FDA, CDC face obstacles in H1N1 fight

October 24, 2009

In Saturday’s NY Times an article discusses the “Shortages, Confusion and Rumors in Flu Fight” (NY Times, page A11, 24OCT09). The Food and Drug Administration and the Centers for Disease Control (CDC) are at the center of fighting the flu outbreak. Despite the difficulties they have been keeping a cool head and doing a good job, which is just what you need during a crisis. As always, there are some who would try to take advantage to make a quick buck from fears about H1N1. This isn’t helped when political “commentators” like Glenn Beck say they want someone with H1N1 to cough in their face so they can do the opposite of what the government recommends. Hogwash. The health professionals at CDC have a webpage with what you should know about H1N1. Listen to CDC, not Glenn Beck and the liberal comic Bill Maher (comedians shouldn’t give out advice during an influenza pandemic). There is a link on the Blogroll, scroll down, under “CDC H1N1 webpage.”

In the mean time, cough into your elbow and wash your hands. When you hear a comic or “commentator” babble about H1N1, change the channel. H1N1 is a very real crisis. We need to take it seriously.

FDA discusses product recalls on new website feature

October 14, 2009

FDA has started a major campaign to explain product recalls to the public. In an extensive article and video called, “FDA 101: Product Recalls – From First Alert to Effectiveness Checks,” FDA explains the process in clear language for the general public. Go to http://www.fda.gov to view for yourself.

FDA recallsWhile FDA discusses that most recalls are voluntary, what isn’t discussed is the fact that FDA currently has limited enforcement authority regarding recalls of hazardous products that FDA regulates. Congress has pending legislation to give FDA increased recall authority, including mandatory recalls for dangerous food products. FDA Commissioner Margaret Hamburg discussed this during her speech to the Regulatory Affairs Professionals Society in Philadelphia (see previous post).

During the time that I worked as an FDA field investigator I would sometimes perform “recall audit checks.” I would go to a hospital, health product distributor, or pharmacy to find out if they had received a recall notice from the manufacturer of the recalled product. Sometimes they had taken prompt action to remove the product from their shelves. Sometimes they would just shrug their shoulders and say they didn’t remember or that they threw away such notifications. There is little FDA can do in that situation because the system is basically voluntary except for the most serious situations. For many, if not most recalls, a voluntary recall system is OK. They are not serious enough to utilize significant agency resources. However, when there are serious public health risks FDA needs the authority to take action.

Hopefully Congress will tmove forward soon with legislation to give FDA the authority it needs to enforce product recalls of significant public health concern.


FDA Orders Postmarket Surveillance Studies on Certain Spinal Systems

October 6, 2009

FDA Spinal Device

FDA Wants Continued Studies of Spinal Systems

FDA is requiring postmarket surveillance studies for the manufacturers of 16 dynamic stabilization systems that are implanted during spinal surgery. The agency continues to indicate that it is taking public health in a serious manner these days. FDA is doing so under Section 522 of the Food Drug and Cosmetic Act. This allows FDA to:

require a manufacturer to conduct postmarket surveillance for any device of the manufacturer which is a class II or class III device the failure of which would be reasonably likely to have serious adverse health consequences or which is intended to be-
(1) implanted in the human body for more than one year, or
(2) a life sustaining or life supporting device used outside a device user facility.

Why is this a big deal? Because currently there are only five active postmarket studies being conducted because of Section 522 and only three of them are for a “510(k)” approval that does not require extensive clinical studies of devices that require a “Pre-Market Approval” or PMA. Not only that, there are currently no 510(k) devices that have been implanted for more than a year.

It seems that postmarket surveillance is going to increase under Commissioner Margaret Hamburg and her principal deputy, Joshua Sharfstein. I certainly would want to know what is going to happen with a medical device implanted in me for a year. I think that most of us would agree that more postmarket surveillance with drugs as well as medical devices is called for.


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FDA Continues Transparency Effort

October 3, 2009

The FDA “Transparency Task Force” (what a name) will hold a public meeting announcing: “FDA Transparency Task Force to Hold 2nd Public Meeting on Ensuring That Agency Information is Useful, Understandable, Accessible.” For more information on the November 3rd meeting go to the FDA website at http://www.fda.gov. FDA says the topics for the meeting are:

1. Early communication about emerging safety issues concerning FDA-regulated products

2. Disclosure of information about product applications that are abandoned, i.e., no work is being done or will be undertaken to have the application approved, or withdrawn by the applicant before approval

3. Communication of agency decisions about pending product applications.

Unfortunately, the organizations that know how to mobilize articulate representatives for public FDA meetings like this are not always the organizations with FDA’s best interests at heart. FDA is a large, complex organization and it can be a little intimidating to think about speaking in public about any specific concerns. Also, some of us don’t live within driving distance of Washington, DC (its on the wrong coast). FDA has set up a “Transparency Blog” where it might be easier to make a contribution. FDA is actually doing a lot of listening these days so please, speak your mind, you just might have something useful and understandable to say.

Link to the FDA Transparency Blog: on Blogroll under FDA Transparency Blog

UPDATE: The FDA issued a press release on 12 March 2010 that said in part:

“As part of the final phase of its transparency initiative, the U.S. Food and Drug Administration is seeking comment from the public and other interested stakeholders on how the agency can increase transparency in its interactions with regulated industry.”

It continues:

“For this final phase, the FDA is particularly interested in comments from all interested parties on how the agency can make improvements in the following areas:

~ Training and education for regulated industry about the FDA regulatory process in general and/or about specific new requirements

~ The guidance development process

~ Maintaining open channels of communication with industry routinely and during crises

~ Providing useful and timely answers to industry questions about specific regulatory issues

Electronic comments may be submitted to:


Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md., 20852. All comments should be identified with docket number FDA–2009–N–0247.”

Posted in the March 12, 2010, Federal Register, the request for electronic or written comments has a deadline of April 12, 2010.”

Read the FDA Press Release:



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