dr. Hamburg sidestepped (or didn't understand) a question regarding the lack of FDA regulations and guidance for advanced therapies and complex medical products. FDA's regulations are antiquated and need updating. There is a real lack of guidance for conducting clinical trials or for new combination products.

I would welcome review by you or your readers at my blog, Carl's Blog on FDA Stuff found at More ...

Thanks,

Carl-

Comments for this article are closed.

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